gamma-aminobutyric acid and Inadequate Sleep 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.

Research Excerpts

Excerpt	Relevance	Reference
"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)
"Pain is a multidimensional response involving several levels of expression ranging from somatosensory to emotional."	2.50	Restless legs syndrome and pain disorders: what's in common? ( Delgado Rodrigues, RN; Goulart, LI; Prieto Peres, MF, 2014)
"Several pieces of evidence suggest that sleep deprivation causes marked alterations in neurotransmitter receptor function in diverse neuronal cell types."	2.45	Consequences of sleep deprivation on neurotransmitter receptor expression and function. ( Kopp, C; Longordo, F; Lüthi, A, 2009)
"Mechanical sleep deprivation and sss mutant flies were used to generate the sleep loss model."	1.91	Sleep loss impairs intestinal stem cell function and gut homeostasis through the modulation of the GABA signalling pathway in Drosophila. ( Chen, H; Du, G; Guo, X; He, L; Liu, M; Zhang, Z; Zhong, Z; Zhou, J, 2023)
"We confirmed that sleep deprivation leads to an increase in cortical cortistatin mRNA expression."	1.37	Activity-dependent brain-derived neurotrophic factor expression regulates cortistatin-interneurons and sleep behavior. ( Jimenez, DV; Lu, B; Martinowich, K; Schloesser, RJ; Weinberger, DR, 2011)
"Treatment with melatonin (5 and 10 mg/kg, ip) significantly improved locomotor activity, weight loss and antianxiety effect as compared to control (sleep deprived)."	1.37	Possible involvement of GABAergic mechanism in protective effect of melatonin against sleep deprivation-induced behavior modification and oxidative damage in mice. ( Kumar, A; Kumar, P; Singh, A, 2011)
"They also demonstrate that sleep deprivation is associated with increased activation of GABAergic neurones in the MnPN and vlPOA."	1.32	Activation of c-fos in GABAergic neurones in the preoptic area during sleep and in response to sleep deprivation. ( Chew, KT; Gong, H; Guzman-Marin, R; McGinty, D; Stewart, D; Szymusiak, R, 2004)
"To investigate the effects of sleep deprivation on the contents of gamma-amino-butyric acid (GABA) and glutamate (GLU) in rat brain."	1.31	Effects of sleep deprivation on gamma-amino-butyric acid and glutamate contents in rat brain. ( Li, QS; Wang, SX, 2002)
"Rapid eye movement sleep deprivation induces significant changes in the contents and proportion of amino-acid neurotransmitter in rat brain."	1.31	Effects of sleep deprivation on gamma-amino-butyric acid and glutamate contents in rat brain. ( Li, QS; Wang, SX, 2002)
"Total sleep deprivation (TSD) is an efficient method to relieve depression."	1.31	Increase in amino acids in the pons after sleep deprivation: a pilot study using proton magnetic resonance spectroscopy. ( Auer, DP; Czisch, M; Murck, H; Steiger, A; Struttmann, T; Wetter, T, 2002)
"Modafinil treatment did not significantly modify the brain cortex content of any of the amino acids tested."	1.29	Paradoxical sleep deprivation increases the content of glutamate and glutamine in rat cerebral cortex. ( Bettendorff, L; Margineanu, I; Sallanon-Moulin, M; Schoffeniels, E; Touret, M; Wins, P, 1996)

Research

Studies (42)

Authors

Clinical Trials (5)

Trial Overview

Trial Outcomes

Change From Baseline at Week 1 in Mean Weekly Pain Scores

Timeframe	Studies, this research(%)	All Research%
pre-1990	2 (4.76)	18.7374
1990's	3 (7.14)	18.2507
2000's	13 (30.95)	29.6817
2010's	18 (42.86)	24.3611
2020's	6 (14.29)	2.80

