gamma-aminobutyric acid has been researched along with Sleep Initiation and Maintenance Disorders in 91 studies
gamma-Aminobutyric Acid: The most common inhibitory neurotransmitter in the central nervous system.
gamma-aminobutyric acid : A gamma-amino acid that is butanoic acid with the amino substituent located at C-4.
Sleep Initiation and Maintenance Disorders: Disorders characterized by impairment of the ability to initiate or maintain sleep. This may occur as a primary disorder or in association with another medical or psychiatric condition.
Excerpt | Relevance | Reference |
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"Safety and efficacy of a once daily controlled-released (CR) formulation of pregabalin was evaluated in patients with fibromyalgia using a placebo-controlled, randomized withdrawal design." | 9.19 | Once daily controlled-release pregabalin in the treatment of patients with fibromyalgia: a phase III, double-blind, randomized withdrawal, placebo-controlled study. ( Arnold, LM; Arsenault, P; Chew, ML; Clair, AG; Huffman, C; Messig, M; Patrick, JL; Pauer, L; Sanin, L; Scavone, JM, 2014) |
"Time to LTR was significantly longer with pregabalin CR versus placebo in fibromyalgia patients who initially showed improvement with pregabalin CR, indicating maintenance of response." | 9.19 | Once daily controlled-release pregabalin in the treatment of patients with fibromyalgia: a phase III, double-blind, randomized withdrawal, placebo-controlled study. ( Arnold, LM; Arsenault, P; Chew, ML; Clair, AG; Huffman, C; Messig, M; Patrick, JL; Pauer, L; Sanin, L; Scavone, JM, 2014) |
"To evaluate the efficacy and safety of pregabalin in the treatment of postherpetic neuralgia (PHN)." | 9.10 | Pregabalin for the treatment of postherpetic neuralgia: a randomized, placebo-controlled trial. ( Bockbrader, H; Corbin, AE; Dworkin, RH; Garofalo, EA; LaMoreaux, L; Poole, RM; Sharma, U; Young, JP, 2003) |
"The efficacy of a new drug, pivagabine (4-[(2,2-dimethyl-1-oxopropyl)amino]butanoic acid, CAS 69542-93-4, Tonerg), was studied on 100 patients affected by insomnia, associated with mood disorders." | 9.08 | Evaluation of the efficacy of pivagabine on insomnia associated with mood disorders. ( Negri, L, 1997) |
" Gabapentin and pregabalin, a very similar drug with the same mechanism of action, bind to a subunit of voltage-dependent calcium channels which are implicated in the aetiopathogenesis of bipolar disorder, anxiety and insomnia." | 8.95 | Biological rationale and potential clinical use of gabapentin and pregabalin in bipolar disorder, insomnia and anxiety: protocol for a systematic review and meta-analysis. ( Atkinson, LZ; Awad, A; Cipriani, A; Forrest, A; Geddes, JR; Harrison, PJ; Houghton, KT; Stockton, S, 2017) |
"We will include all randomised controlled trials (RCTs) reported as double-blind and comparing gabapentin or pregabalin with placebo or any other active pharmacological treatment (any preparation, dose, frequency, route of delivery or setting) in patients with bipolar disorder, anxiety or insomnia." | 8.95 | Biological rationale and potential clinical use of gabapentin and pregabalin in bipolar disorder, insomnia and anxiety: protocol for a systematic review and meta-analysis. ( Atkinson, LZ; Awad, A; Cipriani, A; Forrest, A; Geddes, JR; Harrison, PJ; Houghton, KT; Stockton, S, 2017) |
"We studied the effects of low-dose ozone therapy on the sleep quality of patients with coronary heart disease (CHD) and insomnia by measuring the levels of brain-derived neurotrophic factor (BDNF) and GABA in blood serum." | 8.02 | Low-Dose Ozone Therapy Improves Sleep Quality in Patients with Insomnia and Coronary Heart Disease by Elevating Serum BDNF and GABA. ( Feng, X; Huang, H; Li, Y; Ren, H; Wang, Y; Yu, S, 2021) |
"Forty chronic insomnia participants were randomized to either real or sham rTMS group." | 7.11 | Alteration of gamma-aminobutyric acid in the left dorsolateral prefrontal cortex of individuals with chronic insomnia: a combined transcranial magnetic stimulation-magnetic resonance spectroscopy study. ( Huang, X; Liang, K; Wang, C; Zhang, H, 2022) |
" Given the maximal dosage studied, pregabalin had acceptable tolerability compared to placebo despite a greater incidence of side effects, which were generally mild to moderate in intensity." | 6.71 | Pregabalin for the treatment of postherpetic neuralgia: a randomized, placebo-controlled trial. ( Bockbrader, H; Corbin, AE; Dworkin, RH; Garofalo, EA; LaMoreaux, L; Poole, RM; Sharma, U; Young, JP, 2003) |
"Gabapentin has been extensively prescribed off-label for psychiatric indications, with little established evidence of efficacy." | 6.55 | Biological rationale and potential clinical use of gabapentin and pregabalin in bipolar disorder, insomnia and anxiety: protocol for a systematic review and meta-analysis. ( Atkinson, LZ; Awad, A; Cipriani, A; Forrest, A; Geddes, JR; Harrison, PJ; Houghton, KT; Stockton, S, 2017) |
"Time to LTR was significantly longer with pregabalin CR versus placebo in fibromyalgia patients who initially showed improvement with pregabalin CR, indicating maintenance of response." | 5.19 | Once daily controlled-release pregabalin in the treatment of patients with fibromyalgia: a phase III, double-blind, randomized withdrawal, placebo-controlled study. ( Arnold, LM; Arsenault, P; Chew, ML; Clair, AG; Huffman, C; Messig, M; Patrick, JL; Pauer, L; Sanin, L; Scavone, JM, 2014) |
"Safety and efficacy of a once daily controlled-released (CR) formulation of pregabalin was evaluated in patients with fibromyalgia using a placebo-controlled, randomized withdrawal design." | 5.19 | Once daily controlled-release pregabalin in the treatment of patients with fibromyalgia: a phase III, double-blind, randomized withdrawal, placebo-controlled study. ( Arnold, LM; Arsenault, P; Chew, ML; Clair, AG; Huffman, C; Messig, M; Patrick, JL; Pauer, L; Sanin, L; Scavone, JM, 2014) |
"Pregabalin 150 to 600 mg/day was effective in relieving central neuropathic pain, improving sleep, anxiety, and overall patient status in patients with spinal cord injury." | 5.12 | Pregabalin in central neuropathic pain associated with spinal cord injury: a placebo-controlled trial. ( Chambers, R; Cousins, MJ; Griesing, T; Murphy, TK; Otte, A; Siddall, PJ, 2006) |
"To evaluate the efficacy and safety of pregabalin in the treatment of postherpetic neuralgia (PHN)." | 5.10 | Pregabalin for the treatment of postherpetic neuralgia: a randomized, placebo-controlled trial. ( Bockbrader, H; Corbin, AE; Dworkin, RH; Garofalo, EA; LaMoreaux, L; Poole, RM; Sharma, U; Young, JP, 2003) |
"The efficacy of a new drug, pivagabine (4-[(2,2-dimethyl-1-oxopropyl)amino]butanoic acid, CAS 69542-93-4, Tonerg), was studied on 100 patients affected by insomnia, associated with mood disorders." | 5.08 | Evaluation of the efficacy of pivagabine on insomnia associated with mood disorders. ( Negri, L, 1997) |
"We will include all randomised controlled trials (RCTs) reported as double-blind and comparing gabapentin or pregabalin with placebo or any other active pharmacological treatment (any preparation, dose, frequency, route of delivery or setting) in patients with bipolar disorder, anxiety or insomnia." | 4.95 | Biological rationale and potential clinical use of gabapentin and pregabalin in bipolar disorder, insomnia and anxiety: protocol for a systematic review and meta-analysis. ( Atkinson, LZ; Awad, A; Cipriani, A; Forrest, A; Geddes, JR; Harrison, PJ; Houghton, KT; Stockton, S, 2017) |
" Gabapentin and pregabalin, a very similar drug with the same mechanism of action, bind to a subunit of voltage-dependent calcium channels which are implicated in the aetiopathogenesis of bipolar disorder, anxiety and insomnia." | 4.95 | Biological rationale and potential clinical use of gabapentin and pregabalin in bipolar disorder, insomnia and anxiety: protocol for a systematic review and meta-analysis. ( Atkinson, LZ; Awad, A; Cipriani, A; Forrest, A; Geddes, JR; Harrison, PJ; Houghton, KT; Stockton, S, 2017) |
"We studied the effects of low-dose ozone therapy on the sleep quality of patients with coronary heart disease (CHD) and insomnia by measuring the levels of brain-derived neurotrophic factor (BDNF) and GABA in blood serum." | 4.02 | Low-Dose Ozone Therapy Improves Sleep Quality in Patients with Insomnia and Coronary Heart Disease by Elevating Serum BDNF and GABA. ( Feng, X; Huang, H; Li, Y; Ren, H; Wang, Y; Yu, S, 2021) |
"Considerable evidence implicates the neurotransmitter gamma-aminobutyric acid (GABA) in the biochemical pathophysiology of mood disorders." | 3.70 | GABAA alpha-1 subunit gene not associated with depressive symptomatology in mood disorders. ( Catalano, M; Cusin, C; Di Bella, D; Lattuada, E; Lilli, R; Macciardi, F; Serretti, A; Smeraldi, E, 1998) |
"After 21-day sleep deprivation (SD) in platform water environment, CSD mice model was prepared." | 3.54 | Effects of BXSMD on ESR1 and ESR2 expression in CSD female mice. ( Liang, S; Liu, L; Liu, X; Wang, S; Yang, J; Zhang, Y, 2024) |
"Forty chronic insomnia participants were randomized to either real or sham rTMS group." | 3.11 | Alteration of gamma-aminobutyric acid in the left dorsolateral prefrontal cortex of individuals with chronic insomnia: a combined transcranial magnetic stimulation-magnetic resonance spectroscopy study. ( Huang, X; Liang, K; Wang, C; Zhang, H, 2022) |
"Both AB+AA and AA can relieve insomnia symptoms, but a stronger long-term effect were observed for AB+AA." | 3.11 | Effect of Auricular Acupoint Bloodletting plus Auricular Acupressure on Sleep Quality and Neuroendocrine Level in College Students with Primary Insomnia: A Randomized Controlled Trial. ( Chen, H; Huo, YX; Liu, DN; She, YF; Shi, XL; Sun, H; Wu, JA; Yuan, XR; Zhang, MJ, 2022) |
"One hundred and thirty patients with insomnia were randomized into an observation group and a control group, 65 cases in each one." | 2.79 | [Clinical observation on the neurotransmitters regulation in patients of insomnia differentiated as yang deficiency pattern treated with warm acupuncture and auricular point sticking therapy]. ( Du, L; Liu, XC; Yang, JL; Yang, YS; Zhang, R, 2014) |
"Individuals with major depressive disorder (MDD) often use hypnotics like zolpidem (Ambien(®)) to improve sleep in addition to their selective serotonin reuptake inhibitor (SSRI) regimen." | 2.79 | Zolpidem increases GABA in depressed volunteers maintained on SSRIs. ( Conn, NA; Jensen, JE; Licata, SC; Lukas, SE; Winer, JP, 2014) |
"Aside from treating insomnia, using zolpidem in the presence of SSRIs may have some unidentified therapeutic effects for depressed individuals." | 2.79 | Zolpidem increases GABA in depressed volunteers maintained on SSRIs. ( Conn, NA; Jensen, JE; Licata, SC; Lukas, SE; Winer, JP, 2014) |
"Gabapentin was associated with significantly higher values of KSD Sleep Quality Index and reported TST versus placebo; no other reported outcomes were significant." | 2.79 | A randomized, double-blind, single-dose, placebo-controlled, multicenter, polysomnographic study of gabapentin in transient insomnia induced by sleep phase advance. ( Furey, SA; Hull, SG; Jayawardena, S; Lankford, DA; Mayleben, DW; Rosenberg, RP; Roth, T; Seiden, DJ, 2014) |
" The starting dosage of pregabalin was 75 mg/day and was increased up to as much as 300 mg/day, depending on the individual patient's condition, while tapering off hypnotics." | 2.79 | Effects of pregabalin in patients with hypnotic-dependent insomnia. ( Cho, YW; Song, ML, 2014) |
"Gabapentin was associated with less %stage1 on Day 1, and greater %REM on Day 28, versus placebo." | 2.79 | A randomized, double-blind, placebo-controlled, multicenter, 28-day, polysomnographic study of gabapentin in transient insomnia induced by sleep phase advance. ( Furey, SA; Hull, SG; Jayawardena, S; Leibowitz, MT; Roth, T, 2014) |
" Using plasma gabapentin concentration data obtained after administration of GEn in 12 phase 1 to 3 GEn studies in healthy adults or patients with RLS (dose range, 300-2400 mg/d), a population pharmacokinetic (PK) model was developed by nonlinear mixed-effect modeling using NONMEM." | 2.78 | Population pharmacokinetics and pharmacodynamics of gabapentin after administration of gabapentin enacarbil. ( Cundy, KC; Lal, R; Lassauzet, ML; Luo, W; Sukbuntherng, J; Tovera, J, 2013) |
"Insomnia is a common phenomenon particularly in patients with epilepsy." | 2.77 | Pregabalin increases slow-wave sleep and may improve attention in patients with partial epilepsy and insomnia. ( Bazil, CW; Cole, J; Dave, J; Drake, E; Stalvey, J, 2012) |
