The purpose of this study is to examine the effect of Venlafaxine in improving the negative symptoms of patients with schizophrenia. 30 patients that met DSM-IV criteri for schizophrenia and have prominent negative symptoms will be selected and divided in to two groups by randomized blocking.The common feature of all patients is that they treating with either Risperidone or Olanzapine and do not take any other antipsychotic agent. Patients undergo administration of either Venlafaxine(75mg XR) capsules two times daily plus Risperidoe or Olanzapin (study) or placebo capsules two times daily plus Risperidoe or Olanzapin (control) for 8 weeks. Score of positive and negative symptoms of schizophrenia and general psychopathology will be assessed by Positive and Negative Syndrome Scale (PANSS) in week 0 as a baseline and weeks 4, 6 and 8. Extrapyramidal side effects will be also assessed by Extrapyramidal Syndrome Rating Scale (ESRS) in the same period of the time.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012101011076N1
Registration date:2013-04-29, 1392/02/09
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-04-29, 1392/02/09
Registrant information
Name
Ehsan Salemi
Name of organization / entity
Kurdistan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 87 1356 1822
Email address
ehsansalemi2000@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Kurdistan University of Medical Sciences
Expected recruitment start date
2013-05-03, 1392/02/13
Expected recruitment end date
2013-09-04, 1392/06/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of venlafaxine on negative symptoms of schizophrenia
Public title
Treatment of schizophrenia with venlafaxine
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria
(1)-DSM-IV diagnosis for shizophrenia.
(2)-Age between 18-59 years old.
(3)-Not presenting of moderate to severe depression according to the beck depression inventory.
(4)-Total PANSS Sc ore>60.
(5)- Present of significant negative symptoms (PANSS negative sub score>20).
(6)-Patient medication dose does not change during past 3 month of study.
(7)-Patient's medications must be risperidone or olanzapin.
(8)-Obtaining the written informed consent.
Exclusion criteria:
(1)-Additional diagnosis in axis 1 according to DSM-IV.
(2)-Substance abuse or dependence except nicotine.
(3)-Pregnant women.
(4)-Women in fertility ages which does not use OCP.
(5)-History of allergic reaction to venlafaxine.
(6)-Giving ECT during previous 2 months.
(7)- On methadone maintenance therapy.
(8)-Patients with increased intra ocular pressure or in the risk of close angle glaucoma.
(9)-Hepatic cirrhosis.
(10)-Breast feeding women.
(11)-Cimetidine consumption in the presence of HTN or hepatic impairment.
(12)-Another psychotropic drugs consumption except benzodiazepins.
(13)-Mental Retardation.
Age
From 18 years old to 59 years old
Gender
Both
Phase
3
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
Ethical Committee of Kurdistan University of Medical Sciences
Street address
Pasdaran Blvd-Kurdistan university of Medical Sciences-Deputy of research- sANANDAJ
City
Sanandaj
Postal code
Approval date
2012-11-10, 1391/08/20
Ethics committee reference number
14/28626
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
Before study as baseline;4 weeks after beginning of study;6 weeks after beginning of study and 8 weeks after beginning of study
Method of measurement
PANSS inventory
Secondary outcomes
1
Description
Side effects
Timepoint
Before study as a baseline;4 weeks after beginning of study;6 weeks after beginning of study and 8 weeks after beginning of study
Method of measurement
ESRS inventory
2
Description
Severity of psychiatric symptoms
Timepoint
Before study as baseline;4 weeks after beginning of study;6 weeks after beginning of study and 8 weeks after beginning of study
Method of measurement
BPRS inventory
Intervention groups
1
Description
Intervention group:venlafaxine-XR, 75mg, oral capsules, 2 times daily, for 8 weeks.
Category
Treatment - Drugs
2
Description
Control group, placebo: oral capsules contain starch with the same weight and similar shape with drug; 2 times daily for 8 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Qhods hospital- Sanandajl
Full name of responsible person
Dr Ehsan Salemi
Street address
Psdaran Blvd-Qhods hospital-Sanandaj
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
Sanandaj-Pasdaran Blvd-Kurdistan university of Medical Sciences-Deputy of research
City
Sanandaj
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?