Determine the combined effect of Aripiprazole and Sertraline in the treatment of obsessive-compulsive disorder in adolescents
Design
From the patients referred by the psychiatric colleagues, allocation of type of treatment is done randomly.Due to gradual referral of patients and to maintain balance in groups, permuted block randomization is used that at any moment the difference in the number of samples in each group is less than 2-4. (Blocks 4 and 6). Both treatments are provided in the same coverage that the presenter and the patients will be blind to.
Settings and conduct
Patients are checked in at eight times. The first method is to randomize and receive the drug-free drug at the end of the first and second weeks, and then every two weeks until the end of the study, which will be the 12th week. During the fourth, eighth, and twelfth weekly visits, referral of patients to a psychiatrist Collaborator, the score of Yale Brown scale will be measured. The response to treatment by changing the scale of the scale from the baseline to the end of the study and the comparison between the two drugs is considered. Both treatments are provided in the same cover that the presenter and the patients They will be blind to it.
Participants/Inclusion and exclusion criteria
Obsessive compulsive disorder adolescents referring to psychiatric clinics in Kashan, by psychiatrist based on DSM 5
Intervention groups
In this study, the patients were randomly assigned to two groups with obsessive-compulsive disorder with a score of Yale Brown's questionnaire fitted to this age group above 16. In one group of Sertraline and placebo, and in the other group, Sertraline is co-administered with Aripiprazole.
Main outcome variables
Study of therapeutic effects
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190104042227N1
Registration date:2019-01-25, 1397/11/05
Registration timing:registered_while_recruiting
Last update:2019-01-25, 1397/11/05
Update count:0
Registration date
2019-01-25, 1397/11/05
Registrant information
Name
Reza Safaie
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3781 4191
Email address
safaei-r@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-01, 1397/05/10
Expected recruitment end date
2019-03-20, 1397/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Aripiprazole augmentation of Sertraline in adolescents with obsessive-compulsive disorder
Public title
The effect of Aripiprazole augmentation of Sertraline in adolescents with obsessive-compulsive disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Obsessive-compulsive disorder adolescent patients
Exclusion criteria:
Pregnancy and breastfeeding
Psychotic Psychiatric Disorders
Mental retardation
Substance abuse and alcohol abuse six months before the study began
There is a physical condition that prevents the receiving of medications
Age
From 12 years old to 19 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization using random numbers created by the computer will be performed
Blinding (investigator's opinion)
Double blinded
Blinding description
Double-blind (both patients and researchers) have been kept blind
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kashan University of Medical Sciences
Street address
Ghotb Ravand Blvd, Kashan University of Medical Sciences, Kashan
City
kashan
Province
Isfehan
Postal code
8715988141
Approval date
2018-11-26, 1397/09/05
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1397.051
Health conditions studied
1
Description of health condition studied
Obsessive compulsive disorder
ICD-10 code
F42
ICD-10 code description
Obsessive-compulsive disorder
Primary outcomes
1
Description
The intensity of obsession - compulsion
Timepoint
At the time of arrival, the fourth, eighth and twelfth weeks
Method of measurement
Y-BOCS questionnaire
Secondary outcomes
1
Description
The onset of side effects of drugs
Timepoint
Weeks zero, fourth, eighth and twelfth
Method of measurement
Clinical Examination and Interview
Intervention groups
1
Description
Intervention group: Administration of 50 to 150 mg sertraline daily for 12 weeks
Category
Treatment - Drugs
2
Description
Intervention group: Administration of 50 to 150 mg of Sertraline daily and 5 to 10 mg of Aripiprazole per day for 12 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinics affiliated to Kashan University of Medical Sciences
Full name of responsible person
Assaaryan Fatemeh
Street address
Kargar Nejad Hospital, Qutb Ravandi Blvd
City
kashan
Province
Isfehan
Postal code
8715973446
Phone
+98 31 5554 9111
Email
kargarnejad@kaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Hamidi Gholamali
Street address
Blvd. Ravandi, Kashan University of Medical Sciences
City
Kashan
Province
Isfehan
Postal code
8715973446
Phone
+98 31 5554 9111
Email
kargarnejad@kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Reza Safaei
Position
rezident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Blvd. Ravandi, Kargar Nejad Hospital
City
Kashan
Province
Isfehan
Postal code
8715973446
Phone
+98 31 5554 9111
Email
safaei-r@kaums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Safaei reza
Position
REZIDENT
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Blvd. Ravandi, Kargar Nejad Hospital
City
Kashan
Province
Isfehan
Postal code
8715973446
Phone
+98 31 5554 9111
Email
safaei-r@kaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Assaryan Fatemeh
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
Blvd. Ravandi, Kargar Nejad Hospital
City
Kashan
Province
Isfehan
Postal code
8715973446
Phone
+98 31 5554 9111
Email
dr.reza.safaie62@gmail.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