The efficacy of celecoxib in the treatment of mania
Design
Clinical trial with control group, parallel groups, double blind, randomized, phase 3, 120 patients
Settings and conduct
Patients who agree to participate in group therapy are randomly divided into two groups of intervention and control groups. Patients in the intervention group receive sodium valproate (mood stabilizer) and 400 mg / day celecoxib in two divided doses. The control group is also prescribe sodium valproate and placebo with the same form and taste as celecoxib in two divided doses daily. Each group is followed for 4 weeks to improve the symptoms of mania base on the Mania Young Rating Scale. This evaluation is perform at week 0, 2, and 4 by an evaluator who is blind to the intervention.
Participants/Inclusion and exclusion criteria
1- Age between 18 and 65 years.
2. Diagnosis according to DSM-1V criteria by a psychiatrist.
4. Fill out the informed consent form.
5. Absence of other axis disorders
6. No other supportive therapy or use of cognitive therapy.
Intervention groups
Patients in the intervention group receive sodium valproate and 400 mg twice daily. The control group is also prescribe sodium valproate and placebo with the same form and taste as celecoxib in two divided doses daily.
Main outcome variables
mania
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200306046708N1
Registration date:2020-03-28, 1399/01/09
Registration timing:prospective
Last update:2020-03-28, 1399/01/09
Update count:0
Registration date
2020-03-28, 1399/01/09
Registrant information
Name
najmeh shahini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3215 5653
Email address
drshahini.n@goums.ac.ir
Recruitment status
Not yet recruiting
Funding source
Expected recruitment start date
2633-12-15, 2012/09/24
Expected recruitment end date
2641-04-19, 2020/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Celecoxib added to mood stabilizer for treating acute mania: A randomized, double-blind, placebo-controlled trial
Public title
Evaluation of the efficacy of celecoxib in the treatment of acute mania
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Eligible for Mania Course based on DSM IV - TR Diagnostic Criteria
No other supportive therapy or use of cognitive therapy.
Age between 18 and 65 years.
Fill out the informed consent form.
Exclusion criteria:
Causing side effects.
Willingness to exit the study
Unavailability of the patient.
Age
From 20 days old to 60 days old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method is in a simple way. The randomization tool is random numbers table, with even numbers for one group and odd numbers for another.
Hiding random allocation using envelopes seale
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants; Principal Investigator both are blind to allocation to groups. But the analyzer and the other researcher are aware of type of medications in each group.
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
Hore Ameli
City
Mashhad
Province
Razavi Khorasan
Postal code
0098
Approval date
2015-04-21, 1394/02/01
Ethics committee reference number
921878 Mashhad University Of Medical Science
Health conditions studied
1
Description of health condition studied
mania
ICD-10 code
F31.1
ICD-10 code description
Bipolar disorder, current episode manic without psychotic features