"A 'high-insomnia' subgroup was defined by a baseline HAM for Depression (HAM-D) insomnia factor score greater than 3 (maximum = 6)." | 2.74 | The efficacy of pregabalin and benzodiazepines in generalized anxiety disorder presenting with high levels of insomnia. ( Herman, BK; Mandel, FS; Montgomery, SA; Schweizer, E, 2009) |
"To evaluate pregabalin in central neuropathic pain associated with spinal cord injury." | 2.72 | Pregabalin in central neuropathic pain associated with spinal cord injury: a placebo-controlled trial. ( Chambers, R; Cousins, MJ; Griesing, T; Murphy, TK; Otte, A; Siddall, PJ, 2006) |
"Dizziness was the most common side effect." | 2.71 | Relief of painful diabetic peripheral neuropathy with pregabalin: a randomized, placebo-controlled trial. ( Bockbrader, H; Knapp, LE; Lamoreaux, L; Portenoy, R; Richter, RW; Sharma, U, 2005) |
"Two hundred forty-six men and women with painful diabetic neuropathy received pregabalin (150 or 600 mg/day by mouth) or placebo." | 2.71 | Relief of painful diabetic peripheral neuropathy with pregabalin: a randomized, placebo-controlled trial. ( Bockbrader, H; Knapp, LE; Lamoreaux, L; Portenoy, R; Richter, RW; Sharma, U, 2005) |
" Given the maximal dosage studied, pregabalin had acceptable tolerability compared to placebo despite a greater incidence of side effects, which were generally mild to moderate in intensity." | 2.71 | Pregabalin for the treatment of postherpetic neuralgia: a randomized, placebo-controlled trial. ( Bockbrader, H; Corbin, AE; Dworkin, RH; Garofalo, EA; LaMoreaux, L; Poole, RM; Sharma, U; Young, JP, 2003) |
"Gabapentin is a calcium channel GABAergic modulator that is widely used for pain." | 2.58 | Gabapentin for the treatment of alcohol use disorder. ( Mason, BJ; Quello, S; Shadan, F, 2018) |
"Expert opinion: Alcohol use disorder represents a challenge and large, unmet medical need." | 2.58 | Gabapentin for the treatment of alcohol use disorder. ( Mason, BJ; Quello, S; Shadan, F, 2018) |
"Behavioral therapies for insomnia include the following: sleep hygiene, cognitive behavioral therapy for insomnia, multicomponent behavioral therapy or brief behavioral therapy for insomnia, relaxation strategies, stimulus control, and sleep restriction." | 2.55 | An update of management of insomnia in patients with chronic orofacial pain. ( Almoznino, G; Benoliel, R; Haviv, Y; Sharav, Y, 2017) |
"Gabapentin has been extensively prescribed off-label for psychiatric indications, with little established evidence of efficacy." | 2.55 | Biological rationale and potential clinical use of gabapentin and pregabalin in bipolar disorder, insomnia and anxiety: protocol for a systematic review and meta-analysis. ( Atkinson, LZ; Awad, A; Cipriani, A; Forrest, A; Geddes, JR; Harrison, PJ; Houghton, KT; Stockton, S, 2017) |
"Chronic orofacial pain can greatly improve following treatment of the underlying insomnia, and therefore, re-evaluation of COFP is advised after 1 month of treatment." | 2.55 | An update of management of insomnia in patients with chronic orofacial pain. ( Almoznino, G; Benoliel, R; Haviv, Y; Sharav, Y, 2017) |
"Sleep disorders are treated using anti-insomnia drugs that target ionotropic and G protein-coupled receptors (GPCRs), including γ-aminobutyric acid (GABA) agonists, melatonin agonists, and orexin receptor antagonists." | 2.53 | Sleep Control, GPCRs, and Glucose Metabolism. ( Sakurai, T; Sasaoka, T; Tsuneki, H, 2016) |
"The consequences of insomnia, including issues with mood, behavior, and cognition, are discussed." | 2.53 | Pediatric Insomnia. ( Brown, KM; Malow, BA, 2016) |
"Chronic insomnia is a common condition that affects people worldwide and has negative effects on patients' health and wellbeing." | 2.53 | Advances in the management of chronic insomnia. ( Attarian, H; Kay-Stacey, M, 2016) |
"Therefore, insomnia and alcohol dependence might be best thought of as co-occurring disorders, each of which requires its own treatment." | 2.52 | Assessment and treatment of insomnia in adult patients with alcohol use disorders. ( Brower, KJ, 2015) |
"Insomnia in patients with alcohol dependence has increasingly become a target of treatment due to its prevalence, persistence, and associations with relapse and suicidal thoughts, as well as randomized controlled studies demonstrating efficacy with behavior therapies and non-addictive medications." | 2.52 | Assessment and treatment of insomnia in adult patients with alcohol use disorders. ( Brower, KJ, 2015) |
"Neuroimaging studies in primary insomnia remain relatively few, considering the important prevalence of this disorder in the general population." | 2.50 | Neuroimaging findings in primary insomnia. ( Berman Rosa, M; Dang-Vu, TT; Gouin, JP; O'Byrne, JN, 2014) |
"This review aims to analyze pharmacokinetic profile, plasma level variations so as the metabolism, interactions and possible relation to clinical effect of several drugs which are used primarily as anxiolytics." | 2.49 | Understanding the pharmacokinetics of anxiolytic drugs. ( Altamura, AC; Bareggi, S; Maffini, M; Mauri, MC; Moliterno, D; Paletta, S, 2013) |
"There is a need for a more balanced assessment of the benefits and risks associated with benzodiazepine use, particularly considering pharmacokinetic profile of the drugs to ensure that patients, who would truly benefit from these agents, are not denied appropriate treatment." | 2.49 | Understanding the pharmacokinetics of anxiolytic drugs. ( Altamura, AC; Bareggi, S; Maffini, M; Mauri, MC; Moliterno, D; Paletta, S, 2013) |
"Suvorexant is a dual orexin antagonist currently in Phase III clinical trials for the modulation of sleep and is being developed by Merck." | 2.48 | ACS chemical neuroscience molecule spotlight on Suvorexant. ( Hopkins, CR, 2012) |
"Therefore, exploring the anti-insomnia effects of volatile oils from HAD is of great importance." | 2.44 | Effects of aqueous extracts and volatile oils prepared from Huaxiang Anshen decoction on p-chlorophenylalanine-induced insomnia mice. ( Chen, D; He, C; Li, X; Pu, Y; Shen, M; Wang, M; Zhang, T; Zhou, J, 2024) |
"It is hard to define what ratio of insomnia and daytime hypersomnia is caused by the antiparkinsonian treatment, by the somatic and mental-emotional symptoms of the neurodegenerative disease and by the neurodegenerative brain process itself." | 2.44 | [Sleep disorders in Parkinson syndromes]. ( Kovács, GG; Lalit, N; Péter, H; Szucs, A, 2007) |
"Sleep-onset and maintenance insomnia is a characteristic feature of schizophrenic patients regardless of either their medication status (drug-naive or previously treated) or the phase of the clinical course (acute or chronic)." | 2.43 | Sleep disturbance in schizophrenia. ( Monti, D; Monti, JM, 2005) |
"Chronic insomnia affects a significant proportion of young adult and elderly populations." | 2.43 | Treating insomnia: Current and investigational pharmacological approaches. ( Deacon, S; Ebert, B; Wafford, KA, 2006) |
"Insomnia is a common symptom in schizophrenia, although it is seldom the predominant complaint." | 2.43 | Sleep disturbance in schizophrenia. ( Monti, D; Monti, JM, 2005) |
"Some correlates of insomnia in alcoholic patients are identical to those observed in non-alcoholic insomniacs, including anxiety and depression, tobacco smoking, and the use of alcohol to aid sleep." | 2.42 | Insomnia, alcoholism and relapse. ( Brower, KJ, 2003) |
" The safety and tolerability of GABA-BZ receptor agonists and SUX were high, and no serious adverse effects were observed after switching to LEM." | 1.91 | Efficacy and safety of lemborexant as an alternative drug for patients with insomnia taking gamma-aminobutyric acid-benzodiazepine receptor agonists or suvorexant. ( Inamoto, A; Iwanami, A; Kawai, K; Okino, K; Sanada, K; Suzuki, H; Tomioka, H, 2023) |
"Insomnia is the most common sleep disorder and is often comorbid with mental and physical diseases." | 1.91 | Electroacupuncture of the cymba concha alleviates p-chlorophenylalanine-induced insomnia in mice. ( Peng, Q; Tang, L; Zhang, F; Zhang, X, 2023) |
"AA have certain therapeutic effects on insomnia." | 1.91 | The Effect of Chinese Agarwood Essential Oil with Cyclodextrin Inclusion against PCPA-Induced Insomnia Rats. ( Chen, J; Hua, L; Lai, Y; Li, J; Shi, S; Xu, J; Yang, J; Zhang, S; Zhu, S, 2023) |
"Although gamma-aminobutyric acid-benzodiazepine (GABA-BZ) receptor agonists are used to treat insomnia, their long-term or high-dosage use causes adverse events." | 1.91 | Efficacy and safety of lemborexant as an alternative drug for patients with insomnia taking gamma-aminobutyric acid-benzodiazepine receptor agonists or suvorexant. ( Inamoto, A; Iwanami, A; Kawai, K; Okino, K; Sanada, K; Suzuki, H; Tomioka, H, 2023) |
"The novel dual orexin receptor antagonist lemborexant (LEM) has fewer adverse effects than GABA-BZ receptor agonists." | 1.91 | Efficacy and safety of lemborexant as an alternative drug for patients with insomnia taking gamma-aminobutyric acid-benzodiazepine receptor agonists or suvorexant. ( Inamoto, A; Iwanami, A; Kawai, K; Okino, K; Sanada, K; Suzuki, H; Tomioka, H, 2023) |
"That meets the main mechanism of insomnia in traditional Chinese medicine." | 1.72 | Jiaotaiwan increased GABA level in brain and serum, improved sleep via increasing NREM sleep and REM sleep, and its component identification. ( ChongLiang, L; LuFeng, H; Ren, Y; SiSi, L; Yuan, F; ZhengZhong, Y, 2022) |
"In the caffeine-induced insomnia model, the administration of a Saaz-Saphir mixture increased the sleep time compared to Saaz or Saphir administration alone, which was attributed to the increase in NREM sleep time by the δ-wave increase." | 1.62 | GABA ( Ahn, Y; Cho, HJ; Jo, K; Kwak, WK; Min, B; Suh, HJ, 2021) |
"In this study, PCPA-induced insomnia model was used to explore the sleep-promoting mechanism of enzymolysis peptides from PMM, and its main composition and chemical structure were analyzed." | 1.62 | Enzymolysis peptides from Mauremys mutica plastron improve the disorder of neurotransmitter system and facilitate sleep-promoting in the PCPA-induced insomnia mice. ( Luo, LS; Lv, YB; Yan, JX; Zhang, JL; Zhou, Q, 2021) |
"Established the PCPA insomnia model of mice, The open field test, pentobarbital-induced falling asleep rate, latency of sleeping time, and duration of sleeping time experiments were used to evaluate the behavior of mice, the enzyme-linked immunosorbent assay was used to analyze the content of 5-HT and GABA in hypothalamus and cerebral cortex." | 1.62 | Sedative and hypnotic effects of Perilla frutescens essential oil through GABAergic system pathway. ( Du, Q; Guo, Y; Hu, P; Huang, X; Li, J; Li, W; Liu, S; Ren, G; Shuai, S; Wu, L; Xiao, S; Yang, M; Zhang, K; Zhang, M; Zheng, Q; Zhong, Y; Zhu, L, 2021) |
"Insomnia is a common health problem in modern societies." | 1.56 | Beneficial effect of GABA-rich fermented milk on insomnia involving regulation of gut microbiota. ( Cen, S; Chen, W; Duan, H; Feng, S; Han, X; Tian, F; Xue, Y; Yu, L; Zhai, Q; Zhang, H; Zhao, J, 2020) |
"The extent to which comorbid insomnia contributes to GABAergic or glutamatergic deficiencies in MDD remains unclear." | 1.56 | ( Baer, L; Benson, KL; Bottary, R; Eric Jensen, J; Gonenc, A; Schoerning, L; Winkelman, JW, 2020) |
"Both Major Depressive Disorder (MDD) and Primary Insomnia (PI) have been linked to deficiencies in cortical γ-aminobutyric acid (GABA) and glutamate (Glu) thus suggesting a shared neurobiological link between these two conditions." | 1.56 | ( Baer, L; Benson, KL; Bottary, R; Eric Jensen, J; Gonenc, A; Schoerning, L; Winkelman, JW, 2020) |
"Chronic insomnia is defined as a persistent difficulty with sleep initiation maintenance or non-restorative sleep." | 1.46 | The dual orexin receptor antagonist, DORA-22, lowers histamine levels in the lateral hypothalamus and prefrontal cortex without lowering hippocampal acetylcholine. ( Coleman, PJ; Fox, SV; Gotter, AL; Hodgson, R; Ramirez, AD; Renger, JJ; Roecker, AJ; Smith, SM; Uslaner, JM; Winrow, CJ; Yao, L, 2017) |
"Chronic insomnia is one of the most prevalent central nervous system disorders." | 1.43 | Magnetic Resonance Spectroscopy in Patients with Insomnia: A Repeated Measurement Study. ( Baglioni, C; Feige, B; Hennig, J; Lange, T; Nissen, C; Regen, W; Riemann, D; Spiegelhalder, K, 2016) |
"The findings have implications for PTSD treatment approaches." | 1.40 | Cortical gamma-aminobutyric acid and glutamate in posttraumatic stress disorder and their relationships to self-reported sleep quality. ( Metzler, T; Meyerhoff, DJ; Mon, A; Neylan, TC, 2014) |
