This was a double-blind clinical trial as a comparative study to evaluate the serum level of brain-derived neurotrophic factor in patients with unipolar major depressive disorder treated with electroconvulsive and antidepressants who have been admitted in one of the psychiatric wards of Farshchian Hospital, Hamadan.
In this study, there are 40 admitted patients at the age of 18-40 years who have no systemic disease and no illegal substance abuse; they will be enrolled in the study with informed consent and will be divided into two groups based on randomized blocks. The case study will undergo electroconvulsive treatment and the other group will be treated with antidepressants. Before the treatment and fourth week after it, Beck’s Depression Inventory (BDI) will be completed by all the patients and patients’ blood samples will also be collected in a similar method to measure the serum level of brain-derived neurotrophic factor. Their factor rate and depression intensity will be monitored too.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201207041743N8
Registration date:2012-07-15, 1391/04/25
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-07-15, 1391/04/25
Registrant information
Name
Mohammad Haghighi
Name of organization / entity
Research Center for Behavioral Disorders and Substance Abuse, Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1827 4184
Email address
haghighi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamadan University of Medical Sciences
Expected recruitment start date
2012-07-05, 1391/04/15
Expected recruitment end date
2012-09-21, 1391/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative Study of Brain-Derived Neurotrophic Factor in Depressive patients in treatment with Electro Convulsive Therapy and antidepressant
Public title
Brain-Derived Neurotrophic Factor in Depressive patients
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusive Criteria
1. Patients with unipolar major depressive disorder admitted in one of the psychiatric wards of Farshchian Hospital
2. Aged of 18-40 years
3. No systemic diseases such as diabetes, hypertension, epilepsy and etc
4. No history of alcohol abuse or other illegal substances
5. Patient’s informed consent
Exclusive Criteria
1. Incidence of uncontrollable somatic condition
2. Patient’s unwillingness to continue participation
Age
From 18 years old to 40 years old
Gender
Both
Phase
N/A
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
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Hamadan University of Medical Sciences
Street address
Fahmideh str.Hamadan
City
Hamadan
Postal code
Approval date
2012-07-03, 1391/04/13
Ethics committee reference number
1215/9/35/16/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 4 weeks after treatment
Method of measurement
Beck Depression scale
2
Description
level of Brain-derived neurotrophic factor in serum
Timepoint
Baseline and 4 weeks after treatment
Method of measurement
ELISA
Secondary outcomes
empty
Intervention groups
1
Description
Electero Convulsive Therapy
Category
Treatment - Other
2
Description
Antidepressant drugs
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Farshchian Hospital
Full name of responsible person
Mohammad Haghighi
Street address
Farshchian Hospital
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research center for behavioral disorders and substance abuse, Hamadan university of medical sciences
Full name of responsible person
Dr.Mohammad Ahmadpanah
Street address
honarestan Str.
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research center for behavioral disorders and substance abuse, 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
Mohammad Haghighi
Position
Assistant
Other areas of specialty/work
Street address
Assistant Professor of Psychiatry
City
Hamadan
Postal code
Phone
+98 81 1828 5015
Fax
Email
haghighi@umsha.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Mohammad haghighi
Position
Assistant Professor of Psychiatry
Other areas of specialty/work
Street address
Farshchian Hospital
City
Hamadan
Postal code
Phone
+98 81182851015
Fax
Email
haghighi@umsha.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)