Clinical trial NCT00353028: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Major Depressive Disorder
Keywords: Fluvoxamine Maleate
Depression
Children and Adolescents
Lead sponsor: Solvay Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2006-07-17
Enrollment: 90
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: 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
timeFrame: 8 weeks
Secondary outcomes:
measure: The Clinical Global Impression(CGI) improvement at Week 8
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Chiba prefecture
country: Japan
facility: S114.3.117 Kohnodai Hospital, National Center of N
city: Fukuoka prefecture
country: Japan
facility: S114.3.117 Fukuoka University Hospital
city: Fukuoka prefecture
country: Japan
facility: S114.3.117 Hatakeyama Clinic
city: Fukuoka prefecture
country: Japan
facility: S114.3.117 Kaname Clinic
city: Fukuoka prefecture
country: Japan
facility: S114.3.117 Kashi shinryo Clinic
city: Fukuoka prefecture
country: Japan
facility: S114.3.117 Kashii Sanatorium
city: Fukuoka prefecture
country: Japan
facility: S114.3.117 Kyushu University Hospital
city: Fukuoka prefecture
country: Japan
facility: S114.3.117 Shiranui Hospital
city: Fukuoka prefecture
country: Japan
facility: S114.3.117 Sugahara Tenjin Hospital
city: Hiroshima prefecture
country: Japan
facility: S114.3.117 Hiroshima-city Funairi Hospital
city: Hokkaido prefecture
country: Japan
facility: S114.3.117 Goryokai Hospital
city: Hyogo prefecture
country: Japan
facility: S114.3.117 Kobe University Hospital
city: Kagawa prefecture
country: Japan
facility: S114.3.117 National Hospital Organization Kagawa C
city: Kanagawa Prefecture
country: Japan
facility: S114.3.117 Yokohama City University Hospital
city: Kumamoto prefecture
country: Japan
facility: S114.3.117 National Hospital Organization Kikuti N
city: Kyoto prefecture
country: Japan
facility: S114.3.117 Kyoto University Hospital
city: Mie prefecuture
country: Japan
facility: S114.3.117 National Hospital Organization Sakakiba
city: Nagano prefecture
country: Japan
facility: S114.3.117 Shinshu University Hospital
city: Nagoya prefecture
country: Japan
facility: S114.3.117 Aichi Children's Health and Medical Cen
city: Nagoya prefecture
country: Japan
facility: S114.3.117 Nagoya Mental Clinic
city: Nara prefecture
country: Japan
facility: S114.3.117 Nara Medical University Hospital
city: Osaka prefecture
country: Japan
facility: S114.3.117 Kansai Medical University Takii Hospita
city: Osaka prefecture
country: Japan
facility: S114.3.117 Kusube Clinic
city: Osaka prefecture
country: Japan
facility: S114.3.117 Yasuhara Children's Clinic
city: Tokushima prefecture
country: Japan
facility: S114.3.117 Tokushima University Hospital
Study officials:
affiliation: Solvay Pharmaceuticals
name: Toshiaki Yamaguchi
role: STUDY_DIRECTOR
References: