methylphenidate and Appetite Disorders 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.

Research Excerpts

Excerpt	Relevance	Reference
" This research evaluates the preventive effects of cyproheptadine on sleeping and appetite disorders induced by methylphenidate in ADHD children."	9.30	Preventive effect of cyproheptadine on sleep and appetite disorders induced by methylphenidate: an exploratory randomised, double-blinded, placebo-controlled clinical trial. ( Elyasi, S; Kadkhoda Mezerji, F; Mohammadpour, AH; Moharreri, F, 2019)
" This research evaluates the preventive effects of cyproheptadine on sleeping and appetite disorders induced by methylphenidate in ADHD children."	5.30	Preventive effect of cyproheptadine on sleep and appetite disorders induced by methylphenidate: an exploratory randomised, double-blinded, placebo-controlled clinical trial. ( Elyasi, S; Kadkhoda Mezerji, F; Mohammadpour, AH; Moharreri, F, 2019)
"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)
"Obesity is a major public health problem."	2.41	The role of dopamine in motivation for food in humans: implications for obesity. ( Fowler, JS; Volkow, ND; Wang, GJ, 2002)
"Increased research focusing on the eating disorders has put the clinician on firmer ground when choosing appropriate psychopharmacologic treatments."	2.37	Pharmacologic treatment of eating disorders. ( Gwirtsman, H; Jimerson, DC; Kaye, W; Weintraub, M, 1984)
"Only daytime sleepiness was more common for those receiving α2-adrenergic agonists vs stimulants (38% vs 3%); several adverse effects were reported more commonly for those receiving stimulants vs α2-adrenergic agonists, including moodiness/irritability (50% vs 29%), appetite suppression (38% vs 7%), and difficulty sleeping (21% vs 11%)."	1.62	α2-Adrenergic Agonists or Stimulants for Preschool-Age Children With Attention-Deficit/Hyperactivity Disorder. ( Barbaresi, W; Bax, A; Blum, NJ; Cacia, J; Deavenport-Saman, A; Friedman, S; Harstad, E; LaRosa, A; Loe, IM; Mittal, S; Shults, J; Tulio, S; Vanderbilt, D, 2021)
"Methylphenidate is an amphetamine psychostimulant used as a symptomatic treatment for attention-deficit hyperactivity disorder."	1.37	Methylphenidate: growth retardation. ( , 2011)
"A possibly different mechanism in hypersomnia and hypersexuality is speculated."	1.26	The Kleine-Levine syndrome--a variant? ( Nair, NP; Yassa, R, 1978)

Research

Studies (22)

Authors

Clinical Trials (4)

Trial Overview

Trial Outcomes

Clinical Global Impression - Severity

Timeframe	Studies, this research(%)	All Research%
pre-1990	14 (63.64)	18.7374
1990's	1 (4.55)	18.2507
2000's	3 (13.64)	29.6817
2010's	2 (9.09)	24.3611
2020's	2 (9.09)	2.80

Authors	Studies
Harstad, E	1
Shults, J	1
Barbaresi, W	1
Bax, A	1
Cacia, J	1
Deavenport-Saman, A	1
Friedman, S	1
LaRosa, A	1
Loe, IM	1
Mittal, S	1
Tulio, S	1
Vanderbilt, D	1
Blum, NJ	1
Kadkhoda Mezerji, F	1
Moharreri, F	1
Mohammadpour, AH	1
Elyasi, S	1
Wang, GJ	1
Volkow, ND	1
Fowler, JS	1
Stein, MA	1
Sarampote, CS	1
Waldman, ID	1
Robb, AS	1
Conlon, C	1
Pearl, PL	1
Black, DO	1
Seymour, KE	1
Newcorn, JH	1
Martins, S	1
Tramontina, S	1
Polanczyk, G	1
Eizirik, M	1
Swanson, JM	1
Rohde, LA	1
Gwirtsman, H	1
Kaye, W	1
Weintraub, M	1
Jimerson, DC	1
Lenz, H	1
Cole, SO	1
Billiard, M	1
Guilleminault, C	1
Dement, WC	1
Yassa, R	1
Nair, NP	1
Antelman, SM	1
Caggiula, AR	1
Black, CA	1
Edwards, DJ	1
Lucas, B	1
Sells, CJ	1
Quinn, PO	2
Rapoport, JL	2
Barkley, RA	1
McMurray, MB	1
Edelbrock, CS	1
Robbins, K	1
Conners, CK	1
Eisenberg, L	1
Bradbard, G	1
Riddle, KD	1
Brooks, E	1
Green, LN	1
Cracco, RQ	1
Yoss, RE	1
Daly, DD	1
Fischer, KC	1
Wilson, WP	1

