Evaluation of the effect of Memantine and Escitalopram combination on Severity of Symptoms and Cognitive Function Among Patients with Obsessive-Compulsive Disorder: A double-Blinded Placebo-Controlled, Randomized Clinical Trial
Evaluation of the effect of Memantine and Escitalopram combination on Severity of Symptoms and Cognitive Function Among Patients with Obsessive-Compulsive Disorder (OCD): A Single-Blind Placebo-Controlled, Randomized Clinical Trial
Design
Both groups start with S-citalopram at a dose of 5 mg daily and increase by 5 mg weekly to a maximum dose of 30 mg / day. For the first group, memantine is prescribed at a dose of 10 mg twice a day. For the second group, a placebo with the same shape and size is prescribed twice a day.
Settings and conduct
This study will be a one-way clinical trial that will be performed in 1401 on patients with moderate to severe OCD referred to psychiatric clinics affiliated to Shahid Sadoughi University of Medical Sciences in Yazd
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. Patients 18 to 60 years old
2. Diagnosis of OCD based on DSM-5 by a psychiatrist
3. Patients with Y-BOCS≥21 score
Exclusion criteria:
1) Underlying diseases -1
2) Life-threatening psychological symptoms such as suicide
3) serious medical or neurological disease
4) Mental retardation (based on clinical judgment)
5) Drug use (except nicotine)
6) Pregnancy and lactation
7) History of drug allergy to memantine or S-citalopram
8) Previous psychosurgery history
9) History of refractory OCD
10) The patient's unwillingness to participate in the study
Intervention groups
Group 1: ES-citalopram + memantine Group 2: ES-citalopram + placebo
Main outcome variables
Severity of Obsessive-Compulsive Disorder (OCD) symptoms
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191106045356N11
Registration date:2022-06-30, 1401/04/09
Registration timing:prospective
Last update:2022-06-30, 1401/04/09
Update count:0
Registration date
2022-06-30, 1401/04/09
Registrant information
Name
Mohsen Zabihi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3820 3865
Email address
mzabihi100@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-21, 1401/04/30
Expected recruitment end date
2023-07-21, 1402/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of Memantine and Escitalopram combination on Severity of Symptoms and Cognitive Function Among Patients with Obsessive-Compulsive Disorder: A double-Blinded Placebo-Controlled, Randomized Clinical Trial
Public title
Evaluation of the effect of Memantine and Escitalopram combination on Severity of Symptoms and Cognitive Function Among Patients with Obsessive-Compulsive Disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of OCD based on DSM-5 by a psychiatrist
Patients with a Y-BOCS≥ score of 21
Patients 18 to 60 years
Exclusion criteria:
Age
From 18 years old to 60 years old
Gender
Both
Phase
4
Groups that have been masked
Participant
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is performed based on the RAND function of Excel software and patients are included in one of the two groups according to the table of random numbers obtained from Excel software, respectively, according to the inclusion criteria.
They receive the medication related to their group, which is encoded in uniformly sealed containers. Neither the physician nor the patient intervenes in the selection of the group and they do not know the content of each container of medicine.
Blinding (investigator's opinion)
Single blinded
Blinding description
Drugs and placebo are placed in coded uniform containers, and patients receive one of the containers according to ethical considerations and according to the inclusion criteria and the table of random numbers. Neither the doctor nor the patient knows the medicinal content of each container.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Sadoughi University of Medical Sciences
Street address
Alem sq;Shohadaye Gomnam Blvd
City
Yazd
Province
Yazd
Postal code
۸۹۱۶۹۷۸۴۷۷
Approval date
2022-05-15, 1401/02/25
Ethics committee reference number
درحال پیگیری است.
Health conditions studied
1
Description of health condition studied
Obsessive-Compulsive Disorder
ICD-10 code
ICD-10 code description
K12.0
Primary outcomes
1
Description
obsession score
Timepoint
Before and after treatment
Method of measurement
Examination of the patient and based on a standard questionnaire
Secondary outcomes
1
Description
obsession, stress, and anxiety
Timepoint
Before and after treatment
Method of measurement
DASS-21
Intervention groups
1
Description
Control group: Memantine treatment. Patients' rates of hospitalization, discharge, depression, and psychosocial functioning were evaluated.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
دانشگاه علوم پزشکی شهید صدوقی یزد
Full name of responsible person
Dr. Mohsen Zabihi
Street address
Alem sq.
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3820 3419
Email
mzabihi100@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. Mohsen Mirzaie
Street address
Bahonar sq.
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3726 3733
Email
dvc.research@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Dr. Mohsen Zabihi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Alem sq.
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3820 3419
Email
mzabihi100@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. Mohsen Zabihi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Alem sq.
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3820 3419
Email
mzabihi100@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. Mohsen Zabihi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Alem sq.
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3820 3419
Email
mzabihi100@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