Comparison of the therapeutic response rate of bupropion and citalopram in outpatient patients with major depressive disorder
Design
Patients are randomly placed in one of the two groups treated with bupropion or citalopram. To evaluate the therapeutic response rate, Hamilton Depression Rating Scale (HAM-D) and the cognitive triangle (CTI) questionnaire are used and in three times (before treatment, two weeks after treatment and four weeks after treatment), patients in both groups are placed under these two Tests.
Settings and conduct
Eligible patients referred to psychiatric clinic of 5 Azar Gorgan Educational Center are randomly assigned to one of the bupropion or citalopram groups by a psychiatrist and then referred to a psychiatric resident for evaluation based on CTI and HAM-D. Assessments will be done 3 times by the psychiatric resident.
Participants/Inclusion and exclusion criteria
criteria of inclusion: diagnosis of major depressive disorder based on structured clinical interview and DSM-5; not taking BZDs, antipsychotics and mood stabilizers, and concurrent psychotherapy, not having medical diseases including cardiovascular disease
Intervention groups
Intervention group A receiving bupropion and intervention group B receiving citalopram.
Main outcome variables
Objective therapeutic response is based on a decrease of more than 50% of the baseline score on the Hamilton Depression Rating Scale (HAM-D) measured by the assessor.
Subjective treatment response is based on a decrease in the score from the baseline score on the TCI self-report questionnaire.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190706044121N1
Registration date:2020-01-10, 1398/10/20
Registration timing:prospective
Last update:2020-01-10, 1398/10/20
Update count:0
Registration date
2020-01-10, 1398/10/20
Registrant information
Name
Mitra Joodi Mashad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3234 4198
Email address
drmitrajioodi@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-11, 1398/10/21
Expected recruitment end date
2020-06-20, 1399/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of Bupropion and Citalopram in response rate for patients with Major Depressive Disorder
Public title
Comparative study of Bupropion and Citalopram in response rate for patients with Major Depressive Disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of major depressive disorder based on structured clinical interview and DSM-5
Older than 30 years old
Sufficient fluency in Farsi and literacy reading and writing
lack of any comorbid disorder, especially anxiety disorders and substance use
retarded or normal psychomotor
Exclusion criteria:
previous appropriate response to a certain antidepressants
taking antidepressants when visiting
using BZDs, mood stablizers or antipsychotics
concurrent psychotherapy
medical conditions including cardiovascular disease
suicidal ideations and psychotic symptoms
need to admit to the mental ward
agitation or mixed mood symptoms
Age
From 30 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
104
Randomization (investigator's opinion)
Randomized
Randomization description
Participants in the study were randomly assigned into two groups of intervention (A) and (B). In this way, the cases will be randomly assigned to one of two study groups with the help of random number table and receive the intervention of the same group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Golestan University of Medical Sciences
Street address
Central organization of Golestan University of Medical Sciences, Hirkan Drive
City
Gorgan
Province
Golestan
Postal code
4918936316
Approval date
2019-09-08, 1398/06/17
Ethics committee reference number
IR.GOUMS.REC.1398.180
Health conditions studied
1
Description of health condition studied
Major Depressive Disorder
ICD-10 code
F32
ICD-10 code description
Major depressive disorder, single episode
Primary outcomes
1
Description
objective treatment response
Timepoint
at baseline and 2 and 4 weeks after pharmacotherapy
Method of measurement
Reduction of more than 50% of base score on Hamilton Depression Rating Scale (HAM-D)
2
Description
subjective treatment response
Timepoint
at baseline and after 2 and 4 weeks of pharmacotherapy
Method of measurement
reduction of baseline score in Cognitive Triad Inventory (TCI)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Bupropion (Welban company) with the starter dose of 75 mg/day and maximum dose of 300 mg daily for at least 4 weeks
Category
Treatment - Drugs
2
Description
Control group: Citalopram Pharmaceutical company Abidi The starting dose of 20 mg daily and a maximum dose of 40 mg daily for at least 4 weeks
Health Technology Development Center, the second floor, Library building, Golestan University of Medical Sciences, philosophical complex, 5th km of Sari-Gorgan
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3242 4377
Email
Roshd.center@goums.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
What processes are involved for a request to access data/document
After receiving the request by email or postal address, the researcher will check the request for 10 working days and if the item is usable in professional cases, the data will be provided to the applicant.