Evaluation and comparison of the effects of celecoxib and placebo on the brain-derived neurotrophic factor and on the severity of mania in patients with bipolar mood disorder in manic phase undergoing electroconvulsive therapy
This study aims to assess the effect of adding celecoxib or placebo to the treatment of manic patients undergoing electroconvulsive therapy (ECT) on the serum level of brain-derived neurotrophic factor and severity of mania. This is a randomized double blind study which is conducted in Tehran. Patients, with the diagnosis of manic episode bipolar mood disorder based on DSM-IV, who are planned to receive ECT are included after obtaining a consent form from the guardians.
Patients receive celecoxib (200 mg BD) or placebo a day before beginning of the ECTs and the drug or placebo continues until the end of the 6th ECT session. Blood samples are obtained before the initiation of intervention and are repeated thereafter. Assessment of severity of the disease is done by Young Mania Rating Scale.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201401177202N7
Registration date:2014-05-10, 1393/02/20
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-05-10, 1393/02/20
Registrant information
Name
Padideh Ghaeli
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6695 4709
Email address
pghaeli@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-Chancellor for Reseach of Faculty of Pharmacy, Tehran University of Medical Sciences
Expected recruitment start date
2011-04-21, 1390/02/01
Expected recruitment end date
2013-04-21, 1392/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation and comparison of the effects of celecoxib and placebo on the brain-derived neurotrophic factor and on the severity of mania in patients with bipolar mood disorder in manic phase undergoing electroconvulsive therapy
Public title
Effects of adding celecoxib on brain-derived neurotrophic factor and on the severity of symptoms in patients with bipolar disorder who receive Electroconvulsive therapy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: meeting the DSM-IV criteria for manic episode of bipolar mood disorder; age between 17 and 65 years; order of receiving electroconvulsive therapy Exclusion criteria: history of allergy to NSAIDs; lactating and pregnant women, cerebrovascular hemorrhage; severe hepatic or renal disease, Patients with rheumatologic disease, organic brain syndrome, concomitant taking of other NSAIDs or corticosteroids, severe medical conditions like cardiovascular disorders, respiratory and gasterointestinal disease, receiving electroconvulsive therapy in the past 2 months, stroke, presence of contraindication of receiving electroconvulsive therapy
Age
From 17 years old to 65 years old
Gender
Both
Phase
N/A
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
Ethics Committee of Tehran University of Medical Sciences
Street address
Keshvarz Blvd,Tehran University of Medical Sciences
City
Tehran
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
10809-15866
Health conditions studied
1
Description of health condition studied
Bipolar Mood Disorder, Manic Episode
ICD-10 code
F30
ICD-10 code description
Manic episode
Primary outcomes
1
Description
changes in brain-derived neurotrophic factor
Timepoint
baseline and after sessions 1,3,6 of ECT
Method of measurement
measurment of serum level
Secondary outcomes
1
Description
Severity of mania
Timepoint
baseline and afterECT 3 and 6
Method of measurement
by Young Mania Rating Scale
Intervention groups
1
Description
Intervention group: celecoxib 200 mg BID a day before initiation of the elecltoconvulsive therapy until the 6th elecltoconvulsive treatment
Category
Treatment - Drugs
2
Description
Control group: placebo with similar order as the intervention group and with the same duartion
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Roozbeh Hospital
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Akbar Fotouhi
Street address
6th floor, Tehran University of Medical Sciences, Ghods junction, 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
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
Faculty of Pharmacy, Tehran University of Medical Scienses
Full name of responsible person
Dr Padideh Ghaeli
Position
Professor of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of Medical Scienses
Other areas of specialty/work
Street address
Faculty of Pharmacy, Tehran University of Medical Sciences, 16 Azar Street, Tehran
City
Tehran
Postal code
Phone
+98 21 6695 4709
Fax
Email
pghaeli@sina.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Pharmacy, Tehran University of Medical Scienses
Full name of responsible person
Dr Padideh Ghaeli
Position
Professor of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of Medical Scienses
Other areas of specialty/work
Street address
Faculty of Pharmacy, Tehran University of Medical Scienses, 16th Azar Street, Tehran
City
Tehran
Postal code
Phone
+98 21 6695 2709
Fax
Email
pghaeli@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
Moan Kargar
Position
Clinical Pharmacist
Other areas of specialty/work
Street address
City
Tehran
Postal code
Phone
0
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)