A Study of JNJ-55308942 in the Treatment of Bipolar Depression
- Registration Number
- NCT05328297
- Lead Sponsor
- Janssen Pharmaceutica N.V., Belgium
- 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 available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 116
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description JNJ-55308942 JNJ-55308942 Participants will receive a JNJ-55308942 capsule once daily for 6 weeks. Placebo Placebo Participants will receive a matching placebo capsule once daily for 6 weeks.
- Primary Outcome Measures
Name Time Method Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 6 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.
- Secondary Outcome Measures
Name Time Method Change from Baseline in MADRS Total Score at Week 6 (Genetic Subgroup Analysis) 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.
Number of Participants with Abnormalities in Vital Signs 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.
Change from Baseline in Young Mania Rating Scale (YMRS) Score 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 Clinical Global Impression-Severity Scale (CGI-S) Score Baseline up to Week 6 Change from baseline in CGI-S scale score will be reported.
Change from Baseline in Patient Health Questionnaire (PHQ-9) Score 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 Snaith-Hamilton Pleasure Scale (SHAPS) Total Score at Week 6 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 (Diagnosis Subgroup Analysis) 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.
Number of Participants with Adverse Events (AEs) 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.
Change from Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Score Baseline up to Week 8 Change from baseline in C-SSRS score will be reported.
Change from Baseline in MADRS Total Score at Week 6 (Biomarker Subgroup Analysis) 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 Clinical Laboratory Tests Up to Week 8 Number of participants with abnormalities in clinical laboratory tests (chemistry, hematology, urinalysis) will be reported.
Number of Participants with Abnormalities in Electrocardiograms (ECGs) Up to Week 8 Number of participants with abnormalities in ECG will be reported.
Plasma Concentrations of JNJ-55308942 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 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 Generalized Anxiety Disorder 7 (GAD-7) Score. Baseline up to Week 6 Change from baseline in GAD-7 score will be reported.
Percentage of Participants with Response at Week 6 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 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) 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) 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.
Trial Locations
- Locations (44)
Centrum Badan Klinicznych PI House sp z o o
🇵🇱Gdansk, Poland
Clinical NeuroScience Solutions Inc
🇺🇸Memphis, Tennessee, United States
Chatham-Kent Clinical Trials Research Centre
🇨🇦Chatham, Ontario, Canada
Uniwersytecki Szpital Kliniczny w Bialymstoku Klinika Psychiatrii
🇵🇱Bialystok, Poland
UAB Huntsville Regional Medical Campus
🇺🇸Huntsville, Alabama, United States
Collaborative NeuroScience Network
🇺🇸Torrance, California, United States
Indiana University
🇺🇸Indianapolis, Indiana, United States
The Ohio State University
🇺🇸Columbus, Ohio, United States
Suburban Research Associates
🇺🇸Media, Pennsylvania, United States
North Texas Clinical Trials
🇺🇸Fort Worth, Texas, United States
Preferred Research Partners
🇺🇸Little Rock, Arkansas, United States
Synergy East
🇺🇸Lemon Grove, California, United States
Clinical Neuroscience Solutions Inc
🇺🇸Jacksonville, Florida, United States
Clinical Neuroscience Solutions
🇺🇸Orlando, Florida, United States
The University of Texas Health Science Center at Houston
🇺🇸Houston, Texas, United States
Northwest Clinical Research Center
🇺🇸Bellevue, Washington, United States
Hosp. Univ. I Politecni La Fe
🇪🇸Valencia, Spain
Psychiatric Medicine Associates LLC
🇺🇸Skokie, Illinois, United States
Center for Emotional Fitness
🇺🇸Cherry Hill, New Jersey, United States
Richard H. Weisler, MD & Associates
🇺🇸Raleigh, North Carolina, United States
The University of Texas at Austin Department of Psychiatry, Dell Medical School
🇺🇸Austin, Texas, United States
Case Western Reserve School of Medicine
🇺🇸Cleveland, Ohio, United States
The Medical Arts Health Research Group
🇨🇦West Vancouver, British Columbia, Canada
PROMENTE Sp. z o.o.
🇵🇱Bydgoszcz, Poland
Specjalistyczna Praktyka Lekarska Piotr Zalitacz
🇵🇱Gorlice, Poland
Centrum Medyczne Care Clinic Katowice
🇵🇱Katowice, Poland
Indywidualna Praktyka Lekarska Kinga Bobinska
🇵🇱Lodz, Poland
Filip Rybakowski Specjalistyczna Praktyka Lekarska
🇵🇱Poznan, Poland
Centrum Medyczne HCP Sp. z o.o. Osrodek Badan Klinicznych
🇵🇱Poznan, Poland
Samodzielny Publiczny Zespol Lecznictwa Psychiatrycznego w Siemianowicach Slaskich
🇵🇱Siemianowice Slaskie, Poland
Indywidualna Specjalistyczna Praktyka Lekarska Agnieszka Remlinger Molenda
🇵🇱Suchy Las, Poland
Szpital Nowowiejski Osrodek Badan Klinicznych
🇵🇱Warszawa, Poland
Instytut Psychiatrii I Neurologii
🇵🇱Warszawa, Poland
Ginemedica Sp. z o.o.
🇵🇱Wroclaw, Poland
Hosp. Alvaro Cunqueiro
🇪🇸Vigo, Spain
Przychodnia Lekarsko-Psychologiczna Persona
🇵🇱Wroclaw, Poland
Institucion Hosp Hestia Palau
🇪🇸Barcelona, Spain
Hosp. Univ. Ramon Y Cajal
🇪🇸Madrid, Spain
Centro Salud Mental La Eria
🇪🇸Oviedo, Spain
Hosp. Del Mar
🇪🇸Barcelona, Spain
Hosp. Psiquiatrico Alava
🇪🇸Vitoria Gasteiz, Spain
Hosp Clinic de Barcelona
🇪🇸Barcelona, Spain
Clinica Univ. de Navarra
🇪🇸Pamplona, Spain
Hosp. El Bierzo
🇪🇸Ponferrada, Spain