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The efficacy comparison of Agomelatin and sertralin on depressive episode, in patients with bipolar I disorder

Protocol summary

Study aim
Comparison of the efficacy of sertraline and agomelatine on the depressive phase of bipolar I patients
Design
A clinical trial with a control group with a double-blind and random intervention group in phase 3, on 30 patients, where the intervention group with the letter A and the control group with the letter B are randomly separated.
Settings and conduct
It is performed in Kashan and in the office of the main researcher and among the patients referred to the psychiatric hospital and introduced from the psychiatrist's office. Patients are informed about the research and the type of drug used and explain the existence of a control group without knowing whether it is in the main intervention group or in the control group and that the researcher himself is unaware of the contents of the packages and people in the groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Bipolar I patients in the depressive phase, people 18 to 65 years old with bipolar depression, no other mental problems, no medication in the last 3 months No entry criteria: Psychotic, manic, pregnant and lactating patients, and people with suicidal ideation
Intervention groups
The intervention group is treated with Agomelatine, which is monitored regularly after starting the drug, and during the face-to-face visits and telephone calls, the treatment process and clinical changes, as well as the possible occurrence of side effects, are closely monitored. In the control group, they also receive Sertraline and are monitored and controlled with the same accuracy as the intervention group.
Main outcome variables
The rate of decrease in depression score - Hamilton score - in the two groups treated with sertraline is different from the group treated with agomelatine.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200803048284N1
Registration date: 2020-11-04, 1399/08/14
Registration timing: retrospective

Last update: 2020-11-04, 1399/08/14
Update count: 0
Registration date
2020-11-04, 1399/08/14
Registrant information
Name
Hamidreza Vojgani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5533 4489
Email address
dr.hamidrezavojgani@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-27, 1399/07/06
Expected recruitment end date
2020-10-31, 1399/08/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy comparison of Agomelatin and sertralin on depressive episode, in patients with bipolar I disorder
Public title
Comparison of the effect of Agomelatine and Sertraline on bipolar depression
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
- Patients with bipolar I disorder in the depression phase based on the Hamilton scale and clinical interview based on the criteria of the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) Age: 65-18 No liver disease or no impaired liver test. Do not consume drugs and alcohol - Do not have serious neurological problems (epilepsy, dementia, multiple sclerosis, cerebrovascular accidents) and other psychiatric disorders (obsessive-compulsive disorder or anxiety disorders and post-traumatic stress disorder)
Exclusion criteria:
Existence of psychotic manifestations Existence of mania demonstrations Patients with suicidal ideation Pregnancy and lactation
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
In our study, the two groups of participants selected by the researcher of the project, and the caregiver and executor are unaware of which group of participants are receiving what kind of medicine, so that after selecting people and dividing them into two groups, the drug The same packages in size and shape, distinguished by the Latin letters A&B, are provided to the participating groups by the caretaker, who is also unaware of the contents of the packages.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Kashan University of Medical Sciences
Street address
Kashan, km 3, Qutb Ravandi Blvd., Physician Blvd.
City
Kashan
Province
Isfehan
Postal code
8715988141
Approval date
2020-07-27, 1399/05/06
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1399.060

Health conditions studied

1

Description of health condition studied
Bipolar Depression I
ICD-10 code
F31/4
ICD-10 code description
Bipolar Depression I

Primary outcomes

1

Description
Improve depressive symptoms and depression score based on the Hamilton scale
Timepoint
Depression scores are measured on a Hamilton scale at baseline and before medication, as well as at 2,4,6,8 weeks.
Method of measurement
Using the Hamilton scale

Secondary outcomes

empty

Intervention groups

1

Description
Bipolar I patients who are in a depressive phase and are being treated with Agomelatine are given Agomelatine tablets from Tadbir Kala Pharmaceutical Company at a dose of 25 mg only at bedtime for 8 weeks along with one 500 mg Rahakin tablet from Raha Daroo company or 600 mg (two 300 mg tablets) lithium carbonate from Alhawi Pharmaceutical Company is given orally at bedtime.
Category
Treatment - Drugs

2

Description
Bipolar I patients who are in the depressive phase and are treated with Sertraline are given orally for 8 weeks Sertraline tablets from Dr. Abidi Pharmaceutical Company at a dose of 50 mg daily along with one 500 mg Rahakin tablet from Raha Daroo company or 600 mg (two 300 mg tablets) lithium carbonate from Alhawi Pharmaceutical Company is given orally at bedtime.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Dr. Afshin Ahmadvand's office
Full name of responsible person
Dr. Afshin Ahmadvand
Street address
Shahid Beheshti
City
Kashan
Province
Isfehan
Postal code
8719653363
Phone
+98 31 5545 5410
Email
ahmadvand_a@kaums.ac.ir

2

Recruitment center
Name of recruitment center
Kargarnejad Psychiatric Hospital
Full name of responsible person
Dr. Afshin Ahmadvand
Street address
Kashan, km 3, Qutb Ravandi Boulevard, at the end of Parstar Boulevard
City
Kashan
Province
Isfehan
Postal code
8715973446
Phone
+98 31 5554 9111
Fax
+98 31 5554 0036
Email
Kargarnejad@kaums.ac.ir
Web page address
http://Kargarnejad.kaums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Hamidreza Banafsheh
Street address
Kashan, km 3, Qutb Ravandi Blvd., Physician Blvd.
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 2999
Fax
+98 31 5557 5057
Email
research@kaums.ac.ir
Web page address
http://research.kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Hamid Reza Vajgani
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Alghadir Blvd
City
Kashan
Province
Isfehan
Postal code
8719653363
Phone
003155334489
Email
dr.hamidrezavojgani@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Hamidreza Vojgani
Position
Rezident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Ghotbe ravandi Bld kargarnegad hospital
City
Kashan
Province
Isfehan
Postal code
8719653363
Phone
+98 31 5533 4489
Fax
Email
dr.hamidrezavojgani@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Hamidreza Vojgani
Position
Rezident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Ghotbe ravandi Bld kargarnegad hospital
City
Kashan
Province
Isfehan
Postal code
8719653363
Phone
+98 31 5533 4489
Fax
Email
dr.hamidrezavojgani@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no more information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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