The aim of this study is to investigate the effect of Celecoxib Add-On compared to Haloperidol alone in schizophrenia. A total of 50 patients with schizophrenia admitted to Zare hospital of Sari are randomly assigned into intervention or control group to receive haloperidol 15-30 mg/day plus Celecoxib 400 mg/day or the same dose of haloperidol plus placebo for 5 weeks. Psychotic symptoms are assessed weekly by Positive and Negative Syndrome Scale for 5 weeks.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138809201457N6
Registration date:2010-11-02, 1389/08/11
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-11-02, 1389/08/11
Registrant information
Name
Mehran Zarghami
Name of organization / entity
Research Center for Psychiatry and Behavioral Sciences and Department of Psychiatry, Mazandaran Univ
Country
Iran (Islamic Republic of)
Phone
+98 15 1328 5659
Email address
mzarghami@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mazandaran University of Medical Sciences
Expected recruitment start date
2004-03-10, 1382/12/20
Expected recruitment end date
2005-03-10, 1383/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Celecoxib Add-On Therapy Compared to Haloperidol Alone in Schizophrenia: A Double-Blind, Randomized, Placebo-Controlled Clinical Trial
Public title
Celecoxib Add-On Therapy Compared to Haloperidol Alone in Schizophrenia: A Double-Blind, Randomized, Placebo-Controlled Clinical Trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: DSM-IV-TR criteria for schizophrenia, Information consent of patients and their tutor Exclusion criteria: Infectious diseases, inflammatory diseases, Anti-inflammatory drug consumption Inflammatory
Age
From 18 years old to 65 years old
Gender
Both
Phase
4
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
Mazandaran University of Medical Sciences
Street address
Mazandaran University of Medical Sciences, Moallem Squqre
City
Sari
Postal code
4817844718
Approval date
2003-03-10, 1381/12/19
Ethics committee reference number
108-82
Health conditions studied
1
Description of health condition studied
Schizophrenia
ICD-10 code
F20
ICD-10 code description
Schizophrenia
Primary outcomes
1
Description
Schizophrenia symptoms
Timepoint
weekly
Method of measurement
Positive and Negative Syndrome Scale (PANSS)
Secondary outcomes
empty
Intervention groups
1
Description
Haloperidoloral, 15-30 mg/day, orally, plus Celecoxib, 400 mg/day for 5 weeks
Category
Treatment - Drugs
2
Description
Haloperidoloral, 15-30 mg/day, orally, plus placebo for 5 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Zare Hospital
Full name of responsible person
Mehran Zarghami
Street address
Zare Hospital, Neka Road
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Seyed Jalal Hoseini Mehr
Street address
Mazandaran University of Medical Sciences, Moallem Square
City
Sari
Grant name
10506
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?