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IRCT2014092719295N1 IRCT 2017-03-07 Vice chancellery for Research Shiraz University of Medical Sciences Assessing the effectiveness of treatment by aripiprazole and placebo for control of obsesion in patients with Bipolar mood disorder Research center for Psychiatry and Behavior Science Assessing the effectiveness of treatment by aripiprazole and placebo with lithium and benzodiazepin to control of obsesion in patients with Bipolar mood disorder 2016-05-14 anticipated 40 Complete https://irct.ir/trial/17292 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. 2-3 Condition 1: Bipolar disorder. Condition 2: Obsessive-Compulsive disorder. Intervention 1: The study is a double blind clinical trial. Interventional Group (Group A) is 20 people that receive Aripiprazole in addition to Lithium and Benzodiazepine (if necessary). Administrator is doing Obsession severity assessment at week 0 by Yale Brown questionnaire and main partner do follow in next weeks. Side effects will be evaluated according to the side effects list at weeks 4 and 8. Change in symptoms of obsession also evaluated at weeks 4 and 8. Administrator is present every tuesday to visit patients at the clinic and give number to patient if necessary. Lithium and Benzodiazepine dose prescribed at a level which will control symptoms. Aripiperazol start with initial dose of 5 milligram/day and 5 milligram added every week till reach up to 20 mg daily (Base on tolerance drugs be adjusted). Yale Brown questionnaire has 10 items and each item receives a score of 0 to 4 (no symptoms to maximum). Questions are about time for washing, create problems in life, patient resistance and control on thoughts and rituals. The same questions ask about compulsions. The questionnaire had Validity and reliability in various studies. Intervention 2: This study is a double blind clinical trial. Control Group (Group B) is 20 people that receive Placebo in addition to Lithium and Benzodiazepine (if necessary). Administrator is doing obsession severity assessment at week 0 by Yale Brown questionnaire and main partner do follow in next weeks. Side effects will be evaluated according to the side effects list at weeks 4 and 8. Change in symptoms of obsession also evaluated at weeks 4 and 8. Administrator is present every tuesday to visit patients at the clinic and give number to patient if necessary. Lithium and Benzodiazepine dose prescribed at a level which will control symptoms (drugs Will be adjusted based on patient tolerance). Placebo administered with the same dose of Arippiperazol.
public Zahra Ehsaei
Hafez Hospital, Shiraz University of Medical Sciences
Shiraz Iran (Islamic Republic of) +98 71 3627 9319 Zahraehsaei@yahoo.com Department of Psychiatry, Siraz University of Medical Sciences scientific Ali Sahraian
Department of Psychiatry, Hafez Hospital ,Shiraz University of Medical Sciences
Shiraz Iran (Islamic Republic of) +98 71 3627 9319 Sahraian@sums.ac.ir Psychiatry department, Siraz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Inclusion criteria: Patients with a diagnosis of bipolar disorder according to the DSM IV TR criteria; Yale Brown Score more than 16 at baseline; No important medical condition Exclusion criteria: Patients were not in acute phase of depression and mania; Important medical condition (cardiovascular, Respirator, renal, Gastrointestinal disease); Pregnancy; Yale Brown Score less than 16 at baseline 18 years 65 years Both F31 F42 Bipolar affective disorder Obsessive-compulsive disorder Treatment - Drugs Treatment - Drugs The study is a double blind clinical trial. Interventional Group (Group A) is 20 people that receive Aripiprazole in addition to Lithium and Benzodiazepine (if necessary). Administrator is doing Obsession severity assessment at week 0 by Yale Brown questionnaire and main partner do follow in next weeks. Side effects will be evaluated according to the side effects list at weeks 4 and 8. Change in symptoms of obsession also evaluated at weeks 4 and 8. Administrator is present every tuesday to visit patients at the clinic and give number to patient if necessary. Lithium and Benzodiazepine dose prescribed at a level which will control symptoms. Aripiperazol start with initial dose of 5 milligram/day and 5 milligram added every week till reach up to 20 mg daily (Base on tolerance drugs be adjusted). Yale Brown questionnaire has 10 items and each item receives a score of 0 to 4 (no symptoms to maximum). Questions are about time for washing, create problems in life, patient resistance and control on thoughts and rituals. The same questions ask about compulsions. The questionnaire had Validity and reliability in various studies. This study is a double blind clinical trial. Control Group (Group B) is 20 people that receive Placebo in addition to Lithium and Benzodiazepine (if necessary). Administrator is doing obsession severity assessment at week 0 by Yale Brown questionnaire and main partner do follow in next weeks. Side effects will be evaluated according to the side effects list at weeks 4 and 8. Change in symptoms of obsession also evaluated at weeks 4 and 8. Administrator is present every tuesday to visit patients at the clinic and give number to patient if necessary. Lithium and Benzodiazepine dose prescribed at a level which will control symptoms (drugs Will be adjusted based on patient tolerance). Placebo administered with the same dose of Arippiperazol. Obsession severity. Timepoint: Weeks 0 and 4 and 8. Method of measurement: Yale Brown Test (Y-BOCS). Side edffect. Timepoint: Weeks 4 and 8. Method of measurement: Side effect list. Vice chancellery for Research Shiraz University of Medical Sciences Approved 2016-05-14 Shiraz University of Medical Sciences zand avenue, medical school Shiraz Iran (Islamic Republic of)