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
Regarding the high comorbidity of Obsessive - Compulsive Disorder(OCD) with Bipolar Mood Disorder(BMD) and problems in the treatment of BMD patients (conventional treatment for OCD, may worsen the underlying disease), this study intends to control the effects of topiramate in BMD patients with obsessive-compulsive symptoms compared with the placebo.The population under study is the patients with bipolar mood disorder who will refer to clinics and hospitals of Shiraz University of Medical Sciences. Each group will consist of 16 patients, one of them will receive topiramate in addition to lithium, olanzapine and clonazepam and other group will given placebo and same drugs for 16 weeks. Patients in both groups one and two will chosen through randomly assigned numbers by the trial executive and both the key partner and the patients will be unaware of the treatment. Assess the severity of obsessive-compulsive symptoms in the week zero will done by the trial executive by Y-BOCS (Yale - Brown Obsessive Compulsive Scale)questionnaire and key partner will follow patients next weeks.Drug Side effects based on the drug side effects checklist and changes in the obsessive - compulsive symptoms, based on Y-BOCS questionnaire will assessed at weeks 2,4,8,12,16. 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.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012061310013N1
Registration date:2012-10-05, 1391/07/14
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-10-05, 1391/07/14
Registrant information
Name
Mohamad Bigdeli
Name of organization / entity
Shiraz University of Medical ScienceS
Country
Iran (Islamic Republic of)
Phone
+98 71 1627 9319
Email address
bigdelim@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2012-07-22, 1391/05/01
Expected recruitment end date
2013-03-19, 1391/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
Comparison of topiramate and placebo in controlling the OCD symptoms of bipolar patients
Purpose
Treatment
Inclusion/Exclusion criteria
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.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
32
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Local Ethics Committee of Shiraz University of Medical Sciences
Street address
Central Building of Shiraz University of Medical Sciences, Zand Blvd., Shiraz
City
Shiraz
Postal code
Approval date
2012-05-12, 1391/02/23
Ethics committee reference number
CT -91 -2461
Health conditions studied
1
Description of health condition studied
Bipolar Mood Disorder
ICD-10 code
F31
ICD-10 code description
Bipolar affective disorder, current episode hypomanic
2
Description of health condition studied
Obsessive-Compulsive disorder
ICD-10 code
F42
ICD-10 code description
Predominantly obsessional thoughts or ruminations
Primary outcomes
1
Description
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
Secondary outcomes
1
Description
drug side effects
Timepoint
monthly for 4 months
Method of measurement
checklist of drug side effects
Intervention groups
1
Description
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.
Category
Treatment - Drugs
2
Description
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.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ebn-e-Sina Hospital
Full name of responsible person
Mohamad Bigdeli , MD
Street address
City
Shiraz
2
Recruitment center
Name of recruitment center
Hafez Hospital
Full name of responsible person
Mohamad Bigdeli , MD
Street address
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Gholamreza Hatam, Phd
Street address
Central Building of Shiraz University of Medical Sciences, Zand Blvd., Shiraz
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Psychiatry department of Shiraz University of Medical Sciences
Full name of responsible person
Ali Sahraian, MD
Position
Associate Professor
Other areas of specialty/work
Street address
Hafez Hospital, Chamran Blvd., Shiraz
City
Shiraz
Postal code
Phone
+98 71 1627 9319
Fax
Email
sahraian@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Psychiatry department of Shiraz University of Medical Sciences
Full name of responsible person
Ali Sahraian, MD
Position
Associate Professor
Other areas of specialty/work
Street address
Hafez Hospital, Chamran Blvd., Shiraz
City
Shiraz
Postal code
Phone
+98 71 1627 9319
Fax
Email
sahraian@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Psychiatry department of Shiraz University of Medical Sciences
Full name of responsible person
Mohamad Bigdeli, MD
Position
Psychatry Assistant
Other areas of specialty/work
Street address
Hafez Hospital, Chamran Blvd., Shiraz
City
Shiraz
Postal code
Phone
+98 71 1627 9319
Fax
Email
bigdelim@sums.ac.ir; dr_mohamad_bigdeli@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)