Comparison of Efficacy of Aripiprazole versus Risperidone Augmentation of Selective Serotonin Reuptake Inhibitors for Treatment of Resistant Obsessive Compulsive Disorder: A Randomized Controlled Trial
To compare the efficacy of Aripiprazole versus Risperidone augmentation of SSRIs for in the treatment of resistant OCD.
Design
Two arm parallel group randomised trial, single blinded
Settings and conduct
Lahore general hospital
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
Patients of age 16-65 years of either gender
Patients diagnosed with obsessive compulsive disorder (as per operational definition) with Y-BOCS score ≥16.
Exclusion Criteria:
Pregnant females.
Patient allergic to trial drugs.
Patient having an organic cause for their symptoms.
Patient with comorbid conditions that aggravate the condition or develop depression and anxiety.
Intervention groups
In group A, patients will be given Aripiprazole started with a 2.5 mg daily dose and will be gradually increased to 10 mg daily by the end of the second week. In group B, Risperidone initiated with a 1 mg daily dose and was gradually increased to 2 mg daily by the end of the second week.
Main outcome variables
Y-BOCS SCORE
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230526058298N1
Registration date:2023-06-23, 1402/04/02
Registration timing:prospective
Last update:2023-06-23, 1402/04/02
Update count:0
Registration date
2023-06-23, 1402/04/02
Registrant information
Name
Muhammad Irfan Jamil
Name of organization / entity
Postgraduate Medical institute Lahore, Ameer-ud-din medical college
Country
Pakistan
Phone
+92 311 3773799
Email address
irfanravian51@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-01, 1402/04/10
Expected recruitment end date
2024-01-31, 1402/11/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Efficacy of Aripiprazole versus Risperidone Augmentation of Selective Serotonin Reuptake Inhibitors for Treatment of Resistant Obsessive Compulsive Disorder: A Randomized Controlled Trial
Public title
Comparison of Efficacy of Aripiprazole versus Risperidone Augmentation of Selective Serotonin Reuptake Inhibitors for Treatment of Resistant Obsessive Compulsive Disorder: A Randomized Controlled Trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients of age 16-65 years of either gender
Patients diagnosed with obsessive compulsive disorder (as per operational definition) with Y-BOCS score ≥16.
Exclusion criteria:
Pregnant females
Patient allergic to trial drugs
Patient having an organic cause for their symptoms
Patient with comorbid conditions that aggravate the condition or develop depression and anxiety
Age
From 16 years old to 65 years old
Gender
Both
Phase
1
Groups that have been masked
Participant
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization process will be performed by an principal researcher who is directly involved in the study. The randomization sequence will be generated using a random number generator, and participants will be assigned to their respective groups based on the order of enrollment. The allocation sequence will be concealed from the patients, ensuring that they remain blinded to the upcoming assignments.
Blinding (investigator's opinion)
Single blinded
Blinding description
The allocation sequence will be concealed from the patients, ensuring that they remain blinded to the upcoming assignments. the participants involved in the study will not be aware of their group assignment or the specific treatment they are receiving. However, the investigators and research staff will be aware of the group assignments.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
AMC/PGMI/LAHORE GENERAL HOSPITAL
Street address
Ferozpur road lahore
City
LAHORE
Postal code
54000
Approval date
2021-09-21, 1400/06/30
Ethics committee reference number
00/64/21
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
YALE-BROWN OBSESSIVE COMPULSIVE SCALE
Timepoint
3 months
Method of measurement
scoring system
Secondary outcomes
empty
Intervention groups
1
Description
In group A: Aripiprazole started with a 2.5 mg daily dose and will be gradually increased to 10 mg daily by the end of the second week. Treatment will be continued for 12 weeks.
Category
Treatment - Drugs
2
Description
In group B, Risperidone initiated with a 1 mg daily dose and was gradually increased to 2 mg daily by the end of the second week. Treatment will be continued for 12 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Lahore general hospital lahore
Full name of responsible person
Huma Kanwal
Street address
ferozpur road lahore
City
lahore
Postal code
54000
Phone
+92 333 3222453
Email
drhumazaheer13@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Postgraduate Medical Institute Lahore
Full name of responsible person
Irfan Jamil
Street address
Ferozpur Road Lahore
City
Lahore
Postal code
54000
Phone
+92 311 3773799
Email
irfanravian51@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Postgraduate Medical Institute Lahore
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
Post graduate Medical Institute Lahore
Full name of responsible person
Irfan Jamil
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Ferozpur Road Lahore
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 311 3773799
Email
irfanravian51@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Postgraduate Medical Institute Lahore
Full name of responsible person
Irfan Jamil
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Ferozpur road Lahore
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 311 3773799
Email
irfanravian51@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
lahore general hospital lahore
Full name of responsible person
Huma Kanwal
Position
postgraduate resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
khanpur
City
khanpur
Province
punjab
Postal code
64100
Phone
+92 68 5571035
Email
drhumazaeer13@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
primary outcome only
When the data will become available and for how long
results for lifelong
To whom data/document is available
to all
Under which criteria data/document could be used
for reference
From where data/document is obtainable
email
What processes are involved for a request to access data/document