Fluvoxamine Maleate in the Treatment of Depression/Depressive State : A Post-marketing Clinical Study in Children and Adolescents

Major Depressive Disorder Clinical Trial

Official title:

SME3110 (Fluvoxamine Maleate) in the Treatment of Depression/Depressive State : A Post-marketing Clinical Study in Children and Adolescents (8 Through 18 Years of Age) -A Double-blind, Randomized, Placeb-controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00353028
• Other study ID #: S114.3.117
• Status: Completed
• Phase: Phase 4
• First received: July 14, 2006
• Last updated: March 3, 2010
• Start date: October 2006
• Est. completion date: July 2009

Study information

• Verified date: March 2010
• Source: Solvay Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

This study is to verify the efficacy of fluvoxamine maleate given for 8 weeks in the treatment of children and adolescents with depression or depressive state

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 18 Years

Eligibility

Inclusion Criteria Have a minimum total score of 18 on the JSIGH-D, Weight is within the standard weight ± 2S.D. based on the standard weight for each age in the School Health Statistical Survey Exclusion Criteria Have the following predominant psychiatric diagnosis -Schizophrenia Have previously been treated with fluvoxamine maleate

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• Fluvoxamine maleate
Test product: Fluvoxamine maleate 25mg tablet. In case that the daily dose is one tablet, the study medication will orally be administered once daily, at bedtime. In case that the daily dose is two tablets or higher (maximam:6 tablets), the study mmedica
• Placebo
Placebo

Locations

Country	Name	City	State
Japan	S114.3.117 Kohnodai Hospital, National Center of N	Chiba prefecture
Japan	S114.3.117 Fukuoka University Hospital	Fukuoka prefecture
Japan	S114.3.117 Hatakeyama Clinic	Fukuoka prefecture
Japan	S114.3.117 Kaname Clinic	Fukuoka prefecture
Japan	S114.3.117 Kashi shinryo Clinic	Fukuoka prefecture
Japan	S114.3.117 Kashii Sanatorium	Fukuoka prefecture
Japan	S114.3.117 Kyushu University Hospital	Fukuoka prefecture
Japan	S114.3.117 Shiranui Hospital	Fukuoka prefecture
Japan	S114.3.117 Sugahara Tenjin Hospital	Fukuoka prefecture
Japan	S114.3.117 Hiroshima-city Funairi Hospital	Hiroshima prefecture
Japan	S114.3.117 Goryokai Hospital	Hokkaido prefecture
Japan	S114.3.117 Kobe University Hospital	Hyogo prefecture
Japan	S114.3.117 National Hospital Organization Kagawa C	Kagawa prefecture
Japan	S114.3.117 Yokohama City University Hospital	Kanagawa Prefecture
Japan	S114.3.117 National Hospital Organization Kikuti N	Kumamoto prefecture
Japan	S114.3.117 Kyoto University Hospital	Kyoto prefecture
Japan	S114.3.117 National Hospital Organization Sakakiba	Mie prefecuture
Japan	S114.3.117 Shinshu University Hospital	Nagano prefecture
Japan	S114.3.117 Aichi Children's Health and Medical Cen	Nagoya prefecture
Japan	S114.3.117 Nagoya Mental Clinic	Nagoya prefecture
Japan	S114.3.117 Nara Medical University Hospital	Nara prefecture
Japan	S114.3.117 Kansai Medical University Takii Hospita	Osaka prefecture
Japan	S114.3.117 Kusube Clinic	Osaka prefecture
Japan	S114.3.117 Yasuhara Children's Clinic	Osaka prefecture
Japan	S114.3.117 Tokushima University Hospital	Tokushima prefecture

Sponsors (1)

Lead Sponsor	Collaborator
Solvay Pharmaceuticals

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the time of onset of 50% decrease from baseline in the Japanese Version of the Structured Interview Guide for the Hamilton Depression Rating Scale (JSIGH-D) 17-item total score		8 weeks	No
Secondary	The Clinical Global Impression(CGI) improvement at Week 8		8 weeks	No