Investigating the effect of celecoxib on bipolar disorder
Design
A controlled, parallel-group, double-blind, randomized clinical trial on 60 patients. Randomization using Permuted block randomization method.
Settings and conduct
Patients referred to the clinics and inpatient department of Shahid Yaheinejad Hospital of Babol, whose diagnosis is bipolar disorder. 30 of the participating patients will receive celecoxib and 30 of the patients will receive placebo. The patients will be evaluated by the young mania questionnaire. In the present study, except for the statistical analyst, the rest of the presenters are blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria: having a bipolar disorder and over 18 years of age.
Exclusion criteria: dementia, drug use except for cigarettes and caffeine, serious cardiovascular and kidney diseases.
Intervention groups
Intervention group: receives celecoxib.
Control group: receives placebo.
Main outcome variables
Treatment of signs and symptoms in patients diagnosed with bipolar disorder.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221216056832N1
Registration date:2023-02-01, 1401/11/12
Registration timing:registered_while_recruiting
Last update:2023-02-01, 1401/11/12
Update count:0
Registration date
2023-02-01, 1401/11/12
Registrant information
Name
Farzan Kheirkhah
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 4253 9727
Email address
drfarzankh@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-31, 1401/10/10
Expected recruitment end date
2024-02-29, 1402/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effectiveness of adding celecoxib to sodium valproate in the treatment of patients with bipolar disorder
Public title
Investigating the effect of celecoxib on the treatment of bipolar disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having bipolar disorder
Age above 18 years
Exclusion criteria:
History of dementia
Existence of serious cardiovascular and kidney disease
Consumption of substances except for smoking and caffeine
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data and Safety Monitoring Board
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done using permutation blocks. In this method, the size of the blocks will be 4 and the ratio of two groups in each block will be 1:1. In each block, there will be an equal number of each group, i.e. (2 valproate + placebo) and (2 valproate + celecoxib). In each block, the arrangement of two groups is in random order and this random order was determined by a statistician. In order to hide the treatment process, random codes are written on the medicine canisters, and when drugs are allocated, the codes are recorded on the patients' files. The opening of the codes will be done by a statistician after the study is completed.
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to hide the treatment process, random codes are written on the medicine cans, and when drugs are allocated, the codes are recorded on the patients' files. In case of side effects, the codes are opened. Otherwise, the codes will be opened and analyzed at the end of the study. The use of placebo medicine will be used in a completely similar way in terms of shape and color in the same package. A placebo (oral capsule containing 1000 mg of lactose) is made.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Babol University of Medical Sciences
Street address
Mazandaran-Babol- Shahid Yaheinejad Hospital
City
Babol
Province
Mazandaran
Postal code
4717641367
Approval date
2022-12-12, 1401/09/21
Ethics committee reference number
IR.MUBABOL.HRI.REC.1401.190
Health conditions studied
1
Description of health condition studied
Bipolar Disorder
ICD-10 code
F31.2
ICD-10 code description
Bipolar disorder, current episode manic severe with psychotic features
Primary outcomes
1
Description
Bipolar affective disorde
Timepoint
2, 4 and 8 weeks after starting celecoxib
Method of measurement
Young mania questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: including 30 people in the group treated with celecoxib 400mg along with sodium valproate 20mg/kg daily for 8 weeks
Category
Treatment - Drugs
2
Description
Control group: 30 children will be treated with placebo (oral capsule containing 1000 mg lactose) and sodium valproate 20 mg/kg.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Patients referring to the clinics and inpatient department of Shahid Yaheinejad Hospital
Full name of responsible person
Farzan Kheirkhah
Street address
Babol - Shahid Yahainejad Hospital
City
Babol
Province
Mazandaran
Postal code
4717641367
Phone
+98 11 4253 2797
Email
drfarzankh@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Mehdi Rajab Nia
Street address
Babol - Shahid Yaheinejad Hospital
City
Babol
Province
Mazandaran
Postal code
4717641367
Phone
+98 11 3219 7667
Email
drfarzankh@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Farzan Kheirkhah
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Mazandaran-Babol- Shahid Yaheinejad Hospital
City
Babol
Province
Mazandaran
Postal code
4717641367
Phone
+98 11 4253 9727
Fax
Email
drfarzankh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Farzan Kheirkhah
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Mazandaran-Babol- Shahid Yaheinejad Hospital
City
Babol
Province
Mazandaran
Postal code
4717641367
Phone
+98 11 4253 9727
Fax
Email
drfarzankh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Farzan Kheirkhah
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Mazandaran-Babol- Shahid Yaheinejad Hospital
City
Babol
Province
Mazandaran
Postal code
4717641367
Phone
+98 11 4253 9727
Fax
Email
drfarzankh@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available