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

Solvay

Status and phase: Completed; Phase 4

Conditions: Major Depressive Disorder

Treatments: Drug: Placebo; Drug: Fluvoxamine maleate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00353028

S114.3.117

Details and patient eligibility

About

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

Enrollment: 90 patients

Sex: All

Ages: 8 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 2 patient groups, including a placebo group

F

Experimental group

Treatment:

Drug: Fluvoxamine maleate

P

Placebo Comparator group

Treatment:

Drug: Placebo