Evaluation of the effectc of the synchronised exercise and electroconvalsive therapy on serum brain neurotherupic factor in drug resistance depressive patient
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+antidepressant, exercises +antidepressant and antidepressants only who have been admitted in one of the psychiatric wards of Farshchian Hospital, Hamadan. In this study, there are 60 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 3 groups based on randomized blocks. The first group will undergo electroconvulsive+ antidepressant, second group exercise +antidepressant, and other antidepressant only. Before the treatment and fourth week after it Hamilton depresseion Rating scale 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:IRCT201312271743N12
Registration date:2014-01-07, 1392/10/17
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-01-07, 1392/10/17
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
2013-01-01, 1391/10/12
Expected recruitment end date
2013-06-01, 1392/03/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectc of the synchronised exercise and electroconvalsive therapy on serum brain neurotherupic factor in drug resistance depressive patient
Public title
Brain-Derived Neurotrophic Factor level 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:
60
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
Hamadan University of Medical Sciences
Street address
Fahmideh str.
City
Hamadan
Postal code
Approval date
2009-05-05, 1388/02/15
Ethics committee reference number
18366/9/35/پ
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
Hamiltone 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+ antidepressant drug
Category
Treatment - Drugs
2
Description
exercise +antidepressant
Category
Treatment - Drugs
3
Description
Antidepressant drug
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Farshchian Hospital
Full name of responsible person
Mohammad Haghighi
Street address
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
Mohammad Haghighi
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
Research center for behavioral disorders and substance abuse, Hamadan university of medical sciences
Full name of responsible person
Mohammad Haghighi
Position
Associate professor
Other areas of specialty/work
Street address
Honarestan Str.
City
Hamadan
Postal code
Phone
+98 81 1827 1066
Fax
Email
haghighi@umsha.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Research center for behavioral disorders and substance abuse, Hamadan university of medical sciences
Full name of responsible person
Mohammad Haghighi
Position
Associate professor
Other areas of specialty/work
Street address
Honarestan Str
City
Hamadan
Postal code
Phone
+98 81 1827 1066
Fax
Email
haghighi@umsha.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Research center for behavioral disorders and substance abuse, Hamadan university of medical sciences
Full name of responsible person
Mohammad Haghighi
Position
Associate professor
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)