A Study to Investigate the Safety, Tolerability, and Pharmacodynamics of JNJ-54175446 in Participants With Major Depressive Disorder

NCT02902601 | Completed Phase 1

• 3 other identifiers: CR10820454175446MDD10012016-001929-14
• Study Type: interventional
• Target: 70
• Locations: 2 countries
• Sites: 4

Brief Summary

The primary purpose of this study is to investigate the safety and tolerability of JNJ 54175446 in participants with Major Depressive Disorder (MDD).

Conditions

Depressive Disorder, Major

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events as a Measure of Safety and Tolerability

  Up to Day 17

Secondary Outcomes (24)

• Effect of JNJ-54175446 Versus Placebo on Total Sleep Deprivation (TSD)-Induced Changes in Depressive Symptoms by HDRS17/IDS-C30 Rating Scale

  Baseline, Day 4 and 10: 2 to 8 hours post dose, Day 17

• Effect of JNJ-54175446 Versus Placebo on Total Sleep Deprivation (TSD)-Induced Changes in Depressive Symptoms by QIDS-SR16/QIDS-SR10 Rating Scale

  Baseline, Day 3 and 10: 2 to 8 hours post dose, Day 17

• Effect of JNJ-54175446 Versus Placebo on TSD-Induced Changes in Biomarker Profiles (interleukin [IL]-1 beta, cortisol)

  Day 1 and 4: Predose, 2, 8 hours postdose, Day 10: Predose

• Effect of JNJ-54175446 Versus Placebo on Latency to Persistent Sleep (LPS)

  Baseline, Day 2 to 3 and Day 4 to 5

• Effect of JNJ-54175446 Versus Placebo on Total Sleep Time (TST)

  Baseline, Day 2 to 3 and Day 4 to 5

Study Arms (3)

Group A: JNJ-54175446

EXPERIMENTAL

Participants will receive a loading dose of JNJ-54175446, 600 milligram (mg) on Day 1 followed by JNJ-54175446, 150 mg once daily until Day 10.

Drug: JNJ-54175446, 600 mg; Drug: JNJ-54175446, 150 mg

Group B: Placebo + JNJ-54175446

EXPERIMENTAL

Participants will receive placebo on Days 1 to 3 followed by a loading dose of JNJ-54175446, 600 mg on Day 4 followed by JNJ-54175446, 150 mg once daily until Day 10.

Drug: JNJ-54175446, 600 mg; Drug: JNJ-54175446, 150 mg; Other: Placebo

Group C: Placebo

PLACEBO COMPARATOR

Participants will receive placebo from Day 1 until Day 10.

Other: Placebo

Interventions

JNJ-54175446, 600 mg DRUG

Participants will receive JNJ-54175446, 600 mg as an oral suspension.

Group A: JNJ-54175446; Group B: Placebo + JNJ-54175446

JNJ-54175446, 150 mg DRUG

Participants will receive JNJ-54175446, 150 mg as an oral suspension.

Group A: JNJ-54175446; Group B: Placebo + JNJ-54175446

Placebo OTHER

Matching placebo to JNJ-54175446

Group B: Placebo + JNJ-54175446; Group C: Placebo

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Body mass index (BMI) must be between 18 and 32 kilogram per square meter (kg/m\^2) inclusive
• Related to symptoms of depression: Participant must meet the Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV or V diagnostic criteria for Major Depressive Disorder \[MDD\] (International Classification of Diseases (ICD)-code F32.x and F33.x), without psychotic features, as confirmed by the MINI 6.0; participant must have an IDS-C30 total score greater than or equal to (\>=) 30 using the semi-structured interview guide for the IDS-C30
• Participant is, during this episode of depression, treatment naïve OR treated with at most one Selective serotonin reuptake inhibitor (SSRI) over a minimum of 6 weeks and a maximum of 6 months, and subject is being treated at an adequate dose, showing a partial response at enrolment
• A woman of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test upon admission
• A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for at least 3 months after receiving the last dose of study drug

You may not qualify if:

• Has a primary DSM-IV or V diagnosis of general anxiety disorder (GAD), panic disorder, obsessive compulsive disorder, posttraumatic stress disorder, anorexia nervosa, or bulimia nervosa. Participants with comorbid GAD, social anxiety disorder, or panic disorder for whom MDD is considered the primary diagnosis are not excluded
• Has a length of current major depressive episode greater than (\>) 24 months despite adequate treatment
• Has failed more than 2 treatments with a different pharmacological mode of action despite an adequate dose and duration during a previous, or the current depressive episode
• Participant has a history of substance use disorder according to DSM-V criteria, except nicotine or caffeine, within 6 months before Screening. However, participants who have completed a treatment for (alcohol) addiction more than 8 weeks prior to first dose administration and are under continuous control of the study center, may be included if the risk to fall back is considered minimal and no significant abnormalities are shown in clinical laboratory or other predose safety assessments
• Obstructive sleep apnea/hypopnea (apnea/hypopnea index \>10) or restless legs syndrome (periodic leg movements with arousal index \>15) as assessed on the first or second polysomnography (PSG) recording during screening

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (4)

Unknown Facility

Berlin, Germany

Location

Unknown Facility

Hamburg, Germany

Location

Unknown Facility

Schwerin, Germany

Location

Unknown Facility

Leiden, Netherlands

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

JNJ-54175446

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2016
• First Posted: September 16, 2016
• Study Start: October 17, 2016
• Primary Completion: June 2, 2017
• Study Completion: June 7, 2017
• Last Updated: April 27, 2025

Record last verified: 2025-04

Locations

DE (3); NL (1)