"As expected, PTSD+ had higher depressive and anxiety symptom scores and a higher Insomnia Severity Index (ISI) score." | 1.40 | Cortical gamma-aminobutyric acid and glutamate in posttraumatic stress disorder and their relationships to self-reported sleep quality. ( Metzler, T; Meyerhoff, DJ; Mon, A; Neylan, TC, 2014) |
" Before dosing and at 30, 60, 120, 240 min, general behaviors within 5 min were recorded." | 1.40 | [Mechanism of Bailemian capsules in the treatment of insomnia in mice]. ( Bian, Y; Tang, X, 2014) |
"In middle and high-dose groups, insomnia symptoms improved significantly." | 1.40 | [Mechanism of Bailemian capsules in the treatment of insomnia in mice]. ( Bian, Y; Tang, X, 2014) |
"Insomnia is a prominent modern disease that affects an increasing population." | 1.40 | Discovery of novel insomnia leads from screening traditional Chinese medicine database. ( Chan, YC; Chang, SS; Chen, CY; Chen, HY, 2014) |
"Twenty-seven patients with PTSD (PTSD+) and 18 trauma-exposed controls without PTSD (PTSD-), recruited from United States Army reservists, Army National Guard, and mental health clinics." | 1.40 | Cortical gamma-aminobutyric acid and glutamate in posttraumatic stress disorder and their relationships to self-reported sleep quality. ( Metzler, T; Meyerhoff, DJ; Mon, A; Neylan, TC, 2014) |
"Insomnia is prevalent in pediatrics, particularly in those with neurodevelopmental disorders." | 1.39 | Gabapentin shows promise in treating refractory insomnia in children. ( Malow, BA; Robinson, AA, 2013) |
"The model of insomnia rats were established by PCPA intraperitoneal injection, after the modeling, all the therapeutic group were treated with corresponding drug for one week." | 1.39 | [Effects of extracts from ziziphi spinosae semen and schisandrae chinensis fructus on amino acid neurotransmitter in rats with insomnia induced by PCPA]. ( Chen, JF; Gao, JR; Ji, WB; Jiang, H, 2013) |
"We report a case with refractory insomnia." | 1.39 | Treatment-resistant insomnia treated with pregabalin. ( Di Iorio, G; Di Tizio, L; Martinotti, G; Matarazzo, I, 2013) |
"Gabapentin has shown promise in treating insomnia in adults." | 1.39 | Gabapentin shows promise in treating refractory insomnia in children. ( Malow, BA; Robinson, AA, 2013) |
"Increased GABA levels in persons with insomnia may reflect an allostatic response to chronic hyperarousal." | 1.38 | Cortical GABA levels in primary insomnia. ( Fasula, M; Forselius, E; Mason, GF; Morgan, PT; Pace-Schott, EF; Sanacora, G; Valentine, GW, 2012) |
"Acupuncture can effectively suppress insomnia induced down-regulation of hypothalamic GABA and GABA(A)R in rats and lengthen pole-climbing time, which may contribute to its effect in relieving insomnia." | 1.38 | [Effect of acupuncture at different acupoints on expression of hypothalamic GABA and GABA(A) receptor proteins in insomnia rats]. ( Gao, XY; Ren, S; Wang, PY; Zhou, YL, 2012) |
"Insomnia is closely related to major depressive disorder (MDD) both cross-sectionally and longitudinally, and as such, offers potential opportunities to refine our understanding of the neurobiology of both sleep and mood disorders." | 1.38 | Reduced γ-aminobutyric acid in occipital and anterior cingulate cortices in primary insomnia: a link to major depressive disorder? ( Jensen, JE; Plante, DT; Schoerning, L; Winkelman, JW, 2012) |
"Non-medicated persons with primary insomnia (N = 16) and no sleep complaints (N = 17)." | 1.38 | Cortical GABA levels in primary insomnia. ( Fasula, M; Forselius, E; Mason, GF; Morgan, PT; Pace-Schott, EF; Sanacora, G; Valentine, GW, 2012) |
"The primary insomnia group was distinguished from persons with no sleep complaints on self-reported and polysomnographically measured sleep." | 1.38 | Cortical GABA levels in primary insomnia. ( Fasula, M; Forselius, E; Mason, GF; Morgan, PT; Pace-Schott, EF; Sanacora, G; Valentine, GW, 2012) |
"Human transmissible spongiform encephalopathies (TSEs) or prion diseases are neurodegenerative disorders of infectious, inherited or sporadic origin and include Creutzfeldt-Jakob disease (CJD), Gerstmann-Sträussler-Scheinker disease (GSS), kuru and fatal familial insomnia (FFI)." | 1.30 | Selective neuronal vulnerability in human prion diseases. Fatal familial insomnia differs from other types of prion diseases. ( Budka, H; Flicker, H; Guentchev, M; Voigtländer, T; Wanschitz, J, 1999) |
Timeframe | Studies, this research(%) | All Research% |
---|---|---|
pre-1990 | 2 (2.20) | 18.7374 |
1990's | 6 (6.59) | 18.2507 |
2000's | 22 (24.18) | 29.6817 |
2010's | 39 (42.86) | 24.3611 |
2020's | 22 (24.18) | 2.80 |
Authors | Studies |
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Hong, JSW | 1 |
Atkinson, LZ | 2 |
Al-Juffali, N | 1 |
Awad, A | 2 |
Geddes, JR | 2 |
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Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
---|---|---|---|---|---|---|---|
A Phase 3 Double-blind, Randomized, Placebo-controlled, Safety And Efficacy Study Of Once Daily Controlled Release Pregabalin In The Treatment Of Patients With Fibromyalgia (Protocol A0081245)[NCT01271933] | Phase 3 | 441 participants (Actual) | Interventional | 2011-03-31 | Completed | ||
A Randomized, Double-Blind, Single-Dose, Placebo-Controlled, Multicenter, Polysomnographic Study Of Gabapentin 250 mg And 500 mg In Transient Insomnia Induced By A Sleep Phase Advance[NCT00674752] | Phase 3 | 377 participants (Actual) | Interventional | 2006-03-31 | Completed | ||
Impact of Gabapentin on Slow Wave Sleep in Adult Critically Ill Patient.[NCT04818450] | 60 participants (Actual) | Interventional | 2021-04-19 | Completed | |||
A Randomized, Double-Blind, Placebo-Controlled, Multicenter, 28-day, Polysomnographic Study of Gabapentin 250 mg in Transient Insomnia Induced by a Sleep Phase Advance[NCT00163046] | Phase 3 | 256 participants (Actual) | Interventional | 2005-10-31 | Completed | ||
Comparison of Plasma Orexin-A Levels and Awakening Time From Anesthesia in Patients With and Without Insomnia Who Had Laparoscopic Cholecystectomy Under General Anesthesia[NCT05664295] | 60 participants (Actual) | Observational [Patient Registry] | 2022-12-30 | Completed | |||
A Placebo-controlled, Double -Blind Randomised Trial of Suvorexant in the Management Comorbid Sleep Disorder and Alcohol Dependence[NCT03897062] | Phase 2 | 22 participants (Actual) | Interventional | 2019-08-26 | Terminated (stopped due to Recruitment problems during covid lockdowns resulted in Merck ceasing supply of suvorexant/placebo) | ||
Efficacy of Pregabalin and Duloxetine in Patients With Painful Diabetic Peripheral Neuropathy (PDPN): the Effect of Pain on Cognitive Function, Sleep and Quality of Life (BLOSSOM)[NCT04246619] | Phase 4 | 254 participants (Actual) | Interventional | 2019-11-12 | Terminated (stopped due to The statistical analysis will still provide relevant results with the same statistical power as initially planned.COVID-19 pandemic prolonged the recruiting period and consequently affected the costs of the clinical trial.) | ||
Comparison of Oral Gabapentin and Pregabalin in Postoperative Pain Control After Photorefractive Keratectomy: a Prospective, Randomized Study.[NCT00954187] | 8 participants (Actual) | Interventional | 2009-11-30 | Terminated (stopped due to PI left institution) | |||
Phase IV Study of Ramelteon as an Adjunct Therapy in Non-Diabetic Patients With Schizophrenia[NCT00595504] | Phase 4 | 25 participants (Actual) | Interventional | 2008-01-31 | Completed | ||
Prolonged-release Melatonin Versus Placebo for Benzodiazepine Discontinuation in Patients With Schizophrenia: a Randomized Clinical Trial[NCT01431092] | Phase 4 | 86 participants (Actual) | Interventional | 2011-10-31 | Completed | ||
The Emergence of Abstract Structure Knowledge Across Learning and Sleep[NCT05746299] | 250 participants (Anticipated) | Interventional | 2023-03-29 | Recruiting | |||
Cannabinoids and an Anti-inflammatory Diet for the Treatment of Neuropathic Pain After Spinal Cord Injury[NCT04057456] | Phase 3 | 140 participants (Anticipated) | Interventional | 2023-03-01 | Recruiting | ||
[information is prepared from clinicaltrials.gov, extracted Sep-2024] |
The MOS-SS is a validated self-administered questionnaire consisting of 12 items that assess key constructs of sleep. Instrument scoring yields 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) and two overall sleep problems indices assessing sleep over the past week. Score range for Sleep Disturbance (SD), sleep adequacy (SA), snoring, somnolence, awakening short of breath/headache was 0-100, where higher score=greater SD; greater SA; greater snoring; greater somnolence; greater shortness of breath/headache respectively. Quantity of Sleep (range-0 to 24 hours; higher scores/hours=greater quantity of sleep). Sleep Problem Index I and II: Score Range=0 to 100; higher scores =greater sleep problems. Optimal Sleep (assessed as yes or no), 'Yes' =optimal sleep (average 7-8 hours/night); 'No' =not optimal sleep. (NCT01271933)
Timeframe: Baseline, Week 6
Intervention | hours (Mean) |
---|---|
Pregabalin (Single Blind Phase) | 0.7 |
Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Minutes of interrupted sleep = minutes awake after sleep onset (analogous to wake-time after sleep onset from polysomnography measurements). (NCT01271933)
Timeframe: Baseline, Double blind end point visit (Week 19)
Intervention | Minutes (Least Squares Mean) |
---|---|
Pregabalin (Double Blind Phase) | -3.5 |
Placebo (Double Blind Phase) | -2.3 |
Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Percent sedentary = percent of daytime spent in sedentary activities as determined by the activity counts measured each minute. (NCT01271933)
Timeframe: Baseline, Double blind end point visit (Week 19)
Intervention | Percent of daytime (Least Squares Mean) |
---|---|
Pregabalin (Double Blind Phase) | -1.4 |
Placebo (Double Blind Phase) | -2.0 |
Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Sleep fragmentation index = a measure of sleep relatedness. Sleep fragmentation index calculated from analysis of the periods that participant was not moving (immobile bouts). It is number of immobile bouts that were exactly 1 minute long divided by total number of immobile bouts. Value ranges from 0-100 percent, with low number representing more restful sleep. (NCT01271933)
Timeframe: Baseline, Double blind end point visit (Week 19)
Intervention | Percentage of immobile bouts (Least Squares Mean) |
---|---|
Pregabalin (Double Blind Phase) | -2.5 |
Placebo (Double Blind Phase) | -0.6 |
"Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Total daytime activity = total activity counts during the day." (NCT01271933)
Timeframe: Baseline, Double blind end point visit (Week 19)
Intervention | Counts of total daytime activity (Least Squares Mean) |
---|---|
Pregabalin (Double Blind Phase) | -182.7 |
Placebo (Double Blind Phase) | -6672.2 |
Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Total sleep time = number of minutes asleep between time of sleep onset to morning awakening. (NCT01271933)
Timeframe: Baseline, Double blind end point visit (Week 19)
Intervention | Hours (Least Squares Mean) |
---|---|
Pregabalin (Double Blind Phase) | 0.5 |
Placebo (Double Blind Phase) | 0.1 |
The tiredness assessment in the daily IVRS diary consists of an 11-point NRS ranging from zero (not tired) to 10 (extremely tired). Participants rate their tiredness due to fibromyalgia during the past 24 hours by choosing the appropriate number between 0 (not tired) and 10 (extremely tired). (NCT01271933)
Timeframe: Baseline, Double blind endpoint visit (Week 19)
Intervention | Units on a scale (Least Squares Mean) |
---|---|
Pregabalin (Double Blind Phase) | -2.6 |
Placebo (Double Blind Phase) | -2.5 |
The SSQ is designed to capture subjective behavior in participants with disrupted sleep. Participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night. Participants rated quality of sleep during the past night by selecting a number between 0 (very poor) and 10 (excellent). (NCT01271933)
Timeframe: Baseline, Double blind endpoint visit (Week 19)
Intervention | Units on a scale (Least Squares Mean) |
---|---|
Pregabalin (Double Blind Phase) | 1.9 |
Placebo (Double Blind Phase) | 1.4 |
The SSQ is designed to capture subjective behavior in participants with disrupted sleep. Participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night. (NCT01271933)
Timeframe: Baseline, Double blind endpoint visit (Week 19)
Intervention | Number of times the participant awakened (Least Squares Mean) |
---|---|
Pregabalin (Double Blind Phase) | -0.5 |
Placebo (Double Blind Phase) | -0.8 |
