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

This study is currently recruiting participants.

Verified by Solvay Pharmaceuticals, April 2009

First Received: July 14, 2006 Last Updated: April 28, 2009 History of Changes

Sponsored by:	Solvay Pharmaceuticals
Information provided by:	Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00353028

Purpose

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

Condition	Intervention	Phase
Major Depressive Disorder	Drug: Fluvoxamine Maleate Drug: Placebo	Phase IV

MedlinePlus related topics: Depression

Drug Information available for: Fluvoxamine Fluvoxamine maleate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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, Placebo-Controlled Study

Further study details as provided by Solvay Pharmaceuticals:

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 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The Clinical Global Impression(CGI) improvement at Week 10 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	130
Study Start Date:	June 2006
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
F: Experimental	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 (maximum:6 tablets), the study medication will orally be administered twice daily, after breakfast and at bedtime. Duration: 8 weeks.
P: Placebo Comparator	Drug: Placebo Placebo

Eligibility

Ages Eligible for Study:	8 Years to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00353028

Contacts

Contact: Toshiaki Yamaguchi

Toshiaki.Yamaguchi@solvay.com

Locations

Japan
Site 1	Withdrawn
Hokkaido, Japan
Site 2	Active, not recruiting
Chiba, Japan
Site 3	Withdrawn
Tokyo, Japan
Site 4	Withdrawn
Kanazawa, Japan
Site 5	Recruiting
Mie, Japan
Site 6	Recruiting
Nara, Japan
Site 7	Recruiting
Kyoto, Japan
Site 8	Recruiting
Kagawa, Japan
Site 9	Recruiting
Fukuoka, Japan
Site 10	Completed
Kumamoto, Japan
Site 11	Withdrawn
Osaka, Japan
Site 12	Active, not recruiting
Osaka, Japan
Site 13	Active, not recruiting
Fukuoka, Japan
Site 14	Withdrawn
Tokyo, Japan
Site 15	Withdrawn
Kanagawa, Japan
Site 16	Withdrawn
Fukushima, Japan
Site 17	Active, not recruiting
Fukuoka, Japan
Site 18	Withdrawn
Mie, Japan
Site 19	Active, not recruiting
Hyogo, Japan
Site 20	Withdrawn
Tokyo, Japan
Site 21	Active, not recruiting
Nagano, Japan
Site 43	Not yet recruiting
Hyogo, Japan
Site 23	Recruiting
Kanagawa, Japan
Site 25	Recruiting
Hokkaido, Japan
Site 24	Active, not recruiting
Hiroshima, Japan
Site 26	Recruiting
Fukuoka, Japan
Site 27	Active, not recruiting
Fukuoka, Japan
Site 28	Completed
Osaka, Japan
Site 29	Recruiting
Fukuoka, Japan
Site 30	Withdrawn
Gunma, Japan
Site 31	Recruiting
Nagoya, Japan
Site 32	Recruiting
Osaka, Japan
Site 33	Withdrawn
Tokyo, Japan
Site 34	Not yet recruiting
Tochigi, Japan
Site 35	Recruiting
Fukuoka, Japan
Site 36	Active, not recruiting
Fukuoka, Japan
Site 37	Recruiting
Tokushima, Japan
Site 38	Withdrawn
Hyogo, Japan
Site 39	Not yet recruiting
Oita, Japan
Site 40	Not yet recruiting
Tokyo, Japan
Site 41	Not yet recruiting
Osaka, Japan
Site 42	Not yet recruiting
Nagano, Japan
Site 22	Terminated
Nagoya, Japan

Sponsors and Collaborators

Solvay Pharmaceuticals

Investigators

Study Director:

Global Clinical Director Solvay

Solvay Pharmaceuticals

More Information

No publications provided

Responsible Party:	Solvay Pharmaceuticals ( Toshiaki Yamaguchi )
Study ID Numbers:	S114.3.117
Study First Received:	July 14, 2006
Last Updated:	April 28, 2009
ClinicalTrials.gov Identifier:	NCT00353028 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Solvay Pharmaceuticals:

Fluvoxamine Maleate, Depression, Children and Adolescents

Study placed in the following topic categories:

Neurotransmitter Agents
Depression
Tranquilizing Agents
Fluvoxamine
Psychotropic Drugs
Central Nervous System Depressants
Depressive Disorder, Major
Depressive Disorder
Serotonin Uptake Inhibitors

Serotonin
Behavioral Symptoms
Mental Disorders
Maleic acid
Mood Disorders
Anti-Anxiety Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents

Additional relevant MeSH terms:

Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Depression
Tranquilizing Agents
Fluvoxamine
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Enzyme Inhibitors
Depressive Disorder, Major
Depressive Disorder

Serotonin Uptake Inhibitors
Pharmacologic Actions
Behavioral Symptoms
Serotonin Agents
Mental Disorders
Maleic acid
Therapeutic Uses
Mood Disorders
Anti-Anxiety Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on May 07, 2009