Celecoxib versus placebo as an adjunct in the treatment of Adolescents with bipolar mood disorder: a double blind randomized, placebo controlled study.
The objective of this study is to compare the effects of celecoxib and placebo in the treatment of adolescent bipolar mood disorder in a double-blind clinical trial. Blinding is done for two groups of subjects and raters of the outcomes of the study. Forty children and adolescent patients aged 12 to 18 years with diagnosis of acute phase of bipolar disorder and meeting inclusion criteria will be chosen form Roozbeh Psychiatric Hospital. After obtaining consent from patients they will enter into the double-blind treatment with lithium and risperidone and placebo or lithium and risperidone and celecoxib and the severity of symptoms before treatment and at weeks two, four and eight after treatments will be assessed. Effect of two treatment methods on patients' overall performance will be evaluated before and at eighth week after treatment. All patients will be treated with lithium and risperidone. Patients will be evaluated in terms of side effects.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015080423478N1
Registration date:2016-05-09, 1395/02/20
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-05-09, 1395/02/20
Registrant information
Name
Mohammadreza Mohammadi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5542 2001
Email address
mohammadimr@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tehran University of Medical Sciences, DR Masud Younesian
Expected recruitment start date
2016-04-03, 1395/01/15
Expected recruitment end date
2016-07-05, 1395/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Celecoxib versus placebo as an adjunct in the treatment of Adolescents with bipolar mood disorder: a double blind randomized, placebo controlled study.
Public title
Celecoxib versus placebo as an adjunct in the treatment of Adolescents with bipolar mood disorder.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Bipolar disorder (first episode); acute illness episode; manic phase; and Young Mania Rating Scale score 20 or more; age 12 to 18 years
Exclusion criteria: Liver, kidney, heart and thyroid disorders at present; history of renal dysfunction or heart or a history of stomach ulcers; hypersensitivity to sulfonamides; co-morbidity risk of autism spectrum disorders; the risk of mental retardation; substance abuse over the past year; Mood Disorder caused by physical illness such as seizures; head trauma and other diseases
Age
From 12 years old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Not 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
Research Deputy of Tehran University of Medical Sciences, Keshavarz Avenue
City
Tehran
Postal code
Approval date
2015-08-04, 1394/05/13
Ethics committee reference number
IR.TUMS.REC.1394.517
Health conditions studied
1
Description of health condition studied
Bipolar disorder
ICD-10 code
F31.1, F31
ICD-10 code description
Bipolar affective disorder, current episode manic without psychotic symptoms
Primary outcomes
1
Description
Bipolar disorder
Timepoint
Second week, Forth week, Week eight
Method of measurement
YMRS scale
Secondary outcomes
1
Description
Patient function
Timepoint
Before treatment and at week eight
Method of measurement
CGAS Scale
Intervention groups
1
Description
Intervention group: All patients treated with lithium , and risperidone and celecoxib. The dose of celecoxib is 100 mg twice a day.
Category
Treatment - Drugs
2
Description
Control group: All patients treated with lithium , risperidone and placebo. All patients received a starting dose of risperidone combined with lithium 1 mg in all patients, and within 10 days of the final dose (3 mg) will be.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Child and Adolescent Psychiatric, Rouzbeh Hospital.
Full name of responsible person
Seyed Yaser Musavi
Street address
Roozbeh Hospital ,South Kargar Avenue
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of Medical Sciences, DR Masud Younesian
Full name of responsible person
Mrs. Karimi
Street address
Research Deputy of Tehran University of Medical Sciences, Keshavarz Avenue, Tehran, Iran
City
Tehran
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, Tehran University of Medical Sciences, DR Masud Younesian
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
Tehran University of Medical Science
Full name of responsible person
Seyd Yaser Musavi
Position
Child Psychiatrist
Other areas of specialty/work
Street address
Roozbeh Hospital, South Kargar street , Tehran
City
Tehran
Postal code
Phone
+98 21 5542 1959
Fax
Email
Yaser135778@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Science
Full name of responsible person
Mohammad Reza Mohammadi
Position
Child Psychiatrist
Other areas of specialty/work
Street address
Roozbeh Hospital, South Kargar Street
City
Tehran
Postal code
Phone
+98 21 5542 1959
Fax
Email
Mohammadimr@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Science
Full name of responsible person
Neda Sepasi
Position
Master of Clinical Psychology
Other areas of specialty/work
Street address
Roozbeh Hospital, South Kargar Street
City
Tehran
Postal code
Phone
+98 21 5542 1959
Fax
Email
Neda_s780@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)