Effect of melatonin versus placebo on the sleep improvement and quality of life in patients with bipolar disorder in the manic phase

Effect of melatonin versus placebo on the sleep improvement and quality of life in patients with bipolar disorder in the manic phase: a double-blind randomized clinical trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20120215009014N314

Enrollment

Registered

2019-10-29

Start date

2019-11-12

Completion date

Unknown

Last updated

2019-11-05

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

Conditions

Bipolar disorder. Bipolar disorder

Interventions

Intervention 1: Intervention group: Routine treatment plus melatonin tablets manufactured by Jairus Company 30 mg every night for one week and then 60 mg every night for three weeks. Intervention 2: C

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Age of 18 to 65 years, Bipolar disorder in manic phase

Exclusion criteria

Exclusion criteria: Panic disorder or social phobia, Depressive disorder, Schizophrenia, Alcohol or drug abuse, History of suicide in the past year

Design outcomes

Primary

Measure	Time frame
Quality of sleep. Timepoint: Before the intervention and 4 weeks after that. Method of measurement: By Insomnia Severity Index (ISI).;Quality of life. Timepoint: Before the intervention and 4 weeks after that. Method of measurement: By Young Mania Rating Scale (YMRS).	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactZahra Ghasemian

Hamedan University of Medical Sciences

zahraghasemian758@gmail.com+98 81 3838 0572

Outcome results

None listed

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