methylphenidate has been researched along with Sleep Initiation and Maintenance Disorders in 47 studies
Methylphenidate: A central nervous system stimulant used most commonly in the treatment of ATTENTION DEFICIT DISORDER in children and for NARCOLEPSY. Its mechanisms appear to be similar to those of DEXTROAMPHETAMINE. The d-isomer of this drug is referred to as DEXMETHYLPHENIDATE HYDROCHLORIDE.
methylphenidate : A racemate comprising equimolar amounts of the two threo isomers of methyl phenyl(piperidin-2-yl)acetate. A central stimulant and indirect-acting sympathomimetic, is used (generally as the hydrochloride salt) in the treatment of hyperactivity disorders in children and for the treatment of narcolepsy.
methyl phenyl(piperidin-2-yl)acetate : A amino acid ester that is methyl phenylacetate in which one of the hydrogens alpha to the carbonyl group is replaced by a piperidin-2-yl group.
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 |
|---|---|---|
| "We retrospectively reviewed the records of patients in two prospective controlled clinical trials that we had conducted who had received methylphenidate for cancer-related fatigue." | 3.77 | Factors associated with response to methylphenidate in advanced cancer patients. ( Bruera, E; Chacko, R; Palmer, JL; Yennurajalingam, S, 2011) |
| "Adverse event rates for insomnia (15." | 3.01 | Effect of a Multi-Layer, Extended-Release Methylphenidate Formulation (PRC-063) on Sleep in Adults with ADHD: A Randomized, Double-Blind, Forced-Dose, Placebo-Controlled Trial Followed by a 6-month Open-Label Extension. ( Cataldo, M; Donnelly, G; He, E; Khullar, A; Surman, C; Weiss, MD, 2021) |
| " Safety measures included spontaneously reported treatment-emergent adverse events (TEAEs) and two TEAEs of special interest, appetite suppression and insomnia (with direct questioning on sleep disturbance)." | 2.84 | Efficacy and Safety of HLD200, Delayed-Release and Extended-Release Methylphenidate, in Children with Attention-Deficit/Hyperactivity Disorder. ( Arnold, VK; Bostrom, S; Cutler, AJ; DeSousa, NJ; Incledon, B; López, FA; Marraffino, A; Newcorn, JH; Pliszka, SR; Sallee, FR; Wilens, TE, 2017) |
| "There was a trend for less insomnia in the agomelatine group versus MPH-treated group (4% vs." | 2.82 | Agomelatine as a Treatment for Attention-Deficit/Hyperactivity Disorder in Children and Adolescents: A Double-Blind, Randomized Clinical Trial. ( Akhondzadeh, S; Khiabany, M; Kohi, A; Mohammadi, MR; Mohammadinejad, P; Salardini, E; Shahriari, M; Zeinoddini, A, 2016) |
| " Dosing began at 36 mg/d, with titration in 18-mg increments every 7 days until a predefined outcome (efficacy threshold, maximum dosage of 108 mg/d, or limiting adverse event)." | 2.76 | Long-term safety of OROS methylphenidate in adults with attention-deficit/hyperactivity disorder: an open-label, dose-titration, 1-year study. ( Adler, LA; Berwaerts, J; Cooper, K; Harrison, DD; Orman, C; Palumbo, J; Silber, S; Starr, HL, 2011) |
| "Decreased appetite and insomnia were more common at higher dose levels for both stimulants." | 2.76 | Dose effects and comparative effectiveness of extended release dexmethylphenidate and mixed amphetamine salts. ( Aryal, S; Charney, E; Gruber, R; Newcorn, JH; Sable, C; Stein, MA; Waldman, ID, 2011) |
| "Treatment with methylphenidate resulted in increased sleep efficiency as well as a subjective feeling of improved restorative value of sleep." | 2.73 | Sleep in adults with attention deficit hyperactivity disorder (ADHD) before and during treatment with methylphenidate: a controlled polysomnographic study. ( Alm, B; Kettler, N; Schredl, M; Sobanski, E, 2008) |
| " Headache, anorexia, and insomnia were the most frequently reported treatment-related adverse events." | 2.72 | Once-daily OROS methylphenidate is safe and well tolerated in adolescents with attention-deficit/hyperactivity disorder. ( Bukstein, O; Greenhill, L; Lerner, M; McBurnett, K; McGough, JJ; Stein, M; Wilens, TE, 2006) |
| "OROS methylphenidate HCL (MPH) is a recently developed long-acting stimulant medication used to treat attention-deficit/hyperactivity disorder (ADHD)." | 2.71 | A dose-response study of OROS methylphenidate in children with attention-deficit/hyperactivity disorder. ( Black, DO; Conlon, C; Newcorn, JH; Pearl, PL; Robb, AS; Sarampote, CS; Seymour, KE; Stein, MA; Waldman, ID, 2003) |
