Comparing the effects of Celecoxib with placebo on inflammatory factors and cognitive impairment in mood disorder patients undergoing electroconvulsive therapy (ECT)
This double-blind randomized clinical trial includes 50 patients with diagnosis of mood disorder according to DSM-IV-TR criteria by a psychiatrist who are candidates to receive electroconvulsive therapy. Before beginig of the first electroconvulsive therapy , every patients undrego a complete evaluation in terms of biochemical labaratory test and also inflammatory factors and cognition and memory by MMSE,WMS and Stroop.
YMRS and Hamilton are used for the evaluation of severity of mood disorder.patients receive celecoxib 200 mg BID in one group and placebo in the other group. Electrodes in electroconvulsive therapy are placed bilaterally. Patients undergo the same tests during the course of therapy in diffrene time points. The samples for measurement of inflammatory markers IL-1, IL-6, CRP and TNF-α are centrifuged and plasma will be kept ate -70 c frozen. The statistical analysis will be done using SPSS.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201201247202N2
Registration date:2012-02-11, 1390/11/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-02-11, 1390/11/22
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
Tehran University of Medical Sciences
Expected recruitment start date
2011-03-04, 1389/12/13
Expected recruitment end date
2012-03-04, 1390/12/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effects of Celecoxib with placebo on inflammatory factors and cognitive impairment in mood disorder patients undergoing electroconvulsive therapy (ECT)
Public title
evaluation of adding celecoxib to treatment of mood disorder patients receiving electroconvulsive therapy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: diagnosis of mood disorder according to DSM IV TR criteria by a psychiatrist. Exclusion Cirteria: Patients with Hypersensetivity to celecoxib or other NSAIDs, Patients with rheumatologic disease, Organic Brain Syndrome, Severe Medical Conditions (cardiovascular disorders, hepatic, renal, respiratory, gasterointestinal), diabetes, patients undegoing treatment with of other NSAIDs or corticosteroides, receiving ECT in the past 2 months, hearing or talking problem and pregnanant patients were excluded.
Age
From 18 years old to 55 years old
Gender
Both
Phase
N/A
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 Pharmaceutical Sciences Research Center of Tehran University of Medical Sciences
Street address
Faculty of Pharmacy- Tehran University of Medical Sciences-16th Azar Street- Tehran
City
tehran
Postal code
Approval date
2012-01-28, 1390/11/08
Ethics committee reference number
89-02-33-10809-44959
Health conditions studied
1
Description of health condition studied
mood disorde
ICD-10 code
F30-F39
ICD-10 code description
bipolar affective disorder/ depressive disorder
Primary outcomes
1
Description
change in inflammatory factors
Timepoint
baseline, after ECT 1,3,6
Method of measurement
serum sample
2
Description
change in cognition and memory
Timepoint
baseline, after ECT 1,3,6,
Method of measurement
MMSE,WMS and Stroop
Secondary outcomes
1
Description
efficacy
Timepoint
baseline. after ECT 1,3,6
Method of measurement
Hamilton, YMRS
Intervention groups
1
Description
celecoxib 200 mg BID from a day before first ECT
Category
Treatment - Drugs
2
Description
placebo with the same order and number as celecoxib
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Rouzbeh Hospita of lPsychiatry
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
Vice-Chancellor for Reseach of Faculty of Pharmacy
Street address
Faculty of Pharmacy-Tehran University of Medical Sciences-16th Azar Street-Tehran
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 of Tehran University of Medical Scienses
Full name of responsible person
Dr Padideh Ghaeli
Position
Associate Professor of Clinical Pharmacy,Faculty of Pharmacy of Tehran University of Medical Sciense
Other areas of specialty/work
Street address
Department of Clinical Pharmacy-Faculty of Pharmacy-Tehran University of Medical Scienses-16th 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 of Tehran University of Medical Scienses
Full name of responsible person
Dr Padideh Ghaeli
Position
Doctor of Pharmacy, Clinical Pharmacy Speciality
Other areas of specialty/work
Street address
Department of Clinical Pharmacy-Faculty of Pharmacy-Tehran University of Medical Scienses-16th Azar Street-Tehran
City
Tehran
Postal code
Phone
+98 2100982166954709
Fax
Email
pghaeli@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Mona Kargar
Position
Pharm D. Resident of clinical pharmacy
Other areas of specialty/work
Street address
City
tehran
Postal code
Phone
00
Fax
Email
mkargar@razi.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)