Authors	Studies
Zhao, N	1
Shu, Y	1
Jian, C	1
Zhou, Z	1
Bao, H	1
Li, X	2
Cheng, X	1
Zhao, Y	1
Jin, S	1
Shu, X	1
De Nobrega, AK	1
Noakes, EJ	1
Storch, NA	1
Mellers, AP	1
Lyons, LC	1
Zhou, J	1
He, L	1
Liu, M	2
Guo, X	1
Du, G	1
Zhang, Z	1
Zhong, Z	1
Chen, H	1
Wang, S	1
Liu, L	1
Liang, S	1
Yang, J	1
Zhang, Y	1
Liu, X	1
Ashton, JC	1
Tai, F	1
Wang, C	1
Deng, X	1
Li, R	1
Guo, Z	1
Quan, H	1
Li, S	1
Mehta, R	1
Singh, S	1
Khanday, MA	1
Mallick, BN	1
Briggs, C	1
Hirasawa, M	1
Semba, K	1
Yang, SR	1
Hu, ZZ	1
Luo, YJ	1
Zhao, YN	1
Sun, HX	1
Yin, D	1
Wang, CY	1
Yan, YD	1
Wang, DR	1
Yuan, XS	1
Ye, CB	1
Guo, W	1
Qu, WM	1
Cherasse, Y	1
Lazarus, M	1
Ding, YQ	1
Huang, ZL	1
Edwards, RA	1
Bonfanti, G	1
Grugni, R	1
Manca, L	1
Parsons, B	1
Alexander, J	1
Weigend, S	1
Holst, SC	1
Treyer, V	1
O'Gorman Tuura, RL	1
Meier, J	1
Ametamey, SM	1
Buck, A	1
Landolt, HP	1
Hu, Y	1
Liu, P	1
Yan, JJ	1
Liu, MY	1
Zhang, GQ	1
Zhou, XJ	1
Yu, BY	1
Perry, JC	1
Bergamaschi, CT	1
Campos, RR	1
Silva, AM	1
Tufik, S	1
Pava, MJ	1
den Hartog, CR	1
Blanco-Centurion, C	1
Shiromani, PJ	2
Woodward, JJ	1
Vanini, G	1
Nemanis, K	1
Baghdoyan, HA	2
Lydic, R	1
Anaclet, C	1
Ferrari, L	1
Arrigoni, E	1
Bass, CE	1
Saper, CB	1
Lu, J	1
Fuller, PM	1
Goulart, LI	1
Delgado Rodrigues, RN	1
Prieto Peres, MF	1
Petruccelli, E	1
Lansdon, P	1
Kitamoto, T	1
Xie, F	1
Bao, M	1
Shi, R	1
Yue, Y	1
Guan, Y	1
Wang, Y	1
Kashiwagi, M	1
Hayashi, Y	1
Toossi, H	1
Del Cid-Pellitero, E	1
Jones, BE	4
Murck, H	2
Schubert, MI	1
Schmid, D	1
Schüssler, P	1
Steiger, A	2
Auer, DP	2
Sapin, E	1
Lapray, D	1
Bérod, A	1
Goutagny, R	1
Léger, L	1
Ravassard, P	1
Clément, O	1
Hanriot, L	1
Fort, P	1
Luppi, PH	1
Longordo, F	1
Kopp, C	1
Lüthi, A	1
Martinowich, K	1
Schloesser, RJ	1
Jimenez, DV	1
Weinberger, DR	1
Lu, B	1
Kumar, A	1
Singh, A	1
Kumar, P	1
Tiurenkov, IN	1
Bagmetova, VV	1
Borodkina, LE	1
Berestovitskaia, VM	1
Vasil'eva, OS	1
Wang, SX	1
Li, QS	1
Gong, H	1
McGinty, D	3
Guzman-Marin, R	1
Chew, KT	1
Stewart, D	1
Szymusiak, R	3
Gvilia, I	2
Angara, C	1
Turner, A	1
Guedes, RC	1
Cirelli, C	1
Pompeiano, M	1
Arrighi, P	1
Tononi, G	1
Bettendorff, L	1
Sallanon-Moulin, M	1
Touret, M	1
Wins, P	1
Margineanu, I	1
Schoffeniels, E	1
Maloney, KJ	3
Mainville, L	3
Lee, RS	1
Steffensen, SC	1
Henriksen, SJ	1
Gerashchenko, D	1
Salin-Pascual, R	1
Struttmann, T	1
Czisch, M	1
Wetter, T	1
Fratta, W	1
Collu, M	1
Martellotta, MC	1
Pichiri, M	1
Muntoni, F	1
Gessa, GL	1

Trial	Phase	Enrollment	Study Type	Start Date	Status
A 13 Week, Double-Blind, Placebo-Controlled Phase 4 Trial of Pregabalin (CI-1008, 600 mg/Day) for Relief of Pain in Subjects With Painful Diabetic Peripheral Neuropathy[NCT00159679]	Phase 4	167 participants (Actual)	Interventional	2004-09-30	Completed
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Trial of Pregabalin Versus Placebo in the Treatment of Neuropathic Pain Associated With Diabetic Peripheral Neuropathy[NCT00143156]	Phase 3	450 participants	Interventional	2005-03-31	Completed
A 14-Week, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study To Evaluate The Safety And Efficacy Of Pregabalin (150mg-600mg/Day) Using A Flexible Optimal Dose Schedule In Patients With Painful Diabetic Peripheral Neuropathy (DPN).[NCT00156078]	Phase 4	450 participants	Interventional	2005-01-31	Completed
Randomized, Double-Blind, Multicenter, Placebo-Controlled Study To Evaluate Efficacy And Safety Of Pregabalin (CI-1008) In The Treatment For Pain Associated With Diabetic Peripheral Neuropathy[NCT00553475]	Phase 3	314 participants (Actual)	Interventional	2007-10-31	Completed
Age-related Changes in Sleep-wake Regulation: Effects of Sleep Loss on Possible Molecular Markers of Sleep Need[NCT03813082]		29 participants (Actual)	Interventional	2016-03-01	Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

"The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 1.~Change from baseline: Score at Week 1 minus score at baseline" (NCT00553475)
Timeframe: From baseline to Week 1

Change From Baseline at Week 10 in Mean Weekly Pain Scores

Intervention	score on scale (Least Squares Mean)
Placebo	-0.39
Pregabalin 300 mg/Day	-0.82
Pregabalin 600 mg/Day	-1.14

"The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 10.~Change from baseline: Score at Week 10 minus score at baseline" (NCT00553475)
Timeframe: From baseline to Week 10

Change From Baseline at Week 11 in Mean Weekly Pain Scores

Intervention	score on scale (Least Squares Mean)
Placebo	-1.23
Pregabalin 300 mg/Day	-1.93
Pregabalin 600 mg/Day	-2.10

"The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 11.~Change from baseline: Score at Week 11 minus score at baseline" (NCT00553475)
Timeframe: From baseline to Week 11

Change From Baseline at Week 12 in Mean Weekly Pain Scores

Intervention	score on scale (Least Squares Mean)
Placebo	-1.32
Pregabalin 300 mg/Day	-1.95
Pregabalin 600 mg/Day	-2.09

"The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 12.~Change from baseline: Score at Week 12 minus score at baseline" (NCT00553475)
Timeframe: From baseline to Week 12