| "To compare the side effect profiles of methylphenidate (MPH) and dexamphetamine (DEX) in children with attention deficit hyperactivity disorder (ADHD), as well as to determine which symptoms are genuine adverse effects of stimulant medication, as opposed to aspects of the child's underlying behavioral phenotype." | 2.68 | Side effects of methylphenidate and dexamphetamine in children with attention deficit hyperactivity disorder: a double-blind, crossover trial. ( Barker, M; Efron, D; Jarman, F, 1997) |
| "Experimental sleep disturbances (model insomnia) were produced by the administration of methylphenidate (MPD) 10 mg and caffeine (CAF) 150 mg." | 2.65 | Model insomnia by methylphenidate and caffeine and use in the evaluation of temazepam. ( Matsue, Y; Matsuoka, H; Okuma, T; Toyomura, K, 1982) |
| "Experimental sleep disturbance (model insomnia) was produced by intermittent white noise and the administration of 10 mg of methylphenidate (MPD)." | 2.64 | Model insomnia, noise, and methylphenidate, used for the evaluation of hypnotic drugs. ( Honda, H; Okuma, T, 1978) |
| "Methylphenidate (MPD) is a central nervous system (CNS) stimulant, which belongs to the phenethylamine group and is mainly used in the treatment of attention deficit hyperactive disorder (ADHD)." | 2.53 | From Clinical Application to Cognitive Enhancement: The Example of Methylphenidate. ( Busardò, FP; Cipolloni, L; Frati, P; Kyriakou, C; Zaami, S, 2016) |
| "High incidence of sleep disorders in children with ADHD may be associated with a substantial impact on their quality of life and exacerbation of ADHD symptoms." | 2.47 | Pharmacological treatment of ADHD and the short and long term effects on sleep. ( Guilleminault, C; Huang, YS; Tsai, MH, 2011) |
| "Those disorders discussed are attention deficit disorder, conduct disorders, anxiety disorders, sleep disorders, schizophrenia, autism, Tourette's syndrome, mental retardation, depressive illness, manic depressive illness, eating disorders, and enuresis." | 2.37 | Pharmacologic treatment of psychiatric and neurodevelopmental disorders in children and adolescents (Part 1). ( McDaniel, KD, 1986) |
| "Patients with advanced cancer with poor SQ (PSQI ≥5) were eligible." | 1.62 | Sleep disturbance in patients with cancer: a feasibility study of multimodal therapy. ( Balachandran, D; Bruera, E; Carmack, C; Delgado, M; Eng, C; Guzman Gutierrez, D; Hess, KR; Lim, B; Lu, Z; Ochoa, J; Park, M; Raznahan, M; Williams, JL; Yennurajalingam, S, 2021) |
| "We found significant intraclass correlations in family member response to methylphenidate-immediate release and side effect profile, including emotional symptoms and loss of appetite and weight." | 1.51 | High Familial Correlation in Methylphenidate Response and Side Effect Profile. ( Brand-Gothelf, A; Dubnov-Raz, G; Gazer-Snitovsky, M; Gothelf, D; Weizman, A, 2019) |
| " No occurrences of suicidal ideation or behavior were recorded; the most common open-label treatment-emergent adverse events were typical of stimulant use: decreased appetite, insomnia, and abdominal pain." | 1.46 | Efficacy, Safety, and Tolerability of a Novel Methylphenidate Extended-Release Oral Suspension (MEROS) in ADHD. ( Belden, HW; Berry, SA; Childress, AC; Findling, RL; Robb, AS; Wigal, SB, 2017) |
| " Methylphenidate (MP) appears safe when used in the treatment of depression and fatigue in advanced cancer." | 1.36 | Methylphenidate side effects in advanced cancer: a retrospective analysis. ( Davis, MP; Khoshknabi, DS; Lasheen, W; Mahmoud, F; Rivera, N; Walsh, D, 2010) |
| Timeframe | Studies, this research(%) | All Research% |
|---|---|---|
| pre-1990 | 12 (25.53) | 18.7374 |
| 1990's | 5 (10.64) | 18.2507 |
| 2000's | 13 (27.66) | 29.6817 |
| 2010's | 13 (27.66) | 24.3611 |
| 2020's | 4 (8.51) | 2.80 |
| Authors | Studies |
|---|---|
| López-Muciño, LA | 1 |
| García-García, F | 1 |
| Cueto-Escobedo, J | 1 |
| Acosta-Hernández, M | 1 |
| Venebra-Muñoz, A | 1 |
| Rodríguez-Alba, JC | 1 |
| Yennurajalingam, S | 2 |
| Carmack, C | 1 |
| Balachandran, D | 1 |
| Eng, C | 1 |
| Lim, B | 1 |
| Delgado, M | 1 |
| Guzman Gutierrez, D | 1 |
| Raznahan, M | 1 |
| Park, M | 1 |
| Hess, KR | 1 |
| Williams, JL | 1 |
| Lu, Z | 1 |
| Ochoa, J | 1 |
| Bruera, E | 2 |
| Weiss, MD | 1 |
| Surman, C | 1 |
| Khullar, A | 1 |
| He, E | 1 |
| Cataldo, M | 1 |
| Donnelly, G | 1 |
| Chierrito de Oliveira, D | 1 |
| Guerrero de Sousa, P | 1 |
| Borges Dos Reis, C | 1 |
