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IRCT20181001041192N1 IRCT 2018-12-16 Mazandaran University of Medical Sciences The effect of Aripiprazole on obsessive compulsive symptoms Aripiprazol as an adjuvant on obsessive compulsive symptoms in patients with Schizophrenia – A randomized placebo-controlled study 2018-10-07 anticipated 40 Complete https://irct.ir/trial/34200 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Samples were gradually introduced over time. Blocking was started by sampling, and individuals were classified in those blocks according to the features defined for the characteristics of each block, due to their homogeneity. The subjects were matched for age, sex, and diagnosis. After completing the sampling, they were divided into two groups by block method. Initially the block size was selected. In order to be blinded by the person who performed the sampling, the size of the block was not mentioned. All possible blocks were assigned according to the layout of the individuals in each possible group, and each block was assigned a number. Then the number of blocks was selected from the random numbers table. Individuals were assigned to each of the intervention or control groups, respectively, Blinding description: Participants as well as clinical caregivers were blinded to the drug given to the patient. 3 Obsessive-compulsive symptoms in patients with schizophrenia. Intervention 1: In the intervention group, in addition to prescriptive antipsychotics, aripiprazole tablet was started at a dose of 5 mg per day. The dose of aripiprazole was increased to 10 mg on the second day, on the third day to 15 mg, and on the fourth day to 20 mg, and continued until the end of the study with the same dose. Intervention 2: In the control group, in addition to the antipsychotic treatment administered, placebo tablets, which were similar in shape and color to the aripiprazole pill, were prepared and used such as the dosage given in the aripiprazole group. Yes - There is a plan to make this available What will be shared: Participant data file is publicly available because the information is filled in the questionnaire.The protocol for studying and reporting clinical studies is also available. When: The access period: 3 months after printing the results. To whom: Researchers working at academic institutions. Conditions: Contact the authors by email. Where to obtain: Contact the authors by email. How to obtain: Contact the authors by email. Comments:
public Dr Abbas Massoudzadeh
Jouybar road, Sari.
Sari Iran (Islamic Republic of) 4815733971 +98 911 151 3058 masoudzadeh@yahoo.com Mazandaran University of medical sciences scientific Dr Abbas Massoudzadeh
Jouybar road, Sari.
Sari Iran (Islamic Republic of) 4815733971 +98 911 151 3058 masoudzadeh@yahoo.com Mazandaran University of medical sciences Iran (Islamic Republic of) Women and men admitted to the psychiatric wards of the Zare hospital in Sari, who were between the ages of 18 and 65. Patients diagnosed with schizophrenia based on DSM-5 criteria that simultaneously had obsessive-compulsive symptoms. If they received medications such as mood-stabilizers and anti-depressant medications along with their antipsychotic regimen, their dosage was fixed one month before the study began and during the study. 18 years 65 years Both The presence of psychiatric disorders in the first axis, as bipolar disorder or major depressive disorder. Substance dependency (based on DSM-5, as well as 6-month relapse or substance abuse in the three months prior to the onset of the study or positive urine specimen testing at the start of the study). Patients treated with ECT in the last six months. Individuals with suicidal/homicidal ideas or attempts at the start of the study or 6 months before the start of the study. People with intellectual disabilities. Pregnant or lactating women. Patients with neurological disorders such as dementia, delirium, uncontrolled seizure and head trauma. People with uncontrolled underlying conditions such as cardiovascular disease, liver and kidney failure, various malignancies, endocrine disorders and hematological disorders. Patients who have already been treated with aripiprazole. Patients who had a history of allergy or intolerance to aripiprazole. F20 Schizophrenia Treatment - Drugs Placebo In the intervention group, in addition to prescriptive antipsychotics, aripiprazole tablet was started at a dose of 5 mg per day. The dose of aripiprazole was increased to 10 mg on the second day, on the third day to 15 mg, and on the fourth day to 20 mg, and continued until the end of the study with the same dose. In the control group, in addition to the antipsychotic treatment administered, placebo tablets, which were similar in shape and color to the aripiprazole pill, were prepared and used such as the dosage given in the aripiprazole group. Obsessive-compulsive symptoms in patients with schizophrenia. Timepoint: The beginning of the study and the end of the fourth and sixth weeks. Method of measurement: by the Yale-Brown Obsessive Scale (Y-BOCS). Global Assessment of Functioning. Timepoint: At the beginning of the study, the end of the fourth and sixth weeks. Method of measurement: Global Assessment of Functioning Scale (GAF). Positive and negative and general Symptoms. Timepoint: At the beginning of the study, the end of the fourth and sixth weeks. Method of measurement: Positive and Negative Syndrome Scale (PANSS). Assess extrapyramidal side effects. Timepoint: Weekly. Method of measurement: Abnormal Involuntary Movement Scale(AIMS), Barnes Akathisia Rating Scale (BARS), Simpson-Angus Scale (SAS). Mazandaran University of Medical Sciences Approved 2017-09-27 Mazandaran University of Medical Sciences Jouybar road, Sari. Sari Mazandaran Iran (Islamic Republic of)