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IRCT20110819007373N8 IRCT 2018-12-29 Arak University of Medical Sciences Effectiveness of Aripiprazole in Acute Mania Comparing the Efficacy of Aripiprazole with other Second-Generation Antipsychotics in Acute Mania Symptoms in Manic Patients 2018-12-05 anticipated 50 Complete https://irct.ir/trial/35030 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 patients under study are divided into two groups. The allocation of patients in two groups was based on demographic characteristics and their matching. Based on this, after considering the patients' demographic data, patients were divided into two equal groups of patients, they enrolled in the study and performed desired intervention on them, Blinding description: This means that patients in groups do not know the used drugs, and drugs has similar packaging. 4 Manic. Intervention 1: Intervention group: Aripiprazole is used in these patients, initiating treatment with aripiprazole at a dose of 5 to 15 mg per day, after two weeks, the dose is increased to 5 mg, also at 4 and 6 weeks it also added 5 mg daily for treatment to reach 30 mg per day at the end of 6 weeks. Intervention 2: Control group: In these patients, second-generation antipsychotic therapy is initiated with risperidone 2-3 mg once daily to a maximum of 6 mg per day, with an increase in the dose not to be greater than 1 mg per day and at intervals Less than 24 hours. Starting treatment with olanzapine is 10-15 mg per day, which can increase to 20-25 mg per day. Initiation of quetiapine treatment is 100 mg daily in divided doses. Increasing to 100 mg daily to 400 mg daily in divided doses on day 4 and on days 5 and 6 daily increases to 200 mg to 800 mg per day. Sodium valproate orally at a dose of 250 mg per day, which can be increased to 250 mg three times a day within 3 to 6 days, ultimately increasing to 1200-1500 mg daily in split doses. 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 decision has been taken.
public Hamidreza Jamilian
Amir-Kabir Hospital, Basij Square, Arak.
Arak Iran (Islamic Republic of) 3819693345 +98 86 3313 5075 jamilian.hr@arakmu.ac.ir Arak University of Medical Sciences scientific HamidReza Jamilian
Amir-Kabir Hospital, Basij Square, Arak.
Arak Iran (Islamic Republic of) 3819693345 +98 918 161 8542 jamilian.hr@arakmu.ac.ir Arak University of Medical Sciences Iran (Islamic Republic of) Patients with bipolar I disorder in the phase of mania Age older than 18 years Satisfaction for the study 18 years no limit Both Patients who have used anti-psychotic medicines for the past 30 days Patients who have been using ECT for the past 6 months Patients who are pregnant or breast-feeding Patients with alcohol dependence Cognitive impairment other than bipolar disorder High risk of suicide The use of medication stabilizers other than sodium valproate liver disorders The history of polycystic ovaries Thrombocytopenia F30.1 Manic episode without psychotic symptoms Treatment - Drugs Treatment - Drugs Intervention group: Aripiprazole is used in these patients, initiating treatment with aripiprazole at a dose of 5 to 15 mg per day, after two weeks, the dose is increased to 5 mg, also at 4 and 6 weeks it also added 5 mg daily for treatment to reach 30 mg per day at the end of 6 weeks. Control group: In these patients, second-generation antipsychotic therapy is initiated with risperidone 2-3 mg once daily to a maximum of 6 mg per day, with an increase in the dose not to be greater than 1 mg per day and at intervals Less than 24 hours. Starting treatment with olanzapine is 10-15 mg per day, which can increase to 20-25 mg per day. Initiation of quetiapine treatment is 100 mg daily in divided doses. Increasing to 100 mg daily to 400 mg daily in divided doses on day 4 and on days 5 and 6 daily increases to 200 mg to 800 mg per day. Sodium valproate orally at a dose of 250 mg per day, which can be increased to 250 mg three times a day within 3 to 6 days, ultimately increasing to 1200-1500 mg daily in split doses. Symptoms of acute mania. Timepoint: Initially and 2, 4 and 6 weeks. Method of measurement: Using Yang Mania Rating Scale (YMRS), Clinical Global Impression Questionnaire (CGI) and Young Mania Rating Scale (YMRS). Arak University of Medical Sciences Approved 2018-09-22 Ethics committee of Arak University of Medical Sciences Basij Square Arak Markazi Iran (Islamic Republic of)