| Tonin, FS | 1 |
| Maria Steimbach, L | 1 |
| Virtuoso, S | 1 |
| Fernandez-Llimos, F | 1 |
| Pontarolo, R | 1 |
| Cristina Conegero Sanches, A | 1 |
| Mahajnah, M | 1 |
| Sharkia, R | 1 |
| Shorbaji, N | 1 |
| Zelnik, N | 1 |
| Pliszka, SR | 2 |
| Wilens, TE | 3 |
| Bostrom, S | 1 |
| Arnold, VK | 1 |
| Marraffino, A | 1 |
| Cutler, AJ | 1 |
| López, FA | 1 |
| DeSousa, NJ | 1 |
| Sallee, FR | 1 |
| Incledon, B | 1 |
| Newcorn, JH | 3 |
| Robb, AS | 2 |
| Findling, RL | 1 |
| Childress, AC | 1 |
| Berry, SA | 1 |
| Belden, HW | 1 |
| Wigal, SB | 1 |
| Ibrahim, K | 1 |
| Donyai, P | 1 |
| Gazer-Snitovsky, M | 1 |
| Brand-Gothelf, A | 1 |
| Dubnov-Raz, G | 1 |
| Weizman, A | 1 |
| Gothelf, D | 1 |
| Busardò, FP | 1 |
| Kyriakou, C | 1 |
| Cipolloni, L | 1 |
| Zaami, S | 1 |
| Frati, P | 1 |
| Salardini, E | 1 |
| Zeinoddini, A | 1 |
| Kohi, A | 1 |
| Mohammadi, MR | 1 |
| Mohammadinejad, P | 1 |
| Khiabany, M | 1 |
| Shahriari, M | 1 |
| Akhondzadeh, S | 1 |
| Morash-Conway, J | 1 |
| Gendron, M | 1 |
| Corkum, P | 1 |
| Rapport, MD | 1 |
| Kofler, MJ | 1 |
| Coiro, MM | 1 |
| Raiker, JS | 1 |
| Sarver, DE | 1 |
| Alderson, RM | 1 |
| Ghanizadeh, A | 1 |
| Lasheen, W | 1 |
| Walsh, D | 1 |
| Mahmoud, F | 1 |
| Davis, MP | 1 |
| Rivera, N | 1 |
| Khoshknabi, DS | 1 |
| Adler, LA | 2 |
| Orman, C | 1 |
| Starr, HL | 1 |
| Silber, S | 1 |
| Palumbo, J | 1 |
| Cooper, K | 1 |
| Berwaerts, J | 1 |
| Harrison, DD | 1 |
| Palmer, JL | 1 |
| Chacko, R | 1 |
| Huang, YS | 1 |
| Tsai, MH | 1 |
| Guilleminault, C | 1 |
| Stein, MA | 2 |
| Waldman, ID | 2 |
| Charney, E | 1 |
| Aryal, S | 1 |
| Sable, C | 1 |
| Gruber, R | 1 |
| Tjon Pian Gi, CV | 1 |
| Broeren, JPA | 1 |
| Starreveld, JS | 1 |
| A Versteegh, FG | 1 |
| Sarampote, CS | 1 |
| Conlon, C | 1 |
| Pearl, PL | 1 |
| Black, DO | 1 |
| Seymour, KE | 1 |
| Martins, S | 1 |
| Tramontina, S | 1 |
| Polanczyk, G | 1 |
| Eizirik, M | 1 |
| Swanson, JM | 1 |
| Rohde, LA | 1 |
| Kratochvil, CJ | 2 |
| Lake, M | 1 |
| Walkup, JT | 1 |
| Varley, C | 1 |
| Cummins, TK | 1 |
| Martin, A | 1 |
| McGough, JJ | 1 |
| McBurnett, K | 1 |
| Bukstein, O | 1 |
| Greenhill, L | 1 |
| Lerner, M | 1 |
| Stein, M | 1 |
| Reingold, LS | 1 |
| Morrill, MS | 1 |
| Rostain, AL | 1 |
| Sobanski, E | 1 |
| Schredl, M | 1 |
| Kettler, N | 1 |
| Alm, B | 1 |
| Okuma, T | 2 |
| Matsuoka, H | 1 |
| Matsue, Y | 1 |
| Toyomura, K | 1 |
| Laffont, F | 1 |
| Cathala, HP | 1 |
| Esnault, S | 1 |
| Gilbert, A | 1 |
| Minz, M | 1 |
| Peytourg, MA | 1 |
| Waisbord, P | 1 |
| Golinko, BE | 2 |
| Rubinstein, S | 1 |
| Silver, LB | 1 |
| Licamele, WL | 1 |
| Ahmann, PA | 1 |
| Waltonen, SJ | 1 |
| Olson, KA | 1 |
| Theye, FW | 1 |
| Van Erem, AJ | 1 |
| LaPlant, RJ | 1 |
| Efron, D | 1 |
| Jarman, F | 1 |
| Barker, M | 1 |
| Kittur, S | 1 |
| Hauser, P | 1 |
| Honda, H | 1 |
| Barkley, RA | 1 |
| McMurray, MB | 1 |
| Edelbrock, CS | 1 |
| Robbins, K | 1 |
| McDaniel, KD | 1 |
| Ozaki, N | 1 |
| Iwata, T | 1 |
| Itoh, A | 1 |
| Ohta, T | 1 |
| Okada, T | 1 |
| Kasahara, Y | 1 |
| Conners, CK | 1 |
| Eisenberg, L | 1 |
| Yoss, RE | 1 |
| Daly, DD | 1 |
| Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
|---|---|---|---|---|---|---|---|
| Multimodal Therapy for the Treatment of Sleep Disturbance in Patients With Cancer[NCT01628029] | Phase 2 | 68 participants (Actual) | Interventional | 2014-01-15 | Active, not recruiting | ||
| A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel-Arm, Multi-Center Study Measuring the Efficacy and Safety of PRC-063 in Adult ADHD Patients[NCT02139124] | Phase 3 | 375 participants (Actual) | Interventional | 2014-04-30 | Completed | ||
| A Six-month, Open-label, Multi-center Study of the Safety and Efficacy of PRC-063 in Adults and Adolescents With ADHD[NCT02168127] | Phase 3 | 360 participants (Actual) | Interventional | 2014-05-31 | Completed | ||
| An Open-Label, Dose-Titration, Long-Term Safety Study to Evaluate CONCERTA (Methylphenidate HCL) Extended-release Tablets at Doses of 36 mg, 54 mg, 72 mg, 90 mg, and 108 mg Per Day in Adults With Attention Deficit Hyperactivity Disorder[NCT00326300] | Phase 3 | 560 participants (Actual) | Interventional | 2006-04-30 | Completed | ||
| Sleep and Tolerability of Extended Release Dexmethylphenidate vs. Mixed Amphetamine Salts: A Double Blind, Placebo Controlled Study (SAT STUDY)[NCT00393042] | Phase 3 | 77 participants (Actual) | Interventional | 2006-01-31 | Completed | ||
