Treatment of Mania includes acute & maintenance treatment. Anti-psychotic medicines are among the medicines using in both episodes. In this study, the effects of both typical and atypical anti-psychotic medicines would be compared. Forty patients with Bipolar disorder diagnosis aged 16-50 years, of the outpatients referred to psychiatric clinic, are divided into two groups; the first group takes 10-20 mg Olanzapine for 6 weeks and the second one takes 16-24 mg Perphenazine for 6 weeks. Mania severity would be compared based on young mania rating scale (YMRS) in the week 0, 3 and 6.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201010315060N1
Registration date:2011-09-25, 1390/07/03
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-09-25, 1390/07/03
Registrant information
Name
Ahmad Fakhri
Name of organization / entity
Ahvaz University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 61 1374 3038
Email address
dr.abbas.pezeshki@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Private
Expected recruitment start date
2010-12-22, 1389/10/01
Expected recruitment end date
2011-09-20, 1390/06/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of adding Olanzapine versus Perphenazine on maintenance treatment of bipolar type I in outpatients referred to psychiatric clinic
Public title
Comparing the effect of adding Olanzapine versus Perphenazine on maintenance treatment of bipolar type I in outpatients referred to psychiatric clinic of Ahvaz Golestan Hospital in 2010
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Bipolar disorder diagnosis based on DSM-4-TR; Filling in the personal satisfaction form; Ages between 16-50 years; No Psychotic symptom. Exclusion criteria:
Pregnancy; Organic disorders; Co morbidity; No tendency to admission; No ECT treatment.
Age
From 16 years old to 50 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ahvaz University of Medical Sciences and Health Services
Street address
University City
City
Ahvaz
Postal code
15794-61357
Approval date
2010-04-04, 1389/01/15
Ethics committee reference number
483/2/8
Health conditions studied
1
Description of health condition studied
Mania
ICD-10 code
F30.1
ICD-10 code description
Mania without psychotic symptoms
Primary outcomes
1
Description
Recovery rate based on n YMRS
Timepoint
in weeks 0, 3 & 6.
Method of measurement
YMRS form
Secondary outcomes
1
Description
Decreasing extra pyramidal complications
Timepoint
weeks 0, 3 and 6.
Method of measurement
Clinical examination
Intervention groups
1
Description
First group takes 10-20 mg olanzapine for 6 weeks.
Category
Treatment - Drugs
2
Description
Second group takes 16-24 mg perphenazine for 6 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Psychiatric Clinic of Golestan Hospital
Full name of responsible person
Abbas Pezeshki
Street address
Golestan Hospital
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for Research, Ahvaz University of Medical science and Health Services
Full name of responsible person
Dr.Mostafa Feghi
Street address
University City
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for Research, Ahvaz University of Medical science and Health Services
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
Ahvaz University of Medical Sciences and Health Services