Change From Baseline at Week 13 in Mean Weekly Pain Scores

Intervention	score on scale (Least Squares Mean)
Placebo	-1.36
Pregabalin 300 mg/Day	-2.01
Pregabalin 600 mg/Day	-2.13

"The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 13.~Change from baseline: Score at Week 13 minus score at baseline" (NCT00553475)
Timeframe: From baseline to Week 13

Change From Baseline at Week 2 in Mean Weekly Pain Scores

Intervention	score on scale (Least Squares Mean)
Placebo	-1.38
Pregabalin 300 mg/Day	-2.04
Pregabalin 600 mg/Day	-2.12

"The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 2.~Change from baseline: Score at Week 2 minus score at baseline" (NCT00553475)
Timeframe: From baseline to Week 2

Change From Baseline at Week 3 in Mean Weekly Pain Scores

Intervention	score on scale (Least Squares Mean)
Placebo	-0.57
Pregabalin 300 mg/Day	-1.17
Pregabalin 600 mg/Day	-1.80

"The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 3.~Change from baseline: Score at Week 3 minus score at baseline" (NCT00553475)
Timeframe: From baseline to Week 3

Change From Baseline at Week 4 in Mean Weekly Pain Scores

Intervention	score on scale (Least Squares Mean)
Placebo	-0.80
Pregabalin 300 mg/Day	-1.40
Pregabalin 600 mg/Day	-1.93

"The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 4.~Change from baseline: Score at Week 4 minus score at baseline" (NCT00553475)
Timeframe: From baseline to Week 4

Change From Baseline at Week 5 in Mean Weekly Pain Scores

Intervention	score on scale (Least Squares Mean)
Placebo	-0.89
Pregabalin 300 mg/Day	-1.53
Pregabalin 600 mg/Day	-2.00

"The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 5.~Change from baseline: Score at Week 5 minus score at baseline" (NCT00553475)
Timeframe: From baseline to Week 5

Change From Baseline at Week 6 in Mean Weekly Pain Scores

Intervention	score on scale (Least Squares Mean)
Placebo	-0.91
Pregabalin 300 mg/Day	-1.57
Pregabalin 600 mg/Day	-2.07

"The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 6.~Change from baseline: Score at Week 6 minus score at baseline" (NCT00553475)
Timeframe: From baseline to Week 6

Change From Baseline at Week 7 in Mean Weekly Pain Scores

Intervention	score on scale (Least Squares Mean)
Placebo	-0.94
Pregabalin 300 mg/Day	-1.72
Pregabalin 600 mg/Day	-2.06

"The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 7.~Change from baseline: Score at Week 7 minus score at baseline" (NCT00553475)
Timeframe: From baseline to Week 7

Change From Baseline at Week 8 in Mean Weekly Pain Scores

Intervention	score on scale (Least Squares Mean)
Placebo	-1.04
Pregabalin 300 mg/Day	-1.76
Pregabalin 600 mg/Day	-2.13

"The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 8.~Change from baseline: Score at Week 8 minus score at baseline" (NCT00553475)
Timeframe: From baseline to Week 8

Change From Baseline at Week 9 in Mean Weekly Pain Scores

Intervention	score on scale (Least Squares Mean)
Placebo	-1.18
Pregabalin 300 mg/Day	-1.85
Pregabalin 600 mg/Day	-2.12

"The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 9.~Change from baseline: Score at Week 9 minus score at baseline" (NCT00553475)
Timeframe: From baseline to Week 9

Change From Baseline in Mean Sleep Interference Scores

Intervention	score on scale (Least Squares Mean)
Placebo	-1.20
Pregabalin 300 mg/Day	-1.93
Pregabalin 600 mg/Day	-2.06

The mean change from baseline in the weekly mean sleep interference score at study endpoint. Score range is from 0-10. Higher scores indicate more severe interference with sleep. (NCT00553475)
Timeframe: From baseline to Week 13 or up to study discontinuation (Study Endpoint)

Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Overall Sleep Problems Index

Intervention	score on scale (Least Squares Mean)
Placebo	-0.74
Pregabalin 300 mg/Day	-1.59
Pregabalin 600 mg/Day	-1.36

The mean change from baseline in Medical Outcomes Study - Sleep Scale Scores at study endpoint. Score for overall sleep problems index ranges from 0-100. Higher scores indicate more of the attribute. (NCT00553475)
Timeframe: From baseline to Week 13 or up to study discontinuation (Study Endpoint)

Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Quantity of Sleep

Intervention	score on scale (Least Squares Mean)
Placebo	-7.91
Pregabalin 300 mg/Day	-11.45
Pregabalin 600 mg/Day	-9.73

The mean change from baseline in Medical Outcomes Study - Sleep Scale Scores at study endpoint. Score for quantity of sleep ranges from 0-24. Higher scores indicate more of the attribute named in the subscale. (NCT00553475)
Timeframe: From baseline to Week 13 or up to study discontinuation (Study Endpoint)

Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Sleep Adequacy

Intervention	score on scale (Least Squares Mean)
Placebo	0.37
Pregabalin 300 mg/Day	0.69
Pregabalin 600 mg/Day	0.54

The mean change from baseline in Medical Outcomes Study - Sleep Scale Scores at study endpoint. Score for sleep adequacy ranges from 0-100. Higher scores indicate more of the attribute. (NCT00553475)
Timeframe: From baseline to Week 13 or up to study discontinuation (Study Endpoint)

Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Sleep Disturbance

Intervention	score on scale (Least Squares Mean)
Placebo	12.08
Pregabalin 300 mg/Day	17.69
Pregabalin 600 mg/Day	21.73

The mean change from baseline in Medical Outcomes Study - Sleep Scale Scores at study endpoint. Score for sleep disturbance ranges from 0-100. Higher scores indicate more severe pain. (NCT00553475)
Timeframe: From baseline to Week 13 or up to study discontinuation (Study Endpoint)

Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Sleep Shortness of Breath or Headache

Intervention	score on scale (Least Squares Mean)
Placebo	-9.03
Pregabalin 300 mg/Day	-15.40
Pregabalin 600 mg/Day	-12.81

The mean change from baseline in Medical Outcomes Study - Sleep Scale Scores at study endpoint. Score for sleep shortness of breath or headache ranges from 0-100. Higher scores indicate more of the attribute. (NCT00553475)
Timeframe: From baseline to Week 13 or up to study discontinuation (Study Endpoint)

Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Snoring

Intervention	score on scale (Least Squares Mean)
Placebo	-1.63
Pregabalin 300 mg/Day	-3.02
Pregabalin 600 mg/Day	-4.47

The mean change from baseline in Medical Outcomes Study - Sleep Scale Scores at study endpoint. Score for snoring ranges from 0-100. Higher scores indicate more of the attribute. (NCT00553475)
Timeframe: From baseline to Week 13 or up to study discontinuation (Study Endpoint)

Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Somnolence

Intervention	score on scale (Least Squares Mean)
Placebo	-6.00
Pregabalin 300 mg/Day	-5.96
Pregabalin 600 mg/Day	-1.56

The mean change from baseline in Medical Outcomes Study - Sleep Scale Scores at study endpoint. Score for somnolence ranges from 0-100. Higher scores indicate more of the attribute. (NCT00553475)
Timeframe: From baseline to Week 13 or up to study discontinuation (Study Endpoint)

Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Bodily Pain

Intervention	score on scale (Least Squares Mean)
Placebo	-2.96
Pregabalin 300 mg/Day	0.83
Pregabalin 600 mg/Day	4.83

The mean change from baseline in Short-Form 36-Item Health Survey Scores at study endpoint. Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status. (NCT00553475)
Timeframe: From baseline to Week 13 or up to study discontinuation (Study Endpoint)

Change From Baseline in Short Form 36-Item (SF-36) Health Survey: General Health Perception

Intervention	score on scale (Least Squares Mean)
Placebo	10.34
Pregabalin 300 mg/Day	11.84
Pregabalin 600 mg/Day	12.89

Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Mental Health

Intervention	score on scale (Least Squares Mean)
Placebo	2.31
Pregabalin 300 mg/Day	3.29
Pregabalin 600 mg/Day	4.40

Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Physical Functioning

Intervention	score on scale (Least Squares Mean)
Placebo	3.84
Pregabalin 300 mg/Day	5.33
Pregabalin 600 mg/Day	7.81

Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Role Limitations-Emotional

Intervention	score on scale (Least Squares Mean)
Placebo	2.70
Pregabalin 300 mg/Day	2.43
Pregabalin 600 mg/Day	3.86

Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Role Limitations-Physical

Intervention	score on scale (Least Squares Mean)
Placebo	4.13
Pregabalin 300 mg/Day	5.05
Pregabalin 600 mg/Day	6.35

Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Social Functioning

Intervention	score on scale (Least Squares Mean)
Placebo	4.38
Pregabalin 300 mg/Day	2.28
Pregabalin 600 mg/Day	3.97

Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Vitality

Intervention	score on scale (Least Squares Mean)
Placebo	3.00
Pregabalin 300 mg/Day	8.06
Pregabalin 600 mg/Day	11.16

Change From Baseline in Short-Form McGill Pain Questionnaire: Affective Scores

Intervention	score on scale (Least Squares Mean)
Placebo	5.28
Pregabalin 300 mg/Day	4.20
Pregabalin 600 mg/Day	12.87

The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Affective score ranges from 0-12. Higher scores indicate more severe pain. (NCT00553475)
Timeframe: From baseline to Week 13 or up to study discontinuation (Study Endpoint)

Change From Baseline in Short-Form McGill Pain Questionnaire: Present Pain Intensity Scores

Intervention	score on scale (Least Squares Mean)
Placebo	-0.83
Pregabalin 300 mg/Day	-1.43
Pregabalin 600 mg/Day	-1.39

The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Present pain intensity score ranges from 0-5. Higher scores indicate more severe pain. (NCT00553475)
Timeframe: From baseline to Week 13 or up to study discontinuation (Study Endpoint)

Change From Baseline in Short-Form McGill Pain Questionnaire: Sensory Scores

Intervention	score on scale (Least Squares Mean)
Placebo	-0.59
Pregabalin 300 mg/Day	-0.80
Pregabalin 600 mg/Day	-0.96

The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Sensory score ranges from 0-33. Higher scores indicate more severe pain. (NCT00553475)
Timeframe: From baseline to Week 13 or up to study discontinuation (Study Endpoint)

Change From Baseline in Short-Form McGill Pain Questionnaire: Total Scores

Intervention	score on scale (Least Squares Mean)
Placebo	-2.82
Pregabalin 300 mg/Day	-4.60
Pregabalin 600 mg/Day	-4.95

The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Total score ranges from 0-45. Higher scores indicate more severe pain. (NCT00553475)
Timeframe: From baseline to Week 13 or up to study discontinuation (Study Endpoint)

Change From Baseline in Short-Form McGill Pain Questionnaire: Visual Analogue Scale Scores

Intervention	score on scale (Least Squares Mean)
Placebo	-3.68
Pregabalin 300 mg/Day	-6.03
Pregabalin 600 mg/Day	-6.36

The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Visual Analogue Scale Score ranges from 0-100 mm. Higher scores indicate more severe pain. (NCT00553475)
Timeframe: From baseline to Week 13 or up to study discontinuation (Study Endpoint)

Change From Baseline to Study Endpoint in Mean Weekly Pain Scores

Intervention	mm (Least Squares Mean)
Placebo	-16.92
Pregabalin 300 mg/Day	-24.19
Pregabalin 600 mg/Day	-24.41

Change from baseline: Score at study endpoint minus score at baseline. Study endpoint is defined as the mean of the last seven entries of the daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) while on study medication up to and including day after last dose. (NCT00553475)
Timeframe: From baseline to Week 13 or up to study discontinuation (Study Endpoint)

Change From Baseline to Study Endpoint in Mean Weekly Pain Scores by Groups of Subjects With Expected Similar Plasma Concentrations

Intervention	score on scale (Least Squares Mean)
Placebo	-1.20
Pregabalin 300 mg/Day	-1.82
Pregabalin 600 mg/Day	-1.94

Change from baseline: Score at study endpoint minus score at baseline. Study endpoint is defined as the mean of the last seven entries of the daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) while on study medication up to and including day after last dose. Subjects are classified by exposure to pregabalin, which is estimated by creatinine clearance (CLcr). (NCT00553475)
Timeframe: From baseline to Week 13 or up to study discontinuation (Study Endpoint)

Clinical Global Impression of Change

Intervention	score on scale (Least Squares Mean)
Placebo	-1.27
Expected Exposure Pregabalin 300 mg/Day	-1.93
Expected Exposure Pregabalin 600 mg/Day	-1.90

Clinical Global Impression of Change is a clinician-rated instrument that measures change in patient's overall status on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). (NCT00553475)
Timeframe: Week 13 or up to discontinuation

Number of Responders

Intervention	score on scale (Mean)
Placebo	3.3
Pregabalin 300 mg/Day	2.9
Pregabalin 600 mg/Day	2.7

A responder is defined as a subject with a 50% reduction in weekly mean pain score from baseline to study endpoint. (NCT00553475)
Timeframe: From baseline to Week 13 or up to study discontinuation (Study Endpoint)

Patient Global Impression of Change

Intervention	participants (Number)
Placebo	29
Pregabalin 300 mg/Day	39
Pregabalin 600 mg/Day	16

The Patient Global Impression of Change is a patient-rated instrument that measures change in patient's overall status on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). (NCT00553475)
Timeframe: Week 13 or up to discontinuation

Article	Year
Effects of BXSMD on ESR1 and ESR2 expression in CSD female mice. Journal of ethnopharmacology, 2024, Jan-10, Volume: 318, Issue:Pt B Topics: Animals; Estrogen Receptor alpha; Estrogen Receptor beta; Female; gamma-Aminobutyric Acid; Mice; RNA	2024
Restless legs syndrome and pain disorders: what's in common? Current pain and headache reports, 2014, Volume: 18, Issue:11 Topics: Calcium Channel Blockers; Diagnosis, Differential; Dopamine Agonists; Fibromyalgia; gamma-Aminobutyr	2014
[The Function of REM Sleep: Implications from Transgenic Mouse Models]. Brain and nerve = Shinkei kenkyu no shinpo, 2016, Volume: 68, Issue:10 Topics: Animals; Dreams; gamma-Aminobutyric Acid; Humans; Mice; Mice, Transgenic; Neurons; Sleep Deprivation	2016
Consequences of sleep deprivation on neurotransmitter receptor expression and function. The European journal of neuroscience, 2009, Volume: 29, Issue:9 Topics: Acetylcholine; Adenosine; Animals; Biogenic Monoamines; Brain; gamma-Aminobutyric Acid; Humans; Intr	2009
On some conditions that influence cortical spreading depression. Anais da Academia Brasileira de Ciencias, 1984, Volume: 56, Issue:4 Topics: Aging; Animals; Chlorides; Cortical Spreading Depression; Electroencephalography; gamma-Aminobutyric	1984

