Evaluation of therapeutic effect of varenicline on depression among methadone maintained smokers with major depressive disorder
Design
Double Blind randomized clinical trial with parallel group design
Settings and conduct
Sixty (60) smokers who referred to Yazd addiction treatment clinics and had a primary diagnosis of depression based on the DSM 5 criteria, were randomly divided into two groups of varenicline and placebo
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Persons in ranged 18 to 60 years old ;
Smokers under methadone maintenance therapy;
Patients with major depressive disorder;
Non inclusion criteria:
Create a noticeable and persistent drug problem;
Have a systemic disease ;
Patients with substance use (Based on Self-report);
Patients with psychotic disorder;
Patients with suicidal thoughts;
The patients under treatment with psychiatric drugs;
Depression is follow to substance use ;
Depression is associated with medical illness;
The patient is taking drugs that cause depression.
Intervention groups
Intervention group:The varenicline group, receiving the first three days , 0.5 mg and then 1 mg of varicellin (manufactured by Kowsar Pharmacy Company), received as daily for 6 weeks.
Control group: Placebo group. The starch was prepared in capsule form and was taken for 6 weeks.
In both groups, citalopram 20 mg/day were be given for 6 weeks.
Main outcome variables
Depression Score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190308042972N1
Registration date:2019-10-11, 1398/07/19
Registration timing:retrospective
Last update:2019-10-11, 1398/07/19
Update count:0
Registration date
2019-10-11, 1398/07/19
Registrant information
Name
mohammad talebpoorardakani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3222 1357
Email address
m_talebpoor@yahoo.com.au
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-21, 1396/11/01
Expected recruitment end date
2018-08-21, 1397/05/30
Actual recruitment start date
2018-02-20, 1396/12/01
Actual recruitment end date
2018-11-11, 1397/08/20
Trial completion date
2018-12-06, 1397/09/15
Scientific title
Evaluation ofTherapeutic Effect of Varenicline on Depression among Smokers Methadone Maintaintenance Therapy
Public title
The effect of varenicline on depression in smokers
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Persons in ranged 18 to 60 years old
Smokers under methadone maintenance therapy
Patients with Major depressive disorder
Exclusion criteria:
The patient's desire to withdraw from the study
Create a noticeable and persistent drug problem
Have a systemic disease
Patients with substance use (Based on Self-report)
Patients with psychotic disorder
Patients with suicidal thoughts
The patients under treatment with psychiatric drugs
Depression is follow to substance use
Depression is associated with medical illness
The patient is taking drugs that cause depression
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Actual sample size reached:
55
Randomization (investigator's opinion)
Randomized
Randomization description
By using simple randomized method, individuals were randomly assigned to control and intervention groups. The direction to read random numbers was from the left side. Even numbers were considered for the intervention group and the odd numbers for the control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The drug was prepared by a pharmacist that did Varenicline and placebo (starch) in the form of similar capsules and divided into two groups A and B. Until the end of the study, the participants, patients under methadone treatment, residence , and statistics counselor were not informed .
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Sadoughi University of Medical Sciences, Yazd
Street address
Headquarters of the University of Medical Sciences, Bahonar Square, Yazd
City
Yazd
Province
Yazd
Postal code
8951643745
Approval date
2017-09-03, 1396/06/12
Ethics committee reference number
IR.SSU.MEDICINE.REC.1396.179
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
Depression Score
Timepoint
First, 3 weeks later, 6 weeks later
Method of measurement
Beck Depression Inventory(I-II)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Citalopram tablet was given 20 mg once a day for 6 weeks and Vareniclin tablet (produced by Kowsar Pharmacy Company) 0.5 mg daily for the first three days and then 1 mg tablet daily for 6 weeks.
Category
Treatment - Drugs
2
Description
Control group: Citalopram tablets 20 mg per day and placebo (starch) in the form of capsules was given one day.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr. Dastjerdi's addiction treatment clinic
Full name of responsible person
Dr. Ghasem Dastjerdi
Street address
Dr Dastjerdi Drug Treatment ClinicShahid Hedayati Alley near Sina Lab,Taleghani Blvd, Yazd
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3725 4459
Email
ghasemdastjerdi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr.Masoud Mirzaei
Street address
Headquarters of the Yazd University of Medical Sciences, Bahonar Square, Yazd
City
Yazd
Province
Yazd
Postal code
8915173160.
Phone
+98 35 3724 0171
Email
info@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Dr. Ghasem Dastjerdi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Psychiatry Hospital, Shahid Beheshti Blvd,Taft
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3263 2003
Email
ghasemdastjerdi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Mohammad Talebpoorardakani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Psychiatry Hospital, Shahid Beheshti Blvd,Taft
City
Yazd
Province
Yazd
Postal code
8951643745
Phone
+98 35 3222 1357
Fax
Email
m_talebpoor@yahoo.com.au
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Mohammad Talebpoorardakani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Psychiatry Hospital, Shahid Beheshti Blvd,Taft
City
Yazd
Province
Yazd
Postal code
8951643745
Phone
+98 35 3222 1357
Fax
Email
m_talebpoor@yahoo.com.au
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
No more information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not 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