IRCT | 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.

Protocol summary

Study aim: 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 aripiprazole or lithium plus risperidone.
Design: A clinical trial study with a control group with double-blind and randomized parallel groups in phase 3 on 50 patients, randomly coding identical packages containing drugs in the same size and shape as Omega-3 and placebo
Settings and conduct: Outpatients in Roozbeh Hospital referring to the clinic and being hospitalized in the ward
Participants/Inclusion and exclusion criteria: Bipolar patients in the mixed phase and depression phase (admission conditions) No entry: 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)
Intervention groups: Drug-treated bipolar patients with inadequate response randomly treated with Omega-3 or placebo
Main outcome variables: The effectiveness of Omega-3 on the improvement of mood in bipolar patients under treatment

General information

Reason for update
Acronym
IRCT registration information: IRCT registration number: IRCT20220418054579N1

Registration date: 2023-01-21, 1401/11/01

Registration timing: retrospective

Last update: 2023-01-21, 1401/11/01

Update count: 0
Registration date: 2023-01-21, 1401/11/01

Registrant information: Name

zeynab saadatfar

Name of organization / entity

Country

Iran (Islamic Republic of)

Phone

+98 21 5542 4829

Email address

zynbsadtfr4@gmail.com

Recruitment status: Recruitment complete
Funding source

Expected recruitment start date: 2022-08-23, 1401/06/01
Expected recruitment end date: 2022-12-22, 1401/10/01
Actual recruitment start date: empty
Actual recruitment end date: empty
Trial completion date: empty

Scientific title: 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.

Public title: An assessment on the effectiveness of Omega-3 as add‐on therapy in mood stabilization in patients with bipolar disorder.
Purpose: Treatment
Inclusion/Exclusion criteria: 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)
Age: From 12 years old to 18 years old
Gender: Both

Phase

3

Groups that have been masked

Participant
Investigator

Sample size

Target sample size: 50

Randomization (investigator's opinion)

Randomized

Randomization description

Patients referred to Rozbeh Hospital as outpatients or inpatients diagnosed with bipolar disorder who were treated with lithium and Aripiprazole or lithium and risperidone after being interviewed based on the Ksads questionnaire and completing other questionnaires by the project manager, referred to the clinic. And from the secretary of the clinic, they received the coded medicine, code 1 (omega 3) or code 2 (placebo) randomly.

Blinding (investigator's opinion)

Double blinded

Blinding description

Omega-3 and placebo drugs are in the form of pills of the same shape and size in the same packages marked with codes 1 and 2 and given to the patients by the clinic secretary, so that the prescribing doctor and the patient and the patient's family are not aware of its content.

Placebo

Used

Assignment

Parallel

Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee: Name of ethics committee

Ethics committee of Tehran University of Medical Sciences

Street address

No 3, floor 4, West Roein tan, street modarres, Sq gheibi, city Rey

City

Tehran

Province

Tehran

Postal code

1843753158
Approval date: 2022-03-11, 1400/12/20
Ethics committee reference number: IR.TUMS.MEDICINE.REC.1400.1522

Health conditions studied

1

Description of health condition studied: BIPOLAR
ICD-10 code: F31.6
ICD-10 code description: Bipolar disorder, current episode mixed

Primary outcomes

1

Description: 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 outcomes

1

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

Intervention groups

1

Description: Intervention group: Bipolar patients with insufficient treatment response (according to CGI questionnaire) who are treated with lithium and aripiprazole or lithium and risperidone for six weeks, after interviewing and filling out questionnaires, are randomly treated with 2000 mg of omega-3 daily for 8 weeks and then the questionnaires were taken from the patients again. Manufacturer: Dr. Zahrawi Pharmaceutical Company
Category: Treatment - Drugs

2

Description: Control group: bipolar patients with treatment response, bipolar patients with insufficient treatment response (according to CGI questionnaire) who are treated with lithium and aripiprazole or lithium and risperidone for six weeks, after interview and filling out questionnaires, they are treated with drug Placebo was placed randomly for 8 weeks and then the questionnaires were taken from the patients again. Manufacturer: Dr. Zahrawi Pharmaceutical Company
Category: Treatment - Other

Recruitment centers

1

Recruitment center: Name of recruitment center

Roozbeh hospital

Full name of responsible person

Zeinab Saadatfar

Street address

Tehran University of Medical Sciences, South Kargar Sr., Tehran

City

Tehran

Province

Tehran

Postal code

13337159140

Phone

+98 21 5541 9151

Fax

+98 21 5541 2756

Email

hosp_roozbeh@tums.ac.ir

Web page address

https://roozbehhospital.tums.ac.ir/public/fa

1

Sponsor: Name of organization / entity

Tehran University of Medical Sciences

Full name of responsible person

Lack of financial support

Street address

No 3, floor 4, West Roein tan, street modarres, Sq gheibi, city Rey

City

Tehran

Province

Tehran

Postal code

1843753158

Phone

+98 21 5555 5555

Email

zynbsadtfr4@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?: No
Title of funding source: Lack of financial support
Proportion provided by this source: 1
Public or private sector: Private
Domestic or foreign origin: Domestic
Category of foreign source of funding: empty
Country of origin
Type of organization providing the funding: Other

Person responsible for general inquiries

Contact: Name of organization / entity

Tehran University of Medical Sciences

Full name of responsible person

Zeinab Saadatfar

Position

Assistant Professor of Child and Adolescent Psychiatry

Latest degree

Specialist

Other areas of specialty/work

Psychiatrics

Street address

No 3, floor 4, West Roein tan, street modarres, Sq gheibi, city Rey

City

Tehran

Province

Tehran

Postal code

1843753158

Phone

+98 21 5555 5555

Email

zynbsadtfr4@gmail.com

Person responsible for scientific inquiries

Contact: Name of organization / entity

Tehran University of Medical Sciences

Full name of responsible person

Zeinab Saadatfar

Position

Assistant Professor of Child and Adolescent Psychiatry

Latest degree

Specialist

Other areas of specialty/work

Psychiatrics

Street address

No 3, floor 4, West Roein tan, street modarres, Sq gheibi, city Rey

City

Tehran

Province

Tehran

Postal code

1843753158

Phone

+98 21 5555 5555

Email

zynbsadtfr4@gmail.com

Person responsible for updating data

Contact: Name of organization / entity

Tehran University of Medical Sciences

Full name of responsible person

Zeinab Saadatfar

Position

Assistant Professor of Child and Adolescent Psychiatry

Latest degree

Specialist

Other areas of specialty/work

Psychiatrics

Street address

No 3, floor 4, West Roein tan, street modarres, Sq gheibi, city Rey

City

Tehran

Province

Tehran

Postal code

1843753158

Phone

+98 21 5555 5555

Email

zynbsadtfr4@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD): Undecided - It is not yet known if there will be a plan to make this available
Study Protocol: Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan: Not applicable
Informed Consent Form: Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report: Not applicable
Analytic Code: Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary: Undecided - It is not yet known if there will be a plan to make this available

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.