MedTrace Logo

A Phase 3 Study of Fluvoxamine (SME3110) in Pediatric/Adolescent Patients With Obsessive Compulsive Disorder

NCT01933919 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2017-12-04

Study results available
· View outcomes & findings →

Summary

The objective of the first phase of this study is to evaluate the efficacy of fluvoxamine compared to placebo on change in total score of Japanese version of the Children's Yale-Brown Obsessive Compulsive Scale (JCY-BOCS) 10-item from baseline to the last observation visit (10 weeks) in pediatric/adolescent participants with obsessive compulsive disorder (OCD).

The objective of the second phase of the study is to evaluate the long-term safety and efficacy of fluvoxamine in pediatric/adolescent patients with OCD.

Conditions

  • Obsessive Compulsive Disorder

Interventions

DRUG

Fluvoxamine maleate

Film-coated tablet containing 25 mg of fluvoxamine maleate

DRUG

Placebo

Placebo tablet matching to fluvoxamine maleate

Sponsors & Collaborators

  • Meiji Seika Pharma Co., Ltd.

    collaborator INDUSTRY

  • AbbVie

    lead INDUSTRY

Principal Investigators

  • Susumu Matsuki, BS · AbbVie

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-14
Primary Completion
2015-06-18
Completion
2016-07-01

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01933919 on ClinicalTrials.gov