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The effect of melatonin on circadian rest-activity rhythms

The effect of melatonin on circadian rest-activity rhythms during benzodiazepine tapering in patients with bipolar disorder and comparing it with the control group

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20200913048705N1
Enrollment
66
Registered
2022-02-22
Start date
2021-02-19
Completion date
Unknown
Last updated
2022-03-08

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: Patients with bipolar disorder which take melatonin when their usual benzodiazepine dosage was gradually tapered. Intervention 2: Control group: Patients with bipol

Sponsors

Zahedan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 18 years or above Had a diagnosis of bipolar mood disorder based on DSM-5 Were treated with at least one antipsychotic drug and had a daily use of at least one benzodiazepine drug for a minimum of 3 months

Exclusion criteria

Exclusion criteria: Present with current violent or aggressive behavior Diagnosed with mental retardation, pervasive developmental disorder, dementia, Physical diseases including hepatic impairment, terminal illness, severe somatic comorbidity, or epilepsy Allergic to any compounds in the study medication Fertile women Breastfeeding women Lack of informed consent Comorbid mental disorders Use of opioids and other drugs

Design outcomes

Primary

MeasureTime frame
Circadian rest-activity rhythms. Timepoint: In days one, two and three. Method of measurement: Actigraph.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Elham hajipour

Zahedan University of Medical Sciences

psishahablotfinia@gmail.com+98 54 3351 3777

Outcome results

None listed

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