| The Effects of Methylphenidate (MPH) and Non-invasive Brain Stimulation (tDCS) on Inhibitory Control Children With Attention-Deficit/Hyperactivity Disorder (ADHD)[NCT04964427] | 26 participants (Actual) | Interventional | 2021-02-08 | Completed | |||
| Dose Response Pharmacogenetic Study of ADHD[NCT00663442] | Phase 4 | 48 participants (Actual) | Interventional | 1999-12-31 | Completed | ||
| A Multi-Center, Open Label, Evaluation of the Effect and Safety of Lisdexamfetamine in Children Aged 6-12 With Attention Deficit Hyperactivity Disorder and Autism Spectrum Disorder[NCT03337646] | Phase 4 | 48 participants (Actual) | Interventional | 2018-09-26 | Active, not recruiting | ||
| [information is prepared from clinicaltrials.gov, extracted Sep-2024] | |||||||
Participants were monitored for 4 weeks on treatment (final 2 weeks on stable dose). Clinicians rated subject behavior on the ADHD-5-Rating Scale each week. Primary outcome was based on the final week of treatment. The ADHD-5-RS is an 18-item questionnaire that measures the frequency of ADHD symptoms based on DSM-5 criteria. For each item, clinicians rate how often the behavior is displayed on a scale of 0 (Never or Rarely) to 3 (Very Often). Scores can range from 0 to 54, with lower scores indicating a lower frequency of ADHD symptoms. (NCT02139124)
Timeframe: 4 weeks
| Intervention | units on a scale (Mean) |
|---|---|
| PRC-063 25 mg | 24.2 |
| PRC-063 45 mg | 19.9 |
| PRC-063 70 mg | 24.0 |
| PRC-063 100 mg | 18.7 |
| 0 mg/Day | 26.1 |
The CGI-S scale summarizes the clinician's impression of the participant's symptom severity and ranges from 1-7 with 1 representing normal (not at all ill) and 7 representing extremely ill. (NCT00393042)
Timeframe: 8-10 weeks
| Intervention | units on a scale (Mean) |
|---|---|
| Adderall XR - Placebo | 4.26 |
| Adderall XR - 10 mg | 4.09 |
| Adderall XR - 20 mg | 3.48 |
| Adderall XR - 25/30 mg | 3.56 |
| Focalin XR - Placebo | 4.24 |
| Focalin - 10 mg | 4.24 |
| Focalin XR - 20 mg | 3.63 |
| Focalin XR - 25/30 mg | 3.55 |
Actigraphs (AW64 series) were worn each night and were used to assess participant's sleep patterns in their natural home environment. These computerized wristwatch-like devices collect data generated by movements. They are minimally invasive and allow sleep to be recorded reliably without interfering with the family's routine. One-minute epochs were used to analyze actigraphic sleep sata. Bedtimes and wake times were reported for each participant using sleep logs, and these times were used as the start and end times for the analyses. For each 1-min epoch, the total sum of activity counts were computed. If they exceeded a threshold (threshold sensitivity value = mean score in active period/45), then the epoch was considered waking. If it fell below that threshold, then it was considered sleep.The data for Adderall XR and Focalin XR was combined to look at the cumulative effects that medication has on sleep. (NCT00393042)
Timeframe: 8-10 weeks
| Intervention | minutes (Mean) |
|---|---|
| Placebo | 459.6 |
| 10mg of Either Focalin XR or Adderall XR | 446.7 |
| 20 mg of Either Focalin XR or Adderall XR | 432.17 |
| 25/30mg of Either Focalin XR or Adderall XR | 425.5 |
| Adderall XR All Dose Levels | 438.82 |
| Focalin XR All Dose Levels | 443.2 |
Measures the severity of Total ADHD symptoms, Inattention and Hyperactivity/Impulsive symptoms. The Inattention and Hyperactivity/Impulsive symptoms can range from 0 to 27 each, with a higher score reflecting more severe ADHD symptoms. The total score is calculated by summing the inattention and Hyperactivity/Impulsive subscales. The total score can range from 0 to 54 with a higher score reflecting more severe ADHD symptoms. (NCT00393042)
Timeframe: completed weekly over 8-10 weeks
| Intervention | units on a scale (Mean) | ||
|---|---|---|---|
| Inattention Symptom Subscale Scores | Hyperactivity/Impulsivity Symptom subscale scores | Total Symptoms scores | |
| Adderall XR - 10 mg | 6.40 | 10.78 | 27.15 |
| Adderall XR - 20 mg | 12.2 | 7.92 | 20.12 |
| Adderall XR - 25/30mg | 12.74 | 7.67 | 20.40 |
| Adderall XR - Placebo | 16.61 | 11.41 | 28.02 |
| Focalin XR - 10 mg | 17.51 | 10.84 | 28.35 |
| Focalin XR - 20 mg | 13.33 | 8.49 | 21.82 |
| Focalin XR - 25/30mg | 12.11 | 8.49 | 20.41 |
| Focalin XR - Placebo | 17.31 | 13.24 | 30.58 |