Trial	Phase	Enrollment	Study Type	Start Date	Status
Efficacy of Pharmacologic Management of ADHD in Children and Youth With Autism Spectrum Disorder[NCT05916339]	Phase 4	500 participants (Anticipated)	Interventional	2023-10-01	Not yet recruiting
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
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
Dose Response Pharmacogenetic Study of ADHD[NCT00663442]	Phase 4	48 participants (Actual)	Interventional	1999-12-31	Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

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

Sleep Duration

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

ADHD Parent Rating Scale-IV

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

Dopamine Active Transporter (DAT) 1 Gene Type Effects on ADHD Symptoms

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

Sleep Start Time, and End Time as Determined by Actigraph and Sleep Diary Over 8 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

Weiss Functional Impairment Rating Scale (WFIRS)

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

Article	Year
The role of dopamine in motivation for food in humans: implications for obesity. Expert opinion on therapeutic targets, 2002, Volume: 6, Issue:5 Topics: Animals; Appetite; Brain Chemistry; Corpus Striatum; Dopamine; Dopamine Agonists; Dopamine Antagonis	2002
Pharmacologic treatment of eating disorders. The Psychiatric clinics of North America, 1984, Volume: 7, Issue:4 Topics: Anorexia Nervosa; Anticonvulsants; Antidepressive Agents; Antidepressive Agents, Tricyclic; Central	1984
Hyperkinetic children: the use of stimulant drugs evaluated. The American journal of orthopsychiatry, 1975, Volume: 45, Issue:1 Topics: Achievement; Animals; Attention; Blood Pressure; Central Nervous System; Dextroamphetamine; Feeding	1975

Article	Year
Preventive effect of cyproheptadine on sleep and appetite disorders induced by methylphenidate: an exploratory randomised, double-blinded, placebo-controlled clinical trial. International journal of psychiatry in clinical practice, 2019, Volume: 23, Issue:1 Topics: Attention Deficit Disorder with Hyperactivity; Central Nervous System Stimulants; Child; Child, Pres	2019
A dose-response study of OROS methylphenidate in children with attention-deficit/hyperactivity disorder. Pediatrics, 2003, Volume: 112, Issue:5 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. Pediatrics, 2003, Volume: 112, Issue:5 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. Pediatrics, 2003, Volume: 112, Issue:5 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. Pediatrics, 2003, Volume: 112, Issue:5 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. Pediatrics, 2003, Volume: 112, Issue:5 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. Pediatrics, 2003, Volume: 112, Issue:5 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. Pediatrics, 2003, Volume: 112, Issue:5 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. Pediatrics, 2003, Volume: 112, Issue:5 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. Pediatrics, 2003, Volume: 112, Issue:5 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. Journal of child and adolescent psychopharmacology, 2004,Summer, Volume: 14, Issue:2 Topics: Adolescent; Attention Deficit Disorder with Hyperactivity; Central Nervous System Stimulants; Child;	2004
Nutrient intake and stimulant drugs in hyperactive children. Journal of the American Dietetic Association, 1977, Volume: 70, Issue:4 Topics: Ascorbic Acid; Calcium, Dietary; Child; Clinical Trials as Topic; Dextroamphetamine; Diet; Dietary P	1977
One-year follow-up of hyperactive boys treated with imipramine or methylphenidate. The American journal of psychiatry, 1975, Volume: 132, Issue:3 Topics: Administration, Oral; Body Weight; Child Behavior Disorders; Clinical Trials as Topic; Drug Evaluati	1975
Side effects of methylphenidate in children with attention deficit hyperactivity disorder: a systemic, placebo-controlled evaluation. Pediatrics, 1990, Volume: 86, Issue:2 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. Pediatrics, 1972, Volume: 49, Issue:5 Topics: Achievement; Attention Deficit Disorder with Hyperactivity; Bender-Gestalt Test; Brain Damage, Chron	1972
Imipramine and methylphenidate treatments of hyperactive boys. A double-blind comparison. Archives of general psychiatry, 1974, Volume: 30, Issue:6 Topics: Attention; Child; Child Behavior Disorders; Child, Preschool; Clinical Trials as Topic; Cognition; D	1974

