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COMPLETED Phase 2

A Study of JNJ-61393215 in the Treatment of Depression

NCT04080752 · View on ClinicalTrials.gov ↗

Study Summary

The purpose of this study is to evaluate the efficacy of JNJ-61393215 as adjunctive treatment compared to adjunctive placebo, as assessed by the change from baseline to week 6 on a 17-item Hamilton Depression Rating Scale (HDRS-17) in participants with major depressive disorder (MDD) with anxious distress with a score greater than or equal to (\>=) 2 on item 26 or 27 of the Inventory of Depressive Symptomatology, Clinician Rating -30 (IDS-C30), who have a suboptimal response to current treatment with a standard antidepressant.

Interventions

  • DRUG Placebo
  • DRUG JNJ-61393215

Study Locations (20)

Other

  • ARENSIA — Chisinau
  • City Clinical Psychiatric Hopsital 3 — Moscow
  • Nizny Novgorod clinical psychiatric hospital 1 — Nizny Novgorod
  • Orenburg Regional Clinical Psychiatric Hospital #1 — Orenburg
  • Medical and Rehabilitation Research Center Phoenix — Rostov-on-Don
  • Psychoneurological dispensary 10 — Saint Petersburg
  • City Psychiatric hospital 7 named after I.P.Pavlov — Saint Petersburg
  • Psychoneurological dispensary 1 — Saint Petersburg
  • SHI 'Saratov City Clinical Hospital 2 n.a V.I. Razumovsky — Saratov
  • Saratov Regional Psychiatric hospital named after St. Sofia — Saratov
  • Engels psychiatric hospital — Saratov Region

Georgia

  • Atlanta Institute — Alpharetta
  • Atlanta Center for Medical Research — Atlanta

New York

  • The Medical Research Network, LLC — New York
  • Richmond Behavioural Associates — Staten Island

California

  • Collaborative NeuroScience Network — Garden Grove

Ohio

  • Ohio State University — Columbus

Oklahoma

  • IPS Research Company — Oklahoma City

Pennsylvania

  • Suburban Research Associates — Media

Texas

  • UT Southwestern Medical Center — Dallas

Trial Details

FieldValue
Enrollment Target 222 participants
Start Date 2019-09-17
Est. Completion 2021-09-02
Phase Phase 2

Sponsor

Janssen Research & Development

442 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04080752

The ClinicalTrials.gov registry entry for NCT04080752 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 222 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen Research & Development, which has 442 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Major Depressive Disorder With Anxious Distress appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04080752 reports 20 study locations spanning 8 distinct geographic areas — top geographies include Other, Georgia, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04080752 about?

NCT04080752 is a clinical study titled "A Study of JNJ-61393215 in the Treatment of Depression". The purpose of this study is to evaluate the efficacy of JNJ-61393215 as adjunctive treatment compared to adjunctive placebo, as assessed by the change from baseline to week 6 on a 17-item Hamilton Depression Rating Scale (HDRS-17) in participants with major depressive disorder (MDD) with anxious di...

What is the current status of trial NCT04080752?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 222 participants. The study started on 2019-09-17. Estimated completion is 2021-09-02.

What conditions does trial NCT04080752 study?

This clinical trial studies the following conditions: Major Depressive Disorder With Anxious Distress. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04080752?

The interventions under investigation include: Placebo (DRUG), JNJ-61393215 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04080752?

This trial is sponsored by Janssen Research & Development, which has 442 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04080752 being conducted?

This trial has 20 study locations across California, Georgia, New York, Ohio, Oklahoma. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial