Effect of Melatonin on the components of metabolic syndrome in adolescent bipolarpatients taking risperidone plus lithium carbonate

Effect of Melatonin on the components of metabolic syndrome in adolescent bipolarpatients taking risperidone plus lithium carbonate: a randomized,double blind, placebo-controlled clinical trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT201208071556N44

Enrollment

Registered

2012-08-26

Start date

2012-09-05

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

Bipolar disorder. Bipolar affective disorder

Interventions

Intervention 1: Intervention group:Tablet Risperidone plus lithium plus melatonin( 3 mg/day) for 12 weeks. Intervention 2: Tablet Risperidone plus lithium plus placebo for 12 weeks.

Treatment - Drugs

Placebo

Intervention group:Tablet Risperidone plus lithium plus melatonin( 3 mg/day) for 12 weeks

Tablet Risperidone plus lithium plus placebo for 12 weeks

Eligibility

Sex/Gender

All

Age

11 Years to 17 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: 1-Bipolar Disorder type 1( according to DSM-IV criteria) 2-age between 11-17 3- weight within normal range Exclusion criteria: 1-Active medical disease including seizure, hepatic disease, organic brain syndromes, Diabetes 2-history of metabolic syndrome 3-using appetizers such as antihistamines or appetite suppressors like amphetamines 4-heavy consumption of Xantine drivatives( tea, coffee and cacao)

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Body Mass Index. Timepoint: Baseline and weeks 6-12 after beginig of treatment. Method of measurement: Calculated as body weight (kg) divided by the height in meters squared.;High-density lipoprotein (HDL). Timepoint: Baseline and weeks 6-12 after beginig of treatment. Method of measurement: Biochemistry.;Low- density lipoprotein. Timepoint: Baseline and weeks 6-12 after beginig of treatment. Method of measurement: Biochemistry.;Fasting blood sugar. Timepoint: Baseline and weeks 6-12 after beginig of treatment. Method of measurement: Biochemistry.;TG. Timepoint: Baseline and weeks 6-12 after beginig of treatment. Method of measurement: Biochemistry.;Blood pressure. Timepoint: Baseline and weeks 6-12 after beginig of treatment. Method of measurement: Mercury sphygmomanometer.	—

Measure

Time frame

Body Mass Index. Timepoint: Baseline and weeks 6-12 after beginig of treatment. Method of measurement: Calculated as body weight (kg) divided by the height in meters squared.;High-density lipoprotein (HDL). Timepoint: Baseline and weeks 6-12 after beginig of treatment. Method of measurement: Biochemistry.;Low- density lipoprotein. Timepoint: Baseline and weeks 6-12 after beginig of treatment. Method of measurement: Biochemistry.;Fasting blood sugar. Timepoint: Baseline and weeks 6-12 after beginig of treatment. Method of measurement: Biochemistry.;TG. Timepoint: Baseline and weeks 6-12 after beginig of treatment. Method of measurement: Biochemistry.;Blood pressure. Timepoint: Baseline and weeks 6-12 after beginig of treatment. Method of measurement: Mercury sphygmomanometer.

—

Secondary

Measure	Time frame
Severity of depression. Timepoint: Baseline and weeks 6 and 12 after startin treatment. Method of measurement: By Hamilton depression rating scale.;Severity of mania. Timepoint: Baseline and weeks 6 and 12 after startin treatment. Method of measurement: By Young mania rating scale.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactProf. Shahin Akhondzadeh

Tehran University of Medical Sciences

s.akhond@sina.tums.ac.ir+98 21 5541 2222

Outcome results

None listed

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