Three variations of the DAT 1 gene were observed, the 9/9 allele, the 9/10 allele and the 10/10 allele. The ADHD Rating Scale (ADHD-RS) and Clinical Global Impressions - Severity (CGI-S) measures were used to evaluate how the DAT 1 gene allele type altered the efficacy of the medication. The DAT 1 genotype did not predict differential response to Focalin XR or Adderall XR so the dose levels of each drug was combined to examine how the genotype interacted with the dose level. The ADHD-RS evaluates the severity of the participant's ADHD symptoms and includes two subscales: Inattention and Hyperactivity/Impulsivity. Both subscale scores range from 0 to 27 with a higher score representing more severe symptoms. The subscales are summed to calculate the total score which can range from 0 to 54. The CGI-S scale summarizes the clinician's impression of the participant's symptom severity and ranges from 1-7 with 1 representing normal (not at all ill) and 7 representing extremely ill. (NCT00393042)
Timeframe: 8-10 weeks
| Intervention | units on a scale (Mean) | |||
|---|---|---|---|---|
| ADHD-RS Inattention subscale score | ADHD-RS Hyperactivity/Impulsivity subscale score | ADHD-RS total score | CGI-S score | |
| 10/10 Allele: 10 mg of Adderall XR | 16.13 | 9.63 | 25.77 | 4.07 |
| 10/10 Allele: 10 mg of Focalin XR | 16.56 | 10.63 | 27.19 | 4.19 |
| 10/10 Allele: 20 mg of Adderall XR | 9.36 | 7.07 | 16.43 | 3.21 |
| 10/10 Allele: 20 mg of Focalin XR | 12.56 | 8.41 | 20.96 | 3.52 |
| 10/10 Allele: 25/30 mg of Adderall XR | 11.96 | 7.50 | 19.46 | 3.54 |
| 10/10 Allele: 25/30mg of Focaling XR | 11.15 | 8.65 | 19.81 | 3.31 |
| 10/10 Allele: Placebo of Adderall XR | 15.07 | 11.87 | 26.93 | 4.17 |
| 10/10 Allele: Placebo of Focalin XR | 16.44 | 13.74 | 30.19 | 4.15 |
| 9/10 Allele: 10 mg of Adderall XR | 16.27 | 10.67 | 26.80 | 4.07 |
| 9/10 Allele: 10 mg of Focalin XR | 16.93 | 8.27 | 25.20 | 4.27 |
| 9/10 Allele: 20 mg of Adderall XR | 15.86 | 8.36 | 24.21 | 3.71 |
| 9/10 Allele: 20 mg of Focalin XR | 13.36 | 6.73 | 20.09 | 3.58 |
| 9/10 Allele: 25/30 mg of Adderall XR | 13.43 | 6.43 | 19.86 | 3.50 |
| 9/10 Allele: 25/30 mg of Focalin XR | 13.70 | 7.00 | 20.70 | 3.90 |
| 9/10 Allele: Placebo of Adderall XR | 18.64 | 9.36 | 28.00 | 4.36 |
| 9/10 Allele: Placebo of Focalin XR | 18.08 | 8.92 | 27.08 | 4.31 |
| 9/9 Allele: 10 mg of Adderall XR | 18.83 | 18.33 | 37.17 | 4.33 |
| 9/9 Allele: 10 mg of Focalin XR | 22.20 | 17.40 | 39.60 | 4.60 |
| 9/9 Allele: 20 mg Adderall XR | 19.00 | 14.80 | 33.80 | 4.80 |
| 9/9 Allele: 20 mg of Focalin XR | 16.75 | 14.00 | 30.75 | 4.50 |
| 9/9 Allele: 25/30 mg of Focalin XR | 12.50 | 9.00 | 24.00 | 4.00 |
| 9/9 Allele: 25/30mg of Adderall XR | 15.40 | 10.40 | 25.80 | 4.00 |
| 9/9 Allele: Placebo of Adderall XR | 18.60 | 12.80 | 31.40 | 4.40 |
| 9/9 Allele: Placebo of Focalin XR | 19.33 | 17.33 | 36.67 | 4.67 |
Actigraphs (AW64 series) were worn each night and were used to assess participant's sleep patterns in their natural home environment. These computerized wristwatch-like devices collect data generated by movements. They are minimally invasive and allow sleep to be recorded reliably without interfering with the family's routine. One-minute epochs were used to analyze actigraphic sleep sata. Bedtimes and wake times were reported for each participant using sleep logs, and these times were used as the start and end times for the analyses. For each 1-min epoch, the total sum of activity counts were computed. If they exceeded a threshold (threshold sensitivity value = mean score in active period/45), then the epoch was considered waking. If it fell below that threshold, then it was considered sleep. The data for Adderall XR and Focalin XR was combined to look at the cumulative effects that medication has on sleep. (NCT00393042)
Timeframe: 8-10 weeks
| Intervention | HHMM.SS (Mean) | |
|---|---|---|
| Sleep start time | Sleep End time | |
| 10mg of Either Focalin XR or Adderall XR | 2304 | 0728 |
| 20mg of Either Focalin XR or Adderall XR | 2319 | 0735 |
| 25/30mg of Either Focalin XR or Adderall XR | 2325 | 0732 |
| Adderall XR All Dose Levels | 2309 | 0735 |
| Focalin XR All Dose Levels | 2309 | 0734 |
| Placebo | 2249 | 0742 |
