Comparing the efficacy of L-carnitine and sertraline compared with sertraline alone on severity of depression in patients with major depressive disorder: A double blinded randomized controlled trial
To determine the efficacy of L-carnitine addition to sertraline drug regimen in treatment of major depressive disorder
Design
Clinical trial in phase II, with control group, with parallel group design, double-blind, randomized, on 60 patients with major depressive disorder. Table of random numbers created by a software will be used for randomization.
Settings and conduct
Research place: Psychiatric Clinic of Shahid Yahyanejad and Ayatollah Rouhani Hospitals in Babol; Type of blinding: double-blind; How to blind: Since the group codes are abbreviated as A and B, neither the patient nor the physician knows the type of treatment, and only the research pharmacologist knows how the patients are allocated in the two study groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age of 18 years and over, diagnosis of major depressive disorder based on DSM-5 diagnostic criteria through a clinical interview with a psychiatrist.
Exclusion criteria: history of high mood (mania or hypomania), dementia, mental dysfunction, acute psychiatric disorders according to the psychiatrist, the presence of serious somatic disorders, use of substances except of cigarettes and caffeine and medication which causes depression in the patient.
Intervention groups
Intervention group: will receive 1000 milligram of L-carnitine oral capsule daily made by Vana-Darougostar Pharmaceutical Company along with 100 milligram of sertraline made by Tehran-Daru Pharmaceutical Company.
Control group: will receive a placebo (oral capsule containing 1000 milligram of starch) daily along with 100 mg of sertraline made by Tehran-Daru Pharmaceutical Company.
Main outcome variables
Severity of depression based on Beck depression scale
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150630022991N15
Registration date:2021-02-26, 1399/12/08
Registration timing:registered_while_recruiting
Last update:2021-02-26, 1399/12/08
Update count:0
Registration date
2021-02-26, 1399/12/08
Registrant information
Name
Sussan Moudi
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3236 5683
Email address
sussan.mouodi@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-08, 1399/11/20
Expected recruitment end date
2021-05-21, 1400/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the efficacy of L-carnitine and sertraline compared with sertraline alone on severity of depression in patients with major depressive disorder: A double blinded randomized controlled trial
Public title
The efficacy of L-carnitine addition in treatment of major depressive disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of major depressive disorder based on diagnostic and statistical manual of mental disorders, 5th edition (DSM-5) through a psychiatrist clinical interview
Age 18 years and over
Exclusion criteria:
Previous history of high mood (mania and/ or hypomania)
Presence of dementia
Cognitive dysfunction
Acute psychiatric disorders based on the opinion of a psychiatrist
Serious somatic disorders
Substance dependence, except cigarettes and caffeine
Consumption of drugs that makes the incidence of depression in the patient
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Allocation of patients to the intervention and control groups will be conducted using a simple random method (table of random numbers). Simple random allocation codes will be generated using a computer. A comparative list of patient numbers and the type of desired treatment (abbreviated as A and B for each treatment group) will be determined by the statistical consultant of the project and provided to the researcher.
Blinding (investigator's opinion)
Double blinded
Blinding description
Since the group codes are abbreviated as A and B, neither the patient nor the physician knows the type of treatment, and only the research pharmacologist knows how the patients are allocated in the two study groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Babol University of Medical Sciences
Street address
Ganjafrooz avenue
City
Babol
Province
Mazandaran
Postal code
4717641367
Approval date
2020-10-10, 1399/07/19
Ethics committee reference number
IR.MUBABOL.REC.1399.319
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
2
Description of health condition studied
Major depressive disorder
ICD-10 code
F33.2
ICD-10 code description
Major depressive disorder, recurrent severe without psychotic features
Primary outcomes
1
Description
Severity of depression
Timepoint
At baseline, the third and sixth weeks after the treatment
Method of measurement
Based on Beck depression scale
Secondary outcomes
1
Description
Drug side effects
Timepoint
At baseline, the third and sixth weeks after the treatment
Method of measurement
Medical visit
Intervention groups
1
Description
Intervention group: will receive 1000 milligram of L-carnitine oral capsule daily made by Vana-Darougostar Pharmaceutical Company along with 100 milligram of sertraline made by Tehran-Darou Pharmaceutical Company.
Category
Treatment - Drugs
2
Description
Control group: will receive a placebo (oral capsule containing 1000 milligram of starch) daily along with 100 milligram of sertraline made by Tehran-Darou Pharmaceutical Company.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
The Clinic of Psychiatry, Shahid Yahyanejad Hospital
Full name of responsible person
Sussan Moudi, MD
Street address
Shahid Yahyanejad Hospital, Modarres avenue
City
Babol
Province
Mazandaran
Postal code
4717641367
Phone
+98 11 3222 3594
Fax
+98 11 3222 5035
Email
sussan.mouodi@gmail.com
2
Recruitment center
Name of recruitment center
The Clinic of Psychiatry, Ayatollah Rouhani Hospital
Full name of responsible person
Sussan Moudi, MD
Street address
Ayatollah Rouhani hospital, Ganjafrooz avenue
City
Babol
Province
Mazandaran
Postal code
4717641367
Phone
+98 11 3219 7667
Email
sussan.mouodi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Reza Ghadimi, MD, PhD
Street address
Babol University of Medical Sciences, Ganjafrooz avenue
City
Babol
Province
Mazandaran
Postal code
4717641367
Phone
+98 11 3219 7667
Fax
+98 11 3219 7667
Email
rezaghadimi@yahoo.com
Grant name
Grant code / Reference number
724132847
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol University of Medical Sciences
Full name of responsible person
Sussan Moudi, MD
Position
Associate Professor of Psychiatry
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
Shahid Yahyanejad hospital, Modarres avenue
City
Babol
Province
Mazandaran
Postal code
4717641367
Phone
+98 11 3219 7667
Email
sussan.mouodi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Farzan Kheirkhah, MD
Position
Professor of Psychiatry
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Shahid Yahyanejad hospital, Modarres avenue
City
Babol
Province
Mazandaran
Postal code
4717641367
Phone
+98 11 3219 7667
Email
drfarzankh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Sussan Moudi, MD
Position
Associate Professor of Psychiatry
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
Shahid Yahyanejad hospital, Modarres avenue
City
Babol
Province
Mazandaran
Postal code
4717641367
Phone
+98 11 3219 7667
Email
sussan.mouodi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Because the study participants are identified patients with major depressive disorder, there is no plan to publish the participants' data file, except in the final project report.
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not 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
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
Title and more details about the data/document
Patients-related data file cannot be published.
When the data will become available and for how long
Following the final study report was published.
To whom data/document is available
University researchers
Under which criteria data/document could be used
If more information about the research is needed, it can be achieved by sending an email to the project investigators.
From where data/document is obtainable
Sending an email to the project investigators Dr. Farzan Kheirkhah (drfarzankh@yahoo.com) and/or Dr. Sussan Moudi (sussan.mouodi@gmail.com)
What processes are involved for a request to access data/document
Within a maximum of two months after sending the email to the project investigators