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A Safety and Efficacy Study of JNJ26489112 in Patients With Treatment-Resistant Major Depressive Disorder

NCT01114698 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2025-04-29

No results posted yet for this study

Summary

The purpose of this study is to evaluate the effectiveness and safety of JNJ26489112 compared with an active control (Venlafaxine XR) and placebo in patients with Treatment-Resistant Major Depressive Disorder.

Conditions

Interventions

DRUG

Venlafaxine XR

Venlafaxine XR 75 mg/day administered orally once daily as 2 capsules identical in appearance to JNJ26489112 during the first week increased to 150 mg/day during weeks 2 through 6.

DRUG

Placebo

Placebo: 2 capsules identical in appearance to JNJ26489112 and venlafaxine XR orally administered once daily for 6 weeks.

DRUG

JNJ26489112

JNJ26489112 500 mg/day orally administered once daily as 2 capsules for the first 3 weeks, then dose may be increased to 1000 mg/day by week 4.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC C. Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2012-01-31
Completion
2012-02-29

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

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 NCT01114698 on ClinicalTrials.gov