The SSQ is designed to capture subjective behavior in participants with disrupted sleep. Participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night. (NCT01271933)
Timeframe: Baseline, Double blind endpoint visit (Week 19)
Intervention | Hours (Least Squares Mean) |
---|---|
Pregabalin (Double Blind Phase) | 0.6 |
Placebo (Double Blind Phase) | 0.4 |
Daily Pain Score: Day 1 pain intensity over past 24 hours recorded on waking every morning. 0-10 NRS: 0 (no pain) to 10 (worst possible pain). (NCT01271933)
Timeframe: Baseline, Double blind endpoint visit (Week 19)
Intervention | Units on a scale (Least Squares Mean) |
---|---|
Pregabalin (Double Blind Phase) | -2.9 |
Placebo (Double Blind Phase) | -2.5 |
The MOS-SS is a validated self-administered questionnaire consisting of 12 items that assess key constructs of sleep. Instrument scoring yields 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) and two overall sleep problems indices assessing sleep over the past week. Score range for Sleep Disturbance (SD), sleep adequacy (SA), snoring, somnolence, awakening short of breath/headache was 0-100, where higher score=greater SD; greater SA; greater snoring; greater somnolence; greater shortness of breath/headache respectively. Quantity of Sleep (range-0 to 24 hours; higher scores/hours=greater quantity of sleep). Sleep Problem Index I and II: Score Range=0 to 100; higher scores =greater sleep problems. Optimal Sleep (assessed as yes or no), 'Yes' =optimal sleep (average 7-8 hours/night); 'No' =not optimal sleep. (NCT01271933)
Timeframe: Baseline, Week 19
Intervention | hours (Least Squares Mean) |
---|---|
Pregabalin (Double Blind Phase) | 0.7 |
Placebo (Double Blind Phase) | 0.5 |
Weekly pain scores were calculated from the daily pain diary. Daily Pain Score: Day 1 pain intensity over past 24 hours recorded on waking every morning. 0-10 NRS: 0 (no pain) to 10 (worst possible pain). (NCT01271933)
Timeframe: Baseline, Week 19
Intervention | Units on a scale (Least Squares Mean) |
---|---|
Pregabalin (Double Blind Phase) | -3.1 |
Placebo (Double Blind Phase) | -2.4 |
Participants who did not maintain at least 30% pain response during the DB phase relative to baseline or were discontinued during DB due to lack of efficacy or an adverse event were considered to have a loss of therapeutic response. (NCT01271933)
Timeframe: Randomization to Week 19
Intervention | Participants (Count of Participants) |
---|---|
Pregabalin (Double Blind Phase) | 34 |
Placebo (Double Blind Phase) | 41 |
The time to loss of therapeutic response (LTR) is the time to loss of pain response (<30% pain response relative to the single-blind (SB) baseline mean pain) or withdrawal due to lack of efficacy or adverse events (in the double blind phase). (NCT01271933)
Timeframe: Randomization to Week 19
Intervention | Days (Median) |
---|---|
Pregabalin (Double Blind Phase) | 58 |
Placebo (Double Blind Phase) | 23 |
Weekly pain scores were calculated from the daily pain diary. Daily Pain Score: Day 1 pain intensity over past 24 hours recorded on waking every morning. 0-10 NRS: 0 (no pain) to 10 (worst possible pain). (NCT01271933)
Timeframe: Baseline, Week 6
Intervention | Units on a scale (Mean) |
---|---|
Pregabalin (Single Blind Phase) | -1.6 |
The MOS-SS is a validated self-administered questionnaire consisting of 12 items that assess key constructs of sleep. Instrument scoring yields 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) and two overall sleep problems indices assessing sleep over the past week. Score range for Sleep Disturbance (SD), sleep adequacy (SA), snoring, somnolence, awakening short of breath/headache was 0-100, where higher score=greater SD; greater SA; greater snoring; greater somnolence; greater shortness of breath/headache respectively. Quantity of Sleep (range-0 to 24 hours; higher scores/hours=greater quantity of sleep). Sleep Problem Index I and II: Score Range=0 to 100; higher scores =greater sleep problems. Optimal Sleep (assessed as yes or no), 'Yes' =optimal sleep (average 7-8 hours/night); 'No' =not optimal sleep. (NCT01271933)
Timeframe: Baseline, Week 6
Intervention | Units on a scale (Mean) | ||||||
---|---|---|---|---|---|---|---|
Sleep disturbance | Snoring | Awakening Short of Breath/with a Headache | Sleep adequacy | Somnolence | Sleep Problems Index I | Sleep Problems Index II | |
Pregabalin (Single Blind Phase) | -21.8 | -1.0 | -11.0 | 18.9 | -3.6 | -16.1 | -15.9 |
Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Minutes of interrupted sleep = minutes awake after sleep onset (analogous to wake-time after sleep onset from polysomnography measurements). (NCT01271933)
Timeframe: Baseline, Weeks 11, 12, 13, 14 and 15
Intervention | Minutes (Mean) | ||||
---|---|---|---|---|---|
Minutes of Interrupted Sleep (Week 11) | Minutes of Interrupted Sleep (Week 12) | Minutes of Interrupted Sleep (Week 13) | Minutes of Interrupted Sleep (Week 14) | Minutes of Interrupted Sleep (Week 15) | |
Placebo (Double Blind Phase) | 2.5 | -1.7 | 0.4 | -1.8 | -0.5 |
Pregabalin (Double Blind Phase) | -9.0 | -3.0 | -3.0 | -3.2 | -0.4 |
Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Percent sedentary = percent of daytime spent in sedentary activities as determined by the activity counts measured each minute. (NCT01271933)
Timeframe: Baseline, Weeks 11, 12, 13, 14 and 15
Intervention | Percent of daytime (Mean) | ||||
---|---|---|---|---|---|
Percent Sedentary (Week 11) | Percent Sedentary (Week 12) | Percent Sedentary (Week 13) | Percent Sedentary (Week 14) | Percent Sedentary (Week 15) | |
Placebo (Double Blind Phase) | 1.1 | -1.4 | -0.9 | -1.1 | -1.4 |
Pregabalin (Double Blind Phase) | -0.7 | -0.8 | -1.3 | -2.1 | -1.5 |
Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Sleep fragmentation index = a measure of sleep relatedness. Sleep fragmentation index calculated from analysis of the periods that participant was not moving (immobile bouts). It is number of immobile bouts that were exactly 1 minute long divided by total number of immobile bouts. Value ranges from 0-100 percent, with low number representing more restful sleep. (NCT01271933)
Timeframe: Baseline, Weeks 11, 12, 13, 14 and 15
Intervention | Percentage of immobile bouts (Mean) | ||||
---|---|---|---|---|---|
Sleep Fragmentation Index (Week 11) | Sleep Fragmentation Index (Week 12) | Sleep Fragmentation Index (Week 13) | Sleep Fragmentation Index (Week 14) | Sleep Fragmentation Index (Week 15) | |
Placebo (Double Blind Phase) | 0.1 | -0.4 | -0.3 | -0.6 | -0.9 |
Pregabalin (Double Blind Phase) | -4.4 | -2.8 | -2.2 | -2.4 | -0.9 |
"Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Total daytime activity = total activity counts during the day." (NCT01271933)
Timeframe: Baseline, Weeks 11, 12, 13, 14 and 15
Intervention | Counts of total daytime activity (Mean) | ||||
---|---|---|---|---|---|
Total daytime activity (Week 11) | Total daytime activity ((Week 12) | Total daytime activity ((Week 13) | Total daytime activity ((Week 14) | Total daytime activity ((Week 15) | |
Placebo (Double Blind Phase) | -2083.9 | -6691.1 | 521.8 | -4523.8 | -4649.4 |
Pregabalin (Double Blind Phase) | -1894.1 | -50.7 | -4362.4 | -179.7 | -4138.3 |
Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Total sleep time = number of minutes asleep between time of sleep onset to morning awakening. (NCT01271933)
Timeframe: Baseline, Weeks 11, 12, 13, 14 and 15
Intervention | Hours (Mean) | ||||
---|---|---|---|---|---|
Total Sleep Time (Week 11) | Total Sleep Time (Week 12) | Total Sleep Time (Week 13) | Total Sleep Time (Week 14) | Total Sleep Time (Week 15) | |
Placebo (Double Blind Phase) | 0.0 | 0.1 | 0.1 | 0.1 | 0.3 |
Pregabalin (Double Blind Phase) | 0.5 | 0.5 | 0.4 | 0.4 | 0.2 |
The tiredness assessment in the daily IVRS diary consists of an 11-point NRS ranging from zero (not tired) to 10 (extremely tired). Participants rate their tiredness due to fibromyalgia during the past 24 hours by choosing the appropriate number between 0 (not tired) and 10 (extremely tired). (NCT01271933)
Timeframe: Baseline, Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20
Intervention | Units on a scale (Mean) | |||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 7 | Week 8 | Week 9 | Week 10 | Week 11 | Week 12 | Week 13 | Week 14 | Week 15 | Week 16 | Week 17 | Week 18 | Week 19 | Week 20 | |
Placebo (Double Blind Phase) | -3.0 | -2.8 | -2.9 | -2.6 | -2.5 | -2.5 | -2.6 | -2.5 | -2.6 | -2.7 | -2.5 | -2.4 | -2.4 | -4.9 |
Pregabalin (Double Blind Phase) | -3.4 | -3.3 | -3.2 | -3.2 | -3.1 | -3.4 | -3.2 | -3.2 | -3.4 | -3.1 | -3.4 | -3.2 | -3.1 | -2.7 |
The SSQ is designed to capture subjective behavior in participants with disrupted sleep. Participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night. Participants rated quality of sleep during the past night by selecting a number between 0 (very poor) and 10 (excellent). Mean sleep quality was calculated as the mean of the last seven days, the potential range of responses at each week was therefore 0 (very poor) -10 (excellent), where higher scores indicated better quality of sleep. (NCT01271933)
Timeframe: Baseline, Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20
Intervention | Units on a scale (Mean) | |||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sleep Quality (Week 7) | Sleep Quality (Week 8) | Sleep Quality (Week 9) | Sleep Quality (Week 10) | Sleep Quality (Week 11) | Sleep Quality (Week 12) | Sleep Quality (Week 13) | Sleep Quality (Week 14) N=48,43 | Sleep Quality (Week 15) | Sleep Quality (Week 16) | Sleep Quality (Week 17) | Sleep Quality (Week 18) | Sleep Quality (Week 19) | Sleep Quality (Week 20) | |
Placebo (Double Blind Phase) | 1.9 | 1.7 | 1.8 | 1.7 | 1.7 | 1.7 | 1.9 | 2.1 | 2.0 | 1.9 | 1.9 | 1.8 | 1.5 | 3.3 |
Pregabalin (Double Blind Phase) | 1.9 | 2.0 | 2.1 | 2.2 | 2.3 | 2.1 | 1.9 | 2.2 | 2.2 | 1.9 | 2.2 | 2.1 | 2.0 | 3.1 |
The SSQ is designed to capture subjective behavior in participants with disrupted sleep. Participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night. (NCT01271933)
Timeframe: Baseline, Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20
Intervention | Number of times the participant awakened (Mean) | |||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Subjective No.of Awakenings after Sleep (Week 7) | Subjective No.of Awakenings after Sleep (Week 8) | Subjective No.of Awakenings after Sleep (Week 9) | Subjective No.of Awakenings after Sleep (Week 10) | Subjective No.of Awakenings after Sleep (Week 11) | Subjective No.of Awakenings after Sleep (Week 12) | Subjective No.of Awakenings after Sleep (Week 13) | Subjective No.of Awakenings after Sleep (Week 14) | Subjective No.of Awakenings after Sleep (Week 15) | Subjective No.of Awakenings after Sleep (Week 16) | Subjective No.of Awakenings after Sleep (Week 17) | Subjective No.of Awakenings after Sleep (Week 18) | Subjective No.of Awakenings after Sleep (Week 19) | Subjective No.of Awakenings after Sleep (Week 20) | |
Placebo (Double Blind Phase) | -1.0 | -0.8 | -1.1 | -0.9 | -0.9 | -0.8 | -1.0 | -1.1 | -1.1 | -1.0 | -0.9 | -1.0 | -0.9 | -1.5 |
Pregabalin (Double Blind Phase) | -1.1 | -1.2 | -1.2 | -1.2 | -1.1 | -1.1 | -1.0 | -1.0 | -0.8 | -1.0 | -1.2 | -1.1 | -0.7 | -1.5 |
The SSQ is designed to capture subjective behavior in participants with disrupted sleep. Participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night. Subjective total sleep time was the subjective estimate of the total amount of time the participant was asleep after lights out until final awakening. (NCT01271933)
Timeframe: Baseline, Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20
Intervention | Hours (Mean) | |||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Subjective Total Sleep Time (Week 7) | Subjective Total Sleep Time (Week 8) | Subjective Total Sleep Time (Week 9) | Subjective Total Sleep Time (Week 10) | Subjective Total Sleep Time (Week 11) | Subjective Total Sleep Time (Week 12) | Subjective Total Sleep Time (Week 13) | Subjective Total Sleep Time (Week 14) | Subjective Total Sleep Time (Week 15) | Subjective Total Sleep Time (Week 16) | Subjective Total Sleep Time (Week 17) | Subjective Total Sleep Time (Week 18) | Subjective Total Sleep Time (Week 19) | Subjective Total Sleep Time (Week 20) | |
Placebo (Double Blind Phase) | 0.5 | 0.6 | 0.5 | 0.5 | 0.6 | 0.5 | 0.6 | 0.7 | 0.7 | 0.7 | 0.7 | 0.5 | 0.6 | 0.5 |
Pregabalin (Double Blind Phase) | 0.7 | 0.9 | 0.8 | 0.9 | 0.9 | 0.8 | 0.7 | 0.9 | 0.7 | 0.7 | 0.7 | 0.6 | 0.5 | -0.1 |
The SSQ is designed to capture subjective behavior in participants with disrupted sleep. Participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night. (NCT01271933)
