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IRCT20230814059145N1 IRCT 2023-10-22 Ahvaz University of Medical Sciences Aripiprazole as an adjuvant treatment for obsessive and compulsive symptoms in bipolar disorder Aripiprazole as an adjuvant treatment for obsessive and compulsive symptoms in bipolar disorder: A randomized, double-blind, placebo-controlled clinical trial 2023-11-01 anticipated 46 Complete https://irct.ir/trial/72706 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Other, Purpose: Other, Randomization description: The method of randomization is the use of random numbers that are used from random sequence generation software, which refers to the method used to perform a random sequence on the participants in the study, in such a way that before allocating the individual, the allocation group The finding is not clear. By using sealed opaque mail envelopes with a random sequence, each of the generated random sequences is recorded on a card and the cards are placed inside the mail envelopes in order. In order to maintain the random sequence, the outer surface of the envelopes is numbered in the same order. Finally, the lid of the letter envelopes is glued and placed in a box. At the time of starting the registration of participants, based on the order in which eligible participants entered the study, one of the envelopes will be opened and the assigned group of that participant will be revealed, Blinding description: The patients are randomly divided into two control and intervention groups, the control group receives placebo in addition to the drugs consumed, and the intervention group receives aripiprazole in addition to the drugs consumed, and the main partner of the project and the patient remain unaware of the type of treatment. 3 Bipolar disorder. Intervention 1: Intervention group:The intervention group will receive quetiapine with the addition of sodium valproate and aripiprazole. Aripiprazole will be added to patients' current medications at an initial dose of 5 mg per day, and then the dose will be increased by 5 mg per week up to 20 mg per day.Aripiprazole is produced by Actoverco pharmaceutical company. Intervention 2: Control group: they will receive quetiapine plus sodium valproate and placebo. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Maryam Poorshams
Golestan hospital, Farvardin Blvd, Golestan Ave, Ahvaz Ahvaz
Ahvaz Iran (Islamic Republic of) 6135715794 +98 61 3374 3038 poorshams@ajums.ac.ir Ahvaz University of Medical Sciences scientific Hamzeh Rostami
Golestan hospital, Farvardin Blvd, Golestan Ave, Ahvaz Ahvaz
Ahvaz Iran (Islamic Republic of) 6135715794 +98 61 3374 3038 rostami.h@ajums.ac.ir Ahvaz University of Medical Sciences Iran (Islamic Republic of) Age 18 to 60 years Confirmation of bipolar disorder based on DSM-5 criteria 18 years 60 years Both Not having cardiovascular, respiratory, kidney or digestive diseases Not pregnant Not suffering from drug or alcohol abuse F31 Bipolar disorder Treatment - Drugs Treatment - Drugs Intervention group:The intervention group will receive quetiapine with the addition of sodium valproate and aripiprazole. Aripiprazole will be added to patients' current medications at an initial dose of 5 mg per day, and then the dose will be increased by 5 mg per week up to 20 mg per day.Aripiprazole is produced by Actoverco pharmaceutical company. Control group: they will receive quetiapine plus sodium valproate and placebo Depression. Timepoint: Before the intervention and weeks 4, 8 and 12 after the intervention. Method of measurement: Hamilton. Symptoms of mania. Timepoint: Before the intervention and weeks 4, 8 and 12 after the intervention. Method of measurement: Young mania rating scale. Obsessive compulsive symptoms. Timepoint: Before the intervention and weeks 4, 8 and 12 after the intervention. Method of measurement: Yale brown obsessive compulsive scale scoring. Drug complication. Timepoint: Before the intervention and weeks 4, 8 and 12 after the intervention. Method of measurement: Abnormal Involuntary Movement scale. Ahvaz University of Medical Sciences Approved 2022-11-01 Ethics committee of Ahvaz Jundishapur University of Medical Sciences Ahvaz, Golestan St., Farvardin Blvd., Jundishapur University of Medical Sciences, Ahvaz Ahvaz Khouzestan Iran (Islamic Republic of)