]>
IRCT20220418054579N1 IRCT 2023-01-21 Tehran University of Medical Sciences 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. 2022-08-23 anticipated 50 Complete https://irct.ir/trial/63379 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, 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 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. 3 BIPOLAR. 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 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. Intervention 2: 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. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No end of study
public Zeinab Saadatfar
No 3, floor 4, West Roein tan, street modarres, Sq gheibi, city Rey
Tehran Iran (Islamic Republic of) 1843753158 +98 21 5555 5555 zynbsadtfr4@gmail.com Tehran University of Medical Sciences scientific Zeinab Saadatfar
No 3, floor 4, West Roein tan, street modarres, Sq gheibi, city Rey
Tehran Iran (Islamic Republic of) 1843753158 +98 21 5555 5555 zynbsadtfr4@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Bipolar patients in the mix phase plus depression phase 12 years 18 years Both 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) F31.6 Bipolar disorder, current episode mixed Treatment - Drugs Treatment - Other 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 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 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. The improvement of mood status in bipolar patients. Timepoint: 60 Day. Method of measurement: CGI Questionnaire. Lack of financial support Approved 2022-03-11 Ethics committee of Tehran University of Medical Sciences No 3, floor 4, West Roein tan, street modarres, Sq gheibi, city Rey Tehran Tehran Iran (Islamic Republic of)