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

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

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

Study Overview

• Status: Completed
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Drug: Placebo; Drug: Fluvoxamine maleate

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 4

Contacts and Locations

Study Locations

• Japan
  • Chiba prefecture, Japan
    • S114.3.117 Kohnodai Hospital, National Center of N
  • Fukuoka 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
  • Hiroshima prefecture, Japan
    • S114.3.117 Hiroshima-city Funairi Hospital
  • Hokkaido prefecture, Japan
    • S114.3.117 Goryokai Hospital
  • Hyogo prefecture, Japan
    • S114.3.117 Kobe University Hospital
  • Kagawa prefecture, Japan
    • S114.3.117 National Hospital Organization Kagawa C
  • Kanagawa Prefecture, Japan
    • S114.3.117 Yokohama City University Hospital
  • Kumamoto prefecture, Japan
    • S114.3.117 National Hospital Organization Kikuti N
  • Kyoto prefecture, Japan
    • S114.3.117 Kyoto University Hospital
  • Mie prefecuture, Japan
    • S114.3.117 National Hospital Organization Sakakiba
  • Nagano prefecture, Japan
    • S114.3.117 Shinshu University Hospital
  • Nagoya prefecture, Japan
    • S114.3.117 Aichi Children's Health and Medical Cen
  • Nagoya prefecture, Japan
    • S114.3.117 Nagoya Mental Clinic
  • Nara prefecture, Japan
    • S114.3.117 Nara Medical University Hospital
  • Osaka 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
  • Tokushima prefecture, Japan
    • S114.3.117 Tokushima University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: P	Drug: Placebo; Placebo
Experimental: F	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Time Frame
The Clinical Global Impression(CGI) improvement at Week 8	8 weeks

Collaborators and Investigators

• Sponsor: Solvay Pharmaceuticals
• Investigators: Study Director: Toshiaki Yamaguchi, Solvay Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: October 1, 2006
• Primary Completion (Actual): July 1, 2009
• Study Completion (Actual): July 1, 2009

Study Registration Dates

• First Submitted: July 14, 2006
• First Submitted That Met QC Criteria: July 14, 2006
• First Posted (Estimate): July 17, 2006

Study Record Updates

• Last Update Posted (Estimate): March 4, 2010
• Last Update Submitted That Met QC Criteria: March 3, 2010
• Last Verified: March 1, 2010

More Information

Terms related to this study

• Keywords: Depression; Children and Adolescents; Fluvoxamine Maleate
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Enzyme Inhibitors; Tranquilizing Agents; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Anti-Anxiety Agents; Cytochrome P-450 Enzyme Inhibitors; Antidepressive Agents, Second-Generation; Cytochrome P-450 CYP1A2 Inhibitors; Cytochrome P-450 CYP2C19 Inhibitors; Fluvoxamine
• Other Study ID Numbers: S114.3.117