The primary purpose of this study is to compare the effect of Fluoxetine and Fluvoxamine on child and adolescent depression. In this study, 40 children and adolescents (8-18 years old) who have MDD diagnosis are randomly assigned into two groups to receive either Fluoxetine capsules, 10mg per day, or Fluvoxamine tablets, 25 mg per day. Depression severity of patients using CDI and CGAS scale and drug side effects are assessed at the baseline and 2, 4, and 8 weeks after the interventions.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138901093607N1
Registration date:2010-06-04, 1389/03/14
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-06-04, 1389/03/14
Registrant information
Name
Zahra Sepehrmanesh
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1444 3000
Email address
sepehrmanesh-z@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for Research, Kashan University of Medical Sciences,
Expected recruitment start date
2009-08-23, 1388/06/01
Expected recruitment end date
2010-08-23, 1389/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of Fluoxetine and Fluvoxamine on child and adolescent depression admitted to Akhavan hospital, Kashan.
Public title
Comparing the effect of Fluoxetine and Fluvoxamine on child and adolescent depression admitted to Akhavan hospital, Kashan.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: IQ more than 70 characterized by psychologist and psychiatrist via clinical interview, age 8-17 years, having major depression without psychotic features based on DSM-IV
Exclusion criteria: severe disabling physical illness, other medical problems that counteract with drug use or other antidepressant drugs, Severe mental disorders such as psychotic, bipoular disorders, catatonia symptoms, substance abuse
Age
From 8 years old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kashan University of Medical Sciences
Street address
Kashan University of Medical Sciences
City
Kashan
Postal code
8713783981
Approval date
2009-01-09, 1387/10/20
Ethics committee reference number
پ/29/5/1/3274
Health conditions studied
1
Description of health condition studied
Depression
ICD-10 code
F32
ICD-10 code description
Depressive episode
Primary outcomes
1
Description
Depression severity
Timepoint
Baseline and 2, 4, 8 weeks after the intervention
Method of measurement
CDI and CGAS
Secondary outcomes
1
Description
Body weight
Timepoint
Baseline and 2, 4, and 8 weeks after intervention
Method of measurement
Body weight in Kg
2
Description
Adverse effect
Timepoint
Baseline and 2, 4, and 8 weeks after intervention
Method of measurement
any drug adverse effect
Intervention groups
1
Description
Fluovoxamine, Tablets, 25 mg per day, orally for 8 weeks
Category
Treatment - Drugs
2
Description
Flouxetine, Capsules, 10mg per day, orally for 8 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Akhavan Hospital
Full name of responsible person
Zahra Sepehrmanesh-MD
Street address
Akhavan Hospital, Kashan
City
Kashan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Gholam Ali Hamidi
Street address
Kashan university of medical sciences
City
Kashan
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
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
Kashan University of Medical Sciences
Full name of responsible person
Zahra Sepehrmanesh.MD
Position
Assistant Professor of psychiatry
Other areas of specialty/work
Street address
Akhavan Hospital-Kashan-Iran
City
Kashan
Postal code
87137/83981
Phone
+98 361444302125
Fax
Email
z.sepehrmanesh@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zahra Sepehrmanesh-MD
Position
Assistant Professor of Psychiatry, child and Adolescent Psychiatrist
Other areas of specialty/work
Street address
Kashan University of Medical Sciences
City
Kashan
Postal code
87137/83981
Phone
+98 36 1444 3000
Fax
Email
z.sepehrmanesh@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kashan university of Medical Sciences
Full name of responsible person
Zahra Sepehrmanesh, MD
Position
Assistant Professor
Other areas of specialty/work
Street address
Akhavan Hospital, Kashan University of Medical Sciences
City
Kashan
Postal code
87137/83981
Phone
+98 36 1444 3021
Fax
Email
z.sepehrmanesh@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)