A Randomized, Double-Blind, Multicenter, Placebo-Controlled, Proof-Of-Concept Study to Evaluate the Efficacy, Safety, and Tolerability of Jnj-89495120 as Monotherapy in Adult Participants With Major Depressive Disorder (Mdd)

S
Susan Conroy, MD PhD

Primary Investigator

Recruiting
18 years - 64 years
All
Phase N/A
3 participants needed

Brief description of study

What is the purpose of this study?

The purpose of this study is to evaluate how well JNJ-89495120 works (anti-depressant effects) and how well it is tolerated as compared to placebo on reducing the symptoms of depression in participants with major depressive disorder (MDD).

 

Detailed description of study

What will happen during the study?

The primary objective of this study is to investigate the efficacy of JNJ-89495120 as a monotherapy in
participants with MDD. 

After completing a Screening Phase, which includes an as-needed medication wash-out, participants will receive the double-blind treatment for 2 weeks, which will consist of either active treatment (intermittent, twice-weekly) of JNJ-89495120 (with placebo doses between the active treatment days)or placebo daily. The double-blind treatment phase is followed by an observational 2-week antidepressant-free phase to assess durability of effect and safety. After the completion of the observational phase, participants enter a standard of care (SOC)follow-up phase that lasts up to 6 weeks.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Major depressive disorder, MDD
  • Age: 18 years - 64 years
  • Gender: All

Inclusion Criteria:

  • Primary psychiatric diagnosis of recurrent major depressive disorder, without psychotic features, based on clinical assessment using diagnostic and statistical manual of mental disorders (DSM)-5 criteria and confirmed with the mini international neuropsychiatric interview (MINI)
  • Participant had to have at least one previous major depressive disorder (MDD) episode prior to their current episode
  • Were first diagnosed with depression before the age of 55
  • Are in a current episode of depression: Episode length must be at least 2 months but not longer than 24 months
  • Have taken 0, 1, or 2 treatments for depression in your current episode
  • Body mass index (BMI) within the range 18 to 35 kilograms per square meter (kg/m^2) at screening

Exclusion Criteria:

  • Treatment with vagus nerve stimulation (VNS), electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), deep brain stimulation (DBS), or ketamine/esketamine within the current or past major depressive episodes
  • Current or past DSM-5 diagnosis of bipolar disorder, psychotic disorders, borderline personality disorder, antisocial personality disorder, or current obsessive-compulsive disorder
  • Post-traumatic stress disorder within the past three years of screening
  • Dementia, any dementing disease, intellectual disability, or neurocognitive disorder
  • History of Alcohol and Substance use disorders within 6 months of screening, with the exclusion of nicotine, caffeine, and mild cannabis use disorder, according to the MINI and Clinical Assessment
  • Known allergies, hypersensitivity, or intolerance to JNJ-89495120 or its excipients

Updated on 24 Jun 2025. Study ID: PSYC-JANSSEN-MOONLIGHT-1, 24724

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