We try to show the efficacy of adjunctive topiramate in acute mania in a randomized, double-blind, placebo-controlled study. Patients, aged 18 and over suffering from bipolar I disorder most recent manic episode hospitalized in Razi Psychiatric Hospital, are randomly selected and divided into two groups, control and intervention. The possible risks and benefits of treatment with topiramate would be explained to patients and relatives and a written informed consent is obtained. Using Cohen Statistical Power Analysis, 23 patients are going to be allocated to each group in a double-blind manner. In intervention group patients would receive 900mg/day of lithium carbonate and 2mg/day of risperidone (may be increased if needed to 8mg/day) or equivalent dose of other antipsychotics plus topiramate starting with 50 mg/day and increasing the dose 50 mg each 3 days to reach the maximum dose of 200 mg/day. In control group patients would receive 900mg/day of lithium carbonate and 2mg/day of risperidone (may be increased if needed to 8mg/day) or equivalent dose of other antipsychotics plus placebo. Patients are being interviewed weekly by a psychiatric resident and the response to treatment would be assessed at the baseline and weekly, using YMRS. Compliance, appetite, weight and suicidal ideas and side effects of topiramate and symptoms and signs of lithium toxicity would be assessed in every interview. In the first visit the height and weight would be measured and accordingly BMI is recorded. Duration of the study is 6 weeks after reaching the optimal dose of topiramate which is 200mg/day (8 weeks).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201110317960N1
Registration date:2011-12-09, 1390/09/18
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-12-09, 1390/09/18
Registrant information
Name
Zahra Mirsepassi
Name of organization / entity
University of social welfare and rehabilitation sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8808 2585
Email address
za.mirsepassi@uswr.ac.ir
Recruitment status
Recruitment complete
Funding source
investigator
Expected recruitment start date
2011-07-30, 1390/05/08
Expected recruitment end date
2012-07-29, 1391/05/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of efficacy of lithium and topiramate with lithium and placebo in patients with bipolar I disorder most recent manic episode
Public title
Efficacy of adjunctive topiramate in acute mania
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1) age 18 and over; 2) bipolar I disorder most recent manic episode (according to DSMIV-TR criteria). Exclusion criteria: 1) pregnant woman; 2) lactating woman; 3) presence of disabling medical or neurologic disease; 4) history of kidney disease; 5) history of renal stone; 6) history of hypersensitivity to topiramate.
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
46
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
Unuversity of social welfare and rehabilitation sciences
Street address
Koodakyar, Evin
City
Tehran
Postal code
Approval date
2011-11-22, 1390/09/01
Ethics committee reference number
801/A/2/15497
Health conditions studied
1
Description of health condition studied
bipolar I disorder most recent manic episode
ICD-10 code
F32.1
ICD-10 code description
Moderate depressive episode
2
Description of health condition studied
bipolar I disorder most recent manic episode
ICD-10 code
F32.2
ICD-10 code description
Severe depressive episode without psychotic symptoms
Primary outcomes
1
Description
efficacy of adjunctive topiramate in acute mania
Timepoint
after 8 weeks
Method of measurement
YMRS
Secondary outcomes
1
Description
appetite
Timepoint
after 8 weeks
Method of measurement
interview
2
Description
weight
Timepoint
after 8 weeks
Method of measurement
according to weight
3
Description
side effects of topiramate
Timepoint
after 8 weeks
Method of measurement
interview
4
Description
suicidal ideas
Timepoint
after 8 weeks
Method of measurement
interview
5
Description
compliance
Timepoint
after 8 weeks
Method of measurement
interview and nursing records
6
Description
lithium toxicity
Timepoint
after 8 weeks
Method of measurement
interview and physical examination
Intervention groups
1
Description
In intervention group patients would receive 900mg/day of lithium carbonate and 2mg/day of risperidone (may be increased if needed to 8mg/day) or equivalent dose of other antipsychotics plus topiramate starting with 50 mg/day and increasing the dose 50 mg each 3 days to reach the maximum dose of 200 mg/day.
Category
Treatment - Drugs
2
Description
In control group patients would receive 900mg/day of lithium carbonate and 2mg/day of risperidone (may be increased if needed to 8mg/day) or equivalent dose of other antipsychotics plus placebo.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi Psychiatric Hospital
Full name of responsible person
Zahra Mirsepassi
Street address
City
Shahre Rey
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Zahra Mirsepassi
Street address
Koodakyar, Evin
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of social welfare and rehabilitation 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
University ofsocial welfarw and rehabilitation sciences