A Study to Explore the Efficacy of JNJ-89495120 in the Treatment of Major Depressive Disorder (Moonlight-1)

Janssen (J&J Innovative Medicine)

Status and phase: Enrolling; Phase 2

Conditions: Depressive Disorder, Major

Treatments: Drug: JNJ-89495120; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06785012

89495120MDD2001 (Other Identifier)

Details and patient eligibility

About

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).

Enrollment: 124 estimated patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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124 participants in 3 patient groups, including a placebo group

Arm 1: JNJ-89495120 Dose A

Experimental group

Description:

Participants will receive JNJ-89495120 dose A during the double-blind (DB) treatment phase in Period 1 and Period 2 of the study.

Treatment:

Drug: JNJ-89495120

Arm 2: JNJ-89495120 Dose A and Dose B

Experimental group

Description:

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.

Treatment:

Drug: JNJ-89495120

Arm 3: Placebo Group

Placebo Comparator group

Description:

Participants will receive placebo matched to JNJ-89495120 during the DB treatment phase in Period 1 and Period 2 of the study.

Treatment:

Drug: Placebo