NCT00353028

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for phase_4 major-depressive-disorder

Timeline
Completed

Started Oct 2006

Typical duration for phase_4 major-depressive-disorder

Geographic Reach
1 country

25 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 14, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 17, 2006

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2006

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

March 4, 2010

Status Verified

March 1, 2010

Enrollment Period

2.8 years

First QC Date

July 14, 2006

Last Update Submit

March 3, 2010

Conditions

Major Depressive Disorder

Keywords

Fluvoxamine MaleateDepressionChildren and Adolescents

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • The Clinical Global Impression(CGI) improvement at Week 8

    8 weeks

Study Arms (2)

F

EXPERIMENTAL
Drug: Fluvoxamine maleate

P

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Fluvoxamine maleateDRUG

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

F
PlaceboDRUG

Placebo

P

Eligibility Criteria

Age8 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (25)

S114.3.117 Kohnodai Hospital, National Center of N

Chiba Prefecture, Japan

Location

S114.3.117 Fukuoka University Hospital

Fukuoka Prefecture, Japan

Location

S114.3.117 Hatakeyama Clinic

Fukuoka Prefecture, Japan

Location

S114.3.117 Kaname Clinic

Fukuoka Prefecture, Japan

Location

S114.3.117 Kashi shinryo Clinic

Fukuoka Prefecture, Japan

Location

S114.3.117 Kashii Sanatorium

Fukuoka Prefecture, Japan

Location

S114.3.117 Kyushu University Hospital

Fukuoka Prefecture, Japan

Location

S114.3.117 Shiranui Hospital

Fukuoka Prefecture, Japan

Location

S114.3.117 Sugahara Tenjin Hospital

Fukuoka Prefecture, Japan

Location

S114.3.117 Hiroshima-city Funairi Hospital

Hiroshima Prefecture, Japan

Location

S114.3.117 Goryokai Hospital

Hokkaido Prefecture, Japan

Location

S114.3.117 Kobe University Hospital

Hyogo Prefecture, Japan

Location

S114.3.117 National Hospital Organization Kagawa C

Kagawa Prefecture, Japan

Location

S114.3.117 Yokohama City University Hospital

Kanagawa Prefecture, Japan

Location

S114.3.117 National Hospital Organization Kikuti N

Kumamoto Prefecture, Japan

Location

S114.3.117 Kyoto University Hospital

Kyoto Prefecture, Japan

Location

S114.3.117 National Hospital Organization Sakakiba

Mie Prefecuture, Japan

Location

S114.3.117 Shinshu University Hospital

Nagano Prefecture, Japan

Location

S114.3.117 Aichi Children's Health and Medical Cen

Nagoya Prefecture, Japan

Location

S114.3.117 Nagoya Mental Clinic

Nagoya Prefecture, Japan

Location

S114.3.117 Nara Medical University Hospital

Nara Prefecture, Japan

Location

S114.3.117 Kansai Medical University Takii Hospita

Osaka Prefecture, Japan

Location

S114.3.117 Kusube Clinic

Osaka Prefecture, Japan

Location

S114.3.117 Yasuhara Children's Clinic

Osaka Prefecture, Japan

Location

S114.3.117 Tokushima University Hospital

Tokushima Prefecture, Japan

Location

MeSH Terms

Conditions

Depressive Disorder, MajorDepression

Interventions

Fluvoxamine

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

OximesHydroxylaminesAminesOrganic Chemicals

Study Officials

  • Toshiaki Yamaguchi

    Solvay Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 14, 2006

First Posted

July 17, 2006

Study Start

October 1, 2006

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

March 4, 2010

Record last verified: 2010-03

Locations

JP(25)