The WFIRS consists of 50 questions where respondents are asked to rate their child's functional impairment. The items of the WFIRS are scored on a four point Likert-type rating scale: 0 (never or not at all), 1 (sometimes or somewhat), 2 (often or much) or 3 (very often or very much) and aggregated to produce six domain scores: Family (ranges between 0-24), Learning or School (ranges between 0-33), Self-Concept (ranges between 0-15), Social Activities (ranges between 0-27), Life Skills (ranges between 0-36), and Risky Activities (ranges between 0-42). The subscales are scored by summing the responses in the subsection. The Total score is the sum of all the responses and it ranges between 0-150. The higher the score in each of the subscales the more impairment is recorded, this is also true for the total score. (NCT00393042)
Timeframe: 8-10 weeks
| Intervention | units on a scale (Mean) | ||||||
|---|---|---|---|---|---|---|---|
| Family subscale score | Learning subscale score | Life skills subscale score | Self-concept subscale score | Social activities subscale score | Risky activities subscale score | Total score | |
| Adderall XR - 10 mg | 7.02 | 8.75 | 7.91 | 1.59 | 3.91 | 1.94 | 31.06 |
| Adderall XR - 20 mg | 6.35 | 6.86 | 7.44 | 1.42 | 2.98 | 2.24 | 27.32 |
| Adderall XR - 25/30mg | 6.70 | 6.21 | 7.34 | 1.06 | 3.06 | 1.68 | 26.23 |
| Adderall XR - Placebo | 6.72 | 6.74 | 7.43 | 1.11 | 3.51 | 2.19 | 27.70 |
| Focalin XR - 10 mg | 7.35 | 9.25 | 7.65 | 1.19 | 3.85 | 1.96 | 31.13 |
| Focalin XR - 20 mg | 6.50 | 7.54 | 8.30 | 1.33 | 3.54 | 1.78 | 29.20 |
| Focalin XR - 25/30mg | 6.50 | 7.39 | 7.60 | 1.31 | 3.17 | 1.67 | 27.45 |
| Focalin XR - Placebo | 7.39 | 9.30 | 8.30 | 1.25 | 3.73 | 1.91 | 20.91 |
6 reviews available for methylphenidate and Sleep Initiation and Maintenance Disorders
| Article | Year |
|---|---|
Sleep loss and addiction.
Topics: Animals; Behavior, Addictive; Cocaine; Humans; Methylphenidate; Orexins; Sleep; Sleep Initiation and | 2022 |
Safety of Treatments for ADHD in Adults: Pairwise and Network Meta-Analyses.
Topics: Adrenergic Uptake Inhibitors; Adult; Amphetamine; Atomoxetine Hydrochloride; Attention Deficit Disor | 2019 |
From Clinical Application to Cognitive Enhancement: The Example of Methylphenidate.
Topics: Animals; Attention Deficit Disorder with Hyperactivity; Central Nervous System Stimulants; Cognition | 2016 |
Pharmacological treatment of ADHD and the short and long term effects on sleep.
Topics: Actigraphy; Adolescent; Animals; Attention Deficit Disorder with Hyperactivity; Central Nervous Syst | 2011 |
Pharmacological management of treatment-induced insomnia in ADHD.
Topics: Antidepressive Agents; Attention Deficit Disorder with Hyperactivity; Central Nervous System Stimula | 2005 |
Pharmacologic treatment of psychiatric and neurodevelopmental disorders in children and adolescents (Part 1).
Topics: Adolescent; Aggression; Antidepressive Agents; Antipsychotic Agents; Anxiety, Separation; Attention | 1986 |
19 trials available for methylphenidate and Sleep Initiation and Maintenance Disorders
| Article | Year |
|---|---|
Effect of a Multi-Layer, Extended-Release Methylphenidate Formulation (PRC-063) on Sleep in Adults with ADHD: A Randomized, Double-Blind, Forced-Dose, Placebo-Controlled Trial Followed by a 6-month Open-Label Extension.
Topics: Adult; Attention Deficit Disorder with Hyperactivity; Central Nervous System Stimulants; Delayed-Act | 2021 |
Effect of a Multi-Layer, Extended-Release Methylphenidate Formulation (PRC-063) on Sleep in Adults with ADHD: A Randomized, Double-Blind, Forced-Dose, Placebo-Controlled Trial Followed by a 6-month Open-Label Extension.
Topics: Adult; Attention Deficit Disorder with Hyperactivity; Central Nervous System Stimulants; Delayed-Act | 2021 |
Effect of a Multi-Layer, Extended-Release Methylphenidate Formulation (PRC-063) on Sleep in Adults with ADHD: A Randomized, Double-Blind, Forced-Dose, Placebo-Controlled Trial Followed by a 6-month Open-Label Extension.
Topics: Adult; Attention Deficit Disorder with Hyperactivity; Central Nervous System Stimulants; Delayed-Act | 2021 |
Effect of a Multi-Layer, Extended-Release Methylphenidate Formulation (PRC-063) on Sleep in Adults with ADHD: A Randomized, Double-Blind, Forced-Dose, Placebo-Controlled Trial Followed by a 6-month Open-Label Extension.
Topics: Adult; Attention Deficit Disorder with Hyperactivity; Central Nervous System Stimulants; Delayed-Act | 2021 |
Efficacy and Safety of HLD200, Delayed-Release and Extended-Release Methylphenidate, in Children with Attention-Deficit/Hyperactivity Disorder.
