Study of the effect of melatium on prevention of relapse in patients with bipolar disorder

Study of the effect of melatium on prevention of relapse in patients with bipolar disorder compared with placebo

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20130812014333N158

Enrollment

104

Registered

2020-12-30

Start date

2021-01-04

Completion date

Unknown

Last updated

2021-01-05

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: The intervention group will receive 30 capsules of melatium (effective ingredients are 3 mg of melatonin and 600 mg of lithium per standardized capsule) every 24 hours for 12 weeks. In

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Age between 18 and 60 years No history of chronic physical illness such as diabetes Cardiovascular diseases, respiratory diseases and thyroid diseases Satisfaction of patients to participate in the study At least middle School degree At least one year has passed since the initial diagnosis of the disease

Exclusion criteria

Exclusion criteria: Sleep disorders Simultaneously receive other non-therapeutic treatments Chronic mental disorders, especially personality disorders based on a psychiatrist interview Addiction to drugs Severe side effects of the drug; Patients who need hospitalization

Design outcomes

Primary

Measure	Time frame
Sleep quality. Timepoint: Weeks 3, 6, 9 and after the intervention. Method of measurement: Based on sleep quality questionnaire.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Habibollah Khazaei

Kermanshah University of Medical Sciences

hakhazaie@gmail.com+98 83 8216 0700

Outcome results

None listed

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