Timeframe: Baseline, Double blind endpoint visit (Week 19)
Intervention | Minutes (Least Squares Mean) | |
---|---|---|
Subjective Wake after Sleep Onset | Subjective Latency to Sleep Onset | |
Placebo (Double Blind Phase) | -20.6 | -11.9 |
Pregabalin (Double Blind Phase) | -26.2 | -10.6 |
The SSQ is designed to capture subjective behavior in participants with disrupted sleep. Participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night. (NCT01271933)
Timeframe: Baseline, Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20
Intervention | Minutes (Mean) | |||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Subjective Wake after Sleep Onset (Week 7) | Subjective Wake after Sleep Onset (Week 8) | Subjective Wake after Sleep Onset (Week 9) | Subjective Wake after Sleep Onset (Week 10) | Subjective Wake after Sleep Onset (Week 11) | Subjective Wake after Sleep Onset (Week 12) | Subjective Wake after Sleep Onset (Week 13) | Subjective Wake after Sleep Onset (Week 14) | Subjective Wake after Sleep Onset (Week 15) | Subjective Wake after Sleep Onset (Week 16) | Subjective Wake after Sleep Onset (Week 17) | Subjective Wake after Sleep Onset (Week 18) | Subjective Wake after Sleep Onset (Week 19) | Subjective Wake after Sleep Onset (Week 20) | Subjective Latency to Sleep Onset (Week 7) | Subjective Latency to Sleep Onset (Week 8) | Subjective Latency to Sleep Onset (Week 9) | Subjective Latency to Sleep Onset (Week 10) | Latency to Sleep Onset (Week 11) | Subjective Latency to Sleep Onset (Week 12) | Subjective Latency to Sleep Onset (Week 13) | Subjective Latency to Sleep Onset (Week 14) | Subjective Latency to Sleep Onset (Week 15) | Subjective Latency to Sleep Onset (Week 16) | Subjective Latency to Sleep Onset (Week 17) | Subjective Latency to Sleep Onset (Week 18) | Subjective Latency to Sleep Onset (Week 19) | Subjective Latency to Sleep Onset (Week 20) | |
Placebo (Double Blind Phase) | -32.0 | -28.0 | -33.2 | -26.2 | -37.4 | -31.0 | -31.4 | -43.3 | -35.1 | -35.0 | -36.2 | -37.3 | -23.1 | -7.1 | -19.1 | -12.3 | -16.0 | -18.0 | -18.0 | -18.8 | -16.8 | -21.8 | -19.1 | -20.9 | -20.9 | -18.7 | -19.5 | -28.7 |
Pregabalin (Double Blind Phase) | -27.8 | -27.4 | -27.0 | -26.9 | -29.0 | -26.0 | -22.8 | -27.0 | -31.7 | -25.9 | -31.5 | -32.4 | -27.3 | -22.5 | -15.6 | -19.1 | -18.4 | -19.5 | -18.5 | -16.3 | -17.5 | -20.8 | -19.4 | -15.8 | -23.1 | -16.3 | -16.7 | 23.0 |
The FIQ is a 20-item self-administered questionnaire. FIQ contains 10 subscales, which are combined to yield a total score. There are 11 questions that are related specifically to physical functioning (item 1). The remaining questions assess pain, fatigue, stiffness, difficulty working, and symptoms of anxiousness and depression. The FIQ is scored from 0 to 100, with higher scores indicating more impairment. (NCT01271933)
Timeframe: Baseline, Week 19
Intervention | Units on a scale (Least Squares Mean) | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
Item 1: Physical activities | Item 2: feel good | Item 3: Work missed | Item 4: Do job | Item 5: Pain | Item 6: Fatigue | Item 7: Rested | Item 8: Stiffness | Item 9: Anxiety | Item 10: Depression | Total Score | |
Placebo (Double Blind Phase) | -1.3 | -3.2 | -1.0 | -2.2 | -2.2 | -2.4 | -2.2 | -2.2 | -1.7 | -0.7 | -19.1 |
Pregabalin (Double Blind Phase) | -1.0 | -3.0 | -1.2 | -2.1 | -2.7 | -2.3 | -2.6 | -2.4 | -1.8 | -0.7 | -19.6 |
HADS: participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms. (NCT01271933)
Timeframe: Baseline, Week 19
Intervention | Units on a scale (Least Squares Mean) | |
---|---|---|
HADS-A Anxiety scale | HADS-D Depression scale | |
Placebo (Double Blind Phase) | -1.6 | -1.1 |
Pregabalin (Double Blind Phase) | -0.7 | -1.4 |
Daily Pain Score: Day 1 pain intensity over past 24 hours recorded on waking every morning. 0-10 NRS: 0 (no pain) to 10 (worst possible pain). (NCT01271933)
Timeframe: Baseline, Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20
Intervention | Units on a scale (Mean) | |||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 7 | Week 8 | Week 9 | Week 10 | Week 11 | Week 12 | Week 13 | Week 14 | Week 15 | Week 16 | Week 17 | Week 18 | Week 19 | Week 20 | |
Placebo (Double Blind Phase) | -3.0 | -2.7 | -2.8 | -2.4 | -2.6 | -2.6 | -2.6 | -2.5 | -2.6 | -2.6 | -2.5 | -2.5 | -2.4 | -4.9 |
Pregabalin (Double Blind Phase) | -3.9 | -3.7 | -3.6 | -3.7 | -3.7 | -3.7 | -3.6 | -3.5 | -3.6 | -3.4 | -3.6 | -3.4 | -3.4 | -3.0 |
The MOS-SS is a validated self-administered questionnaire consisting of 12 items that assess key constructs of sleep. Instrument scoring yields 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) and two overall sleep problems indices assessing sleep over the past week. Score range for Sleep Disturbance (SD), sleep adequacy (SA), snoring, somnolence, awakening short of breath/headache was 0-100, where higher score=greater SD; greater SA; greater snoring; greater somnolence; greater shortness of breath/headache respectively. Quantity of Sleep (range-0 to 24 hours; higher scores/hours=greater quantity of sleep). Sleep Problem Index I and II: Score Range=0 to 100; higher scores =greater sleep problems. Optimal Sleep (assessed as yes or no), 'Yes' =optimal sleep (average 7-8 hours/night); 'No' =not optimal sleep. (NCT01271933)
Timeframe: Baseline, Week 19
Intervention | Units on a scale (Least Squares Mean) | ||||||
---|---|---|---|---|---|---|---|
Sleep disturbance | Snoring | Awakening Short of Breath/with a Headache | Sleep adequacy | Somnolence | Sleep Problems Index I | Sleep Problems Index II | |
Placebo (Double Blind Phase) | -15.5 | -2.9 | -4.2 | 17.1 | -6.6 | -13.7 | -14.0 |
Pregabalin (Double Blind Phase) | -25.4 | -2.4 | -8.1 | 23.9 | -11.9 | -19.5 | -19.7 |
The MFI is a 20-item, self-administered questionnaire designed to measure the following dimensions of fatigue: general fatigue, physical fatigue, mental fatigue, reduced motivation, and reduced activity. Items are summed to form subscale scores; there is no overall score. The score range is from 4 to 20, where higher scores indicate greater dysfunction. (NCT01271933)
Timeframe: Baseline, Week 19
Intervention | Units on a scale (Least Squares Mean) | ||||
---|---|---|---|---|---|
General fatigue | Physical fatigue | Reduced activity | Reduced motivation | Mental fatigue | |
Placebo (Double Blind Phase) | -0.1 | 0.2 | -0.3 | 0.3 | 0.1 |
Pregabalin (Double Blind Phase) | 0.1 | -0.1 | 0.0 | 1.0 | -0.1 |
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100. Higher scores indicated a better health-related quality of life. (NCT01271933)
Timeframe: Baseline, Week 19
Intervention | Units on a scale (Least Squares Mean) | |||||||||
---|---|---|---|---|---|---|---|---|---|---|
SF-36 Physical Functioning | SF-36 Role-Physical | SF-36 Pain Index | SF-36 General Health Perceptions | SF-36 Vitality | SF-36 Social Functioning | SF-36 Role-Emotional | SF-36 Mental Health Index | Physical Component Score | Mental Component Score | |
Placebo (Double Blind Phase) | 13.7 | 16.2 | 16.0 | 9.3 | 15.7 | 13.5 | 2.2 | 5.2 | 7.2 | 2.4 |
Pregabalin (Double Blind Phase) | 12.4 | 18.9 | 19.2 | 3.3 | 12.2 | 13.3 | 3.8 | 6.6 | 6.8 | 2.6 |
WPAI: 6 question participant rated questionnaire to determine the degree to which disease state affected work productivity while at work and affected activities outside of work. Subscale scores include percent work time missed due to the health problem; percent impairment while working due to problem; percent overall work impairment due to problem; and percent activity impairment due to problem. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores indicated greater impairment and less productivity. (NCT01271933)
Timeframe: Baseline, Week 19
Intervention | Units on a scale (Least Squares Mean) | |||
---|---|---|---|---|
Percent Work Time Missed | Percent Impairment While Working | Percent Activity Impairment | Percent Overall Work Impairment | |
Placebo (Double Blind Phase) | -26.7 | -15.0 | -19.6 | -17.5 |
Pregabalin (Double Blind Phase) | -7.3 | -14.0 | -16.4 | -15.9 |
PGIC: participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). (NCT01271933)
Timeframe: Week 19
Intervention | Participants (Number) | ||||||
---|---|---|---|---|---|---|---|
Very Much Improved | Much Improved | Minimally Improved | No Change | Minimally Worse | Much Worse | Very Much Worse | |
Placebo (Double Blind Phase) | 7 | 11 | 12 | 11 | 6 | 8 | 2 |
Pregabalin (Double Blind Phase) | 7 | 15 | 14 | 9 | 7 | 7 | 1 |
The questionnaire consists of 3 single-item measures designed to captures the participant's perception of the effect of treatment in terms of the relative benefit, their satisfaction, and their intention or willingness to continue on therapy. (NCT01271933)
Timeframe: Week 19
Intervention | Participants (Number) | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
Benefit from treatment-No | Benefit from treatment-Little benefit | Benefit from treatment-much benefit | Satisfaction from treatment-very dissatisfied | Satisfaction from treatment-a little dissatisfied | Satisfaction from treatment-a little satisfied | Satisfaction from treatment-very satisfied | Willing to continue treatment-very unwilling | Willing to continue treatment-little unwilling | Willing to continue treatment-little bit willing | Willing to continue treatment-very willing | |
Placebo (Double Blind Phase) | 11 | 16 | 30 | 6 | 8 | 13 | 30 | 4 | 8 | 11 | 34 |
Pregabalin (Double Blind Phase) | 3 | 15 | 41 | 4 | 10 | 10 | 36 | 8 | 6 | 9 | 37 |
C-CASA was used to categorize and summarize results from the Sheehan Suicidality Tracking Scale (S-STS) and the Columbia Suicidality Severity Rating Scale (C-SSRS). S-STS was an 8-item prospective rating scale that tracked treatment-emergent suicidal ideation and behaviors. Items 1a, 2 to 6, 7a, 8 were scored on a 5-point Likert scale (ranges 0 [not at all] to 4 [extremely]). Items 1, 1b, and 7 required yes or no responses. S-STS total score range 0-30. Lower score=reduced suicidal tendency. C-SSRS was a participant rated questionnaire to assess suicidal ideation, suicidal behavior, actual attempts (yes or no responses), and intensity of ideation (rated 1=low severity to 5=high severity). Responses on S-STS or C-SSRS were mapped to C-CASA categories as: Completed suicide; suicide attempt; preparatory acts; suicide ideation; self-injurious behavior, intent unknown; not enough information; self-injurious behavior, no suicide intent; other, no deliberate self harm. (NCT01271933)
Timeframe: Week 1 to Week 7 and Week 11 to Week 20
Intervention | Participants (Number) | |||
---|---|---|---|---|
Week 11 | Week 15 | Week 19 | Week 20 | |
Placebo (Double Blind Phase) | 0 | 1 | 3 | 1 |
Pregabalin (Double Blind Phase) | 3 | 1 | 1 | 1 |
C-CASA was used to categorize and summarize results from the Sheehan Suicidality Tracking Scale (S-STS) and the Columbia Suicidality Severity Rating Scale (C-SSRS). S-STS was an 8-item prospective rating scale that tracked treatment-emergent suicidal ideation and behaviors. Items 1a, 2 to 6, 7a, 8 were scored on a 5-point Likert scale (ranges 0 [not at all] to 4 [extremely]). Items 1, 1b, and 7 required yes or no responses. S-STS total score range 0-30. Lower score=reduced suicidal tendency. C-SSRS was a participant rated questionnaire to assess suicidal ideation, suicidal behavior, actual attempts (yes or no responses), and intensity of ideation (rated 1=low severity to 5=high severity). Responses on S-STS or C-SSRS were mapped to C-CASA categories as: Completed suicide; suicide attempt; preparatory acts; suicide ideation; self-injurious behavior, intent unknown; not enough information; self-injurious behavior, no suicide intent; other, no deliberate self harm. (NCT01271933)
Timeframe: Week 1 to Week 7 and Week 11 to Week 20
Intervention | Participants (Number) | ||||
---|---|---|---|---|---|
Week 1 | Week 2 | Week 3 | Week 6 | Week 7 | |
Pregabalin (Single Blind Phase) | 5 | 6 | 4 | 16 | 10 |
Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Sleep fragmentation index = a measure of sleep relatedness. Sleep fragmentation index calculated from analysis of the periods that participant was not moving (immobile bouts). It is number of immobile bouts that were exactly 1 minute long divided by total number of immobile bouts. Value ranges from 0-100 percent, with low number representing more restful sleep. (NCT01271933)
Timeframe: Baseline, Weeks 3, 4, 5, 6 and 7
Intervention | Percentage of immobile bouts (Mean) | ||||
---|---|---|---|---|---|
