An assessment on the effectiveness of Omega-3 as add-on therapy in mood stabilization in patients with bipolar disorder.

Phase 3

• Conditions: BIPOLAR.; Bipolar disorder, current episode mixed; F31.6

• Registration Number: IRCT20220418054579N1
• Lead Sponsor: Tehran University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 7 February 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Bipolar patients in the mix phase plus depression phase

Exclusion Criteria

Mentally retarded patients
Patients with autism spectrum
No drug use of any kind in the last month
Suffering from physical and neurological diseases
Contraindication to Omega-3 (heart problems)

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Treatment response score in the CGI questionnaire. Timepoint: 60 day. Method of measurement: Questionnaire (CGI), Questionnaire (KSADS), Questionnaire (YMRS), Questionnaire (BDI), Questionnaire (Conner’s) Based on the above questionnaires, the patient enters the study in the mixed phase without comorbidities such as psychosis, autism and mental retardation and is treated with Omega 3 or placebo. Then, the response to treatment is measured with the CGI questionnaire.

Secondary Outcome Measures

Name	Time	Method
The improvement of mood status in bipolar patients. Timepoint: 60 Day. Method of measurement: CGI Questionnaire.