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A Study to Explore the Efficacy of JNJ-67953964 in the Treatment of Depression

NCT03559192 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 181

Last updated 2025-04-29

Study results available
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Summary

The purpose of this study is to evaluate the efficacy of JNJ-67953964 compared to placebo when administered as adjunctive treatment in participants with Major Depressive Disorder (MDD) partially responsive to selective serotonin reuptake inhibitor/ serotonin-norepinephrine reuptake inhibitor (SSRI/SNRI) treatment in terms of reduction of symptoms of depression, as assessed by the change from baseline on the Montgomery Asberg Depression Rating Scale (MADRS) in non-responders during the placebo lead-in period.

Conditions

  • Depressive Disorder, Major

Interventions

DRUG

JNJ-67953964

JNJ-67953964 10 mg will be administered as two 5-mg capsules orally once daily.

DRUG

Placebo

Matching placebo will be administered as 2 capsules orally once daily.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-07-16
Primary Completion
2020-05-06
Completion
2020-05-06
FDA Drug
Yes

Countries

  • United States
  • Germany
  • Moldova
  • Russia
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

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 NCT03559192 on ClinicalTrials.gov