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IRCT2012061310013N1 IRCT 2012-10-05 Shiraz University of Medical Sciences Comparison of topiramate and placebo in controlling the OCD symptoms of bipolar patients Comparison of treatment of bipolar disorder (lithium + olanzapine + clonazepam) and placebo with a treatment regimen containing topiramate in controlling the OCD symptoms of bipolar patients 2012-07-22 anticipated 32 Complete https://irct.ir/trial/10510 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. N/A Condition 1: Bipolar Mood Disorder. Condition 2: Obsessive-Compulsive disorder. Intervention 1: 16 patient intervention group will recieve topiramate in addition to lithium,olanzapine and clonazepam for 16 weeks.Dose of lithium, olanzapine, and clonazepam will sufficient for patients symptoms control. Topiramate Begins with an initial dose of 25mg/day and 25mg a week adds up to 200mg/day. Intervention 2: 16 patients control group will recieve placebo in addition to lithium,olanzapine and clonazepam for 16 weeks.Dose of lithium, olanzapine, and clonazepam will sufficient for patients symptoms control.placebo Begins with an initial dose of 25mg/day and 25mg a week adds up to 200mg/day.

public Ali Sahraian, MD

Hafez Hospital, Chamran Blvd., Shiraz

Shiraz Iran (Islamic Republic of) +98 71 1627 9319 sahraian@sums.ac.ir Psychiatry department of Shiraz University of Medical Sciences scientific Ali Sahraian, MD

Hafez Hospital, Chamran Blvd., Shiraz

Shiraz Iran (Islamic Republic of) +98 71 1627 9319 sahraian@sums.ac.ir Psychiatry department of Shiraz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Inclusion criteria: Fulfilling DSM-IV-TR criteria for bipolar mood disorder; have not Major medical problem ( cardiovascular, respiratory, renal or gastrointestinal disease); not pregnant; not alcohol or other substances abuser; scores >= 18 in Yale- Brown Obsessive Compulsive Scale questionnaire. Exclusion criteria; failure to cooperate in the ongoing project for the periodical visits; non-qualification for inclusion criteria. no limit no limit Both F31 F42 Bipolar affective disorder, current episode hypomanic Predominantly obsessional thoughts or ruminations Treatment - Drugs Placebo 16 patient intervention group will recieve topiramate in addition to lithium,olanzapine and clonazepam for 16 weeks.Dose of lithium, olanzapine, and clonazepam will sufficient for patients symptoms control. Topiramate Begins with an initial dose of 25mg/day and 25mg a week adds up to 200mg/day. 16 patients control group will recieve placebo in addition to lithium,olanzapine and clonazepam for 16 weeks.Dose of lithium, olanzapine, and clonazepam will sufficient for patients symptoms control.placebo Begins with an initial dose of 25mg/day and 25mg a week adds up to 200mg/day. Obsessive-compulsive signs&symptoms in BMD patients. Timepoint: before intervention and then monthly for 4 months. Method of measurement: Yale- Brown Obsessive Compulsive Scale questionaire. Drug side effects. Timepoint: monthly for 4 months. Method of measurement: checklist of drug side effects. Shiraz University of Medical Sciences Approved 2012-05-12 Local Ethics Committee of Shiraz University of Medical Sciences Central Building of Shiraz University of Medical Sciences, Zand Blvd., Shiraz Shiraz Iran (Islamic Republic of)