Protocol summary

Summary
This study is conducted to evaluate negative symptoms reduction of schizophrenia in inpatients on typical antipsychotic augmentation with citalopram in Ahvaz Golestan Hospital 1389. This study is a randomized double blind clinical trial conducted on 40 patients with schizophrenia, meeting the eligibility criteria. The patients will be randomly assigned to receive either citalopram (20 mg for first week and 40 mg for the next weeks) or placebo. Depression is rule out by Hamilton depression rating scale. PANSS is used to assess negative and positive symptoms at the baseline and 3rd and 6th weeks.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138902113843N1
Registration date: 2010-12-01, 1389/09/10
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2010-12-01, 1389/09/10
Registrant information
Name
Niloufar Khajeddin
Name of organization / entity
Ahvaz Jundishapor University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1374 3038
Email address
khajeddin@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2010-08-23, 1389/06/01
Expected recruitment end date
2011-02-20, 1389/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Typical Antipsychotic Augmentation with citalopram in reduction of Negative Symptoms in Inpatient schizophrenia in Ahvaz Golestan Hospital 1389
Public title
Negative symptom treatment in schizophrenia disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Diagnosis of schizophrenia based on DSM-IV TR structured clinical interview by a psychiatrist (faculty member and psychiatry resident), prominent negative Symptoms (PANSS negative score more than 15) , total PANSS score more than 50, no liver disease, no treatment with ECT within 6 months, age between 18 and 70, illness duration at least 1 year. Exclusion criteria: depressive disorder based on DSM-IV TR interview and more than 17 score by Hamilton depression rating scale , MR, schizoaffective, Bipolar disorder, Neurological disorders , severe organic disease for example IHD or CHF, treatment with anti depressants or lithium, deaf mute, substance abuse within 1 month ago (except nicotine and caffeine), use of any other drugs which had interactions with this study, active suicidal or homicidal thoughts, breast feeding or pregnancy, past history of allergy or complications with study medication, EPS, at least 3 months interval with the last dose of long term antipsychotic medication
Age
From 18 years old to 70 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
Ahvaz Jundishapor University of Medical Sciences
Street address
Golestan Blvd., Ahvaz
City
Ahvaz
Postal code
0098
Approval date
empty
Ethics committee reference number
348/20/8/پ

Health conditions studied

1

Description of health condition studied
Schizophrenia disorder
ICD-10 code
F20
ICD-10 code description
paranoid schizophrenia, hebephrenic schizophrenia, catatonic schizophrenia ,undiffrentiated schizophrenia

Primary outcomes

1

Description
positive symptoms, negative symptoms, general psychopatology
Timepoint
Days 0, 21, and 42
Method of measurement
PANSS scale

Secondary outcomes

1

Description
Extrapyramidal side effects
Timepoint
Days 0, 21, and 42
Method of measurement
SIMPSON ANGUS SCALE

Intervention groups

1

Description
citalopram 20mg on the 1st till 7th days, then 40mg on 8th till 42 days.
Category
Treatment - Drugs

2

Description
placebo 1tablet on the 1st till 7th days, then 2 tablets in 8th till 42 days.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Golestan hospital
Full name of responsible person
Dr Niloufar Khajeddin
Street address
Golestan hospital, psychiatry department
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr Niloufar Khajeddin
Street address
Golestan hospital, psychiatry department
City
Ahvaz
Grant name
2-124500
Grant code / Reference number
10506
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz Jundishapur 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
Ahvaz Jundishapor University of Medical Sciences
Full name of responsible person
Dr Niloufar Khajeddin
Position
Assistant professor of Psychiatry
Other areas of specialty/work
Street address
Golestan Blv
City
Ahvaz
Postal code
Phone
+98 61 1374 3038
Fax
+98 61 1374 3038
Email
khajeddinn@gmail.com
Web page address
www.ajums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz Jundishapor University of Medical Sciences
Full name of responsible person
Dr Niloufar Khajeddin
Position
Assistant professor of psychiatry
Other areas of specialty/work
Street address
Golestan Blv
City
Ahvaz
Postal code
Phone
+98 61 1374 3038
Fax
+98 61 1374 3038
Email
khajeddinn@gmail.com
Web page address
www.ajums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz Jundishapor University of Medical Sciences
Full name of responsible person
Dr Niloufar Khajeddin
Position
Assistant professor of psychiatry
Other areas of specialty/work
Street address
Golestan Blv
City
Ahvaz
Postal code
Phone
+98 61 1374 3038
Fax
+98 61 1374 3038
Email
khajeddinn@gmail.com
Web page address
www.ajums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...