This study was designed determine the efficacy of bupropion versus placebo in subjects with negative symptoms of schizophrenia.
A convenience sample of 40 patients of both genders aged 18-60 years who were living in psychiatric care centers were randomly treated with bupropion (300 mg daily) or placebo. The diagnosis of schizophrenia was confirmed by a psychiatrist based on Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria. Before and after the intervention, severity of negative symptoms was determined using a reliable and valid Persian version of Scales for the Assessment of Negative Symptoms (SANS).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013100114850N1
Registration date:2013-10-18, 1392/07/26
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-10-18, 1392/07/26
Registrant information
Name
Neda Shariat
Name of organization / entity
Markaze jame ravanpezeshki
Country
Iran (Islamic Republic of)
Phone
+98 35 2622 2004
Email address
yazd.ravanpezeshki@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
yazd medical science university of shahid sadughi
Expected recruitment start date
2011-01-01, 1389/10/11
Expected recruitment end date
2013-01-01, 1391/10/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determine the efficacy of bupropion versus placebo in subjects with negative symptoms of schizophrenia
Public title
The effects of bupropion on negative symptoms in schizophrenia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion:age of 15 to 60 years old, presence of negative symptoms
Exclusion:presence of depression,substance abuse,suicidal ideation,sever psychosis,sever medical illness,pregnancy and lactation
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
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
Ethics committee of yazd medical science university of shahid sadughi
Street address
Yazd, medical science university of shahid sadughi Yazd,
City
Yazd
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
5223
Health conditions studied
1
Description of health condition studied
Negative symptoms in schizophrenia
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Negative symptoms
Timepoint
Onset and end of trial
Method of measurement
Scale for the assessment of negative symptoms inquirement
Secondary outcomes
empty
Intervention groups
1
Description
Bupropion (100 mg TDS,12 weeks) in intervention group
Category
Treatment - Drugs
2
Description
Placebo( simirarly to bupropion,TDS,12 weeks) in control group
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Behzisty center of yazd
Full name of responsible person
Street address
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd medical science university of shahid sadughi
Full name of responsible person
DR mirmohammady
Street address
Yazd ,medical science university
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd medical science university of shahid sadughi
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
Yazd medical science university of shahid sadughi
Full name of responsible person
Neda shariat
Position
GP,resident of psychiatry
Other areas of specialty/work
Street address
Yazd,safaeeyeh
City
Yazd
Postal code
Phone
+98 35 2623 2004
Fax
Email
Nedashariat@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd medical science university of shahid sadughi
Full name of responsible person
Neda shariat
Position
GP
Other areas of specialty/work
Street address
Yazd medical science university of shahid sadughi
City
Yazd
Postal code
Phone
+98 35 2623 2004
Fax
Email
Nedashariat@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)