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Comparing the Effects of Agomelatonin and Olanzapine in Insomnia

Investigating Effects of Agomelatine and Olanzapine in Insomnia with Bipolar Patients

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20100127003210N31
Enrollment
40
Registered
2025-06-10
Start date
2025-06-10
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

Insomnia in bipolar patients. Bipolar disorder

Interventions

Intervention 1: Intervention group: One 5 mg oral tablet of olanzapine, Sobhan Company. Orally at night before bedtime for 6 weeks to assess primary goals and then for 4 weeks to assess secondary goal

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
16 Years to 50 Years

Inclusion criteria

Inclusion criteria: Diagnosis of Bipolar Disorder by Psychiatrist Based on DSM-5 and SCID Obtain informed consent from the patient or caretaker Age range 16-50 years. Note: this disease is more common in young people The presence of symptoms of insomnia in patients Patient has not taking psychiatric medication in the last 3 months

Exclusion criteria

Exclusion criteria: History of severe liver disease, heart disease, epilepsy, dementia; that can interfere with the safe administration of agomelatine or olanzapine Known severe allergic reactions or hypersensitivity to agomelatine, olanzapine or any excipients of these drugs Pregnancy or breastfeeding or planning to become pregnant during the study period, as these drugs may pose risks to the developing fetus Presence of prominent neurological or organic disorder Presence of simultaneous diagnosis of type one and two bipolar disorder Received ECT in the last 6 weeks Narcotic or opioid use

Design outcomes

Primary

MeasureTime frame
Insomnia. Timepoint: The patients filled the ISI questionnaire before receiving the medicine, then two days after, and then weekly for 6 weeks or until discharge. Method of measurement: Insomnia Severity Index questionnaire.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMaria Tavakoli Ardakani

Shahid Beheshti University of Medical Sciences

mariatavakoli@sbmu.ac.ir+98 21 8887 3704

Outcome results

None listed

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