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A Study to Explore the Efficacy of JNJ-89495120 in the Treatment of Major Depressive Disorder
A Study to Explore the Efficacy of JNJ-89495120 in the Treatment of Major Depressive Disorder

NCT06785012

Active Not RecruitingPhase 2

Sponsor: Janssen Research & Development, LLC

Conditions: Depressive Disorder, Major

Interventions: JNJ-89495120, Placebo

Countries: United States

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).

Eligibility overview

Sex: ALL

Age: 18 Years to 64 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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
Locations (44)
  • Huntsville, Alabama, United States
  • Chandler, Arizona, United States
  • Phoenix, Arizona, United States
  • Tucson, Arizona, United States
  • Tucson, Arizona, United States
  • Bellflower, California, United States
  • Encino, California, United States
  • Garden Grove, California, United States
  • Newport Beach, California, United States
  • Orange, California, United States
  • Redlands, California, United States
  • San Diego, California, United States
  • San Jose, California, United States
  • Santa Ana, California, United States
  • Temecula, California, United States
  • Walnut Creek, California, United States
  • Denver, Colorado, United States
  • Fort Myers, Florida, United States
  • Hollywood, Florida, United States
  • Homestead, Florida, United States
  • Maitland, Florida, United States
  • Miami, Florida, United States
  • Miami, Florida, United States
  • Pembroke Pines, Florida, United States
  • Tampa, Florida, United States
  • West Palm Beach, Florida, United States
  • Atlanta, Georgia, United States
  • Decatur, Georgia, United States
  • Snellville, Georgia, United States
  • Chicago, Illinois, United States
  • + 14 more on CT.gov