Sweating is common side effect in patients who use sertraline. This study will be conducted to evaluate the effect of oxybutinine on serteralin induced sweating in patients with depression. In this double blind clinical trial, according to diagnostic and statistical manual IV-TR criteria, patients with diagnosis of major depressive disorder and are under treatment with serteraline and having sweating, will be randomly assign in two groups(intervention group and control group). After signing the informed consent, the degree of the patients' sweating will be recorded. Intervention group will take 5 mg of oxibutinine twice a day and control group will take placebo twice a day for two weeks. After 2weeks, patients sweating degree will be re-evaluated. Then the results will be compared in study groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201101045547N1
Registration date:2011-05-16, 1390/02/26
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-05-16, 1390/02/26
Registrant information
Name
Zahra Sherafat
Name of organization / entity
Medical sience university
Country
Iran (Islamic Republic of)
Phone
+98 913 357 0273
Email address
z.sherafat@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Hamedan Univerity of Medical Sciences
Expected recruitment start date
2010-12-22, 1389/10/01
Expected recruitment end date
2011-12-22, 1390/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Randomized clinical trial of the effect of oxybutinine on serteralin induced sweating in patients with depression
Public title
Effect of oxybutinine on serteralin induced sweating in patients with depression
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with major depressive disorder according to diagnostic and statistical manual IV- TR criteria that are using serteraline as a treatment and have sweating as side effect
Exclusion criteria:
Patients with psychotic features; addiction; anxiety disorders; age under18 and above65 years old; patients with hypertension, cardiac disease, urinary problems, cataract, increased eye pressure; patient with personality disorder and patients who are taking the other medications
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
140
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
Medical sience university of hamedan
Street address
Medical sience university of hamedan
City
Hamedan
Postal code
Approval date
2010-12-06, 1389/09/15
Ethics committee reference number
137614/9/35/16پ
Health conditions studied
1
Description of health condition studied
Mjor depressive disorder
ICD-10 code
F32.9
ICD-10 code description
Depressive episode, unspecified
Primary outcomes
1
Description
Sweating
Timepoint
Before intervention, 2weeks after intervention
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
]Intervention group: oxybutinine tablet 5mg 2 times a day for 2 weeks
Category
Treatment - Drugs
2
Description
Control group: Placebo tablets, two times a day or 2 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinic of Farshchian psychiatry hospital
Full name of responsible person
Dr.Sherafat.zahra
Street address
Clinic of Farshchian psychiatry hospital
City
Hamedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Medical sience university of hamedan
Full name of responsible person
Dr.Ghaleiiha.Ali
Street address
Deputy of research,Medical sience university of hamedan
City
Hamedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?