The objective of this study was to assess Efficacy of adjunctive Celecoxib in improvement of Obsessive-compulsive disorder
This study is a double blind case – control study in a large referral psychiatric university hospital in Iran (Mashhad) from june 2014 to September 2015
Inclusion criteria: patients were met DSM IV criteria for diagnosis of OCD by a psychiatrist based on structured interview
exclusion criteria: they met criteria for bipolar I or bipolar II disorder; eating disorders, personality disorders, substance dependence or abuse history of gastrointestinal bleeding, and use of anymedications identified as contra-indicated with COX-2 inhibitors
all Patients were referred to ibne sina clinic visited by resident of psychiatry and after witten informed consent they randomized to receive celecoxib or placebo .in case group SSRI plus celecoxib 400 mg/day (200 mg bid) and in placebo group SSRI plus placebo in same shape and dose Patients were assessed with the Y-BOCS and CGI at baseline and 4, 8 and 12 weeks after the start of the treatment. Examinations of the patients during the treatment period was performed by blind psychiatrist trained
Hamilton depression and anxiety tests for all patients by a psychiatrist at baseline and after 12 weeks will be done. Patients will be enrolled according to Hamilton test if they don’t requires medical treatment for anxiety and severe depression
All side effects of medications at each visit based on the list prepared by the assistant psychiatry and if necessary tests will be done according to the discretion of the psychiatrist.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201512235280N21
Registration date:2016-01-05, 1394/10/15
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-01-05, 1394/10/15
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
Vice chancellor for research Mashhad University of Medical Sciences
Expected recruitment start date
2014-05-22, 1393/03/01
Expected recruitment end date
2015-08-23, 1394/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of adjunctive Celecoxib in improvement of Obsessive-compulsive disorder
Public title
Efficacy of adjunctive Celecoxib in improvement of Obsessive-compulsive disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion:
Patients were considered for participation in the project if they were met DSM-1V criteria for diagnosis of OCD. The diagnosis was confirmed by a psychiatrist based on structured interview ; A minimum score of 21 or above on the Yale–Brown Obsessive–Compulsive Scale (Y-BOCS).
Exclusion:
The patients did not receive any Psychotropic medications such as selective serotonin reuptake inhibitors (SSRIs), tricyclic Antidepressants (TCAs), or monoamine oxide inhibitors for 4 weeks preceding entry into the trial Patients; they suffered from known autoimmune disease; bipolar I or bipolar II disorder; eating disorders; personality disorders; mental retardation; substance dependence or abuse; had a concurrent medical illness; history of seizures that would contraindicate use of the study medication; receiving ECT; peptic ulcers or a history of gastrointestinal bleeding; use of any medications identified as contra-indicated with COX-2 inhibitors.
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:
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
Ethical Committee of Mashhad University of Medical sciences
Street address
Ghoraishy Building, University St.
City
Mashhad
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
922796
Health conditions studied
1
Description of health condition studied
Obsessive-compulsive disorder
ICD-10 code
F42
ICD-10 code description
Obsessive-compulsive disorder
Primary outcomes
1
Description
Obsessive-compulsive disorder
Timepoint
baseline, 4, 8, 12 weeks
Method of measurement
Yale–Brown Obsessive–Compulsive Scale (Y-BOCS)
2
Description
Depression
Timepoint
Baseline,12 th weeks
Method of measurement
Hamilton Depression Rating Scale
3
Description
Anxiety
Timepoint
Baseline,12 th weeks
Method of measurement
Hamilton Anxiety Rating Scale
4
Description
Illness severity
Timepoint
Baseline, 1, 2, 3,4 weeks
Method of measurement
Clinical Global Impression (CGI)
Secondary outcomes
1
Description
Side Effect
Timepoint
baseline, 4, 8, 12 weeks
Method of measurement
Check List
Intervention groups
1
Description
In case group SSRI plus celecoxib 400 mg/day (200 mg bid).
Category
Treatment - Drugs
2
Description
placebo group SSRI plus placebo in same shape and dose.