Cyproheptadine effect on insomnia and loss of appetite caused by methylphenidate in ADHD children

Evaluate the effectiveness of cyproheptadine on prevention of sleep disorders and appetite caused by the consumption of methylphenidate in children with ADHD and its effects on the efficiency of methyl Fndyt

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT2015070623099N1

Enrollment

Registered

2015-10-18

Start date

2015-04-12

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Attention deficit hyperactivity disorder. Disturbance of activity and attention

Interventions

Intervention 1: Intervention Groups: cyproheptadine, tablets 4 mg, orally, two half a tablet twice a day for 2 months. Intervention 2: In the control group: placebo, tablet, taken orally, once daily f

Treatment - Drugs

Intervention Groups: cyproheptadine, tablets 4 mg, orally, two half a tablet twice a day for 2 months

In the control group: placebo, tablet, taken orally, once daily for two months.

Eligibility

Sex/Gender

All

Age

2 Years to 12 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: patient satisfaction; age older than 3 years old; no use of concomitant medications that have a significant impact on sleep or appetite. Exclusion criteria: the risk of renal failure; the risk of cardiovascular diseases; the risk of thyroid diseases; sensitivity to cyproheptadine; intolerance side effects.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Weight. Timepoint: Baseline; second week; forth week; sixth week; eighth week. Method of measurement: In kilograms and is using the Digital Scale.;Height. Timepoint: Baseline; second week; forth week; sixth week; eighth week. Method of measurement: Measured in meters.;Growth rate. Timepoint: Baseline; second week; forth week; sixth week; eighth week. Method of measurement: In grams per day.;Changes in sleep by PSQI scale. Timepoint: Baseline; second week; forth week; sixth week; eighth week. Method of measurement: Using PSQI questionnaire.	—

Measure

Time frame

Weight. Timepoint: Baseline; second week; forth week; sixth week; eighth week. Method of measurement: In kilograms and is using the Digital Scale.;Height. Timepoint: Baseline; second week; forth week; sixth week; eighth week. Method of measurement: Measured in meters.;Growth rate. Timepoint: Baseline; second week; forth week; sixth week; eighth week. Method of measurement: In grams per day.;Changes in sleep by PSQI scale. Timepoint: Baseline; second week; forth week; sixth week; eighth week. Method of measurement: Using PSQI questionnaire.

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Secondary

Measure	Time frame
Dry mouth. Timepoint: Baseline; second week; forth week; sixth week; eighth week. Method of measurement: Questionnaire.;Swelling. Timepoint: Baseline; second week; forth week; sixth week; eighth week. Method of measurement: Questionnaire.;Sleepiness during the day. Timepoint: Baseline; second week; forth week; sixth week; eighth week. Method of measurement: Questionnaire.;Gastrointestinal side effects (diarrhea, nausea, vomiting and abdominal pain). Timepoint: Baseline; second week; forth week; sixth week; eighth week. Method of measurement: Questionnaire.;Skin reactions. Timepoint: Baseline; second week; forth week; sixth week; eighth week. Method of measurement: Questionnaire.;Methylphenidate trade name. Timepoint: Baseline; second week; forth week; sixth week; eighth week. Method of measurement: Questionnaire.	—

Measure

Time frame

Dry mouth. Timepoint: Baseline; second week; forth week; sixth week; eighth week. Method of measurement: Questionnaire.;Swelling. Timepoint: Baseline; second week; forth week; sixth week; eighth week. Method of measurement: Questionnaire.;Sleepiness during the day. Timepoint: Baseline; second week; forth week; sixth week; eighth week. Method of measurement: Questionnaire.;Gastrointestinal side effects (diarrhea, nausea, vomiting and abdominal pain). Timepoint: Baseline; second week; forth week; sixth week; eighth week. Method of measurement: Questionnaire.;Skin reactions. Timepoint: Baseline; second week; forth week; sixth week; eighth week. Method of measurement: Questionnaire.;Methylphenidate trade name. Timepoint: Baseline; second week; forth week; sixth week; eighth week. Method of measurement: Questionnaire.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFaeze Kadkhoda Mezerji

Mashhad University of Medical Sciences - School of Pharmacy

kadkhodaf891@mums.ac.ir+98 51 3893 6424

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026