Phase 2
N=116
A Study of JNJ-55308942 in the Treatment of Bipolar Depression
Bipolar Disorder
Bottom Line
View on ClinicalTrials.gov: NCT05328297 ↗Enrolled (actual)
116
Serious AEs
4.4%
Results posted
Jul 2025
Primary outcome: Primary: Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score up to Week 6 — -16.0; -15.4 Units on a scale — p==0.438
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- JNJ-55308942 (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Janssen Pharmaceutica N.V., Belgium
- Primary completion
- May 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score up to Week 6 |
-16.0; -15.4 | =0.438 |
| SECONDARY Change From Baseline in Snaith-Hamilton Pleasure Scale (SHAPS) Total Score up to Week 6 |
-8.2; -8.3 | — |
| SECONDARY Change From Baseline in MADRS Total Score up to Week 6 (Genetic Subgroup Analysis) |
-15.2; -16.5; -18.2; -13.1 | — |
| SECONDARY Change From Baseline in MADRS Total Score up to Week 6 (Diagnosis Subgroup Analysis) |
-15.5; -15.3; -17.7; -15.7 | — |
| SECONDARY Change From Baseline in MADRS Total Score up to Week 6 (Biomarker Subgroup Analysis) |
-12.5; -13.9; -17.2; -16.6 | — |
| SECONDARY Number of Participants With Treatment-emergent Clinically Important Abnormalities in Vital Signs |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Change From Baseline in Clinical Laboratory Values in Male Hormone: Inhibin B |
-5.9; 3.1; -2.1; -1.8; -1.2; 7.3 | — |
| SECONDARY Change From Baseline in Clinical Laboratory Values in Male Hormone: Luteinizing Hormone |
0.15; 0.29; -0.11; 0.63; -0.35; 0.84 | — |
| SECONDARY Change From Baseline in Clinical Laboratory Values in Male Hormone: Prolactin |
0.347; 1.803; 0.551; 1.465; -0.160; 1.748 | — |
| SECONDARY Change From Baseline in Clinical Laboratory Values in Male Hormones: Sex Hormone Binding Globulin, Testosterone (Free), Testosterone (High Sensitivity), and Testosterone (Low Sensitivity) |
-1.976; -0.574; -4.020; -0.274; -2.520; 1.058 | — |
| SECONDARY Number of Participants With Abnormal Laboratory Values: Serum Chemistry |
2; 2; 0; 2; 1; 0 | — |
| SECONDARY Number of Participants With Clinically Significant Abnormal Laboratory Values: Hematology |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Clinically Significant Abnormal Laboratory Values: Urinalysis |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) |
22; 28 | — |
| SECONDARY Number of Participants With Treatment-emergent Abnormalities in Electrocardiograms (ECGs) |
1; 0; 0; 0; 0; 1 | — |
| SECONDARY Change From Baseline in Young Mania Rating Scale (YMRS) Total Score |
-1.2; -1.1 | — |
| SECONDARY Number of Participants Who Reported Suicidal Ideation (SI) or Suicidal Behavior (SB) Using With Columbia Suicide Severity Rating Scale (C-SSRS) Score |
3; 6; 1; 0; 49; 53 | — |
| SECONDARY Change From Baseline in Clinical Global Impression-Severity Scale (CGI-S) Score |
-1.9; -1.7 | — |
| SECONDARY Plasma Concentrations of JNJ-55308942 |
0.00; 406.13; 407.72; 531.20; 868.01; 892.54 | — |
| SECONDARY Change From Baseline in Patient Reported Outcomes Measurement Information System (PROMIS) Score - Ability to Participate in Social Roles and Activities (APS) T-Scores |
2.51; 1.69; 5.33; 4.49; 6.52; 5.00 | — |
| SECONDARY Change From Baseline in Patient Health Questionnaire-9 (PHQ-9) Total Score |
-2.8; -3.1; -5.2; -4.7; -6.4; -5.1 | — |
| SECONDARY Change From Baseline in Generalized Anxiety Disorder 7 (GAD-7) Total Score |
-3.8; -4.2; -5.0; -4.5; -5.7; -5.7 | — |
| SECONDARY Number of Participants Who Achieved Response at Week 6 |
27; 31 | — |
| SECONDARY Number of Participants Who Achieved Remission at Week 6 |
25; 30 | — |
| SECONDARY Change From Baseline in MADRS Total Score up to Week 6 (Subgroup of Participants With Messenger Ribonucleic Acid [mRNA] Transcript Levels) |
NA; NA | — |
| SECONDARY Change From Baseline in MADRS Total Score up to Week 6 (Concomitant Medication Subgroup Analysis) |
-15.5; -16.2; -16.3; -15.6; -13.0; 5.0 | — |
Summary
The purpose of this study is to evaluate the efficacy of JNJ-55308942 compared to placebo on symptoms of depression in participants with bipolar disorder (BD) in a major depressive episode (MDE) at Week 6.
Eligibility Criteria
Inclusion Criteria
- Have a primary diagnostic and statistical manual of mental disorders (5th edition) (DSM-5) diagnosis of bipolar disorder (BD) (Type I or II) without current psychotic features, as confirmed by the mini international neuropsychiatric interview (MINI)
- Medically stable on the basis of physical examination, medical history, and vital signs performed at screening. Any abnormalities must be consistent with the underlying illness in the study population. This determination must be recorded in the participant's source documents and initialed by the investigator
- Have a body mass index (BMI) between 18.0 and 35.0 kilograms per meter square (kg/m^2) inclusive (BMI = weight/height^2)
- A woman of childbearing potential (WOCBP) must have a negative highly sensitive serum pregnancy test (beta-human chorionic gonadotropin [beta-hCG]) at screening and a negative urine pregnancy test before the first dose of study intervention
Exclusion Criteria
- Currently meets the DSM-5 criteria for Manic Episode (ME) on the MINI
- Received transcranial magnetic stimulation (TMS), any transcranial electrical stimulation, including transcranial direct current stimulation (tDCS), vagal nerve stimulation (VNS) and/or deep brain stimulation (DBS) within 6 weeks prior to randomization
- History of moderate to severe cannabis misuse according to DSM-5 criteria within 6 months before screening
- History of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy that in the opinion of the investigator is considered cured with minimal risk of recurrence)
Data sourced from ClinicalTrials.gov (NCT05328297). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.