Sleep Fragmentation Index (Week 3) | Sleep Fragmentation Index (Week 4) | Sleep Fragmentation Index (Week 5) | Sleep Fragmentation Index (Week 6) | Sleep Fragmentation Index (Week 7) | |
Pregabalin (Single Blind Phase) | -0.8 | -2.5 | -2.8 | -2.6 | 0.7 |
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100. Higher scores indicated a better health-related quality of life. (NCT01271933)
Timeframe: Baseline, Week 6
Intervention | Units on a scale (Mean) | |||||||||
---|---|---|---|---|---|---|---|---|---|---|
SF-36 Physical Functioning | SF-36 Role-Physical | SF-36 Pain Index | SF-36 General Health Perceptions | SF-36 Vitality | SF-36 Social Functioning | SF-36 Role-Emotional | SF-36 Mental Health Index | Physical Component Score | Mental Component Score | |
Pregabalin (Single Blind Phase) | 14.0 | 17.8 | 20.7 | 8.5 | 18.2 | 12.9 | 8.6 | 7.9 | 7.2 | 4.5 |
Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Minutes of interrupted sleep = minutes awake after sleep onset (analogous to wake-time after sleep onset from polysomnography measurements). (NCT01271933)
Timeframe: Baseline, Weeks 3, 4, 5, 6 and 7
Intervention | Minutes (Mean) | ||||
---|---|---|---|---|---|
Minutes of Interrupted Sleep (Week 3) | Minutes of Interrupted Sleep (Week 4) | Minutes of Interrupted Sleep (Week 5) | Minutes of Interrupted Sleep (Week 6) | Minutes of Interrupted Sleep (Week 7) | |
Pregabalin (Single Blind Phase) | -5.3 | -5.9 | -7.0 | -6.6 | 0.7 |
Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Percent sedentary = percent of daytime spent in sedentary activities as determined by the activity counts measured each minute. (NCT01271933)
Timeframe: Baseline, Weeks 3, 4, 5, 6 and 7
Intervention | Percent of daytime (Mean) | ||||
---|---|---|---|---|---|
Percent Sedentary (Week 3) | Percent Sedentary (Week 4) | Percent Sedentary (Week 5) | Percent Sedentary (Week 6) | Percent Sedentary (Week 7) | |
Pregabalin (Single Blind Phase) | 0.7 | 0.7 | 0.6 | 0.3 | 0.2 |
"Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Total daytime activity = total activity counts during the day." (NCT01271933)
Timeframe: Baseline, Weeks 3, 4, 5, 6 and 7
Intervention | Counts of total daytime activity (Mean) | ||||
---|---|---|---|---|---|
Total daytime activity (Week 3) | Total daytime activity (Week 4) | Total daytime activity (Week 5) | Total daytime activity (Week 6) | Total daytime activity (Week 7) | |
Pregabalin (Single Blind Phase) | 10264.3 | 10588.1 | 8635.8 | 7134.2 | 18420.7 |
Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Total sleep time = number of minutes asleep between time of sleep onset to morning awakening. (NCT01271933)
Timeframe: Baseline, Weeks 3, 4, 5, 6 and 7
Intervention | Hours (Mean) | ||||
---|---|---|---|---|---|
Total Sleep Time (Week 3) | Total Sleep Time (Week 4) | Total Sleep Time (Week 5) | Total Sleep Time (Week 6) | Total Sleep Time (Week 7) | |
Pregabalin (Single Blind Phase) | -0.1 | 0.4 | 0.3 | 0.3 | 0.6 |
The tiredness assessment in the daily interactive voice response system (IVRS) diary consists of an 11-point NRS ranging from zero (not tired) to 10 (extremely tired). Participants rate their tiredness due to fibromyalgia during the past 24 hours by choosing the appropriate number between 0 (not tired) and 10 (extremely tired). (NCT01271933)
Timeframe: Baseline, Weeks 1, 2, 3, 4, 5, 6
Intervention | Units on a scale (Mean) | |||||
---|---|---|---|---|---|---|
Week 1 | Week 2 | Week 3 | Week 4 | Week 5 | Week 6 | |
Pregabalin (Single Blind Phase) | -0.7 | -1.2 | -1.6 | -2.0 | -2.2 | -2.3 |
The SSQ is designed to capture subjective behavior in participants with disrupted sleep. Participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night. (NCT01271933)
Timeframe: Baseline, Weeks 1, 2, 3, 4, 5, 6
Intervention | Number of times the participant awakened (Mean) | |||||
---|---|---|---|---|---|---|
Subjective No.of Awakenings after Sleep (Week 1) | Subjective No.of Awakenings after Sleep (Week 2) | Subjective No.of Awakenings after Sleep (Week 3) | Subjective No.of Awakenings after Sleep (Week 4) | Subjective No.of Awakenings after Sleep (Week 5) | Subjective No.of Awakenings after Sleep (Week 6) | |
Pregabalin (Single Blind Phase) | -0.8 | -1.0 | -1.1 | -1.1 | -1.2 | -1.2 |
The SSQ is designed to capture subjective behavior in participants with disrupted sleep. Participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night. (NCT01271933)
Timeframe: Baseline, Weeks 1, 2, 3, 4, 5, 6
Intervention | Hours (Mean) | |||||
---|---|---|---|---|---|---|
Subjective Total Sleep Time (Week 1) | Subjective Total Sleep Time (Week 2) | Subjective Total Sleep Time (Week 3) | Subjective Total Sleep Time (Week 4) | Subjective Total Sleep Time (Week 5) | Subjective Total Sleep Time (Week 6) | |
Pregabalin (Single Blind Phase) | 0.6 | 0.6 | 0.6 | 0.7 | 0.7 | 0.7 |
The SSQ is designed to capture subjective behavior in participants with disrupted sleep. Participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night. Participants rated quality of sleep during the past night by selecting a number between 0 (very poor) and 10 (excellent). Mean sleep quality was calculated as the mean of the last seven days, the potential range of responses at each week was therefore 0 (very poor) -10 (excellent), where higher scores indicated better quality of sleep. (NCT01271933)
Timeframe: Baseline, Weeks 1, 2, 3, 4, 5, 6
Intervention | Units on a scale (Mean) | |||||
---|---|---|---|---|---|---|
Sleep quality (Week 1) | Sleep quality (Week 2) | Sleep quality (Week 3) | Sleep quality (Week 4) | Sleep quality (Week 5) | Sleep quality (Week 6) | |
Pregabalin (Single Blind Phase) | 1.0 | 1.2 | 1.5 | 1.6 | 1.7 | 1.7 |
The SSQ is designed to capture subjective behavior in participants with disrupted sleep. Participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night. (NCT01271933)
Timeframe: Baseline, Weeks 1, 2, 3, 4, 5, 6
Intervention | Minutes (Mean) | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Subjective Wake after Sleep Onset (Week 1) | Subjective Wake after Sleep Onset (Week 2) | Subjective Wake after Sleep Onset (Week 3) | Subjective Wake after Sleep Onset (Week 4) | Subjective Wake after Sleep Onset (Week 5) | Subjective Wake after Sleep Onset (Week 6) | Subjective Latency to Sleep Onset (Week 1) | Subjective Latency to Sleep Onset (Week 2) | Subjective Latency to Sleep Onset (Week 3) | Subjective Latency to Sleep Onset (Week 4) | Subjective Latency to Sleep Onset (Week 5) | Subjective Latency to Sleep Onset (Week 6) | |
Pregabalin (Single Blind Phase) | -19.1 | -22.4 | -25.0 | -27.5 | -31.4 | -32.8 | -10.3 | -13.0 | -15.5 | -19.6 | -20.0 | -16.9 |
The FIQ is a 20-item self-administered questionnaire. FIQ contains 10 subscales, which are combined to yield a total score. There are 11 questions that are related specifically to physical functioning (item 1). The remaining questions assess pain, fatigue, stiffness, difficulty working, and symptoms of anxiousness and depression. The FIQ is scored from 0 to 100, with higher scores indicating more impairment. (NCT01271933)
Timeframe: Baseline, Week 6
Intervention | Units on a scale (Mean) | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
Item 1: Physical activities | Item 2: Feel good | Item 3: Work missed | Item 4: Do job | Item 5: Pain | Item 6: Fatigue | Item 7: Rested | Item 8: Stiffness | Item 9: Anxiety | Item 10: Depression | Total Score | |
Pregabalin (Single Blind Phase) | -0.9 | -2.2 | -0.5 | -1.5 | -1.6 | -1.4 | -1.7 | -1.8 | -1.2 | -0.6 | -13.4 |
HADS: participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms. (NCT01271933)
Timeframe: Baseline, Week 6
Intervention | Units on a scale (Mean) | |
---|---|---|
HADS-A Anxiety scale | HADS-D Depression scale | |
Pregabalin (Single Blind Phase) | -1.8 | -1.5 |
Daily Pain Score: Day 1 pain intensity over past 24 hours recorded on waking every morning. 0-10 numeric rating scale (NRS): 0 (no pain) to 10 (worst possible pain). (NCT01271933)
Timeframe: Baseline, Weeks 1, 2, 3, 4, 5, 6
Intervention | Units on a scale (Mean) | |||||
---|---|---|---|---|---|---|
Week 1 | Week 2 | Week 3 | Week 4 | Week 5 | Week 6 | |
Pregabalin (Single Blind Phase) | -0.9 | -1.5 | -2.0 | -2.3 | -2.5 | -2.6 |
The MFI is a 20-item, self-administered questionnaire designed to measure the following dimensions of fatigue: general fatigue, physical fatigue, mental fatigue, reduced motivation, and reduced activity. Items are summed to form subscale scores; there is no overall score. The score range is from 4 to 20, where higher scores indicate greater dysfunction. (NCT01271933)
Timeframe: Baseline, Week 6
Intervention | Units on a scale (Mean) | ||||
---|---|---|---|---|---|
General fatigue | Physical fatigue | Reduced activity | Reduced motivation | Mental fatigue | |
Pregabalin (Single Blind Phase) | -0.2 | 0.1 | -0.2 | 0.2 | -0.1 |
WPAI: 6 question participant rated questionnaire to determine the degree to which disease state affected work productivity while at work and affected activities outside of work. Subscale scores include percent work time missed due to the health problem; percent impairment while working due to problem; percent overall work impairment due to problem; and percent activity impairment due to problem. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores indicated greater impairment and less productivity. (NCT01271933)
Timeframe: Baseline, Week 6
Intervention | Units on a scale (Mean) | |||
---|---|---|---|---|
Percent Work Time Missed | Percent Impairment While Working | Percent Activity Impairment | Percent Overall Work Impairment | |
Pregabalin (Single Blind Phase) | -5.8 | -10.0 | -13.5 | -12.3 |
PGIC: participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). (NCT01271933)
Timeframe: Week 6
Intervention | Participants (Number) | ||||||
---|---|---|---|---|---|---|---|
Very Much Improved | Much Improved | Minimally Improved | No Change | Minimally Worse | Much Worse | Very Much Worse | |
Pregabalin (Single Blind Phase) | 24 | 77 | 103 | 46 | 16 | 18 | 5 |
The questionnaire consists of 3 single-item measures designed to captures the participant's perception of the effect of treatment in terms of the relative benefit, their satisfaction, and their intention or willingness to continue on therapy. (NCT01271933)
Timeframe: Week 6
Intervention | Participants (Number) | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
Benefit from treatment-No | Benefit from treatment-Little benefit | Benefit from treatment-much benefit | Satisfaction from treatment-very dissatisfied | Satisfaction from treatment-a little dissatisfied | Satisfaction from treatment-a little satisfied | Satisfaction from treatment-very satisfied | Willing to continue treatment-very unwilling | Willing to continue treatment-little unwilling | Willing to continue treatment-little bit willing | Willing to continue treatment-very willing | |
Pregabalin (Single Blind Phase) | 69 | 137 | 211 | 52 | 59 | 103 | 203 | 68 | 33 | 49 | 266 |
A comparison between the ramelteon group and the placebo group of change in abdominal fat measured by a DEXA scan, assessed at Baseline and Week 8. (NCT00595504)
Timeframe: Baseline and Week 8
Intervention | g (Mean) |
---|---|
Ramelteon | 3934.86 |
Placebo (Sugar Pill) | 5120.92 |
A comparison between the ramelteon group and the placebo group of change in insulin resistance measured by the homeostatic model assessment of insulin resistance (HOMA-IR), assessed at Baseline and Week 8. (NCT00595504)
Timeframe: Baseline and Week 8
Intervention | HOMA score (Mean) |
---|---|
Ramelteon | 2.4 |
Placebo (Sugar Pill) | 2.36 |
A comparison between the ramelteon group and the placebo group in change in waist circumference (measured in cm) measured at Baseline and Week 8. (NCT00595504)
Timeframe: Baseline and Week 8
Intervention | cm (Mean) |
---|---|
Ramelteon | 106.09 |
Placebo (Sugar Pill) | 108.37 |
23 reviews available for gamma-aminobutyric acid and Sleep Initiation and Maintenance Disorders
Article | Year |
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Gabapentin and pregabalin in bipolar disorder, anxiety states, and insomnia: Systematic review, meta-analysis, and rationale.
Topics: Amines; Anxiety; Bipolar Disorder; Calcium Channels; Cyclohexanecarboxylic Acids; Gabapentin; gamma- | 2022 |
Effects of BXSMD on ESR1 and ESR2 expression in CSD female mice.
Topics: Animals; Estrogen Receptor alpha; Estrogen Receptor beta; Female; gamma-Aminobutyric Acid; Mice; RNA | 2024 |
Biological rationale and potential clinical use of gabapentin and pregabalin in bipolar disorder, insomnia and anxiety: protocol for a systematic review and meta-analysis.
