A Study of JNJ-55308942 in the Treatment of Bipolar Depression

• ClinicalTrials.gov Identifier: NCT05328297
• Recruitment Status: Recruiting
• First Posted: April 14, 2022
• Last Update Posted: March 27, 2024
• Sponsor: Janssen Pharmaceutica N.V., Belgium
• Information provided by (Responsible Party): Janssen Pharmaceutica N.V., Belgium

Tracking Information

• First Submitted Date: April 11, 2022
• First Posted Date: April 14, 2022
• Last Update Posted Date: March 27, 2024
• Actual Study Start Date: June 3, 2022
• Estimated Primary Completion Date: March 22, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 11, 2022)

Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 6 [ Time Frame: Baseline and Week 6 ]

Change from baseline in MADRS total score at Week 6 will be reported. The MADRS is a clinician-rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The scale consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score of 60. Higher scores represent a more severe condition.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: September 15, 2023)

• Change from Baseline in Snaith-Hamilton Pleasure Scale (SHAPS) Total Score at Week 6 [ Time Frame: Baseline and Week 6 ]
  Change from baseline in SHAPS total score at Week 6 will be reported.
• Change from Baseline in MADRS Total Score at Week 6 (Genetic Subgroup Analysis) [ Time Frame: Baseline and Week 6 ]
  Change from baseline in MADRS total score at Week 6 in participants who are heterozygous or homozygous for a specific single nucleotide polymorphism (SNP) (genetic subgroup analysis) will be reported.
• Change from Baseline in MADRS Total Score at Week 6 (Diagnosis Subgroup Analysis) [ Time Frame: Baseline and Week 6 ]
  Change from Baseline in MADRS total score at Week 6 in participants with bipolar disorder (BD) diagnostic subtypes (diagnosis subgroup analysis) will be reported.
• Change from Baseline in MADRS Total Score at Week 6 (Biomarker Subgroup Analysis) [ Time Frame: Baseline and Week 6 ]
  Change from baseline in MADRS total score at Week 6 in subgroups of participants with specific biomarker profiles (biomarker subgroup analysis) will be reported.
• Number of Participants with Abnormalities in Vital Signs [ Time Frame: Up to Week 8 ]
  Number of participants with abnormalities in vital signs (pulse/heart rate, systolic blood pressure [SBP], diastolic blood pressure [DBP], respiratory rate) will be reported.
• Number of Participants with Abnormalities in Clinical Laboratory Tests [ Time Frame: Up to Week 8 ]
  Number of participants with abnormalities in clinical laboratory tests (chemistry, hematology, urinalysis) will be reported.
• Number of Participants with Adverse Events (AEs) [ Time Frame: Up to Week 8 ]
  An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention.
• Number of Participants with Abnormalities in Electrocardiograms (ECGs) [ Time Frame: Up to Week 8 ]
  Number of participants with abnormalities in ECG will be reported.
• Change from Baseline in Young Mania Rating Scale (YMRS) Score [ Time Frame: Baseline up to Week 6 ]
  Change from baseline in YMRS score will be reported. The YMRS is a rating scale used to assess manic symptoms.
• Change from Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Score [ Time Frame: Baseline up to Week 8 ]
  Change from baseline in C-SSRS score will be reported.
• Change from Baseline in Clinical Global Impression-Severity Scale (CGI-S) Score [ Time Frame: Baseline up to Week 6 ]
  Change from baseline in CGI-S scale score will be reported.
• Plasma Concentrations of JNJ-55308942 [ Time Frame: Days 1, 8, 15, 29, 43 ]
  Plasma samples will be analyzed to determine concentrations of JNJ-55308942 using a validated, specific, and sensitive liquid chromatography-mass spectrometry/mass spectrometry (LC-MS/MS) method.
• Change from Baseline in Patient Reported Outcome Measurement (PROMIS) Score - Ability to Participate in Social Roles and Activities Scores [ Time Frame: Baseline, up to Week 6 ]
  Change from baseline in PROMIS score- ability to participate in social roles and activity scores score will be reported. Participation in social roles and activities item bank assesses the perceived ability to perform one's usual social roles and activities.
• Change from Baseline in Patient Health Questionnaire (PHQ-9) Score [ Time Frame: Baseline up to Week 6 ]
  Change from baseline in PHQ-9 will be reported. PHQ-9 score used to assess the severity of depression in the participants.
• Change from Baseline in Generalized Anxiety Disorder 7 (GAD-7) Score. [ Time Frame: Baseline up to Week 6 ]
  Change from baseline in GAD-7 score will be reported.
• Percentage of Participants with Response at Week 6 [ Time Frame: Week 6 ]
  Percentage of participants with response (greater than or equal to [>=] 50 percent [%] improvement in MADRS total score) at Week 6 will be reported.
• Number of Participants with Remission at Week 6 [ Time Frame: Week 6 ]
  Number of participants with remission (MADRS total score less than or equal to [<=] 12) at Week 6 will be reported.
• Change from Baseline in MADRS Total Score at Week 6 (Subgroup of Participants with Messenger Ribonucleic Acid [mRNA] Transcript Levels) [ Time Frame: Baseline and Week 6 ]
  Change from baseline in MADRS total score at Week 6 in participants with levels of specific mRNA transcripts that exceed the median level will be reported.
• Change from Baseline in MADRS Total Score at Week 6 (Mood Stabilizer Subgroup Analysis) [ Time Frame: Baseline and Week 6 ]
  Change from baseline in MADRS total score at Week 6 in subgroup of participants with BD not taking any mood stabilizer or antipsychotic, taking a mood stabilizer alone, taking an antipsychotic alone, and taking a combination of a mood stabilizer and an antipsychotic (concomitant medication subgroup analysis) will be reported.