Article	Year
Frontiers in immunology, 2022, Volume: 13 Topics: Animals; Cytokines; Dysbiosis; gamma-Aminobutyric Acid; Hormones; Lactobacillus; Macaca mulatta; Sle	2022
Sleep Modulates Alcohol Toxicity in International journal of molecular sciences, 2022, Oct-11, Volume: 23, Issue:20 Topics: Animals; Drosophila; Drosophila melanogaster; Drosophila Proteins; Ethanol; Female; gamma-Aminobutyr	2022
Sleep loss impairs intestinal stem cell function and gut homeostasis through the modulation of the GABA signalling pathway in Drosophila. Cell proliferation, 2023, Volume: 56, Issue:9 Topics: Animals; Drosophila; gamma-Aminobutyric Acid; Homeostasis; RNA, Ribosomal, 16S; Sleep Deprivation; S	2023
A radical hypothesis on the nature of sleep. Medical hypotheses, 2020, Volume: 134 Topics: Adaptation, Physiological; Cytokines; Dexamethasone; Fatigue; gamma-Aminobutyric Acid; Humans; Model	2020
Treadmill exercise ameliorates chronic REM sleep deprivation-induced anxiety-like behavior and cognitive impairment in C57BL/6J mice. Brain research bulletin, 2020, Volume: 164 Topics: Animals; Anxiety; Behavior, Animal; Cognitive Dysfunction; Dopamine; gamma-Aminobutyric Acid; Hippoc	2020
Reciprocal changes in noradrenaline and GABA levels in discrete brain regions upon rapid eye movement sleep deprivation in rats. Neurochemistry international, 2017, Volume: 108 Topics: Animals; Brain; Brain Chemistry; Cerebral Cortex; gamma-Aminobutyric Acid; Hippocampus; Male; Norepi	2017
Sleep Deprivation Distinctly Alters Glutamate Transporter 1 Apposition and Excitatory Transmission to Orexin and MCH Neurons. The Journal of neuroscience : the official journal of the Society for Neuroscience, 2018, 03-07, Volume: 38, Issue:10 Topics: Animals; Excitatory Amino Acid Transporter 2; gamma-Aminobutyric Acid; Hypothalamic Hormones; Hypoth	2018
The rostromedial tegmental nucleus is essential for non-rapid eye movement sleep. PLoS biology, 2018, Volume: 16, Issue:4 Topics: Animals; Channelrhodopsins; Clozapine; Dopamine; Dopaminergic Neurons; Dorsal Raphe Nucleus; Electro	2018
Predicting Responses to Pregabalin for Painful Diabetic Peripheral Neuropathy Based on Trajectory-Focused Patient Profiles Derived from the First 4 Weeks of Treatment. Advances in therapy, 2018, Volume: 35, Issue:10 Topics: Analgesics; Chronic Pain; Diabetic Neuropathies; Female; gamma-Aminobutyric Acid; Humans; Male; Midd	2018
Predicting Responses to Pregabalin for Painful Diabetic Peripheral Neuropathy Based on Trajectory-Focused Patient Profiles Derived from the First 4 Weeks of Treatment. Advances in therapy, 2018, Volume: 35, Issue:10 Topics: Analgesics; Chronic Pain; Diabetic Neuropathies; Female; gamma-Aminobutyric Acid; Humans; Male; Midd	2018
Predicting Responses to Pregabalin for Painful Diabetic Peripheral Neuropathy Based on Trajectory-Focused Patient Profiles Derived from the First 4 Weeks of Treatment. Advances in therapy, 2018, Volume: 35, Issue:10 Topics: Analgesics; Chronic Pain; Diabetic Neuropathies; Female; gamma-Aminobutyric Acid; Humans; Male; Midd	2018
Predicting Responses to Pregabalin for Painful Diabetic Peripheral Neuropathy Based on Trajectory-Focused Patient Profiles Derived from the First 4 Weeks of Treatment. Advances in therapy, 2018, Volume: 35, Issue:10 Topics: Analgesics; Chronic Pain; Diabetic Neuropathies; Female; gamma-Aminobutyric Acid; Humans; Male; Midd	2018
Predicting Responses to Pregabalin for Painful Diabetic Peripheral Neuropathy Based on Trajectory-Focused Patient Profiles Derived from the First 4 Weeks of Treatment. Advances in therapy, 2018, Volume: 35, Issue:10 Topics: Analgesics; Chronic Pain; Diabetic Neuropathies; Female; gamma-Aminobutyric Acid; Humans; Male; Midd	2018
Predicting Responses to Pregabalin for Painful Diabetic Peripheral Neuropathy Based on Trajectory-Focused Patient Profiles Derived from the First 4 Weeks of Treatment. Advances in therapy, 2018, Volume: 35, Issue:10 Topics: Analgesics; Chronic Pain; Diabetic Neuropathies; Female; gamma-Aminobutyric Acid; Humans; Male; Midd	2018
Predicting Responses to Pregabalin for Painful Diabetic Peripheral Neuropathy Based on Trajectory-Focused Patient Profiles Derived from the First 4 Weeks of Treatment. Advances in therapy, 2018, Volume: 35, Issue:10 Topics: Analgesics; Chronic Pain; Diabetic Neuropathies; Female; gamma-Aminobutyric Acid; Humans; Male; Midd	2018
Predicting Responses to Pregabalin for Painful Diabetic Peripheral Neuropathy Based on Trajectory-Focused Patient Profiles Derived from the First 4 Weeks of Treatment. Advances in therapy, 2018, Volume: 35, Issue:10 Topics: Analgesics; Chronic Pain; Diabetic Neuropathies; Female; gamma-Aminobutyric Acid; Humans; Male; Midd	2018
Predicting Responses to Pregabalin for Painful Diabetic Peripheral Neuropathy Based on Trajectory-Focused Patient Profiles Derived from the First 4 Weeks of Treatment. Advances in therapy, 2018, Volume: 35, Issue:10 Topics: Analgesics; Chronic Pain; Diabetic Neuropathies; Female; gamma-Aminobutyric Acid; Humans; Male; Midd	2018
