The effect of melatonin on circadian rest-activity rhythms
Phase 3
- Conditions
- Bipolar disorder.Bipolar disorder
- Registration Number
- IRCT20200913048705N1
- Lead Sponsor
- Zahedan University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 66
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
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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Circadian rest-activity rhythms. Timepoint: In days one, two and three. Method of measurement: Actigraph.
- Secondary Outcome Measures
Name Time Method