This is a randomized, double-blind clinical trial to evaluate the efficacy of thiamine in treating major depressive disorder. In this study 50 patients, referred to psychiatry ward of Farshchian Hospital will be enrolled in the study with consent inform ,who have been diagnosed as MDD based on DSM-V and their age is between 18 to 50 years.
Overall objective: Determine the efficacy of thiamine in treatment major depressive disorder. Applicable objective: If thiamine has positive effect on the amount or rate of depression improvement in patients, it can be applied as an effective treatment along with other treatments for depression. Exclusion criteria: Other psychiatric disorders, along with major depression; Debilitating somatic illness, along with major depression; History of Alcohol or Substances abuse in the last year; Magnesium deficiency; Thiamine deficiency in laboratory evaluation; Hyperthyroidism.
The patients will be divided into two groups based on randomized blocks. Intervention and control groups will be matched about demographic and disease related indicators such as age, sex, disease severity. Patients in the intervention group will receive 20 mg fluoxetine with 300 mg thiamine per day and the control group will receive 20 mg fluoxetine with placebo, for 3 months. Before the treatment and the intervals of 3, 6 and 12 weeks after the treatment, the patients’ depression will be assessed through Hamilton Depression Rating Scale and finally the improvement rate of the both groups compared to each other.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013070913929N1
Registration date:2013-08-12, 1392/05/21
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-08-12, 1392/05/21
Registrant information
Name
Hassan Davari
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1827 4185
Email address
h.davari@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for Research and Technology of Hamadan University of Medical Sciences
Expected recruitment start date
2013-08-23, 1392/06/01
Expected recruitment end date
2014-06-22, 1393/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the therapeutic effects of thiamine plus fluoxetine and fluoxetine alone in the patients with major depressive disorder
Public title
Effectiveness of thiamine in treatment of depression
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
- Diagnosis of major depressive disorder (MDD), according to DSM-V
-Age between 18 to 50 years.
Exclusion criteria:
- Patients with other psychiatric disorders, along with major depression
-Debilitating somatic illness, along with major depression
-Suffering from Wernicke Syndrome
-History of alcohol or substances abuse in the last year
-Known gastrointestinal disease
-History of long-term dialysis
-Suffering from congestive heart failure with long-term use of diuretics
-Magnesium deficiency
-Suffering from anorexia nervosa
-Allergy and sensitivity to thiamine
-Thiamine deficiency in laboratory evaluation
-Hyperthyroidism
Age
From 18 years old to 50 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
Vice chancellor for Research and Technology of Hamadan University of Medical Sciences
Street address
Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Postal code
65178
Approval date
2013-06-08, 1392/03/18
Ethics committee reference number
16/35/9/710/پ/د
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 symptoms of Depression
Timepoint
Baseline and 3weeks, 6weeks ,12weeks after treatment
Method of measurement
Hamilton Depression Rating Scale
Secondary outcomes
empty
Intervention groups
1
Description
Administration of fluoxetine +placebo
Category
Treatment - Drugs
2
Description
Administration of fluoxetine+thiamine
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Farshchian Hospital in Hamadan
Full name of responsible person
Street address
Farshchian Hospital, Hamadan
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for Research and Technology of Hamadan University of Medical Sciences
Full name of responsible person
Dr. Heydar Tavilani
Street address
Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for Research and Technology of Hamadan 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
Hamadan University of Medical Sciences
Full name of responsible person
Dr. Hassan Davari
Position
Resident of Psychiatry
Other areas of specialty/work
Street address
Farshchian Hospital, Hamadan
City
Hamadan
Postal code
Phone
+98 81 1827 4185
Fax
Email
h.davari@umsha.ac.ir, davarihassan11@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Dr. Ali Ghaleiha
Position
Associate Professor
Other areas of specialty/work
Street address
Farshchian Hospital, Hamadan
City
Hamadan
Postal code
Phone
+98 81 1827 4185
Fax
Email
ghaleiha@umsha.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Dr. Hassan Davari
Position
Resident of Psychiatry
Other areas of specialty/work
Street address
Farshchian Hospital, Hamadan
City
Hamadan
Postal code
Phone
+98 81 1827 4185
Fax
Email
h.davari@umsha.ac.ir, davarihassan11@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)