Investigation of the efficacy of Modafinil augmentation of antidepressant treatment on working memory in patients with major depressive disorder: A randomized double-blind clinical trial
The main aim of this study is to evaluate the efficacy of Modafinil augmentation of antidepressant treatment on working memory in patients with major depressive disorder through a double-blind randomized, placebo-controlled clinical trial.
Design
Double-blind randomized, placebo-controlled clinical trial with 90 participants
Settings and conduct
Outpatient clinic of Ebn'e Sina hospital and psychiatric offices in Mashhad.
Blinding of participants,researchers and evaluators.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1- Confirmed history of major depressive disorder based on the DSM-5 criteria, now in the recovery phase and receiving SSRIs or SNRIs;
2- Beck Depression Inventory score less than 28;
3- 18 to 40 years old;
4-The patient has not had more than three episodes;
5- Mean score of 30 for positive affect and 15 for negative; affect on Positive and Negative Affect Schedule (PANAS);
6- Completing the informed consent form.
Exclusion criteria:
1- Suffering any other major psychiatric illnesses;
2- Thyroid, immunological or neurological problems and other contraindications to Modafinil (such as refractory hypertension or history of cardiac arrhythmia) based on clinical history;
4- Mental retardation;
5- History of head injury or substance abuse;
Intervention groups
The intervention group receive Modafinil for eight weeks in addition to standard antidepressant medication with SSRIs or SNRIs. The drug is initially administered for one week at dose of 100 mg/day and then continued at dose of 200 mg/day. The control group receive standard antidepressant medication and placebo for eight weeks according to the protocol. At weeks 0, 2, 4, and 8, working memory in participants whose Positive and Negative Affect Schedule (PANAS) scores is within normal range is assessed by word/non word span test.
Main outcome variables
Working memory
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20091019002611N4
Registration date:2019-10-02, 1398/07/10
Registration timing:prospective
Last update:2019-10-02, 1398/07/10
Update count:0
Registration date
2019-10-02, 1398/07/10
Registrant information
Name
Mohammad Reza Fayyazi Bordbar
Name of organization / entity
Psychiatry and Bahavioral Sciences Research Center, Psychiatry group, Mashhad University of Medical
Country
Iran (Islamic Republic of)
Phone
00985117112721 , 00985117002306
Email address
fayyazimr@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-22, 1398/07/30
Expected recruitment end date
2020-05-21, 1399/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the efficacy of Modafinil augmentation of antidepressant treatment on working memory in patients with major depressive disorder: A randomized double-blind clinical trial
Public title
The efficacy of Modafinil on working memory in patients with major depressive disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Confirmed history of major depressive disorder based on the DSM-5 criteria, now in the recovery phase and receiving SSRIs or SNRIs
Beck Depression Inventory score less than 28
18 to 40 years old
The patient has not had more than three episodes
Mean score of 30 for positive affect and 15 for negative affect on Positive and Negative Affect Schedule (PANAS) test
Completing the informed consent form
Exclusion criteria:
Suffering any other major psychiatric illnesses
Thyroid, immunological or neurological problems and other contraindications to Modafinil (such as refractory hypertension or history of cardiac arrhythmia) based on clinical history
Mental retardation
History of head injury or substance abuse
Age
From 18 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Randomized block design, table of random numbers, sealed envelopes
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants are unaware of the target group (intervention or control), researchers and evaluators are unaware of each participant dedicated group.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Mashhad university of medical sciences, Daneshgah ST., Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
91357-345
Approval date
2019-03-12, 1397/12/21
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1398.274
Health conditions studied
1
Description of health condition studied
Major depressive disorder
ICD-10 code
F33.0
ICD-10 code description
Major depressive disorder, recurrent, mild
Primary outcomes
1
Description
Working memory capacity, measured by Persian word/non word span test
Timepoint
weeks 0, 2, 4 & 8 of drug administration
Method of measurement
Persian word/non word span test
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group receive Modafinil for eight weeks in addition to standard antidepressant medication with SSRIs or SNRIs. The drug is initially administered for one week at dose of 100 mg/day and then continued at dose of 200 mg/day.
Category
Treatment - Drugs
2
Description
Control group: the intervention group receive placebo for eight weeks in addition to standard antidepressant medication with SSRIs or SNRIs.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Outpatient private and public psychiatric clinics in Mashhad
Full name of responsible person
Mohammad Reza Fayyazi Bordbar
Street address
Ebn'e Sina hospital, Horr Ameli Blvd., Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9195983134
Phone
+98 51 3711 2701
Email
fayyazimr@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Mashhad University of medical sciences, Daneshgah St., Mashhad, Iran