Evaluation of Typical Antipsychotic Augmentation with Sertraline in Reduction of Negative Symptoms in patients with Schizophrenia in Ahwaz Golestan Hospital
The aim of this study was to evaluate the efficacy of sertraline added to typical antipsychotics for the treatment of negative symptoms of patients with schizophrenia disorder. This study is a randomized double blind, with placebo control, unicameral, phase 2 clinical trial. Inclusion criteria for the study: schizophrenia; negative score more than 15 in PANSS. Exclusion criteria for the study: patient withdrew from the study and drug side effects. Number of patients in the study are 30. The efficacy of sertraline and placebo in reduction of social withdrawal‚ emotional withdrawal‚ blunted affect and other negative symptoms was assessed weekly with PANSS scale during 6 weeks.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014041317246N1
Registration date:2014-04-23, 1393/02/03
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-04-23, 1393/02/03
Registrant information
Name
Somayeh Raz
Name of organization / entity
Ahwaz Jondishapour University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 61 1336 7543
Email address
raz.s@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and Technology Development- Ahwaz Jondishapur University of Medical Sciences
Expected recruitment start date
2012-04-20, 1391/02/01
Expected recruitment end date
2012-11-20, 1391/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Typical Antipsychotic Augmentation with Sertraline in Reduction of Negative Symptoms in patients with Schizophrenia in Ahwaz Golestan Hospital
Public title
The Effect of Sertraline In Treatment Of Schizophrenia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria for this study are as follows: schizophrenia - a negative score more than 15 in PANSS; no liver disease; not treated with ECT in the past six months; during illness for over one year; aged between 21 to 63 years old.
The Exclusion criteria are: depression; mental retardation; schizoaffective disorder; bipolar disorder; a neurological disorder such as epilepsy, Parkinson's disease; a risky physical illness such as cardiac ischemia or heart failure; use of antidepressants or lithium for whatever reason; Leisure drug; drug abuse within one recent month (except nicotine and caffeine); extrapyramidal side effects; deafness or dumbness active suicidal or homicidal thoughts; pregnant or lactating women; at least 3 months have passed since the last time the use of long-acting antipsychotics; drugs with a history of hypersensitivity or serious interest in the study; the patient withdrew from the study and side effects.
Age
From 21 years old to 63 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
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
Ahwaz Jondishapur University of Medical Sciences
Street address
Ahwaz Jondishapur University of Medical Sciences, Golestan Blvd
City
Ahwaz
Postal code
6481958956
Approval date
2011-07-27, 1390/05/05
Ethics committee reference number
ETH201
Health conditions studied
1
Description of health condition studied
schizophrenia
ICD-10 code
F20
ICD-10 code description
The schizophrenic disorders are characterized in general by fundamental and characteristic distortions of thinking and perception, and affects that are inappropriate or blunted. Clear consciousness and intellectual capacity are usually maintained although
Primary outcomes
1
Description
Emotional withdrawal
Timepoint
Before intervention,1 week after intervention, 3 weeks after intervention, 6 weeks after intervention
Method of measurement
PANSS(Positive and Negative Symptom Scale)
2
Description
Social withdrawal
Timepoint
Before intervention, 1 week after intervention, 3 weeks after intervention, 6 weeks after intervention
Method of measurement
PANSS(Positive and Negative Symptom Scale)
3
Description
Blunted affect
Timepoint
Before intervention,1 week after intervention, 3 weeks after intervention, 6 weeks after intervention
Method of measurement
PANSS(Positive and Negative Symptom Scale)
4
Description
Other negative symptoms
Timepoint
Before intervevtion, 1 week after intervention, 3 weeks after intervention, 6 weeks after intervention
Method of measurement
PANSS(Positive and Negative Symptom Scale)
Secondary outcomes
1
Description
Side effects
Timepoint
One week after intervention,3 weeks after intervention,6 weeks after intervention
Method of measurement
Interview with patient
Intervention groups
1
Description
Sertraline, tab 50 mg, oral, once a day, for 6 weeks
Category
Treatment - Drugs
2
Description
Placebo, tab 50 mg, oral, once a day, for 6 weeeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of psychiatry
Full name of responsible person
Somayeh Raz
Street address
Department of Psychiatry, Golestan Hospital, Farvardin Av.
City
Ahwaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology Development-Ahwaz Jondishapur University of Medical Sci
Full name of responsible person
Dr. Nader Saki
Street address
Vice Chancellor for Research and Technology Development-Ahwaz Jondishapur University of Medical Sciences
City
Ahwaz
Grant name
ندارد
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research and Technology Development-Ahwaz Jondishapur University of Medical Sci
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
Ahwaz Jondishapur University of Medical Sciences
Full name of responsible person
Dr. Seyed Moammad Seyed Ghafari Dezfuli
Position
Assistant professor of psychiatry-psychiatrist
Other areas of specialty/work
Street address
Ahwaz Jondishapur University of Medical Sciences, Golestan Blvd
City
Ahwaz
Postal code
6481958956
Phone
+98 61 1336 7543
Fax
+98 64 2427 5326
Email
raz.s@ajums.ac.ir
Web page address
www.ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahwaz Jondishapur University of Medical Sciences
Full name of responsible person
Somayeh Raz
Position
Resident of psychiatry
Other areas of specialty/work
Street address
Ahwaz Jondishapur University of Medical Sciences, Golestan Blvd
City
Ahwaz
Postal code
6481958956
Phone
+98 61 1336 7543
Fax
+98 64 2427 5326
Email
raz.s@ajums.ac.ir
Web page address
www.ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahwaz Jondishapur University of Medical Sciences
Full name of responsible person
Dr. Seyed Mohammad Seyed Ghafari Dezfuli
Position
Assistant professor of psychiatry-psychiatrist
Other areas of specialty/work
Street address
Ahwaz Jondishapur University of Medical Sciences, Golestan Blvd
City
Ahwaz
Postal code
6481958956
Phone
+98 61 1336 7543
Fax
+98 64 2427 5326
Email
raz.s@ajums.ac.ir
Web page address
www.ajums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)