The purpose of the present investigation is to assess the efficacy of Ketamine as an adjuvant agent in the treatment of major depression in a six-week double-blind, placebo controlled trial. Fifty adult inpatient who meet the DSM- 5 criteria for major depression will participate in the trial. Patients who have a baseline Hamilton Rating Scale for Depression score of at least 20 will be allocated into two groups. 25 patients will receive sertraline up to 150 mg/day plusketamine 50mg/day and 25 participants will receive sertraline up to 150 mg/day plus placebo. Patients were assessed by a psychiatrist at baseline and after 2, 4 and 6 weeks after the medication started. Depression severity will be assessed by Hamilton Depression Rating Scale which will be the primary outcome measure.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201608071556N93
Registration date:2016-08-07, 1395/05/17
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-08-07, 1395/05/17
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
2016-08-22, 1395/06/01
Expected recruitment end date
2017-11-21, 1396/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of oral ketamine in treatment of patients with Major depressive disorder: A double – blind controlled trial
Public title
Efficacy of oral ketamine in treatment of patients with Major depressive disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age between 18 –60 years old; moderate to severe major depressive disorder based on Diagnostic & Statistical Mental Disorders (DSM-5); HRSD score above20; signing informed consent. Exclusion criteria: receiving antidepressant drugs within the last month; cardiovascular disease; pregnancy and lactation; receiving ECT (Electroconvulsive Therapy) during the last two months; thyroid disease; alcohol & drug abuse.
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
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
Ethics Committee of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Keshavarz Blvd.
City
Tehran
Postal code
Approval date
2016-07-25, 1395/05/04
Ethics committee reference number
IR.TUMS.VCR.REC.1395.355
Health conditions studied
1
Description of health condition studied
Major Depression
ICD-10 code
F32
ICD-10 code description
Major Depressive episode
Primary outcomes
1
Description
Severity of depression
Timepoint
Baseline and weeks: 2, 4 and 6 after beginig of treatment
Method of measurement
Hamiltion Depression Rating Scale 17-Item
Secondary outcomes
empty
Intervention groups
1
Description
Tablet sertraline up to 150 mg/day plus capsule ketamine 50 mg per day as intervention group for 6 weeks
Category
Treatment - Drugs
2
Description
Tablet sertraline up to 150 mg/day plus 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
Dr. Shahin Akhondzadeh
Street address
Roozbeh Hospital, South Kargar Street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Masoud Yunesian
Street address
Tehran University of Medical Sciences, Keshvarz 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
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 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, South Kargar Street
City
Tehran
Postal code
Phone
+98 21 5541 2222
Fax
Email
s.akhond@sina.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)