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IRCT20181026041468N1 IRCT 2019-07-04 Arak University of Medical Sciences Comparing the Efficacy of Aripiprazole with other Second-Generation Antipsychotics in smoke cessation of inpatient Manic sufferers Comparing the Efficacy of Aripiprazole with other Second-Generation Antipsychotics in smoke cessation of inpatient Manic sufferers 2019-09-23 anticipated 40 Complete https://irct.ir/trial/39424 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In order to randomization, we will use the block method. Accordingly, the cases will be divided into two groups. The allocation of patients in two groups would be based on demographic characteristics and matching. Therefore, after considering the patients' demographic data, they will be divided into two equal groups of participants. The study will start by performing desired intervention on each group, Blinding description: Patients in either groups are unaware of the used drugs, and drugs has similar package. 4 Condition 1: Bipolar mood disorder. Condition 2: Nicotine dependence. Intervention 1: Intervention group: In the intervention group, treatment with Aripiprazole will initiate at baseline dose of 5 to 15 mg per day. After two weeks the dose may increase by 5 mg, as well as at weeks 4 and 6. This can be 5 mg per day to reach maximum 30 mg per day at the end of 6 weeks. Intervention 2: Control group: in control group, second-generation anti-psychotics except Aripiprazole including Risperidone, Olanzapine and Quetiapine will be prescribed. 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 It is not yet known if there will be a plan to make this available
public Mehran Shayganfard
Alamolhoda
Arak Iran (Islamic Republic of) 3819693345 +98 86 3313 5075 mshayganfard@yahoo.com Arak University of Medical Sciences scientific Mehran Shayganfard
Alamolhoda
Arak Iran (Islamic Republic of) 3819693345 +98 86 3313 5075 mshayganfard@yahoo.com Arak University of Medical Sciences Iran (Islamic Republic of) Bipolar disorder type-I patients in manic phase older than 18 Informed consent 18 years no limit Both Use of anti-psychotic medicines during the recent past 30 days Use of ECT during the recent past 6 months Pregnancy or breast-feeding Alcohol dependence Psychiatric disorders other than bipolar disorder High risk of suicide The use of mood stabilizers other than sodium valproate liver disease Positive history of polycystic ovaries Thrombocytopenia F34 F17 Persistent mood [affective] disorders Nicotine dependence Treatment - Drugs Treatment - Drugs Intervention group: In the intervention group, treatment with Aripiprazole will initiate at baseline dose of 5 to 15 mg per day. After two weeks the dose may increase by 5 mg, as well as at weeks 4 and 6. This can be 5 mg per day to reach maximum 30 mg per day at the end of 6 weeks. Control group: in control group, second-generation anti-psychotics except Aripiprazole including Risperidone, Olanzapine and Quetiapine will be prescribed. Nicotine dependence. Timepoint: 0, 1, 2, 4, 6 weeks. Method of measurement: Nicotine Dependence Syndrome Scale (NDSS). Arak University of Medical Sciences Approved 2019-02-24 Ethics committee of Arak University of Medical Sciences Alamolhoda Arak Markazi Iran (Islamic Republic of)