Comparison of therapeutic effects of modafinil plus sertraline versus sertraline plus placebo in outpatient treatment of major depressive disorder: a clinical trial
Comparison of the effects of Modafinil plus Sertralin and Sertralin plus placebo in treatment of major depressive disorder
Design
Triple blind clinical trial consisting of case and control groups; third phase on 50 patients.
Settings and conduct
We did sampling during 6 months at Imam Hossein hospital, Karaj. Telephone follow-up was done 6 weeks after initiation of treatment. In this study; patients, physician and analysor will be kept blind. Using placebo similar in shape to Modafinil for patients and specific codes for analysor and physician, they will be kept blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Diagnosis of Major depressive disorder; Obtaining informed consent.
Non-inclusion criteria: Diagnosis of bipolar mood disorder, ADHD or any underlying medical disease; use of any illicit drugs; past history of suicide
Intervention groups
Intervention group: receiving 200 mg of Modafinil each 12 hours plus standard dose of Sertraline for 6 weeks.
Control group: receiving placebo plus standard dose of Sertraline for 6 weeks
Main outcome variables
Fatigue severity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180522039784N1
Registration date:2020-08-09, 1399/05/19
Registration timing:retrospective
Last update:2020-08-09, 1399/05/19
Update count:0
Registration date
2020-08-09, 1399/05/19
Registrant information
Name
Pouria Chaghamirzayi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3450 2485
Email address
pouriachaghamirzayi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-23, 1398/07/01
Expected recruitment end date
2020-02-19, 1398/11/30
Actual recruitment start date
2019-09-23, 1398/07/01
Actual recruitment end date
2020-02-18, 1398/11/29
Trial completion date
2020-04-19, 1399/01/31
Scientific title
Comparison of therapeutic effects of modafinil plus sertraline versus sertraline plus placebo in outpatient treatment of major depressive disorder: a clinical trial
Public title
Evaluation of the effect of Modafinil in the treatment of major depressive disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of major depressive disorder
Informed consent
Exclusion criteria:
Diagnosis of bipolar mood disorder, ADHD or any underlying medical disease
Use of any illicit drugs
Use of any medication that interferes modafinil action
Past history of suicide
Past history of receiving ECT
Pregnancy
Daily use of more than 250 mg of caffeine
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
50
Actual sample size reached:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Based on the number of clinic's receipt (being even or odds) patients will be divided in two groups. Patients with even turns will be allocated to control group.
Blinding (investigator's opinion)
Triple blinded
Blinding description
We will give each patient a specific code, which neither physician or analysor won't know that which code belongs to which group. Using placebo similar in shape to modafinil, patients won't informed their group. After analysis, research's manager will replace codes with actual groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Alborz University of Medical Sciences
Street address
Imam hussain hospital; Mahdasht road
City
karaj
Province
Alborz
Postal code
1631735361
Approval date
2019-09-22, 1398/06/31
Ethics committee reference number
IR.ABZUMS.REC.1399.095
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
Fatigue severity
Timepoint
Before intervention and 6 weeks after initiation
Method of measurement
Fatigue severity scale
2
Description
Mood cahnges
Timepoint
Before intervention and 6 weeks after initiation
Method of measurement
Beck's depression inventory
Secondary outcomes
1
Description
Drug side effects
Timepoint
Six weeks after intervention
Method of measurement
Obtaining history
Intervention groups
1
Description
Intervention group: receiving 200 mg of Modafinil each 12 hours plus standard dose of Sertraline for 6 weeks.
Category
Treatment - Drugs
2
Description
Control group: receiving placebo every 12 hours plus standard dose of Sertraline for 6 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Psychiatry clinic of Imam Hussain Hospital
Full name of responsible person
Dr. Marzie Assare
Street address
Mahdasht road
City
karaj
Province
Alborz
Postal code
1631735361
Phone
+98 26 3622 0118
Email
emamhosseinhp.karaj@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Dr. Reza Bayrami
Street address
Nabovvat Blvd
City
Karaj
Province
Alborz
Postal code
1631735361
Phone
+98 26 3255 5000
Email
abzumc.ac.ir@gmial.com
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Karaj University of Medical Sciences
Proportion provided by this source
20
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
Karaj University of Medical Sciences
Full name of responsible person
Hamed Shabani
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Medical Education
Street address
Dabestan street; Seyedkhandan
City
Tehran
Province
Alborz
Postal code
1631735361
Phone
+98 21 8846 7286
Email
Pacino1373@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Dr. Marzie Assare
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
Alborz University of Medical Sciences; Nabovvat blvd
City
Karaj
Province
Alborz
Postal code
1631735361
Phone
+98 21 8846 7286
Email
hhsgdn@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Pouria Mirzayi
Position
Consultant
Latest degree
Medical doctor
Other areas of specialty/work
Epidemiology
Street address
Golshahr avenue
City
Karaj
Province
Alborz
Postal code
1631735361
Phone
+98 902 890 2005
Email
Pouriachaghamirzayi@yahoo.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
I will be willing to share this information with researchers who are conducting larger studies.I will give data to vice chancellor for research
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