Predicting Responses to Pregabalin for Painful Diabetic Peripheral Neuropathy Based on Trajectory-Focused Patient Profiles Derived from the First 4 Weeks of Treatment. Advances in therapy, 2018, Volume: 35, Issue:10 Topics: Analgesics; Chronic Pain; Diabetic Neuropathies; Female; gamma-Aminobutyric Acid; Humans; Male; Midd	2018
Predicting Responses to Pregabalin for Painful Diabetic Peripheral Neuropathy Based on Trajectory-Focused Patient Profiles Derived from the First 4 Weeks of Treatment. Advances in therapy, 2018, Volume: 35, Issue:10 Topics: Analgesics; Chronic Pain; Diabetic Neuropathies; Female; gamma-Aminobutyric Acid; Humans; Male; Midd	2018
Predicting Responses to Pregabalin for Painful Diabetic Peripheral Neuropathy Based on Trajectory-Focused Patient Profiles Derived from the First 4 Weeks of Treatment. Advances in therapy, 2018, Volume: 35, Issue:10 Topics: Analgesics; Chronic Pain; Diabetic Neuropathies; Female; gamma-Aminobutyric Acid; Humans; Male; Midd	2018
Predicting Responses to Pregabalin for Painful Diabetic Peripheral Neuropathy Based on Trajectory-Focused Patient Profiles Derived from the First 4 Weeks of Treatment. Advances in therapy, 2018, Volume: 35, Issue:10 Topics: Analgesics; Chronic Pain; Diabetic Neuropathies; Female; gamma-Aminobutyric Acid; Humans; Male; Midd	2018
Predicting Responses to Pregabalin for Painful Diabetic Peripheral Neuropathy Based on Trajectory-Focused Patient Profiles Derived from the First 4 Weeks of Treatment. Advances in therapy, 2018, Volume: 35, Issue:10 Topics: Analgesics; Chronic Pain; Diabetic Neuropathies; Female; gamma-Aminobutyric Acid; Humans; Male; Midd	2018
Predicting Responses to Pregabalin for Painful Diabetic Peripheral Neuropathy Based on Trajectory-Focused Patient Profiles Derived from the First 4 Weeks of Treatment. Advances in therapy, 2018, Volume: 35, Issue:10 Topics: Analgesics; Chronic Pain; Diabetic Neuropathies; Female; gamma-Aminobutyric Acid; Humans; Male; Midd	2018
Predicting Responses to Pregabalin for Painful Diabetic Peripheral Neuropathy Based on Trajectory-Focused Patient Profiles Derived from the First 4 Weeks of Treatment. Advances in therapy, 2018, Volume: 35, Issue:10 Topics: Analgesics; Chronic Pain; Diabetic Neuropathies; Female; gamma-Aminobutyric Acid; Humans; Male; Midd	2018
Dynamic changes in cerebral and peripheral markers of glutamatergic signaling across the human sleep-wake cycle. Sleep, 2019, 10-21, Volume: 42, Issue:11 Topics: Adult; Basal Ganglia; Brain; Brain-Derived Neurotrophic Factor; Fragile X Mental Retardation Protein	2019
Effect of kai xin san on learning and memory in a rat model of paradoxical sleep deprivation. Journal of medicinal food, 2013, Volume: 16, Issue:4 Topics: Animals; Behavior, Animal; Brain; Brain-Derived Neurotrophic Factor; Cognition Disorders; Cyclic AMP	2013
Interconnectivity of sympathetic and sleep networks is mediated through reduction of gamma aminobutyric acidergic inhibition in the paraventricular nucleus. Journal of sleep research, 2014, Volume: 23, Issue:2 Topics: Animals; Bicuculline; Blood Pressure; Down-Regulation; gamma-Aminobutyric Acid; Heart Rate; Kidney;	2014
Endocannabinoid modulation of cortical up-states and NREM sleep. PloS one, 2014, Volume: 9, Issue:2 Topics: Action Potentials; Animals; Arachidonic Acids; Benzoxazines; Cerebral Cortex; Endocannabinoids; gamm	2014
GABAergic transmission in rat pontine reticular formation regulates the induction phase of anesthesia and modulates hyperalgesia caused by sleep deprivation. The European journal of neuroscience, 2014, Volume: 40, Issue:1 Topics: 3-Mercaptopropionic Acid; Anesthetics, General; Animals; Consciousness; GABA Agents; GABA Uptake Inh	2014
The GABAergic parafacial zone is a medullary slow wave sleep-promoting center. Nature neuroscience, 2014, Volume: 17, Issue:9 Topics: Animals; Electroencephalography; GABAergic Neurons; gamma-Aminobutyric Acid; Integrases; Male; Medul	2014
Exaggerated Nighttime Sleep and Defective Sleep Homeostasis in a Drosophila Knock-In Model of Human Epilepsy. PloS one, 2015, Volume: 10, Issue:9 Topics: Animals; Animals, Genetically Modified; Circadian Rhythm; Disease Models, Animal; Disease Susceptibi	2015
Anesthetic propofol normalized the increased release of glutamate and γ-amino butyric acid in hippocampus after paradoxical sleep deprivation in rats. Neurological research, 2015, Volume: 37, Issue:12 Topics: Animals; gamma-Aminobutyric Acid; Glutamic Acid; Hippocampus; Hypnotics and Sedatives; Male; Microdi	2015
Homeostatic regulation through GABA and acetylcholine muscarinic receptors of motor trigeminal neurons following sleep deprivation. Brain structure & function, 2017, Volume: 222, Issue:7 Topics: Acetylcholine; Animals; Cell Count; Electroencephalography; gamma-Aminobutyric Acid; Gene Expression	2017
Localization of the brainstem GABAergic neurons controlling paradoxical (REM) sleep. PloS one, 2009, Volume: 4, Issue:1 Topics: Animals; Brain Stem; Disorders of Excessive Somnolence; GABA Plasma Membrane Transport Proteins; gam	2009
