The purpose of the present investigation is to assess the efficacy of Modafinil as an adjuvant agent in the treatment of major depression in a six-week double-blind, placebo controlled trial. Method: 40 adult outpatients who meet the DSM- IV-TR criteria for major depression will participate in the trial. Patients who have a baseline Hamilton Rating Scale for Depression score of at least 22 will be allocated into two groups. 20 patients will receive Fluoxetine 40 mg/day plus Modafinil 400 mg/day (200 mg bid) (morning and evening) and 20 patients will receive Fluoxetine 40 mg/day plus placebo. Patients will be assessed by a psychiatrist at baseline and after 2, 4 and 6 weeks after the medication started using Hamilton Rating Scale for Depression(HRSD). Side effects will be also evaluated using a checklist.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138902301556N15
Registration date:2010-05-24, 1389/03/03
Registration timing:prospective
Last update:
Update count:0
Registration date
2010-05-24, 1389/03/03
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
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2010-06-05, 1389/03/15
Expected recruitment end date
2010-07-23, 1389/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trial of adjunctive Modafinil treatment in patients with major depression: a double blind and placebo controlled trial.
Public title
Modafinil and treatment of major depression
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Presence of Major Depressive Disorder based on DSM-IV criteria, Baseline Hamilton Depression Rating Scale (HAM-D) (17-item) score of at least 22,age between 18 to 50 years old . Exclusion criteria: Presence of Psychosis, any diagnosis in Axis I and II, Receiving psychotropic medications, receiving any antidepressants during past one month or ECT in past two months, Presence of hypothyroidism or cardiovascular problems, nursing or pregnant women
Age
From 18 years old to 50 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Keshavarz Blvd
City
Tehran
Postal code
Approval date
2009-12-06, 1388/09/15
Ethics committee reference number
5725
Health conditions studied
1
Description of health condition studied
major depressive disorder
ICD-10 code
F32
ICD-10 code description
Depressive episode
Primary outcomes
1
Description
Severity of depression
Timepoint
Baseline and weeks 2,4 and 6
Method of measurement
Hamiltion Depression Rating Scale 17-Item
Secondary outcomes
empty
Intervention groups
1
Description
Capsule Fluoxetine 40 mg/day plus Capsule Modafinil (400 mg/day) as intervention group for 6 weeks
Category
Treatment - Drugs
2
Description
Cap fluoxetine 40 mg/day plus Cap. placebo as control group for 6 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Roozbeh Hospital
Full name of responsible person
Prof. Shahin Akhondzadeh
Street address
Roozbeh Hospital
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Akbar Fotouhi
Street address
Keshavarz Blvd
City
Tehran
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
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Prof. Shahin Akhondzadeh
Position
Prof. of Clinical Psychopharmacology
Other areas of specialty/work
Street address
Roozbeh Hospital-South Kargar street
City
Tehran
Postal code
Phone
+98 21 5541 2222
Fax
Email
s.akhond@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Prof. Shahin Akhondzadeh
Position
Prof. of Clinical Psychopharmacology
Other areas of specialty/work
Street address
Roozbeh Hospital
City
Tehran
Postal code
Phone
+98 21555412222
Fax
Email
S.akhond@sina.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)