Article	Year
Adult attention deficit/hyperactivity disorder in the ambulatory care setting: Erratum. JAAPA : official journal of the American Academy of Physician Assistants, 2020, Volume: 33, Issue:11 Topics: Ambulatory Care; Atomoxetine Hydrochloride; Attention Deficit Disorder with Hyperactivity; Bupropion	2020
α2-Adrenergic Agonists or Stimulants for Preschool-Age Children With Attention-Deficit/Hyperactivity Disorder. JAMA, 2021, 05-25, Volume: 325, Issue:20 Topics: Adrenergic alpha-2 Receptor Agonists; Attention Deficit Disorder with Hyperactivity; Central Nervous	2021
Methylphenidate: growth retardation. Prescrire international, 2011, Volume: 20, Issue:120 Topics: Adolescent; Attention Deficit Disorder with Hyperactivity; Central Nervous System Stimulants; Child;	2011
[Kleine-Levin-syndrome (author's transl)]. Wiener medizinische Wochenschrift (1946), 1980, Jun-15, Volume: 130, Issue:11 Topics: Adolescent; Body Water; Disorders of Excessive Somnolence; Feeding and Eating Disorders; Female; Hum	1980
A menstruation-linked periodic hypersomnia. Kleine-Levin syndrome or new clinical entity? Neurology, 1975, Volume: 25, Issue:5 Topics: Adolescent; Disorders of Excessive Somnolence; Electroencephalography; Estrogens, Conjugated (USP);	1975
The Kleine-Levine syndrome--a variant? The Journal of clinical psychiatry, 1978, Volume: 39, Issue:3 Topics: Adult; Disorders of Excessive Somnolence; Feeding and Eating Disorders; Humans; Hypothalamus; Male;	1978
Stress reverse the anorexia induced by amphetamine and methylphenidate but not fenfluramine. Brain research, 1978, Mar-31, Volume: 143, Issue:3 Topics: Animals; Anorexia; Dextroamphetamine; Dose-Response Relationship, Drug; Feeding and Eating Disorders	1978
Symposium: behavior modification by drugs. 3. The clinical use of stimulant drugs in children. Pediatrics, 1972, Volume: 49, Issue:5 Topics: Adolescent; Attention Deficit Disorder with Hyperactivity; Child; Dextroamphetamine; Feeding and Eat	1972
Kleine-Levin syndrome. A case with EEG evidence of periodic brain dysfunction. Archives of neurology, 1970, Volume: 22, Issue:2 Topics: Adult; Arousal; Brain; Electroencephalography; Feeding and Eating Disorders; Follow-Up Studies; Huma	1970
On the treatment of narcolepsy. The Medical clinics of North America, 1968, Volume: 52, Issue:4 Topics: Dextroamphetamine; Feeding and Eating Disorders; Humans; Methamphetamine; Methylphenidate; Narcoleps	1968
Methylphenidate and the hyperkinetic state. Diseases of the nervous system, 1971, Volume: 32, Issue:10 Topics: Ataxia; Child; Drug Synergism; Feeding and Eating Disorders; Humans; Hyperkinesis; Hypertension; Met	1971

methylphenidate and Appetite Disorders