Due to the fact that research on the treatment of bipolar II disorder has not been conducted in our country. The aim of this study was to evaluate and compare the effect of bupropion and venlafaxine in the treatment of bipolar II disorder, which has also been confirmed by new psychiatric authorities.
Design
Clinical trial with control group, with two parallel groups of three-way blind, randomized, phase 2-3 on 60 patients. The Balanced Block method was used for randomization
Settings and conduct
The patient with depressive episode of bipolar II disorder referred to the specialized clinic of Golestan Hospital are randomly divided into two groups and treated with two different drugs. Only the supervisor is aware of the content of the drugs.
Participants/Inclusion and exclusion criteria
Admission Requirement: Participants must meet the DSM V Diagnostic Criteria for Bipolar II Depressive episode. Condition of non-entry: Rapid cycling disorder and mixed episode.
Intervention groups
One group will receive venlafaxine 75 mg daily for 4 weeks and the second group 75 mg bupropion daily for 4 weeks.
Main outcome variables
Treatment of Depressive Episode Bipolar II Disorder.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200913048698N1
Registration date:2020-12-12, 1399/09/22
Registration timing:registered_while_recruiting
Last update:2020-12-12, 1399/09/22
Update count:0
Registration date
2020-12-12, 1399/09/22
Registrant information
Name
Khatereh Asadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3374 3001
Email address
dr.kh.asadi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-10, 1399/09/20
Expected recruitment end date
2021-01-09, 1399/10/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of effect of Venlafaxin and Bupropion in treatment of Depressive episode of Bipolar II disorder
Public title
Comparison of Venlafaxine and Bupropion on depression of Bipolar II disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of Depressive episode of Bipolar II disorder according to DSM V
Ability to take oral medication
informed consent from the patient or parents
The patient has not used another antidepressant within four weeks of starting the drug
Exclusion criteria:
Sucidal tought
Psychosis
The current episode is mixed
Rapid cycling
Dyspepsia or peptic ulcer
Pregnant and lactating women
Intellectual disabilitie
History of alcohol and substance abuse up to six months before the start of the project
The patient's depression is caused by a physical illness using drugs or medication
Existence of any severe and chronic physical illness, cerebrovascular disease, seizures or history of substance use
Psychotic depression
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, block randomization method is used.A computer algorithm written in SAS (Statistical Analysis System) is used for performing a block randomization with randomaly selected block size of 4, 8 and 12.
Example out put from the SAS algorithm;
Block 1; size;4
1. 4. Control
2. 4 Control
3. 4 Intervention
4. 4. Intervention
Block 2; size ;4
1. 4 Control
2. 4. Intervention
3. 4 Control
4. 4. Intervention
Block 3; size ;8
1. 8. Control
2. 8. Intervention
3. 8. Control
4. 8. Intervention
5. 8. Intervention
6. 8 Intervention
7. 8 Control
8. 8. Control
The main idea of block randomization is to divide patients into M blocks of size 2N, so that in eachblock N patients are assigned to control group and N patients are assigned to intervention group.The selection of blocks is based on individual characteristics. The block is then randomly selected. This method ensures equal treatment allocation per block provided the block is fully utilized.
The size of the block, depending on the number of treatments, should be short enough to prevent imbalance, and large enough to prevent guessing treatment allocation in each group during the study. The size of the block should be at least twice the number of treatment groups. The size of the block is not stated in the study so that researchers are blind to it.
If the blocks are expressed, the treatment series in each block can be guessed. This can lead to selection bias. The solution to prevent this error is to: (1) Lack of disclose the block mechanism (2) Use random block size.
In each group, the drugs will be given to the patients in the same way, and the drug will be found on the same days and in the same way. Everyone on the research team, like patients and their families, will be unaware of the treatment groups designed.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Patients are treated with medication packages pre-determined by the study supervisor (supervisor).Drug packages are quite similar in shape.The patient and the facilitator are not aware of the contents of the packages. In addition, collecting patient assessment information and completing forms is done by the project manager and his assistant who are not aware of the content of the packages.The data analysis stage will be performed by the project consultant and the project manager who are not aware of the contents of the drug packages and only the group of patients (group one or two) will be identified for data analysis, so the study is three-blind.And from the stage of patient admission to the study, data collection and data analysis of the contents of the two drug groups is not clear.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz University of Medical Sciences
Street address
Golestan hospital., Golestan alley
City
Ahvaz
Province
Khouzestan
Postal code
61357-33118
Approval date
2020-02-09, 1398/11/20
Ethics committee reference number
IR.AJUMS.REC.1398.831
Health conditions studied
1
Description of health condition studied
Bipolar II disorder
ICD-10 code
F31.81
ICD-10 code description
Bipolar II disorder
Primary outcomes
1
Description
Depression Score Hamilton Questionnaire
Timepoint
Depression score of Hamilton questionnaire is calculated before intervention, and 14, 21 and 28 days after intervention
Method of measurement
Hamilton Questionnaire
Secondary outcomes
1
Description
Hypo mania score with MDQ questionnaire
Timepoint
Before starting the intervention
Method of measurement
MDQ Questionnaire
Intervention groups
1
Description
Intervention group: This group receives 75 mg Bupropion tablets made in Iran equivalent to 75 mg every morning and re-evaluated by Hamilton Depression Inventory two weeks, three weeks and four weeks after the start of the intervention.
Category
Treatment - Drugs
2
Description
Control group: This group receive Venlafaxine 75 mg tablet made in Iran, has been standardized with bupropion, equivalent to 75 mg daily, and after two weeks, three weeks and four weeks from the start of the intervention by the Hamilton questionnaire is re-evaluated.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan hospital
Full name of responsible person
Ahmad Fakhri
Street address
Golestan alley
City
Ahvaz
Province
Khouzestan
Postal code
61357-33118
Phone
+98 61 3374 3038
Fax
+98 61 3374 3038
Email
fakhri_s@ajums.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Amir Ahmad Moghaddam
Street address
Golestan Alley
City
Ahwaz
Province
Khouzestan
Postal code
61357-33118
Phone
+98 61 3374 3001
Fax
+98 61 3374 3038
Email
Info@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Khatere Asadi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Golestan Alley
City
Ahwaz
Province
Khouzestan
Postal code
61357-33118
Phone
+98 61 3374 3038
Fax
+98 61 3374 3038
Email
dr.kh.asadi@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Hamze Rostami
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Golestan Alley
City
Ahwaz
Province
Khouzestan
Postal code
61357-33118
Phone
+98 61 3374 3038
Fax
+98 61 3374 3038
Email
Rostami@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Khatereh Asadi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Psychiatry group office., Golestan hospital., Ahvaz city
City
Ahvaz
Province
Khouzestan
Postal code
61357-33118
Phone
+98 61 3374 3001
Fax
+98 61 3374 3038
Email
dr.kh.asadi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All data is potentially shareable after unidentified individuals
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
It will be available to researchers working in academic and scientific institutions
Under which criteria data/document could be used
Researchers working in academic and scientific centers are allowed to request documents for scientific use
What processes are involved for a request to access data/document
Researchers working in academic and scientific centers should send a request for documents to the above address, the files will be sent as soon as possible