Activity-dependent brain-derived neurotrophic factor expression regulates cortistatin-interneurons and sleep behavior. Molecular brain, 2011, Mar-09, Volume: 4 Topics: Animals; Behavior, Animal; Biomarkers; Brain-Derived Neurotrophic Factor; Circadian Rhythm; Electros	2011
Possible involvement of GABAergic mechanism in protective effect of melatonin against sleep deprivation-induced behavior modification and oxidative damage in mice. Indian journal of experimental biology, 2011, Volume: 49, Issue:3 Topics: Animals; Antioxidants; Anxiety; Behavior, Animal; Flumazenil; GABA Modulators; gamma-Aminobutyric Ac	2011
[Fenibut and its citrate prevent psychoneurological disorders caused by chronic stress (paradoxical sleep deprivation)]. Eksperimental'naia i klinicheskaia farmakologiia, 2012, Volume: 75, Issue:6 Topics: Adrenal Glands; Animals; Avoidance Learning; Behavior, Animal; Citrates; Cognition Disorders; gamma-	2012
Effects of sleep deprivation on gamma-amino-butyric acid and glutamate contents in rat brain. Di 1 jun yi da xue xue bao = Academic journal of the first medical college of PLA, 2002, Volume: 22, Issue:10 Topics: Animals; Brain; gamma-Aminobutyric Acid; Glutamic Acid; Male; Rats; Rats, Sprague-Dawley; Sleep Depr	2002
Activation of c-fos in GABAergic neurones in the preoptic area during sleep and in response to sleep deprivation. The Journal of physiology, 2004, May-01, Volume: 556, Issue:Pt 3 Topics: Animals; Brain; Brain Chemistry; Cell Count; Electroencephalography; Electromyography; gamma-Aminobu	2004
Different neuronal populations of the rat median preoptic nucleus express c-fos during sleep and in response to hypertonic saline or angiotensin-II. The Journal of physiology, 2005, Dec-01, Volume: 569, Issue:Pt 2 Topics: Angiotensin II; Animals; Body Fluids; Cell Count; gamma-Aminobutyric Acid; Glutamate Decarboxylase;	2005
Hyperalgesia induced by REM sleep loss: a phenomenon in search of a mechanism. Sleep, 2006, Volume: 29, Issue:2 Topics: Acetylcholine; Adenosine; Anxiety; Chronic Disease; Depression; Drug Therapy; Drug-Related Side Effe	2006
Preoptic area neurons and the homeostatic regulation of rapid eye movement sleep. The Journal of neuroscience : the official journal of the Society for Neuroscience, 2006, Mar-15, Volume: 26, Issue:11 Topics: Animals; Biomarkers; Electroencephalography; gamma-Aminobutyric Acid; Genes, fos; Glutamate Decarbox	2006
Fos-positive cells associated with forced wakefulness in the hypothalamus of the rat are not GABAergic. Archives italiennes de biologie, 1995, Volume: 133, Issue:2 Topics: Animals; gamma-Aminobutyric Acid; Glutamate Decarboxylase; Hypothalamus; Immunohistochemistry; In Si	1995
Paradoxical sleep deprivation increases the content of glutamate and glutamine in rat cerebral cortex. Sleep, 1996, Volume: 19, Issue:1 Topics: Animals; Arousal; Benzhydryl Compounds; Central Nervous System Stimulants; Cerebral Cortex; gamma-Am	1996
Differential c-Fos expression in cholinergic, monoaminergic, and GABAergic cell groups of the pontomesencephalic tegmentum after paradoxical sleep deprivation and recovery. The Journal of neuroscience : the official journal of the Society for Neuroscience, 1999, Apr-15, Volume: 19, Issue:8 Topics: Acetylcholine; Analysis of Variance; Animals; Biogenic Monoamines; Electroencephalography; gamma-Ami	1999
c-Fos expression in GABAergic, serotonergic, and other neurons of the pontomedullary reticular formation and raphe after paradoxical sleep deprivation and recovery. The Journal of neuroscience : the official journal of the Society for Neuroscience, 2000, Jun-15, Volume: 20, Issue:12 Topics: Animals; Electroencephalography; Electromyography; gamma-Aminobutyric Acid; Glutamate Decarboxylase;	2000
Discharge profiles of ventral tegmental area GABA neurons during movement, anesthesia, and the sleep-wake cycle. The Journal of neuroscience : the official journal of the Society for Neuroscience, 2001, Mar-01, Volume: 21, Issue:5 Topics: Action Potentials; Anesthetics; Animals; Arousal; Circadian Rhythm; Electroencephalography; Electrom	2001
Effects of hypocretin-saporin injections into the medial septum on sleep and hippocampal theta. Brain research, 2001, Sep-14, Volume: 913, Issue:1 Topics: Acetylcholine; Animals; Antibodies, Monoclonal; Choline O-Acetyltransferase; Cholinergic Agents; Cho	2001
c-Fos expression in dopaminergic and GABAergic neurons of the ventral mesencephalic tegmentum after paradoxical sleep deprivation and recovery. The European journal of neuroscience, 2002, Volume: 15, Issue:4 Topics: Animals; Cell Count; Dopamine; gamma-Aminobutyric Acid; Gene Expression; Glutamate Decarboxylase; Im	2002
Increase in amino acids in the pons after sleep deprivation: a pilot study using proton magnetic resonance spectroscopy. Neuropsychobiology, 2002, Volume: 45, Issue:3 Topics: Adult; Amino Acids; Depressive Disorder; Female; gamma-Aminobutyric Acid; Glutamic Acid; Glutamine;	2002
Stress-induced insomnia: opioid-dopamine interactions. European journal of pharmacology, 1987, Oct-27, Volume: 142, Issue:3 Topics: 2,3,4,5-Tetrahydro-7,8-dihydroxy-1-phenyl-1H-3-benzazepine; Animals; Antipsychotic Agents; Appetite	1987

gamma-aminobutyric acid and Inadequate Sleep