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Comparison of the effect of Agomelatine and Sertraline on bipolar depression

The efficacy comparison of Agomelatin and sertralin on depressive episode, in patients with bipolar I disorder

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20200803048284N1
Enrollment
30
Registered
2020-11-04
Start date
2020-09-27
Completion date
Unknown
Last updated
2020-11-30

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

Conditions

Bipolar Depression I. Bipolar Depression I

Interventions

Intervention 1: Bipolar I patients who are in a depressive phase and are being treated with Agomelatine are given Agomelatine tablets from Tadbir Kala Pharmaceutical Company at a dose of 25 mg only at

Sponsors

Kashan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: - Patients with bipolar I disorder in the depression phase based on the Hamilton scale and clinical interview based on the criteria of the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) Age: 65-18 No liver disease or no impaired liver test. Do not consume drugs and alcohol - Do not have serious neurological problems (epilepsy, dementia, multiple sclerosis, cerebrovascular accidents) and other psychiatric disorders (obsessive-compulsive disorder or anxiety disorders and post-traumatic stress disorder)

Exclusion criteria

Exclusion criteria: Existence of psychotic manifestations Existence of mania demonstrations Patients with suicidal ideation Pregnancy and lactation

Design outcomes

Primary

MeasureTime frame
Improve depressive symptoms and depression score based on the Hamilton scale. Timepoint: Depression scores are measured on a Hamilton scale at baseline and before medication, as well as at 2,4,6,8 weeks. Method of measurement: Using the Hamilton scale.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHamid Reza Vajgani

Kashan University of Medical Sciences

dr.hamidrezavojgani@gmail.com003155334489

Outcome results

None listed

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