Protocol summary

Summary
objective: this study would be done to investigate the effects of citalopram treatment on the level of change in the alpha and theta brain waves of patient with major depressive disorder referred to farshchian hospital, hamadan methods: 30 cases available random sampling of patients referred to the psychiatric ward after checking of the include and exclude criteria's on the basis of the criterion of the Diagnostic and Statistical Manual of mental disorders 4th edition will be selected. Inclusion criteria’s are only pure major depressive disorders that receive only citalopram and they don’t have any suicidal ideation. They are not post partum depression and they were not substance abuser in one year ago. Exclusion criteria’s are death, don’t like to continue and drug side effects.At first the scores of Hamilton depression scale plus scores in Quantitive ElectroEncephalography for all patients will be achieved. Then patients would be receiving for two months citalopram with a dose of 20-40 mg daily. Again they will response to Hamilton depression scales also their changes in level of alpha and theta will be record. Then the results of the pre and post test will be compared.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201203049202N1
Registration date: 2012-04-25, 1391/02/06
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2012-04-25, 1391/02/06
Registrant information
Name
Boshra Rahimi
Name of organization / entity
Hamedan University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1837 1533
Email address
b.rahimi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Center For Behavioral Disorders And Substanses Abuse Of Hamedan University Of Medical Sciences
Expected recruitment start date
2012-04-08, 1391/01/20
Expected recruitment end date
2013-04-08, 1392/01/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation the effects of Citalopram on the level of change in the alpha and theta brain waves of patient with major depressive disorder referred to Farshchian hospital, Hamadan
Public title
the effects of citalopram on brain waves of patients with major depressive disorder
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria:the patient doesn’t have another psychiatric diseases;the patient doesn’t have any medical problem;the patient doesn’t have history of epilepsy; the patient doesn’t percept another antidepressant drugs;the patient isn't postpartum depression;the patient doesn’t have treatment with ECT in three months ago;the patient doesn’t have any material or psychiatric drugs abuse in 1 year ago;the patient doesn’t have suicidal idea exclusion criteria:if patient is dead;if patient has any side effect of the drug;if patient don't like to continue
Age
No age limit
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Unit Of Hamadan University Of Medical Sciences
Street address
Hamadan University Of Medical Sciences, Shahid Fahmide Street, Hamedan
City
hamadan
Postal code
65178
Approval date
2011-08-27, 1390/06/05
Ethics committee reference number
d-p-16-35-9-1730

Health conditions studied

1

Description of health condition studied
major depressive dosorder
ICD-10 code
f30-f39
ICD-10 code description
Mood [affective] disorders

Primary outcomes

1

Description
major depressive disorder
Timepoint
before intervention & 2 months after intervention
Method of measurement
hamilton depression rating scale

Secondary outcomes

1

Description
response to treatment
Timepoint
2 months after intervention
Method of measurement
hamilton depression rating scale

Intervention groups

1

Description
citalopram 20- 40 mg oral once in day for 2 months
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Psychiatric Clinic Of Hamadan Farshchian Hospital
Full name of responsible person
Boshra Rahimi
Street address
Farshchian Hospital, Honarestan Ave, Hamadan
City
hamadan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research Center For Behavioural Disorders And Substances Abuse Of Hamadan University Of Medical Scie
Full name of responsible person
dr heidar tavilani
Street address
Medical University, Opposite To Mardom Park, Shahid Fahmide Street, Hamadan
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 Behavioural Disorders And Substances Abuse Of Hamadan University Of Medical Scie
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
Boshra Rahimi
Position
Resident of psychiatry
Other areas of specialty/work
Street address
Psychiatric group, Farshchian Hospital, Honarestan Ave, Hamadan
City
hamadan
Postal code
65168-4-8741
Phone
+98 81 1827 4191
Fax
Email
b.rahimi@umsha.ac.ir/rahimi.boshra@gmail.com
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
Psychiatrist. Professor Assistant
Other areas of specialty/work
Street address
Psychiatric group, Farshchian Hospital, Honarestan Ave, Hamadan
City
hamadan
Postal code
65168-4-8741
Phone
+98 81 1827 4191
Fax
Email
haghighi@umsha.ac.ir/dr_haghighi-ps@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Hamadan University Of Medical Sciences
Full name of responsible person
Boshra Rahimi
Position
Resident of psychiatry
Other areas of specialty/work
Street address
Psychiatric group, Farshchian Hospital, Honarestan Ave, Hamadan
City
hamadan
Postal code
65168-4-8741
Phone
+98 81 1827 4191
Fax
Email
b.rahimi@umsha.ac.ir/rahimi.boshra@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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