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

An assessment on the effectiveness of Omega-3 as add-on therapy in mood stabilization in adolescents with bipolar disorder under treatment consuming lithium plus second-generation antipsychotic (aripiprazole or risperidone): a double-blind clinical trial.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20220418054579N1

Enrollment

Registered

2023-01-21

Start date

2022-08-23

Completion date

Unknown

Last updated

2023-02-07

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

Conditions

BIPOLAR. Bipolar disorder, current episode mixed

Interventions

Intervention 1: Intervention group: Bipolar patients with insufficient treatment response (according to CGI questionnaire) who are treated with lithium and aripiprazole or lithium and risperidone for

Eligibility

Sex/Gender

All

Age

12 Years to 18 Years

Inclusion criteria

Inclusion criteria: Bipolar patients in the mix phase plus depression phase

Exclusion criteria

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)

Design outcomes

Secondary

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

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactZeinab Saadatfar

Tehran University of Medical Sciences

zynbsadtfr4@gmail.com+98 21 5555 5555

Outcome results

None listed

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