Original Secondary Outcome Measures (submitted: April 11, 2022)

• Change from Baseline in Snaith-Hamilton Pleasure Scale (SHAPS) Total Score at Week 6 [ Time Frame: Baseline and Week 6 ]
  Change from baseline in SHAPS total score at Week 6 will be reported.
• Change from Baseline in MADRS Total Score at Week 6 (Genetic Subgroup Analysis) [ Time Frame: Baseline and Week 6 ]
  Change from baseline in MADRS total score at Week 6 in participants who are heterozygous or homozygous for a specific single nucleotide polymorphism (SNP) (genetic subgroup analysis) will be reported.
• Change from Baseline in MADRS Total Score at Week 6 (Diagnosis Subgroup Analysis) [ Time Frame: Baseline and Week 6 ]
  Change from Baseline in MADRS total score at Week 6 in participants with bipolar disorder (BD) diagnostic subtypes (diagnosis subgroup analysis) will be reported.
• Change from Baseline in MADRS Total Score at Week 6 (Biomarker Subgroup Analysis) [ Time Frame: Baseline and Week 6 ]
  Change from baseline in MADRS total score at Week 6 in subgroups of participants with specific biomarker profiles (biomarker subgroup analysis) will be reported.
• Change from Baseline in MADRS Total Score at Week 6 (Subgroup of Participants with Messenger Ribonucleic Acid [mRNA] Transcript Levels) [ Time Frame: Baseline and Week 6 ]
  Change from baseline in MADRS total score at Week 6 in participants with levels of specific mRNA transcripts that exceed the median level will be reported.
• Number of Participants with Abnormalities in Vital Signs [ Time Frame: Up to Week 8 ]
  Number of participants with abnormalities in vital signs (heart rate, systolic blood pressure [SBP], diastolic blood pressure [DBP]) will be reported.
• Number of Participants with Abnormalities in Clinical Laboratory Tests [ Time Frame: Up to Week 8 ]
  Number of participants with abnormalities in clinical laboratory tests (chemistry, hematology, urinalysis) will be reported.
• Number of Participants with Adverse Events (AEs) [ Time Frame: Up to Week 8 ]
  An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention.
• Number of Participants with Abnormalities in Electrocardiograms (ECGs) [ Time Frame: Up to Week 8 ]
  Number of participants with abnormalities in ECG will be reported.
• Change from Baseline in Young Mania Rating Scale (YMRS) Score [ Time Frame: Baseline up to Week 6 ]
  Change from baseline in YMRS score will be reported. The YMRS is a rating scale used to assess manic symptoms.
• Change from Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Score [ Time Frame: Baseline up to Week 8 ]
  Change from baseline in C-SSRS score will be reported.
• Change from Baseline in Clinical Global Impression-Severity Scale (CGI-S) Score [ Time Frame: Baseline up to Week 6 ]
  Change from baseline in CGI-S scale score will be reported.
• Plasma Concentrations of JNJ-55308942 [ Time Frame: Days 1, 8, 15, 29, 43 ]
  Plasma samples will be analyzed to determine concentrations of JNJ-55308942 using a validated, specific, and sensitive liquid chromatography-mass spectrometry/mass spectrometry (LC-MS/MS) method.
• Change from Baseline in Snaith-Hamilton Pleasure Scale (SHAPS) Score [ Time Frame: Baseline up to Week 6 ]
  Change from baseline in SHAPS score will be reported.
• Change from Baseline in Patient Reported Outcome Measurement (PROMIS) Score - Ability to Participate in Social Roles and Activities Scores [ Time Frame: Baseline, up to Week 6 ]
  Change from baseline in PROMIS score- ability to participate in social roles and activity scores score will be reported. Participation in social roles and activities item bank assesses the perceived ability to perform one's usual social roles and activities.
• Change from Baseline in Patient Health Questionnaire (PHQ-9) Score [ Time Frame: Baseline up to Week 6 ]
  Change from baseline in PHQ-9 will be reported. PHQ-9 score used to assess the severity of depression in the participants.
• Change from Baseline in Generalized Anxiety Disorder 7 (GAD-7) Score. [ Time Frame: Baseline up to Week 6 ]
  Change from baseline in GAD-7 score will be reported.
• Percentage of Participants with Response at Week 6 [ Time Frame: Week 6 ]
  Percentage of participants with response (greater than or equal to [>=] 50 percent [%] improvement in MADRS total score) at Week 6 will be reported.
• Number of Participants with Remission at Week 6 [ Time Frame: Week 6 ]
  Number of participants with remission (MADRS total score less than or equal to [<=] 12) at Week 6 will be reported.
• Change from Baseline in MADRS Total Score at Week 6 (Mood Stabilizer Subgroup Analysis) [ Time Frame: Baseline and Week 6 ]
  Change from baseline in MADRS total score at Week 6 in participants with BD using a mood stabilizer and in participants with BD not using a mood stabilizer (mood stabilizer subgroup analysis) will be reported.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study of JNJ-55308942 in the Treatment of Bipolar Depression
• Official Title: A Randomized, Stratified, Double-blind, Placebo-Controlled Study to Investigate the Efficacy, Safety and Tolerability of JNJ-55308942 in Bipolar Depression
• Brief 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Bipolar Disorder

