Efficacy of Serteralin add-on therapy to Atypical Antipsychotics on maintenance therapy of schizophrenia patients on depression and level of function: Isfahan 2011-12
Main goal:efficay of Sertraline add-on therapy to Atypical antipsychotics in maintenance therapy of Schizophrenia patients .This study is double -blind placebo-control unicentric study . 54 schizophrenia patients (27 in intervention and 27 in control grops) who are in remission according to PANSS questionare were given Sertraline or placebo after informed consent. PANSS ;CDSS ; QLS and GAF questionare were completed at weeks 0,8,12. Inclusion criteria :1-age 16-65; 2-substance abuse or sever medical abuse. exclusion :sever side effects.final goal:adding Sertraline to antipsychotic regimen to decrease depression and increase quality of life and function of this patints.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201110187839N1
Registration date:2011-11-13, 1390/08/22
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-11-13, 1390/08/22
Registrant information
Name
Ghadir Mohammad Hoseiny
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1447 8669
Email address
ghadir-mhb@resident.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2011-05-22, 1390/03/01
Expected recruitment end date
2011-11-11, 1390/08/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of Serteralin add-on therapy to Atypical Antipsychotics on maintenance therapy of schizophrenia patients on depression and level of function: Isfahan 2011-12
Public title
Effect of Sertraline on Schizophrenia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:1-age:16-65y/o; 2-no substance abuse or sever medical disease; 3-no pregnancy or breast feeding; 4- patients medication should be one of atypical antipsychotics(Risperidone,Olanzapine,Aripiperazole,Quetiapine or Clozapine); 5- the patients are not in acute phase of disease; 6- the patients are on maintenance medication.
Exclusion criteria:1-sever side effects; 2-no intrest in patient or his/her family to maintain on the study; 3-pregnancy; 4-drug non-tolerance.
Age
From 16 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
54
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Azadi sq., Isfahan, Iran.
City
isfahan
Postal code
Approval date
2011-05-20, 1390/02/30
Ethics committee reference number
3878/8/12 on 15-5-2011
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
score of Depression
Timepoint
before starting study and after weeks 8,12
Method of measurement
CDSS(Calgray Depressive Scale of Schizophrenia)
2
Description
score of Quality of Life
Timepoint
before starting study and after weeks 8,12.
Method of measurement
QLS questionare (Quality of life in Schizophrenia)
3
Description
score of Psychosis
Timepoint
before starting study and after weeks 8,12.
Method of measurement
PANSS questionare (Positive And Negative Syndrome Scale)
4
Description
Level of Function
Timepoint
before starting study and after weeks 8,12.
Method of measurement
GAF questionare (Global Assessment of Function)
Secondary outcomes
1
Description
side-effects of medication
Timepoint
weeks 8,12
Method of measurement
quastionare of side effects
Intervention groups
1
Description
Sertraline 50 mg/day was started for intervention group that could rise to 200mg/day gradually.In control group placbo pills that are identical to sertraline was prescribed.Both drug and placebo daily dosage was 1 tablet per day.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Noor hospital, Isfahan
Full name of responsible person
Miss Qasemi,psychologist
Street address
Noor hospital, Ostandari st., Isfahan, Iran
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr.Aazarm
Street address
Isfahan University of Medical Sciences, Azadi sq., Isfahan, Iran
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan University of Medical 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
Isfahan University of Medical Sciences
Full name of responsible person
Ghadir Mohammad Hoseiny
Position
Resident of Psychiatry
Other areas of specialty/work
Street address
Noor hospital, Ostandari st., Isfahan, Iran.
City
isfahan
Postal code
Phone
+98 31 1447 8669
Fax
Email
ghadir-mhb@resident.mui.ac.ir drghadir@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Victoria Omranifard
Position
Psychiatrist
Other areas of specialty/work
Street address
Noor hospital, Ostandari st., Isfahan, Iran
City
Isfahan
Postal code
Phone
+98 31 1222 2727
Fax
Email
v_omranifard@med.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Ghadir Mohammad Hoseiny
Position
Resident of Psychiatry
Other areas of specialty/work
Street address
Noor hospital, Ostandari st., Isfahan, Iran.
City
Isfahan
Postal code
Phone
+98 31 1447 8669
Fax
Email
ghadir-mhb@resident.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)