The objective of this randomized, double-blind, placebo controlled study is to test the hypothesis that the addition of Vortioxetine would improve psychopathology in subjects with schizophrenia treated with Risperidone. 50 patients with chronic schizophrenia will receive Risperidone (6 mg/day) combined with either placebo (N=25) or20 mg/day of Vortioxetine (N=25) for 8 weeks. Efficacy will be defined as the change from baseline to endpoint in score on the Positive and Negative Syndrome Scale (PANSS). Side effects will be also evaluated using checklist and Extra-pyramidal Symptoms Rating Scale.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201710241556N100
Registration date:2017-10-24, 1396/08/02
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-10-24, 1396/08/02
Registrant information
Name
Shahin Akhondzadeh
Name of organization / entity
Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5541 2222
Email address
s.akhond@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2017-11-09, 1396/08/18
Expected recruitment end date
2019-11-08, 1398/08/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Vortioxetine as adjunctive treatment of negative symptoms in patients with schizophrenia: a double blind and placebo controlled trial
Public title
Vortioxetine as adjunctive treatment of schizophrenia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:1-Diagnosis of Schizophrenia based on DSM-5 criteria; 2- Age between 18-60; 3-Chronic Schizophrenia- duration of the disorder more than 2 years; 4-Minimum score of 20 in negative sub score. 5-being stable on risperidone for the last 2 months. Exclusion criteria:1-Any serious medical or neurological problem; 2- IQ less than 70; 3- Substance dependence during the last 6 months(except for nicotine and caffeine); 4- Score on HDRS less than 14 5-receiving ECT during the last 3 months ; 6-Acute or chronic systemic diseases; 7- History of neurosurgery; 8- History of head trauma.
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
50
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 Tehran University of Medical Sciences
Street address
Keshavarz Blvd.
City
ٰTehran
Postal code
Approval date
2017-09-23, 1396/07/01
Ethics committee reference number
IR.TUMS.VCR.REC.1396.3556
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 weeks 2-4-8 after beginig of treatment
Method of measurement
Positive and Negative Syndrome Scale (PANSS)
Secondary outcomes
empty
Intervention groups
1
Description
Tablet Risperidone (6 mg/day) combined with 20mg/day Vortioxetine as intervention group for 8 weeks
Category
Treatment - Drugs
2
Description
Tablet Risperidone (6 mg/day) combined with placebo as control group for 8 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Roozbeh Hospital
Full name of responsible person
Dr. Shahin Akhondzadeh
Street address
Roozbeh Hospital, South Kargar Sreet
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Masoud Yunesian
Street address
Keshavarz Blvd.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Prof. Shahin Akhondzadeh
Position
Prof. of Clinical Psychopharmacology
Other areas of specialty/work
Street address
Roozbeh Hospital, South Kargar Street
City
Tehran
Postal code
Phone
+98 21 5541 2222
Fax
Email
s.akhond@sina.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Prof. Shahin Akhondzadeh
Position
Prof. of Clinical Psychopharmacology
Other areas of specialty/work
Street address
Roozbeh Hospital, South Kargar Street
City
Tehran
Postal code
Phone
+98 21 5541 2222
Fax
Email
s.akhond@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Prof. Shahin Akhondzadeh
Position
Prof. of Clinical Psychopharmacology
Other areas of specialty/work
Street address
Roozbeh Hospital, South Kargar Street
City
Tehran
Postal code
Phone
+98 21 5541 2222
Fax
Email
s.akhond@sina.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)