The aim of this study is to survey the effect of trazosin on sertralin inducing sweating. In this double blind clinical trial, 134 depressed patients (with DSM IV-TR criteria) on the treatment with sertralin who suffered from sweating were enrolled and randomly assigned to receive 1mg trazosin in bed time or similar amount of placebo. Two weeks later, intensity of sweating was recorded at the baseline and after two weeks after the intervention and compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138905064459N1
Registration date:2010-10-23, 1389/08/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-10-23, 1389/08/01
Registrant information
Name
Ali Ghaleiha
Name of organization / entity
Hamadan University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 81 1827 9001
Email address
vc_research@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy Dean of Research, Hamadan University of Medical Sciences
Expected recruitment start date
2009-04-04, 1388/01/15
Expected recruitment end date
2009-10-07, 1388/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Trazosin on sweating of Sertralin side effect in depressed patients: a double blind clinical trial study
Public title
Effect of Trazosin on sweating of Sertralin side effect in depressed patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: The patients who referred to the psychology clinic of Farshchian Hospital or to the private clinic of the psychologists of Hamadan city and were depressed based on the DSM IV-TR criteria, had sweating side effect due to the consumption of Sertralin
Exclusion criteria: not willing to participate in each stage of the experiment, presence of systemic disease such as hypertension, diabetes, presence of other psychological disorder, using other medicine or suffering from the side effect of Trazosin or placebo like orthostatic hypotension, vertigo, headache
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
134
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research ethics committee of Hamadan University of Medical Sciences
Street address
Research ethics committee, Deputy Dean of Research, Hamadan University of Medical Sciences
City
Hamadan
Postal code
65178518
Approval date
2008-07-27, 1387/05/06
Ethics committee reference number
56578/9/35/16/پ
Health conditions studied
1
Description of health condition studied
Depressive Disorder
ICD-10 code
F32
ICD-10 code description
Depressive episode
Primary outcomes
1
Description
sweating
Timepoint
Baseline and 2 weeks after the intervention
Method of measurement
visual analog scale
Secondary outcomes
1
Description
headache
Timepoint
daily
Method of measurement
case talking
2
Description
sexual insufficiency
Timepoint
daily
Method of measurement
physical axam and case talking
3
Description
orthostatic hypotension
Timepoint
Daily
Method of measurement
physical axam and case talking
4
Description
palpitation
Timepoint
daily
Method of measurement
physical axam and case talking
5
Description
vertigo
Timepoint
Daily
Method of measurement
physical axam and case talking
6
Description
nasal cogestion
Timepoint
Daily
Method of measurement
physical axam and case talking
Intervention groups
1
Description
control: placebo, tablet 1mg in bed time, for two weeks
Category
Placebo
2
Description
Intervention: Trazosin, Tablet 1m in bed time, for two weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Behavioral disorders and substance abuse research center of Hamadan University of Medical Sciences
Full name of responsible person
Ali ghaleiha, Psychiatrist, Assistant Professor
Street address
Farshchian hospital, behavioral disorders and substance abuse research center
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy Dean of Research, Hamadan University of Medical Sciences
Full name of responsible person
Ali Ghaleiha
Street address
Deputy Dean of Research, Hamadan University of Medical Sciences
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy Dean of Research, Hamadan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Deputy Dean of Research, Hamadan University of Medical Sciences
Full name of responsible person
Ali Ghaleiha
Position
Deputy Dean of Research, Psychologist
Other areas of specialty/work
Street address
Deputy Dean of Research, Hamadan University of Medical Sciences
City
Hamadan
Postal code
65178518
Phone
+98 81 1827 9001
Fax
+98 81 1826 3911
Email
vc_research@umsha.ac.ir, ghaleiha@umsha.ac.ir
Web page address
www.umsha.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Deputy Dean of Research, Hamadan University of Medical Sciences
Full name of responsible person
Ali Ghaleiha
Position
psychologist
Other areas of specialty/work
Street address
Deputy Dean of Research, Hamadan University of Medical Sciences
City
Hamadan
Postal code
65178518
Phone
+98 81 1827 9001
Fax
+98 81 1826 3911
Email
vc_research@umsha.ac.ir, ghaleiha@umsha.ac.ir
Web page address
www.umsha.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Deputy Dean of Research, Hamadan University of Medical Sciences
Full name of responsible person
Ali Ghaleiha
Position
Deputy Dean of Research, Psychologist
Other areas of specialty/work
Street address
Deputy Dean of Research, Hamadan University of Medical Sciences
City
Hamadan
Postal code
65178518
Phone
+98 81 1827 9001
Fax
+98 81 1826 3911
Email
vc_research@umsha.ac.ir, ghaleiha@umsha.ac.ir
Web page address
www.umsha.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)