Investigating the effect of dextromethorphan in the treatment of depression
Design
Randomized double blind and placebo-controlled clinical trial. Patients are randomly divided (with allocation ratio 1:1) into two groups of intervention or control based on blocks of 4 using the computerized randomization list.
Settings and conduct
This study will be performed on patients attending Roozbeh Hospital. Patients who meet the inclusion and exclusion criteria will be included.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age between 18-65 - Diagnosis of major depressive disorder based on DSM-V (score between 14 and 17). Exclusion criteria: Serious suicidal thoughts - psychosis - co-occurring psychiatric disorder such as bipolar disorder, schizophrenia - alcohol and drug use disorders - personality disorder - ECT in the last two months - thyroid problems - history of cardiovascular disease - diabetes - autoimmune disease - active infection - neurological diseases (epilepsy, stroke, dementia), hematology, liver and kidney diseases - cancer - pregnancy and breastfeeding.
Intervention groups
Intervention group: sertraline tablet at a dose of 100 mg/day once a day and dextromethorphan at a dose of 30 mg three times a day - Control group: sertraline tablet at a dose of 100 mg/day once a day and placebo three times a day.
Main outcome variables
Depression severity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090117001556N160
Registration date:2024-07-23, 1403/05/02
Registration timing:prospective
Last update:2024-07-23, 1403/05/02
Update count:0
Registration date
2024-07-23, 1403/05/02
Registrant information
Name
Shahin Akhondzadeh
Name of organization / entity
Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5541 2222
Email address
s.akhond@sina.tums.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-09-22, 1403/07/01
Expected recruitment end date
2026-09-23, 1405/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Dextromethorphan as an adjuvant therapy to sertraline in major depressive disorder: A randomized, double-blind, placebo-controlled trial
Public title
The effect of dextromethorphan in the treatment of depression
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18-65
Diagnosis of major depressive disorder based on DSM-V (score between 14 and 17).
Exclusion criteria:
Serious suicidal thoughts
psychosis
co-occurring psychiatric disorder such as bipolar disorder, schizophrenia
alcohol and drug use disorders
personality disorder
ECT in the last two months
thyroid problems
history of cardiovascular disease
diabetes
autoimmune disease
active infection
neurological diseases (epilepsy, stroke, dementia), hematology, liver and kidney diseases
cancer
pregnancy and breastfeeding
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Permuted block randomization: using A and B blocks with n=4; AABB, ABAB, ABBA, BABA, BAAB, BBAA. We randomly use the blocks to achieve total sample size. ("A" and "B" are the study groups).
Blinding (investigator's opinion)
Double blinded
Blinding description
The participants, care providers and outcome assessors will be blind regarding grouping. All the participants believe that they are taking the main medication (the participants who are taking placebo are not aware of it). Care providers and outcome assessors do not know which participants have received the main medication and which participants have received placebo. Thus, there is no orientation in their work process.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of School of Medicine, Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Pour Sina St., Qods St., Enghelab St.
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2024-03-11, 1402/12/21
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1403.176
Health conditions studied
1
Description of health condition studied
Major depressive disorder
ICD-10 code
F32
ICD-10 code description
Major depressive disorder, single episode
Primary outcomes
1
Description
Severity of depression
Timepoint
Weeks: 0, 2, 4 and 6
Method of measurement
By Hamilton Depression Rating Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: sertraline tablet at a dose of 100 mg/day once a day and dextromethorphan at a dose of 30 mg three times a dayfor six weeks
Category
Treatment - Drugs
2
Description
Control group: sertraline tablet at a dose of 100 mg/day once a day and placebo three times a day.for six weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Roozbeh hospital
Full name of responsible person
Dr. Mohammad Reza Mohammadi
Street address
Roozbeh Hospital, South Kargar Street, Tehran.
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 2222
Email
mohammadimr@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Ali Akbari Sari
Street address
Terran University of Medical Sciences, Ghods St., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3658
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Dr. Shahin Akhondzadeh
Position
Professor of clinical psychopharmacology
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Roozbeh Hospital, South Kargar Street, Tehran.
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 2222
Email
s.akhond@sina.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Shahin Akhondzadeh
Position
Professor of clinical psychopharmacology
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Roozbeh Hospital, South Kargar Street, Tehran.
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 2222
Email
s.akhond@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Shahin Akhondzadeh
Position
Professor of clinical psychopharmacology
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Roozbeh Hospital, South Kargar Street, Tehran.
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 2222
Email
s.akhond@sina.tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The data will be distributed through final report.
When the data will become available and for how long
5 years from 2024 to 2029.
To whom data/document is available
Academic researchers.
Under which criteria data/document could be used
Users should cite the resource of data.
From where data/document is obtainable
Those who are interested can send their request to receive the documents and methods related to the research by email to Dr. Shahin Akhondzadeh.
What processes are involved for a request to access data/document