Topics: Appetite; Attention Deficit Disorder with Hyperactivity; Central Nervous System Stimulants; Child; D | 2017 |
Agomelatine as a Treatment for Attention-Deficit/Hyperactivity Disorder in Children and Adolescents: A Double-Blind, Randomized Clinical Trial.
Topics: Acetamides; Adolescent; Attention Deficit Disorder with Hyperactivity; Central Nervous System Stimul | 2016 |
The role of sleep quality and quantity in moderating the effectiveness of medication in the treatment of children with ADHD.
Topics: Attention; Attention Deficit Disorder with Hyperactivity; Child; Delayed-Action Preparations; Double | 2017 |
Unexpected effects of methylphenidate in attention-deficit/hyperactivity disorder reflect decreases in core/secondary symptoms and physical complaints common to all children.
Topics: Attention Deficit Disorder with Hyperactivity; Child; Cross-Over Studies; Dose-Response Relationship | 2008 |
Long-term safety of OROS methylphenidate in adults with attention-deficit/hyperactivity disorder: an open-label, dose-titration, 1-year study.
Topics: Adolescent; Adult; Age Factors; Aged; Attention Deficit Disorder with Hyperactivity; Delayed-Action | 2011 |
Dose effects and comparative effectiveness of extended release dexmethylphenidate and mixed amphetamine salts.
Topics: Adolescent; Amphetamines; Appetite; Attention Deficit Disorder with Hyperactivity; Central Nervous S | 2011 |
Melatonin for treatment of sleeping disorders in children with attention deficit/hyperactivity disorder: a preliminary open label study.
Topics: Attention Deficit Disorder with Hyperactivity; Central Nervous System Depressants; Central Nervous S | 2003 |
A dose-response study of OROS methylphenidate in children with attention-deficit/hyperactivity disorder.
Topics: Adolescent; Attention Deficit Disorder with Hyperactivity; Central Nervous System Stimulants; Child; | 2003 |
A dose-response study of OROS methylphenidate in children with attention-deficit/hyperactivity disorder.
Topics: Adolescent; Attention Deficit Disorder with Hyperactivity; Central Nervous System Stimulants; Child; | 2003 |
A dose-response study of OROS methylphenidate in children with attention-deficit/hyperactivity disorder.
Topics: Adolescent; Attention Deficit Disorder with Hyperactivity; Central Nervous System Stimulants; Child; | 2003 |
A dose-response study of OROS methylphenidate in children with attention-deficit/hyperactivity disorder.
Topics: Adolescent; Attention Deficit Disorder with Hyperactivity; Central Nervous System Stimulants; Child; | 2003 |
A dose-response study of OROS methylphenidate in children with attention-deficit/hyperactivity disorder.
Topics: Adolescent; Attention Deficit Disorder with Hyperactivity; Central Nervous System Stimulants; Child; | 2003 |
A dose-response study of OROS methylphenidate in children with attention-deficit/hyperactivity disorder.
Topics: Adolescent; Attention Deficit Disorder with Hyperactivity; Central Nervous System Stimulants; Child; | 2003 |
A dose-response study of OROS methylphenidate in children with attention-deficit/hyperactivity disorder.
Topics: Adolescent; Attention Deficit Disorder with Hyperactivity; Central Nervous System Stimulants; Child; | 2003 |
A dose-response study of OROS methylphenidate in children with attention-deficit/hyperactivity disorder.
Topics: Adolescent; Attention Deficit Disorder with Hyperactivity; Central Nervous System Stimulants; Child; | 2003 |
A dose-response study of OROS methylphenidate in children with attention-deficit/hyperactivity disorder.
Topics: Adolescent; Attention Deficit Disorder with Hyperactivity; Central Nervous System Stimulants; Child; | 2003 |
Weekend holidays during methylphenidate use in ADHD children: a randomized clinical trial.
Topics: Adolescent; Attention Deficit Disorder with Hyperactivity; Central Nervous System Stimulants; Child; | 2004 |
Once-daily OROS methylphenidate is safe and well tolerated in adolescents with attention-deficit/hyperactivity disorder.
Topics: Adolescent; Anorexia; Attention Deficit Disorder with Hyperactivity; Central Nervous System Stimulan | 2006 |
Sleep in adults with attention deficit hyperactivity disorder (ADHD) before and during treatment with methylphenidate: a controlled polysomnographic study.
Topics: Adult; Arousal; Attention Deficit Disorder with Hyperactivity; Central Nervous System Stimulants; Fe | 2008 |
Model insomnia by methylphenidate and caffeine and use in the evaluation of temazepam.
Topics: Adult; Anti-Anxiety Agents; Caffeine; Drug Evaluation; Electroencephalography; Electrooculography; H | 1982 |
Side effects of dexedrine in hyperactive children: operationalization and quantification in a short-term trial.
Topics: Anorexia; Attention Deficit Disorder with Hyperactivity; Body Weight; Child; Dextroamphetamine; Dose | 1982 |
Placebo-controlled evaluation of Ritalin side effects.
Topics: Adolescent; Appetite; Attention Deficit Disorder with Hyperactivity; Child; Child Behavior; Child, P | 1993 |
Side effects of methylphenidate and dexamphetamine in children with attention deficit hyperactivity disorder: a double-blind, crossover trial.
Topics: Adolescent; Appetite; Attention Deficit Disorder with Hyperactivity; Central Nervous System Stimulan | 1997 |
Model insomnia, noise, and methylphenidate, used for the evaluation of hypnotic drugs.
