A Study to Investigate the Safety, Tolerability, and Pharmacodynamics of JNJ-54175446 in Participants With Major Depressive Disorder
Status and phase
Completed
Phase 1
Conditions
Depressive Disorder, Major
Treatments
Drug: JNJ-54175446, 600 mg
Other: Placebo
Drug: JNJ-54175446, 150 mg
Study type
Interventional
Funder types
Industry
Identifiers
Details and patient eligibility
About
The primary purpose of this study is to investigate the safety and tolerability of JNJ 54175446 in participants with Major Depressive Disorder (MDD).
Enrollment
70 patients
Sex
All
Ages
18 to 64 years old
Volunteers
No Healthy Volunteers
Inclusion criteria
- 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
Exclusion criteria
- 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
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Double Blind
70 participants in 3 patient groups, including a placebo group
Group A: JNJ-54175446
Experimental group
Description:
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.
Treatment:
Drug: JNJ-54175446, 150 mg
Drug: JNJ-54175446, 600 mg
Group B: Placebo + JNJ-54175446
Experimental group
Description:
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.
Treatment:
Drug: JNJ-54175446, 150 mg
Other: Placebo
Drug: JNJ-54175446, 600 mg
Group C: Placebo
Placebo Comparator group
Description:
Participants will receive placebo from Day 1 until Day 10.
Treatment:
Other: Placebo
Trial contacts and locations
4
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Data sourced from clinicaltrials.gov
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