The evaluation of the effect of adding Clonidine to Sertraline in the severity of attachment and suffering from detachment in depression of the post-breakup women.
The evaluation of the effect of adding Clonidine to Sertraline in the severity of attachment and suffering from detachment in depression of the post-breakup women.
Design
90 patients of Razi Hospital psychiatric clinic are included in the study, divided into two 45 patients groups. After 8 weeks follow up, patients will score their severity of attachment and suffering from detachment with visual analog scale. Then the scores of two groups rating from 0 to 100 will compared.
Settings and conduct
Patients visited in psychiatric clinic of Razi Hospital will be included in the study. After taking history they will be placed in intervention or control group according to inclusion and exclusion criteria and severity of attachment and suffering from detachment will be measured by visual analog scale. After 2 months of treatment, severity of attachment and suffering from detachment will be remeasured. Scores of both groups will be compared with each other.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Females aging 20-40; The experience of emotional breakup in the last 6 months; informed consent (voluntary participation)
Exclusion criteria:
Comorbid anxiety disorder, Obsessive compulsive disorder; Personality Disorder, Substance abuse, Psychosis, Bipolar Disorder; Antihypertensive medication; History of Heart disease; Depression due to medical disorder; Egodystonic attachment and dependency; Severe depression with Beck score of 35 and above; Essential turnovers after breakup e.g. divorce
Intervention groups
One group will treated with Sertraline 50 mg and the other, with Sertraline 50 mg plus 1/4 Clonidine 0.2 mg
Main outcome variables
severity of attachment and suffering from detachment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100105002999N10
Registration date:2018-06-27, 1397/04/06
Registration timing:registered_while_recruiting
Last update:2018-06-27, 1397/04/06
Update count:0
Registration date
2018-06-27, 1397/04/06
Registrant information
Name
Alireza Farnam
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 5951
Email address
farnama@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-20, 1396/12/01
Expected recruitment end date
2018-08-23, 1397/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The evaluation of the effect of adding Clonidine to Sertraline in the severity of attachment and suffering from detachment in depression of the post-breakup women.
Public title
The evaluation of the effect of adding Clonidine to Sertraline in the severity of attachment and suffering from detachment in depression of the post-breakup women.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Females aging 20-40
The experience of emotional breakup in the last 6 months
informed consent(voluntary participation)
Exclusion criteria:
Comorbid anxiety disorder, Obsessive compulsive disorder Personality Disorder, Substance abuse, Psychosis, Bipolar Disorder
Antihypertensive medication
History of Heart disease
Depression due to medical disorder
Egodystonic attachment and dependency
Severe depression with Beck score of 35 and above
Essential turnovers after breakup e.g. divorce
Age
From 20 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
simple randomization
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 Tabriz University of Medical Sciences
Street address
Razi Hospital,El goli Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2018-02-04, 1396/11/15
Ethics committee reference number
IR.TBZMED.REC.1396.986
Health conditions studied
1
Description of health condition studied
Depression
ICD-10 code
F32
ICD-10 code description
Major depressive disorder, single episode
Primary outcomes
1
Description
Severity of attachment
Timepoint
measurement of the severity of attachment at the beginning and 8 weeks after intervention
Method of measurement
Visual analogue scale
2
Description
Suffering from detachment
Timepoint
measurement of the suffering from detachment at the beginning and 8 weeks after intervention
Method of measurement
Visual analogue scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Sertraline 50 milligram orally once daily plus 1/4 Clonidine 0.2 milligram Orally at night
Category
Treatment - Drugs
2
Description
Control group: Sertraline 50 milligram Orally once daily.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi Hospital
Full name of responsible person
Azar Heidarzadeh
Street address
El goli Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3380 3353
Fax
+98 41 3380 3353
Email
a.heidarzadeh67@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Abolghasem Jouyban
Street address
Golgasht Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3335 7310
Email
ajouyban@hotmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Azar Heidarzadeh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Razi Hospital, El goli Ave. , Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3380 3353
Email
a.heidarzadeh67@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Azar Heidarzadeh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Razi Hospital, Elgoli Ave., Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3380 3353
Email
a.heidarzadeh67@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Azar Heidarzadeh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Razi Hospital, Elgoli Ave., Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3380 3353
Email
a.heidarzadeh67@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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Only outcome information will share including visual analog scores and ages.
When the data will become available and for how long
6 months after publication
To whom data/document is available
For people working in academic institutions
Under which criteria data/document could be used
For research purposes, not for treatment
No research data publication
From where data/document is obtainable
Azar Heidarzadeh +989141051492
What processes are involved for a request to access data/document
Phone contact and to recieve documents after 1 week