Intervention

• Drug: JNJ-55308942
  JNJ-55308942 capsules will be administered orally.
• Drug: Placebo
  Matching placebo capsules will be administered orally.

Study Arms

• Experimental: JNJ-55308942
  Participants will receive a JNJ-55308942 capsule once daily for 6 weeks.
  Intervention: Drug: JNJ-55308942
• Placebo Comparator: Placebo
  Participants will receive a matching placebo capsule once daily for 6 weeks.
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: November 7, 2023): 115
• Original Estimated Enrollment (submitted: April 11, 2022): 164
• Estimated Study Completion Date: May 21, 2024
• Estimated Primary Completion Date: March 22, 2024 (Final data collection date for primary outcome measure)

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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 64 Years (Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Study Contact; 844-434-4210; Participate-In-This-Study@its.jnj.com

• Listed Location Countries: Canada, Poland, Spain, United States

Administrative Information

• NCT Number: NCT05328297
• Other Study ID Numbers: CR109116; 2021-004790-31 ( EudraCT Number ); 55308942BIP2001 ( Other Identifier: Janssen Pharmaceutica N.V., Belgium )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
• URL: https://www.janssen.com/clinical-trials/transparency

• Current Responsible Party: Janssen Pharmaceutica N.V., Belgium
• Original Responsible Party: Same as current
• Current Study Sponsor: Janssen Pharmaceutica N.V., Belgium
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Janssen Pharmaceutica N.V., Belgium Clinical Trial; Janssen Pharmaceutica N.V., Belgium

• PRS Account: Janssen Pharmaceutica N.V., Belgium
• Verification Date: March 2024