Status:
COMPLETED
Fluvoxamine Maleate in the Treatment of Depression/Depressive State : A Post-marketing Clinical Study in Children and Adolescents
Lead Sponsor:
Solvay Pharmaceuticals
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
8-18 years
Phase:
PHASE4
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
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT00353028
Start Date
October 1 2006
End Date
July 1 2009
Last Update
March 4 2010
Active Locations (25)
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1
S114.3.117 Kohnodai Hospital, National Center of N
Chiba Prefecture, Japan
2
S114.3.117 Fukuoka University Hospital
Fukuoka Prefecture, Japan
3
S114.3.117 Hatakeyama Clinic
Fukuoka Prefecture, Japan
4
S114.3.117 Kaname Clinic
Fukuoka Prefecture, Japan