Topics: Amines; Anti-Anxiety Agents; Anxiety Disorders; Bipolar Disorder; Cyclohexanecarboxylic Acids; Doubl | 2017 |
Gabapentin for the treatment of alcohol use disorder.
Topics: Alcohol Drinking; Alcoholism; Amines; Animals; Calcium Channel Blockers; Cyclohexanecarboxylic Acids | 2018 |
Understanding the sleep-wake cycle: sleep, insomnia, and the orexin system.
Topics: Animals; Benzodiazepines; Brain; Brain Mapping; Circadian Rhythm; Cognitive Behavioral Therapy; Comb | 2013 |
Neuroimaging findings in primary insomnia.
Topics: Affective Symptoms; Arousal; Cerebral Cortex; Comorbidity; gamma-Aminobutyric Acid; Hippocampus; Hum | 2014 |
Assessment and treatment of insomnia in adult patients with alcohol use disorders.
Topics: Acamprosate; Alcohol Deterrents; Alcoholism; Amines; Anti-Anxiety Agents; Anticonvulsants; Antipsych | 2015 |
Pediatric Insomnia.
Topics: Actigraphy; Adolescent; Amines; Anti-Anxiety Agents; Autism Spectrum Disorder; Central Nervous Syste | 2016 |
Not a single but multiple populations of GABAergic neurons control sleep.
Topics: Animals; Brain; GABAergic Neurons; gamma-Aminobutyric Acid; Humans; Rats; Receptors, GABA; Sleep; Sl | 2017 |
Advances in the management of chronic insomnia.
Topics: Cognitive Behavioral Therapy; GABA Agents; gamma-Aminobutyric Acid; Humans; Prevalence; Relaxation T | 2016 |
Sleep Control, GPCRs, and Glucose Metabolism.
Topics: Animals; gamma-Aminobutyric Acid; Glucose; Humans; Melatonin; Receptors, G-Protein-Coupled; Sleep; S | 2016 |
An update of management of insomnia in patients with chronic orofacial pain.
Topics: Amines; Anticonvulsants; Antidepressive Agents; Benzodiazepines; Chronic Pain; Cognitive Behavioral | 2017 |
[Update on the treatment of restless legs syndrome].
Topics: Amines; Analgesics, Opioid; Anticonvulsants; Baths; Benzodiazepines; Cyclohexanecarboxylic Acids; Do | 2009 |
ACS chemical neuroscience molecule spotlight on Suvorexant.
Topics: Animals; Azepines; Clinical Trials, Phase I as Topic; Clinical Trials, Phase III as Topic; gamma-Ami | 2012 |
Understanding the pharmacokinetics of anxiolytic drugs.
Topics: Adrenergic beta-Antagonists; Amines; Anti-Anxiety Agents; Anticonvulsants; Anxiety Disorders; Atenol | 2013 |
[Development of compounds active in insomnia: recent developments and methodological aspects].
Topics: Benzodiazepines; Circadian Rhythm; Clinical Trials as Topic; Drug Design; GABA Agonists; GABA-A Rece | 2003 |
Insomnia, alcoholism and relapse.
Topics: Acetylcholine; Adenosine; Alcoholism; Dopamine; gamma-Aminobutyric Acid; Glutamic Acid; Humans; Nore | 2003 |
Sleep disturbance in schizophrenia.
Topics: Brain; Dopamine; gamma-Aminobutyric Acid; Humans; Schizophrenia; Sleep Initiation and Maintenance Di | 2005 |
Sleep disturbance in schizophrenia.
Topics: Brain; Dopamine; gamma-Aminobutyric Acid; Humans; Schizophrenia; Sleep Initiation and Maintenance Di | 2005 |
Sleep disturbance in schizophrenia.
Topics: Brain; Dopamine; gamma-Aminobutyric Acid; Humans; Schizophrenia; Sleep Initiation and Maintenance Di | 2005 |
Sleep disturbance in schizophrenia.
Topics: Brain; Dopamine; gamma-Aminobutyric Acid; Humans; Schizophrenia; Sleep Initiation and Maintenance Di | 2005 |
Sleep disturbance in schizophrenia.
Topics: Brain; Dopamine; gamma-Aminobutyric Acid; Humans; Schizophrenia; Sleep Initiation and Maintenance Di | 2005 |
Sleep disturbance in schizophrenia.
Topics: Brain; Dopamine; gamma-Aminobutyric Acid; Humans; Schizophrenia; Sleep Initiation and Maintenance Di | 2005 |
Sleep disturbance in schizophrenia.
Topics: Brain; Dopamine; gamma-Aminobutyric Acid; Humans; Schizophrenia; Sleep Initiation and Maintenance Di | 2005 |
Sleep disturbance in schizophrenia.
Topics: Brain; Dopamine; gamma-Aminobutyric Acid; Humans; Schizophrenia; Sleep Initiation and Maintenance Di | 2005 |
Sleep disturbance in schizophrenia.
Topics: Brain; Dopamine; gamma-Aminobutyric Acid; Humans; Schizophrenia; Sleep Initiation and Maintenance Di | 2005 |
Treating insomnia: Current and investigational pharmacological approaches.
Topics: Animals; Electroencephalography; GABA-A Receptor Agonists; gamma-Aminobutyric Acid; Humans; Hypnotic | 2006 |
[Sleep disorders in Parkinson syndromes].
Topics: Acetylcholine; Antidepressive Agents; Antiparkinson Agents; Diagnosis, Differential; Disorders of Ex | 2007 |
Pontine reticular formation (PnO) administration of hypocretin-1 increases PnO GABA levels and wakefulness.
Topics: Animals; Arousal; Body Temperature; gamma-Aminobutyric Acid; Injections; Intracellular Signaling Pep | 2008 |
Sleep-promoting effects of melatonin: at what dose, in whom, under what conditions, and by what mechanisms?
Topics: Adult; Aged; Body Temperature Regulation; Circadian Rhythm; gamma-Aminobutyric Acid; Humans; Hypnoti | 1997 |
Sex, steroids, and sleep: a review.
Topics: Animals; Depressive Disorder; Female; gamma-Aminobutyric Acid; Gonadal Steroid Hormones; Humans; Hyp | 1999 |
23 trials available for gamma-aminobutyric acid and Sleep Initiation and Maintenance Disorders
Article | Year |
---|---|
Alteration of gamma-aminobutyric acid in the left dorsolateral prefrontal cortex of individuals with chronic insomnia: a combined transcranial magnetic stimulation-magnetic resonance spectroscopy study.
Topics: Dorsolateral Prefrontal Cortex; gamma-Aminobutyric Acid; Humans; Magnetic Resonance Spectroscopy; Pr | 2022 |
Effect of Auricular Acupoint Bloodletting plus Auricular Acupressure on Sleep Quality and Neuroendocrine Level in College Students with Primary Insomnia: A Randomized Controlled Trial.
Topics: Acupressure; Acupuncture Points; Bloodletting; gamma-Aminobutyric Acid; Humans; Sleep Initiation and | 2022 |
[Effect of acupuncture combined with low frequency rTMS on comorbid mild-to-moderate depressive disorder and insomnia: a randomized controlled trial].
Topics: Acupuncture Points; Acupuncture Therapy; Brain-Derived Neurotrophic Factor; Depressive Disorder; gam | 2023 |
Effects of pregabalin in patients with hypnotic-dependent insomnia.
Topics: Female; gamma-Aminobutyric Acid; Humans; Hypnotics and Sedatives; Male; Middle Aged; Pregabalin; Sle | 2014 |
Once daily controlled-release pregabalin in the treatment of patients with fibromyalgia: a phase III, double-blind, randomized withdrawal, placebo-controlled study.
Topics: Adult; Aged; Analgesics; Delayed-Action Preparations; Double-Blind Method; Drug Dosage Calculations; | 2014 |
Zolpidem increases GABA in depressed volunteers maintained on SSRIs.
Topics: Adult; Depressive Disorder, Major; Female; GABA-A Receptor Agonists; gamma-Aminobutyric Acid; Humans | 2014 |
A randomized, double-blind, single-dose, placebo-controlled, multicenter, polysomnographic study of gabapentin in transient insomnia induced by sleep phase advance.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Amines; Calcium Channel Blockers; Cyclohexanecarboxylic | 2014 |
A randomized, double-blind, single-dose, placebo-controlled, multicenter, polysomnographic study of gabapentin in transient insomnia induced by sleep phase advance.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Amines; Calcium Channel Blockers; Cyclohexanecarboxylic | 2014 |
A randomized, double-blind, single-dose, placebo-controlled, multicenter, polysomnographic study of gabapentin in transient insomnia induced by sleep phase advance.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Amines; Calcium Channel Blockers; Cyclohexanecarboxylic | 2014 |
A randomized, double-blind, single-dose, placebo-controlled, multicenter, polysomnographic study of gabapentin in transient insomnia induced by sleep phase advance.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Amines; Calcium Channel Blockers; Cyclohexanecarboxylic | 2014 |
A randomized, double-blind, placebo-controlled, multicenter, 28-day, polysomnographic study of gabapentin in transient insomnia induced by sleep phase advance.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Amines; Calcium Channel Blockers; Cyclohexanecarboxylic | 2014 |
[Clinical observation on the neurotransmitters regulation in patients of insomnia differentiated as yang deficiency pattern treated with warm acupuncture and auricular point sticking therapy].
Topics: Acupuncture Points; Acupuncture Therapy; Acupuncture, Ear; Adult; Aged; Female; gamma-Aminobutyric A | 2014 |
A randomized double-blind pilot trial of gabapentin versus placebo to treat alcohol dependence and comorbid insomnia.
Topics: Adult; Alcohol Drinking; Alcoholism; Amines; Antimanic Agents; Cyclohexanecarboxylic Acids; Dose-Res | 2008 |
Randomized, double-blind, placebo-controlled study of XP13512/GSK1838262 in patients with RLS.
Topics: Adult; Amines; Anti-Anxiety Agents; Carbamates; Central Nervous System; Cyclohexanecarboxylic Acids; | 2009 |
The effects of pregabalin on sleep disturbance symptoms among individuals with fibromyalgia syndrome.
Topics: Analgesics; Double-Blind Method; Female; Fibromyalgia; gamma-Aminobutyric Acid; Humans; Male; Medica | 2009 |
Psychometric properties of a single-item scale to assess sleep quality among individuals with fibromyalgia.
Topics: Adult; Analysis of Variance; Double-Blind Method; Female; Fibromyalgia; gamma-Aminobutyric Acid; Hum | 2009 |
The efficacy of pregabalin and benzodiazepines in generalized anxiety disorder presenting with high levels of insomnia.
Topics: Adult; Anxiety Disorders; Benzodiazepines; Double-Blind Method; Female; gamma-Aminobutyric Acid; Hum | 2009 |
Pregabalin increases slow-wave sleep and may improve attention in patients with partial epilepsy and insomnia.
Topics: Adolescent; Adult; Anticonvulsants; Attention Deficit Disorder with Hyperactivity; Cross-Over Studie | 2012 |
Population pharmacokinetics and pharmacodynamics of gabapentin after administration of gabapentin enacarbil.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Amines; Carbamates; Cyclohexanecarboxylic Acids; Female; | 2013 |
Pregabalin for the treatment of postherpetic neuralgia: a randomized, placebo-controlled trial.
Topics: Adult; Affect; Aged; Analgesics, Non-Narcotic; Dizziness; Double-Blind Method; Edema; Female; gamma- | 2003 |
Open pilot study of gabapentin versus trazodone to treat insomnia in alcoholic outpatients.
Topics: Acetates; Alcoholism; Amines; Antidepressive Agents, Second-Generation; Cyclohexanecarboxylic Acids; | 2003 |
Relief of painful diabetic peripheral neuropathy with pregabalin: a randomized, placebo-controlled trial.
Topics: Aged; Analgesia; Analgesics; Anticonvulsants; Calcium Channel Blockers; Calcium Channels; Diabetic N | 2005 |
Relief of painful diabetic peripheral neuropathy with pregabalin: a randomized, placebo-controlled trial.
Topics: Aged; Analgesia; Analgesics; Anticonvulsants; Calcium Channel Blockers; Calcium Channels; Diabetic N | 2005 |
Relief of painful diabetic peripheral neuropathy with pregabalin: a randomized, placebo-controlled trial.
Topics: Aged; Analgesia; Analgesics; Anticonvulsants; Calcium Channel Blockers; Calcium Channels; Diabetic N | 2005 |
Relief of painful diabetic peripheral neuropathy with pregabalin: a randomized, placebo-controlled trial.
Topics: Aged; Analgesia; Analgesics; Anticonvulsants; Calcium Channel Blockers; Calcium Channels; Diabetic N | 2005 |
Pregabalin in central neuropathic pain associated with spinal cord injury: a placebo-controlled trial.
Topics: Adult; Affect; Aged; Aged, 80 and over; Analgesics; Anxiety; Disability Evaluation; Dose-Response Re | 2006 |
Exploratory polysomnographic evaluation of pregabalin on sleep disturbance in patients with epilepsy.
Topics: Adult; Aged; Anticonvulsants; Dose-Response Relationship, Drug; Double-Blind Method; Drug Administra | 2007 |
Evaluation of the efficacy of pivagabine on insomnia associated with mood disorders.
Topics: Adult; Blood Pressure; Double-Blind Method; Female; gamma-Aminobutyric Acid; Heart Rate; Humans; Mal | 1997 |
Gabapentin treatment for insomnia associated with alcohol dependence.
