The objective of this randomized, double-blind, placebo controlled study is to test the hypothesis that the addition of omega-3 fatty acids would improve psychopathology in subjects with schizophrenia treated with typical antipsychotics. A total of 36 patients with chronic DSM-IV-diagnosed schizophrenia will receive chlorpromazine (1000 mg/day or equivalent dose of other typical antipsychotics) combined with either placebo or 3000 mg/day of omega-3 for 6 months. Efficacy will be defined as the change from baseline to endpoint in score on the Positive and Negative Syndrome Scale (PANSS).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138811022935N3
Registration date:2010-10-07, 1389/07/15
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-10-07, 1389/07/15
Registrant information
Name
Farzin Rezaei
Name of organization / entity
Kurdistan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 87 1356 1822
Email address
farrezaei@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Kurdistan University of Medical Sciences
Expected recruitment start date
2010-08-14, 1389/05/23
Expected recruitment end date
2011-02-15, 1389/11/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of omega-3 on negative and positive symptoms in patients with chronic schizophrenia: a double blind and placebo controlled trial
Public title
Omega-3 in the treatment of schizophrenia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Age between 18 and 60, diagnosis of Schizophrenia based on DSM IV, chronic Schizophrenia
Exclusion Criteria: Substance dependence, any serious medical problem
Age
From 18 years old to 60 years old
Gender
Male
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
36
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
Kurdistan University of Medical Sciences
Street address
Pasdaran Blvd
City
Sanandaj
Postal code
Approval date
2007-03-19, 1385/12/28
Ethics committee reference number
10194
Health conditions studied
1
Description of health condition studied
schizophrenia
ICD-10 code
F20
ICD-10 code description
Schizophrenia
Primary outcomes
1
Description
Severity of schizophrenia
Timepoint
Baseline and 6 months after beginnig of treatmen
Method of measurement
Positive and Negative Syndrome Scale (PANSS)
Secondary outcomes
empty
Intervention groups
1
Description
Tablet chlorpromazine (1000mg/day ) or equivalent doses of typical antipsychotics combined with 3000mg/day of omega-3 as intervention group for 6 months
Category
Treatment - Drugs
2
Description
Tablets chlorpromazine(1000 mg/day) or equivalent doses of typical antipsychotics combined with placebo as control group for 6 months
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Bahar institute
Full name of responsible person
Farzin Rezaei
Street address
Baharan district
City
Sanandaj
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kurdistan University of Medical Sciences
Full name of responsible person
Dr Ataollah Heydari
Street address
Deputy of research, Kurdistan university of Medical Sciences, Pasdaran Blvd., Sanandaj
City
Sanandaj
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?