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

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
Fluvoxamine maleate
Placebo
Sponsored by
Solvay Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Fluvoxamine Maleate, Depression, Children and Adolescents

Eligibility Criteria

8 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • S114.3.117 Kohnodai Hospital, National Center of N
  • S114.3.117 Fukuoka University Hospital
  • S114.3.117 Hatakeyama Clinic
  • S114.3.117 Kaname Clinic
  • S114.3.117 Kashi shinryo Clinic
  • S114.3.117 Kashii Sanatorium
  • S114.3.117 Kyushu University Hospital
  • S114.3.117 Shiranui Hospital
  • S114.3.117 Sugahara Tenjin Hospital
  • S114.3.117 Hiroshima-city Funairi Hospital
  • S114.3.117 Goryokai Hospital
  • S114.3.117 Kobe University Hospital
  • S114.3.117 National Hospital Organization Kagawa C
  • S114.3.117 Yokohama City University Hospital
  • S114.3.117 National Hospital Organization Kikuti N
  • S114.3.117 Kyoto University Hospital
  • S114.3.117 National Hospital Organization Sakakiba
  • S114.3.117 Shinshu University Hospital
  • S114.3.117 Aichi Children's Health and Medical Cen
  • S114.3.117 Nagoya Mental Clinic
  • S114.3.117 Nara Medical University Hospital
  • S114.3.117 Kansai Medical University Takii Hospita
  • S114.3.117 Kusube Clinic
  • S114.3.117 Yasuhara Children's Clinic
  • S114.3.117 Tokushima University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

F

P

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

The Clinical Global Impression(CGI) improvement at Week 8

Full Information

First Posted
July 14, 2006
Last Updated
March 3, 2010
Sponsor
Solvay Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00353028
Brief Title
Fluvoxamine Maleate in the Treatment of Depression/Depressive State : A Post-marketing Clinical Study in Children and Adolescents
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Solvay Pharmaceuticals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
Fluvoxamine Maleate, Depression, Children and Adolescents

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
F
Arm Type
Experimental
Arm Title
P
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Fluvoxamine maleate
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
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
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
The Clinical Global Impression(CGI) improvement at Week 8
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Toshiaki Yamaguchi
Organizational Affiliation
Solvay Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
S114.3.117 Kohnodai Hospital, National Center of N
City
Chiba prefecture
Country
Japan
Facility Name
S114.3.117 Fukuoka University Hospital
City
Fukuoka prefecture
Country
Japan
Facility Name
S114.3.117 Hatakeyama Clinic
City
Fukuoka prefecture
Country
Japan
Facility Name
S114.3.117 Kaname Clinic
City
Fukuoka prefecture
Country
Japan
Facility Name
S114.3.117 Kashi shinryo Clinic
City
Fukuoka prefecture
Country
Japan
Facility Name
S114.3.117 Kashii Sanatorium
City
Fukuoka prefecture
Country
Japan
Facility Name
S114.3.117 Kyushu University Hospital
City
Fukuoka prefecture
Country
Japan
Facility Name
S114.3.117 Shiranui Hospital
City
Fukuoka prefecture
Country
Japan
Facility Name
S114.3.117 Sugahara Tenjin Hospital
City
Fukuoka prefecture
Country
Japan
Facility Name
S114.3.117 Hiroshima-city Funairi Hospital
City
Hiroshima prefecture
Country
Japan
Facility Name
S114.3.117 Goryokai Hospital
City
Hokkaido prefecture
Country
Japan
Facility Name
S114.3.117 Kobe University Hospital
City
Hyogo prefecture
Country
Japan
Facility Name
S114.3.117 National Hospital Organization Kagawa C
City
Kagawa prefecture
Country
Japan
Facility Name
S114.3.117 Yokohama City University Hospital
City
Kanagawa Prefecture
Country
Japan
Facility Name
S114.3.117 National Hospital Organization Kikuti N
City
Kumamoto prefecture
Country
Japan
Facility Name
S114.3.117 Kyoto University Hospital
City
Kyoto prefecture
Country
Japan
Facility Name
S114.3.117 National Hospital Organization Sakakiba
City
Mie prefecuture
Country
Japan
Facility Name
S114.3.117 Shinshu University Hospital
City
Nagano prefecture
Country
Japan
Facility Name
S114.3.117 Aichi Children's Health and Medical Cen
City
Nagoya prefecture
Country
Japan
Facility Name
S114.3.117 Nagoya Mental Clinic
City
Nagoya prefecture
Country
Japan
Facility Name
S114.3.117 Nara Medical University Hospital
City
Nara prefecture
Country
Japan
Facility Name
S114.3.117 Kansai Medical University Takii Hospita
City
Osaka prefecture
Country
Japan
Facility Name
S114.3.117 Kusube Clinic
City
Osaka prefecture
Country
Japan
Facility Name
S114.3.117 Yasuhara Children's Clinic
City
Osaka prefecture
Country
Japan
Facility Name
S114.3.117 Tokushima University Hospital
City
Tokushima prefecture
Country
Japan

12. IPD Sharing Statement

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

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