Topics: Adult; Drug Evaluation; Electroencephalography; Flurazepam; Humans; Hypnotics and Sedatives; Male; M | 1978 |
Side effects of methylphenidate in children with attention deficit hyperactivity disorder: a systemic, placebo-controlled evaluation.
Topics: Adolescent; Attention Deficit Disorder with Hyperactivity; Child; Dose-Response Relationship, Drug; | 1990 |
Symposium: behavior modification by drugs. II. Psychological effects of stimulant drugs in children with minimal brain dysfunction.
Topics: Achievement; Attention Deficit Disorder with Hyperactivity; Bender-Gestalt Test; Brain Damage, Chron | 1972 |
22 other studies available for methylphenidate and Sleep Initiation and Maintenance Disorders
| Article | Year |
|---|---|
Sleep disturbance in patients with cancer: a feasibility study of multimodal therapy.
Topics: Adult; Aged; Aged, 80 and over; Central Nervous System Stimulants; Combined Modality Therapy; Double | 2021 |
The Clinical Characteristics of ADHD Diagnosed in Adolescents in Comparison With Younger Children.
Topics: Adolescent; Attention Deficit Disorder with Hyperactivity; Central Nervous System Stimulants; Child; | 2020 |
Efficacy, Safety, and Tolerability of a Novel Methylphenidate Extended-Release Oral Suspension (MEROS) in ADHD.
Topics: Attention Deficit Disorder with Hyperactivity; Central Nervous System Stimulants; Child; Cross-Over | 2017 |
Drug Holidays From ADHD Medication: International Experience Over the Past Four Decades.
Topics: Adolescent; Attention Deficit Disorder with Hyperactivity; Central Nervous System Stimulants; Child; | 2015 |
High Familial Correlation in Methylphenidate Response and Side Effect Profile.
Topics: Adolescent; Adult; Appetite; Attention Deficit Disorder with Hyperactivity; Central Nervous System S | 2019 |
Insomnia, night terror, and depression related to clonidine in attention-deficit/hyperactivity disorder.
Topics: Adrenergic alpha-Agonists; Attention Deficit Disorder with Hyperactivity; Central Nervous System Sti | 2008 |
Methylphenidate side effects in advanced cancer: a retrospective analysis.
Topics: Adult; Aged; Aged, 80 and over; Akathisia, Drug-Induced; Anorexia; Central Nervous System Stimulants | 2010 |
Factors associated with response to methylphenidate in advanced cancer patients.
Topics: Anorexia; Anxiety; Central Nervous System Stimulants; Depression; Drug Monitoring; Dyspnea; Fatigue; | 2011 |
Sleepiness versus sleeplessness: shift work and sleep disorders.
Topics: Amphetamines; Benzhydryl Compounds; Central Nervous System Stimulants; Circadian Rhythm; Diagnosis, | 2004 |
Less is more: inpatient management of a child with complex pharmacotherapy.
Topics: Aggression; Amphetamines; Attention Deficit Disorder with Hyperactivity; Child; Clonidine; Depressio | 2006 |
Combination pharmacotherapy for adult ADHD.
Topics: Adolescent; Adult; Antidepressive Agents, Tricyclic; Attention Deficit Disorder with Hyperactivity; | 2006 |
Sleep disturbances and ADHD medications.
Topics: Adolescent; Atomoxetine Hydrochloride; Attention Deficit Disorder with Hyperactivity; Central Nervou | 2007 |
[Effects of temazepam on experimental insomnia induced by methylphenidate in man].
Topics: Adolescent; Adult; Anti-Anxiety Agents; Double-Blind Method; Habituation, Psychophysiologic; Humans; | 1982 |
Side effects of dextroamphetamine and methylphenidate in hyperactive children--a brief review.
Topics: Anorexia; Attention Deficit Disorder with Hyperactivity; Body Weight; Child; Dextroamphetamine; Grow | 1984 |
Clonidine for stimulant-related sleep problems.
Topics: Attention Deficit Disorder with Hyperactivity; Child; Clonidine; Dextroamphetamine; Drug Therapy, Co | 1994 |
Improvement of sleep and behavior by methylphenidate in Alzheimer's disease.
Topics: Aged; Alzheimer Disease; Drug Administration Schedule; Hospitalization; Humans; Male; Mental Disorde | 1999 |
Another long-acting methylphenidate (Metadate CD).
Topics: Anorexia; Attention Deficit Disorder with Hyperactivity; Child; Child, Preschool; Clinical Trials as | 2001 |
A treatment trial of delayed sleep phase syndrome with triazolam.
Topics: Adult; Arousal; Circadian Rhythm; Depressive Disorder; Dose-Response Relationship, Drug; Drug Admini | 1989 |
Symposium: behavior modification by drugs. 3. The clinical use of stimulant drugs in children.
Topics: Adolescent; Attention Deficit Disorder with Hyperactivity; Child; Dextroamphetamine; Feeding and Eat | 1972 |
Amphetamine-type drugs for hyperactive children.
Topics: Appetite; Attention Deficit Disorder with Hyperactivity; Body Weight; Brain; Child; Dextroamphetamin | 1972 |
On the treatment of narcolepsy.
Topics: Dextroamphetamine; Feeding and Eating Disorders; Humans; Methamphetamine; Methylphenidate; Narcoleps | 1968 |
Methylphenidate (Ritalin).
Topics: Anorexia Nervosa; Antidepressive Agents; Anxiety; Depression; Humans; Methylphenidate; Sleep Initiat | 1969 |