The aim of the present study is to assess the efficacy of Celecoxib as an adjuvant agent in the treatment of bipolar disorder(mania episode) in a six-week double-blind, placebo controlled trial. 50 patient with mania hospitalized in Roozbeh and Qods Hospitals who meet inclusion criteria will participate in the trial. Patients will be randomly allocated into two groups. The first group (25 patients) will receive Valproate 600-800 mg/day plus Celecoxib 400 mg/day (200 mg bid); the second group( 25 patients) 20 will receive Valproate 600-800 mg/day plus placebo. Severity of mania and extrapyramidal side effects will be assessed by Young Mania Rating Scale and Extrapyramidal Symptoms Rating Scale (ESRS) at baseline and after1, 2, 4 and 6 weeks after the trial started. Liver function tests will be done 4 weeks after the medication started
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201307171556N53
Registration date:2013-07-18, 1392/04/27
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-07-18, 1392/04/27
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; Kurdistan University of Medical Sciences
Expected recruitment start date
2013-09-23, 1392/07/01
Expected recruitment end date
2015-09-23, 1394/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of celecoxib as an adjunct in the treatment of bipolar disorder: A double blind and placebo controlled trial
Public title
Efficacy of celecoxib in the treatment of bipolar disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: meeting the DSM-IV criteria for Bipolar Disorder; age between 18 and 65 years; a score of at least 20 points on the Young Mania Rating Scale;
Exclusion criteria: hyper- or hypothyroidism; substance dependence(except for Nicotine); IQ lower than 70; history of allergy to Celecoxib; lactating and pregnant women; gastro-intestinal ulcer or hemorrhage; cerebrovascular hemorrhage; severe hepatic disease
Age
From 18 years old to 65 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
Keshvarz Blvd
City
Tehran
Postal code
Approval date
2013-07-13, 1392/04/22
Ethics committee reference number
22216
Health conditions studied
1
Description of health condition studied
Bipolar Disorder
ICD-10 code
F31
ICD-10 code description
Mania episode
Primary outcomes
1
Description
Severity of mania
Timepoint
Baseline and weerks 1, 2, 4, 6
Method of measurement
by Young Mania Rating Scale
Secondary outcomes
1
Description
Severity of extrapyramidal side effects
Timepoint
Baseline and weerks 1, 2, 4, 6
Method of measurement
By Extrapyramidal Symptom Rating Scale(ESRS)
Intervention groups
1
Description
Intervention group: Valproate 600-800 mg/day plus Celecoxib 400 mg/day for 6 weeks
Category
Treatment - Drugs
2
Description
Control group: Valproate 600-800 mg/day plus placebo for 6 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Roozbeh Hospital
Full name of responsible person
Dr. Shahin Akhondzadeh
Street address
South Kargar Sreeet, Roozbeh Hospital
City
Tehran
2
Recruitment center
Name of recruitment center
Qods Hospital
Full name of responsible person
Dr. Farzin Rezaei
Street address
Qods hospiatal, Pasdaran Blvd., Sanandaj
City
Sanandaj
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Prof. Akbar Fotouhi
Street address
Keshvarz 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
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
2
Sponsor
Name of organization / entity
Vice chancellor for research, Kurdistan University of Medical Sciences
Full name of responsible person
Dr Ataollah Heydari
Street address
Pasdaran Blvd, Kurdistan university of Medical Sciences, Deputy of research, Sanandaj Sanandaj
City
Sanandaj
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Kurdistan University of Medical Sciences
Proportion provided by this source
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
South Kargar street; Roozbeh Hospital
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
South Kargar Street; Roozbeh Hospital,
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
South Karegar street; Roozbeh Hospital
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)