A Study to Explore the Efficacy of JNJ-89495120 in the Treatment of Major Depressive Disorder
Purpose
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).
Condition
- Depressive Disorder, Major
Eligibility
- Eligible Ages
- Between 18 Years and 64 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Arm 1: JNJ-89495120 Dose A |
Participants will receive JNJ-89495120 dose A during the double-blind (DB) treatment phase in Period 1 and Period 2 of the study. |
|
|
Experimental Arm 2: JNJ-89495120 Dose A and Dose B |
Participants will receive JNJ-89495120 dose A in Period 1 followed by JNJ-89495120 dose B in Period 2 during the DB treatment phase of the study. |
|
|
Placebo Comparator Arm 3: Placebo Group |
Participants will receive placebo matched to JNJ-89495120 during the DB treatment phase in Period 1 and Period 2 of the study. |
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Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- Janssen Research & Development, LLC