Topics: Acetates; Adult; Alcoholism; Amines; Anticonvulsants; Comorbidity; Cyclohexanecarboxylic Acids; Fema | 2000 |
45 other studies available for gamma-aminobutyric acid and Sleep Initiation and Maintenance Disorders
Article | Year |
---|---|
Jiaotaiwan increased GABA level in brain and serum, improved sleep via increasing NREM sleep and REM sleep, and its component identification.
Topics: Animals; Brain; Drugs, Chinese Herbal; gamma-Aminobutyric Acid; Male; Mice; Rats; Rats, Sprague-Dawl | 2022 |
GABA
Topics: Acids; Animals; Bicuculline; Caffeine; Cyclohexenes; Disease Models, Animal; Electroencephalography; | 2021 |
Lower dACC glutamate in cannabis users during early phase abstinence.
Topics: Cannabinoid Receptor Agonists; Cannabis; Dronabinol; gamma-Aminobutyric Acid; Glutamic Acid; Gyrus C | 2022 |
The Positive Effects of
Topics: Animals; Caffeine; gamma-Aminobutyric Acid; Mice; Mice, Inbred ICR; Plant Extracts; Quality of Life; | 2022 |
Effective Components and Molecular Mechanism of Agarwood Essential Oil Inhalation and the Sedative and Hypnotic Effects Based on GC-MS-Qtof and Molecular Docking.
Topics: Animals; Fenclonine; gamma-Aminobutyric Acid; Gas Chromatography-Mass Spectrometry; Glutamic Acid; H | 2022 |
Sedative-hypnotic effects of Boropinol-B on mice via activation of GABAA receptors.
Topics: Animals; gamma-Aminobutyric Acid; Hypnotics and Sedatives; Mice; Pentobarbital; Rats; Receptors, GAB | 2023 |
Sedative-hypnotic effects of Boropinol-B on mice via activation of GABAA receptors.
Topics: Animals; gamma-Aminobutyric Acid; Hypnotics and Sedatives; Mice; Pentobarbital; Rats; Receptors, GAB | 2023 |
Sedative-hypnotic effects of Boropinol-B on mice via activation of GABAA receptors.
Topics: Animals; gamma-Aminobutyric Acid; Hypnotics and Sedatives; Mice; Pentobarbital; Rats; Receptors, GAB | 2023 |
Sedative-hypnotic effects of Boropinol-B on mice via activation of GABAA receptors.
Topics: Animals; gamma-Aminobutyric Acid; Hypnotics and Sedatives; Mice; Pentobarbital; Rats; Receptors, GAB | 2023 |
Sedative-hypnotic effects of Boropinol-B on mice via activation of GABAA receptors.
Topics: Animals; gamma-Aminobutyric Acid; Hypnotics and Sedatives; Mice; Pentobarbital; Rats; Receptors, GAB | 2023 |
Sedative-hypnotic effects of Boropinol-B on mice via activation of GABAA receptors.
Topics: Animals; gamma-Aminobutyric Acid; Hypnotics and Sedatives; Mice; Pentobarbital; Rats; Receptors, GAB | 2023 |
Sedative-hypnotic effects of Boropinol-B on mice via activation of GABAA receptors.
Topics: Animals; gamma-Aminobutyric Acid; Hypnotics and Sedatives; Mice; Pentobarbital; Rats; Receptors, GAB | 2023 |
Sedative-hypnotic effects of Boropinol-B on mice via activation of GABAA receptors.
Topics: Animals; gamma-Aminobutyric Acid; Hypnotics and Sedatives; Mice; Pentobarbital; Rats; Receptors, GAB | 2023 |
Sedative-hypnotic effects of Boropinol-B on mice via activation of GABAA receptors.
Topics: Animals; gamma-Aminobutyric Acid; Hypnotics and Sedatives; Mice; Pentobarbital; Rats; Receptors, GAB | 2023 |
The Effect of Chinese Agarwood Essential Oil with Cyclodextrin Inclusion against PCPA-Induced Insomnia Rats.
Topics: Animals; Cyclodextrins; Fenclonine; gamma-Aminobutyric Acid; Neurotransmitter Agents; Oils, Volatile | 2023 |
Efficacy and safety of lemborexant as an alternative drug for patients with insomnia taking gamma-aminobutyric acid-benzodiazepine receptor agonists or suvorexant.
Topics: gamma-Aminobutyric Acid; Humans; Receptors, GABA-A; Retrospective Studies; Sleep Initiation and Main | 2023 |
Electroacupuncture of the cymba concha alleviates p-chlorophenylalanine-induced insomnia in mice.
Topics: Animals; Electroacupuncture; Fenclonine; gamma-Aminobutyric Acid; Hypothalamus; Mice; Sleep Initiati | 2023 |
Sleep-promoting activity of amylase-treated Ashwagandha (Withania somnifera L. Dunal) root extract via GABA receptors.
Topics: Amylases; gamma-Aminobutyric Acid; Pentobarbital; Plant Extracts; Receptors, GABA; Sleep; Sleep Init | 2023 |
Effects of aqueous extracts and volatile oils prepared from Huaxiang Anshen decoction on p-chlorophenylalanine-induced insomnia mice.
Topics: Animals; beta-Cyclodextrins; Dopamine; Fenclonine; gamma-Aminobutyric Acid; Hypnotics and Sedatives; | 2024 |
Sedative and hypnotic effects of compound Anshen essential oil inhalation for insomnia.
Topics: Administration, Inhalation; Animals; Aromatherapy; Brain; Citrus sinensis; Female; gamma-Aminobutyri | 2019 |
Beneficial effect of GABA-rich fermented milk on insomnia involving regulation of gut microbiota.
Topics: Animals; Cultured Milk Products; Fatty Acids, Volatile; gamma-Aminobutyric Acid; Gastrointestinal Mi | 2020 |
Topics: Adult; Depression; Depressive Disorder, Major; gamma-Aminobutyric Acid; Glutamic Acid; Gyrus Cinguli | 2020 |
Sedative and hypnotic effects of Perilla frutescens essential oil through GABAergic system pathway.
Topics: Administration, Inhalation; Animals; Disease Models, Animal; Female; gamma-Aminobutyric Acid; Gas Ch | 2021 |
Low-Dose Ozone Therapy Improves Sleep Quality in Patients with Insomnia and Coronary Heart Disease by Elevating Serum BDNF and GABA.
Topics: Brain-Derived Neurotrophic Factor; Catalase; Coronary Disease; Depression; gamma-Aminobutyric Acid; | 2021 |
Enzymolysis peptides from Mauremys mutica plastron improve the disorder of neurotransmitter system and facilitate sleep-promoting in the PCPA-induced insomnia mice.
Topics: Animals; Brain; Brain-Derived Neurotrophic Factor; Dopamine; gamma-Aminobutyric Acid; Hypnotics and | 2021 |
Molecular Regulation of Betulinic Acid on α3β4 Nicotinic Acetylcholine Receptors.
Topics: Acetylcholine; Animals; Betulinic Acid; Binding Sites; Cattle; Electrophysiology; gamma-Aminobutyric | 2021 |
The dual orexin receptor antagonist, DORA-22, lowers histamine levels in the lateral hypothalamus and prefrontal cortex without lowering hippocampal acetylcholine.
Topics: Acetylcholine; Animals; gamma-Aminobutyric Acid; Hippocampus; Histamine; Hypothalamic Area, Lateral; | 2017 |
The Effect of sequential bilateral low-frequency rTMS over dorsolateral prefrontal cortex on serum level of BDNF and GABA in patients with primary insomnia.
Topics: Adult; Brain-Derived Neurotrophic Factor; Correlation of Data; Female; gamma-Aminobutyric Acid; Huma | 2019 |
Structure: the anatomy of sleep.
Topics: Adolescent; Adult; Child; gamma-Aminobutyric Acid; Humans; Infant, Newborn; Sleep; Sleep Initiation | 2013 |
Discovery of novel insomnia leads from screening traditional Chinese medicine database.
Topics: Binding Sites; Caffeic Acids; Citric Acid; Coumaric Acids; Databases, Chemical; Drugs, Chinese Herba | 2014 |
Treatment-resistant insomnia treated with pregabalin.
Topics: Female; gamma-Aminobutyric Acid; Humans; Middle Aged; Pregabalin; Restless Legs Syndrome; Sleep Init | 2013 |
[Effects of extracts from ziziphi spinosae semen and schisandrae chinensis fructus on amino acid neurotransmitter in rats with insomnia induced by PCPA].
Topics: Animals; Disease Models, Animal; Drugs, Chinese Herbal; Female; Fenclonine; Fruit; gamma-Aminobutyri | 2013 |
Cortical gamma-aminobutyric acid and glutamate in posttraumatic stress disorder and their relationships to self-reported sleep quality.
Topics: Arousal; Aspartic Acid; Cerebral Cortex; gamma-Aminobutyric Acid; Glutamic Acid; Gyrus Cinguli; Huma | 2014 |
[Mechanism of Bailemian capsules in the treatment of insomnia in mice].
Topics: Animals; Capsules; gamma-Aminobutyric Acid; Injections, Intraperitoneal; Mice; Serotonin; Sleep; Sle | 2014 |
Magnetic Resonance Spectroscopy in Patients with Insomnia: A Repeated Measurement Study.
Topics: Adult; Brain; Brain Chemistry; Case-Control Studies; Female; gamma-Aminobutyric Acid; Glutamic Acid; | 2016 |
Insomnia may increase anesthetic requirement.
Topics: Abdominal Pain; Adult; Anesthetics, Inhalation; Carbon Dioxide; Cholecystectomy, Laparoscopic; Consc | 2016 |
What is the effective component in suanzaoren decoction for curing insomnia? Discovery by virtual screening and molecular dynamic simulation.
Topics: Binding Sites; Blood-Brain Barrier; Brain; Computer Simulation; Drugs, Chinese Herbal; gamma-Aminobu | 2008 |
Reduced brain GABA in primary insomnia: preliminary data from 4T proton magnetic resonance spectroscopy (1H-MRS).
Topics: Adult; alpha-Amino-3-hydroxy-5-methyl-4-isoxazolepropionic Acid; Brain; Cross-Sectional Studies; Dia | 2008 |
GABA tea helps sleep.
Topics: Adult; Camellia sinensis; gamma-Aminobutyric Acid; Humans; Male; Phytotherapy; Plant Extracts; Sleep | 2009 |
Paroxysmal arousals and myoclonic movements associated with interictal epileptiform discharges in NREM and REM sleep.
Topics: Adolescent; Amines; Antiparkinson Agents; Arousal; Chromosome Disorders; Chromosome Inversion; Chrom | 2011 |
Reduced γ-aminobutyric acid in occipital and anterior cingulate cortices in primary insomnia: a link to major depressive disorder?
Topics: Actigraphy; Adult; Brain Mapping; Case-Control Studies; Creatine; Depressive Disorder, Major; Female | 2012 |
Nighttime awakenings responding to gabapentin therapy in late premenopausal women: a case series.
Topics: Adult; Amines; Anti-Anxiety Agents; Cyclohexanecarboxylic Acids; Estradiol; Female; Follicle Stimula | 2012 |
The role of GABA in primary insomnia.
Topics: Brain Chemistry; Female; gamma-Aminobutyric Acid; Humans; Male; Sleep Initiation and Maintenance Dis | 2012 |
Cortical GABA levels in primary insomnia.
Topics: Adult; Brain Chemistry; Case-Control Studies; Female; gamma-Aminobutyric Acid; Humans; Magnetic Reso | 2012 |
Gabapentin shows promise in treating refractory insomnia in children.
Topics: Adolescent; Amines; Anticonvulsants; Child; Child, Preschool; Cyclohexanecarboxylic Acids; Female; F | 2013 |
[Effect of acupuncture at different acupoints on expression of hypothalamic GABA and GABA(A) receptor proteins in insomnia rats].
Topics: Acupuncture Points; Acupuncture Therapy; Animals; Disease Models, Animal; gamma-Aminobutyric Acid; H | 2012 |
Gabapentin efficacy in reducing nighttime awakenings in premenopausal women: a class effect of GABAergic medications or unique property of gabapentin only?
Topics: Amines; Anti-Anxiety Agents; Cyclohexanecarboxylic Acids; Female; gamma-Aminobutyric Acid; Humans; P | 2012 |
Hyperalgesia induced by REM sleep loss: a phenomenon in search of a mechanism.
Topics: Acetylcholine; Adenosine; Anxiety; Chronic Disease; Depression; Drug Therapy; Drug-Related Side Effe | 2006 |
Cellular mechanisms of benzodiazepine action.
Topics: Animals; Anti-Anxiety Agents; Anxiety; Benzodiazepines; gamma-Aminobutyric Acid; Humans; Mice; Model | 1982 |
Removal of GABAergic inhibition in the mediodorsal nucleus of the rat thalamus leads to increases in heart rate and blood pressure.
Topics: Animals; Autonomic Nervous System Diseases; Bicuculline; Blood Pressure; GABA Antagonists; GABA-A Re | 1998 |
GABAA alpha-1 subunit gene not associated with depressive symptomatology in mood disorders.
Topics: Adult; Anxiety; Bipolar Disorder; Delusions; Depression; DNA; Female; gamma-Aminobutyric Acid; Genet | 1998 |
Selective neuronal vulnerability in human prion diseases. Fatal familial insomnia differs from other types of prion diseases.
Topics: Adult; Brain; Female; gamma-Aminobutyric Acid; Humans; Immunohistochemistry; Male; Middle Aged; Neur | 1999 |
Stress-induced insomnia: opioid-dopamine interactions.
Topics: 2,3,4,5-Tetrahydro-7,8-dihydroxy-1-phenyl-1H-3-benzazepine; Animals; Antipsychotic Agents; Appetite | 1987 |