Effect of Melatonin in side effects of second-generation antipsychotic medications

Melatonin attenuates antipsychotic metabolic effects:

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT2016051027832N1

Enrollment

100

Registered

2016-09-27

Start date

2015-04-03

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

Condition 1: schizophrenia. Condition 2: bipolar disorder. Schizophrenia Bipolar affective disorder

Interventions

Intervention 1: control: Tab Placebo Hs oral for 8 weeks. Intervention 2: intervention: melatonin tablet 3 mg oral HS for 8 weeks.

Prevention

control: Tab Placebo Hs oral for 8 weeks

intervention: melatonin tablet 3 mg oral HS for 8 weeks

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: men and women 18 to 64 years old who have recently been treated with second-generation antipsychotics; Exclusion criteria: patients with high blood pressure, diabetes, lipid disorders, thyroid disorders and liver diseases; a history of sensitivity to melatonin; high risk of suicide or aggression; pregnant women or lactating; patients at any time during the study drugs antipsychotic abandoned or Do not take two doses of melatonin pill; substance Abuse or dependence in the last 6 months;

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Blood pressure. Timepoint: before intervention and the end of 4th week & 8th week. Method of measurement: mmhg.;HDL. Timepoint: before intervention and the end of 4th week & 8th week. Method of measurement: mg/dl.;FBS. Timepoint: before intervention and the end of 4th week & 8th week. Method of measurement: mg/dl.;Cholesterol. Timepoint: before intervention and the end of 4th week & 8th week. Method of measurement: mg/dl.;BMI. Timepoint: before intervention and the end of 4th week & 8th week. Method of measurement: kg/m2.;Waist. Timepoint: before intervention and the end of 4th week & 8th week. Method of measurement: cm.	—

Measure

Time frame

Blood pressure. Timepoint: before intervention and the end of 4th week & 8th week. Method of measurement: mmhg.;HDL. Timepoint: before intervention and the end of 4th week & 8th week. Method of measurement: mg/dl.;FBS. Timepoint: before intervention and the end of 4th week & 8th week. Method of measurement: mg/dl.;Cholesterol. Timepoint: before intervention and the end of 4th week & 8th week. Method of measurement: mg/dl.;BMI. Timepoint: before intervention and the end of 4th week & 8th week. Method of measurement: kg/m2.;Waist. Timepoint: before intervention and the end of 4th week & 8th week. Method of measurement: cm.

—

Secondary

Measure	Time frame
Side effects of melatonin. Timepoint: the end of 4th week & 8th week. Method of measurement: clinical interview and physical examination.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMansour Agahi

Kashan Universiy Of Medical Scienses

mansour_e2000@yahoo.comagahi-ma@kaums.ac.ir+98 31 5554 2999

Outcome results

None listed

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