Comparison of the effect of Bupropion with sertraline on the treatment of depression in Parkinson patients.
Design
Two-way blind clinical trial, with two parallel groups, randomized in 42 patients
Settings and conduct
The study is being conducted at Roozbeh Psychiatric Hospital. Depressed Parkinson's patients are randomly divided into two groups. One group will receive bupropion and the second group will receive sertraline. Drugs will be given to patients in envelopes without medication information, and the primary outcome assessor is not aware of patient grouping, so the study will be double-blind.
Participants/Inclusion and exclusion criteria
Criteria for entry into the study: Parkinson's patients with depression.
Criteria for not entering the study: history of other major neurological disorders such as epilepsy, history of head trauma, vascular disorders, stroke and dementia and history of other major psychiatric disorders including bipolar disorder, schizophrenia, substance abuse and history of antipsychotic drugs. One last year.
Intervention groups
There are two intervention groups in this study:
Intervention group 1: Bupropion with an initial dose of 75 mg daily and if there is no initial response after one month, the dose will be increased to 150 mg daily.
Intervention Group 2: Sertraline with a daily dose of 50 mg and if there is no initial response after one month, the dose will be increased to 100 mg daily.
Main outcome variables
depression severity; Parkinson severity; duration of depression
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200513047429N1
Registration date:2020-06-28, 1399/04/08
Registration timing:registered_while_recruiting
Last update:2020-06-28, 1399/04/08
Update count:0
Registration date
2020-06-28, 1399/04/08
Registrant information
Name
Ashraf Fayazi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8896 3223
Email address
fayaziyalda@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-09, 1399/03/20
Expected recruitment end date
2020-12-10, 1399/09/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Bupropion with sertraline on the treatment of depression in Parkinson patients.
Public title
Comparison Bupropion with srtraline on the depression in Parkinson
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Parkinson's patients with major depression,
Exclusion criteria:
Absence history of other major neurological disorders, such as epilepsy, head trauma, vascular disorders, stroke and dementia, and other major psychiatric disorders, including bipolar disorder, schizophrenia, substance abuse, and use of Antipsychotics in the last 6 months
Age
No age limit
Gender
Both
Phase
4
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
42
Randomization (investigator's opinion)
Randomized
Randomization description
Our study is a randomized double-blind trial. Both patients and assessors will be unaware of the type of intervention for each patient.For randomization, we will use the simple randomization method, and for this purpose, Random number table will be used. First, the researcher predetermines the table to read the numbers (eg, top, bottom, left, or right), and the researcher also specifies how the numbers will be assigned to the two intervention groups ((For example, odd numbers for the Bupropion group and even numbers for the sertraline group). The researcher then touches one of the numbers and moves in one of the predefined directions, recording the numbers and assigning them to different groups. A nurse who is not involved in the intervention and delivery of the results, and delivers the medicine to the patient based on the patient's membership.
Blinding (investigator's opinion)
Double blinded
Blinding description
Medications are given to a patient in a packet without medication information. Any subsequent follow-up of the patient will be performed by a physician who is unaware of the patient's membership.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical sciences
Street address
No. 2 East Sahand Alley., Babataher Ave., Fatemi Ave.,
City
Tehran
Province
Tehran
Postal code
1414655541
Approval date
2020-04-28, 1399/02/09
Ethics committee reference number
IR.TUMS.VCR.REC.1399.297
Health conditions studied
1
Description of health condition studied
Depression
ICD-10 code
F32.8
ICD-10 code description
Other depressive episodes
2
Description of health condition studied
Parkinson
ICD-10 code
G20
ICD-10 code description
Parkinson's disease
Primary outcomes
1
Description
Severity of depression based on Beck's questionnaire
Timepoint
Measuring depression before intervention and then 1 and 3 month after intervention
Method of measurement
Beck's depression questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Depressed Parkinson's patients will be prescribed Bupropion tablets at an initial dose of 75 mg daily, and if there is no initial response after one month, the dose will be increased to 150 mg daily. The above drug is manufactured by Abidi Pharmaceutical Company
Category
Treatment - Drugs
2
Description
Intervention group: Depressed patients with Parkinson's disease, Sertraline at a dose of 50 mg daily, and if there is no initial response after one month, an increase in dose to 100 mg daily will be prescribed. It is an drug from Abidi Pharmaceutical Company
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Roozbeh hospital
Full name of responsible person
Fayazi Ashraf
Street address
south Kargar Ave.
City
Tehran
Province
Tehran
Postal code
۱۳۳۳۷۱۵۹۱۴
Phone
+98 21 5541 9151
Fax
+98 21 5541 9113
Email
hosp_roozbeh@tums.ac.ir
Web page address
http://roozbehhospital.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Sahraian
Street address
Keshavarz Boulevard, corner of Quds Street, Central University Organization, sixth floor
City
Tehran
Province
Tehran
Postal code
1417653911
Phone
+98 21 8163 3686
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fayazi Ashraf
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Keshavarz Boulevard, corner of Quds Street, Central University Organization, sixth floor
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 6649 2271
Email
tums_edu@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ashraf Fayazi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
No. 2, East Sahand Alley, Babataher Ave., Fatemi Ave., Tehran City
City
Tehran
Province
Tehran
Postal code
1414655541
Phone
+98 21 8896 3223
Fax
Email
Fayaziyalda@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ashraf Fayazi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
No. 2, East Sahand Alley, Babataher Ave., Fatemi Ave., Tehran City
City
Tehran
Province
Tehran
Postal code
1414655541
Phone
+98 21 8896 3223
Fax
Email
Fayaziyalda@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available