]>
IRCT2016121228173N3 IRCT 2017-08-01 Vice chancellor for research, Tabriz University of Medical Sciences Effect of Aripiprazole on Smoking Rate in Male Bipolar Mood Disorder I Clinical trial Comparison of the effect of Aripiprazole and placebo on the rate of smoking in male patients with type I bipolar disorder 2017-01-20 anticipated 40 Complete https://irct.ir/trial/22909 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: Randomization by blocking method. N/A Bipolar Mood Disorder, current episode manic without psychotic feauters. Intervention 1: Intervention group: Aripiprazole is administered at a dose of 10 mg per day for 6 weeks. Intervention 2: Control group: Placebo in terms of shape, size and weight similar to the َAripiprazole drug for 6 weeks.
public DR Mohammad Taher Taieb Zadegan
Razi Hospital, Shahid Bakeri Blvd (Elgoli), Tabriz.
Tabriz Iran (Islamic Republic of) +98 41 3380 4486 drtayebzadeganmt@yahoo.com Razi Hospital scientific DR Sepideh Herizchi
Razi Hospital, Shahid Bakeri Blvd (Elgoli), Tabriz.
Tabriz Iran (Islamic Republic of) +98 41 3380 4486 herizchis@tbzmed.ac.ir Research Center of Psychiatry and Behavioral Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Inclusion Criteria: The definitive diagnosis of bipolar I disorder according to DSM-IV-TR criteria; being in the partial or complete recovery phase based on Yang Mania Rating Scale; having the necessary criteria for diagnosis of nicotine dependence according to DSM-IV-TR criteria; age 18-60 Years old; male gender and consent to attend the study through the signing of informed consent. ٍExclusion Criteria: history of any allergic reaction to drug disorder with respect to Aripiprazole or other anti psychotics; dependence on other substances (based on the patient's history and the outcome of the test of morphine and methamphetamine at the start of the intervention); the use of other drugs used to quit nicotine; Use of medications other than bipolar disorder; history of physical illness (liver failure, renal failure); history of mental retardation; occurrence of any side effects due to Aripiprazole; history of cognitive impairment (dementia). 18 years 60 years Male f31.1 The patient is currently manic, without psychotic symptoms (as in F30.1), and has had at least one other affective episode (hypomanic, manic, depressive, or mixed) in the past. Treatment - Drugs Placebo Intervention group: Aripiprazole is administered at a dose of 10 mg per day for 6 weeks Control group: Placebo in terms of shape, size and weight similar to the َAripiprazole drug for 6 weeks Smoking rate (nicotine). Timepoint: before intervention,Six weeks after the intervention. Method of measurement: Fagerstrom Test for Nicotine Dependence (FTQ). Side effects of Aripiperazole. Timepoint: First and Fourth Week of Intervention. Method of measurement: Glasgow Antipsychotic Side‐effect Scale (GASS). Vice chancellor for research, Tabriz University of Medical Sciences Approved 2016-12-11 Ethics committee of Tabriz University of Medical Sciences International Relations Office, No 2 Central Building, Tabriz University of Medical Sciences, University Street. Tabriz Iran (Islamic Republic of)