Memantine augmentation of escitalopram in treatment of executive function among patients with OCD, a Double-blind placebo controlled randomized clinical trial
Comparison of the effect of treatment with escitalopram and memantine with escitalopram and placebo in improving the executive function and symptoms of patients with obsessive-compulsive disorder
Design
Double blind, placebo controlled, randomized clinical trial with parallel group design of 60 patients
Settings and conduct
To conduct this study, a sample of 60 people is needed which are selected from the patients attending Ibn Sina Hospital and Clinic and Professor Mohrari in Shiraz. The patients are informed about the study either in person or by phone. The conditions and the procedure are explained to them and their consent is obtained.
Patients who meet the conditions for entering the study are divided into two groups of 30 people and receive the drugs according to the descriptions.
In weeks 0, 4, 8, 12 and 16, patients complete the Y-BOCS questionnaire to evaluate their treatment process.
In weeks 0 and 16, the BDEFS questionnaire is completed by the patients to check the executive function.
In weeks 4, 8, 12 and 16, the side effects of the drug are evaluated by a questionnaire.
Participants/Inclusion and exclusion criteria
Diagnosis of Obsessive compulsive disorder based on Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-V) Criteria
Yale - Brown Obsessive Compulsive Scale (Y-BOCS) score equal or more than 18
Intervention groups
In the control group, escitalopram starts with a dose of 5 mg per day and after 4 weeks the dose is increased to 10 mg per day and continues this way until the end of 16 weeks. This group receives placebo along with escitalopram.
Intervention group receives escitalopram in the same way as the control group. This group receives memantine at a dose of 10 mg per day along with escitalopram.
Main outcome variables
Yale - Brown Obsessive Compulsive Scale score
Barkley Deficits in Executive Functioning Scale scone
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211118053093N5
Registration date:2023-06-25, 1402/04/04
Registration timing:prospective
Last update:2023-06-25, 1402/04/04
Update count:0
Registration date
2023-06-25, 1402/04/04
Registrant information
Name
Kimia Sahraian
Name of organization / entity
Eghlid Higher Education Center
Country
Iran (Islamic Republic of)
Phone
+98 71 3630 3886
Email address
leilarazeghian1366@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-23, 1402/05/01
Expected recruitment end date
2023-09-23, 1402/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Memantine augmentation of escitalopram in treatment of executive function among patients with OCD, a Double-blind placebo controlled randomized clinical trial
Public title
Memantine in treatment of OCD
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
OCD diagnosis based on DSM-V criteria
Y-BOCS score equal or more than 18
Exclusion criteria:
Drug abuse
Pregnancy
Medical problems
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
After gathering the patients randomization will be performed by main researcher by using random number table. The patients will be divided into 2 groups which everyone contains 30 patiens.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants do not know which group they are in.
The data analyser does not know which group it is analysing.
The number of weeks of drug use is the same, so the patient is blinded to the type of treatment.Data analysis is given only data and does not know what treatment was done for witch group.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Kilometer 13 of Shiraz-Isfahan highway, Ostad Mohrari Hospital
Barkley Deficits in Executive Functioning Scale score
Timepoint
Week 0 and 16
Method of measurement
Barkley Deficits in Executive Functioning Scale questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Control group: In the control group, escitalopram starts with a dose of 5 mg per day and after 4 weeks the dose is increased to 10 mg per day and continues this way until the end of 16 weeks. This group receives placebo along with escitalopram.
Category
Treatment - Drugs
2
Description
Intervention group: receives escitalopram in the same way as the control group. This group receives memantine at a dose of 10 mg per day along with escitalopram.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Professor Moharari Psychiatric Hospital
Full name of responsible person
Leila RazeghianJahromi
Street address
13 km Shiraz-Isfahan, Ostad Mohrari Hospital
City
Shiraz
Province
Fars
Postal code
71441-13331
Phone
+98 71 3260 5701
Email
leilarazeghian1366@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Leila RazeghianJahromi
Street address
13 km Shiraz-Isfahan, Ostad Mohrari Hospital
City
Shiraz
Province
Fars
Postal code
71441-13331
Phone
+98 71 3260 5701
Email
leilarazeghian1366@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Leila Razeghian Jahromi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
13 km Shiraz-Isfahan, Ostad Mohrari Hospital
City
Shiraz
Province
Fars
Postal code
71441-13331
Phone
+98 71 3260 5701
Email
leilarazeghian1366@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Leila Razeghian Jahromi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
13 km Shiraz-Isfahan, Ostad Mohrari Hospital
City
Shiraz
Province
Fars
Postal code
71441-13331
Phone
+98 71 3260 5701
Email
leilarazeghian1366@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Leila Razeghian Jahromi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
13 km Shiraz-Isfahan, Ostad Mohrari Hospital
City
Shiraz
Province
Fars
Postal code
71441-13331
Phone
+98 71 3260 5701
Email
leilarazeghian1366@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