The aim of this study is Beneficial Antipsychotic Effects of Celecoxib Add – on Therapy Compared to Clozapine Alone in Schizophrenia. In a double–blinded clinical trial, 40 patients (with definite diagnosis of schizophrenia and without treatment resistance according to DSM IV criteria) were randomly assigned to two groups. 20 patients received clozapine plus 200 mg/day celecoxib and 20 received clozapine plus placebo for 4 weeks. Improvement of patients was assessed by the PANSS at week 2 and 4.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201301095280N11
Registration date:2013-02-16, 1391/11/28
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-02-16, 1391/11/28
Registrant information
Name
Raheleh Nejati
Name of organization / entity
Mashhad University of Medical Scinces, Ibn-e- Sina Psychiatric Hospital
Country
Iran (Islamic Republic of)
Phone
+98 51 3711 2540
Email address
nejatir2@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2005-09-23, 1384/07/01
Expected recruitment end date
2006-09-23, 1385/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Beneficial Antipsychotic Effects of Celecoxib Add – on Therapy Compared to Clozapine Alone in Schizophrenia
Public title
Beneficial Antipsychotic Effects of Celecoxib Add – on Therapy Compared to Clozapine Alone in Schizophrenia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: diagnosis of schizophrenia based on DSM-IV criteria; not using long acting antipsychotics since the last month; not using any oral antipsychotic except clozapine since the last week. Exclusion criteria: any side effects of drugs; need to changing antipsychotic drugs or adding new one.
Age
No age limit
Gender
Both
Phase
2-3
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
Mashhad University of Medical Sciences
Street address
Ghoreish building, Daneshgah Street.
City
Mashhad
Postal code
Approval date
2005-09-01, 1384/06/10
Ethics committee reference number
5508
Health conditions studied
1
Description of health condition studied
Schizophrenia
ICD-10 code
F20
ICD-10 code description
Schizophrenia
Primary outcomes
1
Description
schizophrenia
Timepoint
Baseline, 2nd, 4th weeks.
Method of measurement
PANSS test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: clozapine plus 100 mg/day celecoxib, towice a day, One month.
Category
Treatment - Drugs
2
Description
Control group: clozapine plus placebo.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ebn-e- sina hospital
Full name of responsible person
Street address
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Marjan Ardakanian
Street address
Ghoreish building, Daneshgah street
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Roya Samadi
Position
Resident
Other areas of specialty/work
Street address
Ebn-e-sina hospital. Hore ameli blvd.
City
Mashhad
Postal code
Phone
+98 51 1711 2721
Fax
Email
samadir881@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Ali Akhondpour Manteghi
Position
Assistant Professor
Other areas of specialty/work
Street address
Ibn-E- Sina Hospital, Hore Ameli blvd.
City
Mashhad
Postal code
Phone
+98 51 1711 2721
Fax
Email
manteghia@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Roya Samadi
Position
Resident
Other areas of specialty/work
Street address
Ebn-e-sina hospital. Hore ameli blvd.
City
Mashhad
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)