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

Bipolar Disorder Clinical Trial

Official title:

A Randomized, Stratified, Double-blind, Placebo-Controlled Study to Investigate the Efficacy, Safety and Tolerability of JNJ-55308942 in Bipolar Depression

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05328297
• Other study ID #: CR109116
• Secondary ID: 2021-004790-3155
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: June 3, 2022
• Est. completion date: May 21, 2024

Study information

• Verified date: May 2024
• Source: Janssen Pharmaceutica N.V., Belgium
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 116
• Est. completion date: May 21, 2024
• Est. primary completion date: May 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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)

Related Conditions & MeSH terms

• Bipolar Disorder

Intervention

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

Locations

Country	Name	City	State
Canada	Chatham-Kent Clinical Trials Research Centre	Chatham	Ontario
Canada	The Medical Arts Health Research Group	West Vancouver	British Columbia
Poland	Uniwersytecki Szpital Kliniczny w Bialymstoku Klinika Psychiatrii	Bialystok
Poland	PROMENTE Sp. z o.o.	Bydgoszcz
Poland	Centrum Badan Klinicznych PI-House sp. z o.o.	Gdansk
Poland	Specjalistyczna Praktyka Lekarska Piotr Zalitacz	Gorlice
Poland	Centrum Medyczne Care Clinic Katowice	Katowice
Poland	Indywidualna Praktyka Lekarska Kinga Bobinska	Lodz
Poland	Centrum Medyczne HCP Sp. z o.o. Osrodek Badan Klinicznych	Poznan
Poland	Filip Rybakowski Specjalistyczna Praktyka Lekarska	Poznan
Poland	Samodzielny Publiczny Zespol Lecznictwa Psychiatrycznego w Siemianowicach Slaskich	Siemianowice Slaskie
Poland	Indywidualna Specjalistyczna Praktyka Lekarska Agnieszka Remlinger Molenda	Suchy Las
Poland	Instytut Psychiatrii I Neurologii	Warszawa
Poland	Szpital Nowowiejski Osrodek Badan Klinicznych	Warszawa
Poland	Ginemedica Sp. z o.o.	Wroclaw
Poland	Przychodnia Lekarsko-Psychologiczna Persona	Wroclaw
Spain	Hosp. Clinic de Barcelona	Barcelona
Spain	Hosp. Del Mar	Barcelona
Spain	Institucion Hosp Hestia Palau	Barcelona
Spain	Hosp. Univ. Ramon Y Cajal	Madrid
Spain	Centro Salud Mental La Eria	Oviedo
Spain	Clinica Univ. de Navarra	Pamplona
Spain	Hosp. El Bierzo	Ponferrada
Spain	Hosp. Univ. I Politecni La Fe	Valencia
Spain	Hosp. Alvaro Cunqueiro	Vigo
Spain	Hosp. Psiquiatrico Alava	Vitoria Gasteiz
United States	The University of Texas at Austin Department of Psychiatry, Dell Medical School	Austin	Texas
United States	Northwest Clinical Research Center	Bellevue	Washington
United States	Center for Emotional Fitness	Cherry Hill	New Jersey
United States	Case Western Reserve School of Medicine	Cleveland	Ohio
United States	The Ohio State University	Columbus	Ohio
United States	North Texas Clinical Trials	Fort Worth	Texas
United States	The University of Texas Health Science Center at Houston	Houston	Texas
United States	UAB Huntsville Regional Medical Campus	Huntsville	Alabama
United States	Indiana University	Indianapolis	Indiana
United States	Clinical Neuroscience Solutions Inc	Jacksonville	Florida
United States	Synergy East	Lemon Grove	California
United States	Preferred Research Partners	Little Rock	Arkansas
United States	Suburban Research Associates	Media	Pennsylvania
United States	Clinical NeuroScience Solutions Inc	Memphis	Tennessee
United States	Clinical Neuroscience Solutions	Orlando	Florida
United States	Richard H. Weisler, MD & Associates	Raleigh	North Carolina
United States	Psychiatric Medicine Associates LLC	Skokie	Illinois
United States	Collaborative NeuroScience Network	Torrance	California

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Pharmaceutica N.V., Belgium

Countries where clinical trial is conducted

United States,  Canada,  Poland,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at 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.	Baseline and Week 6
Secondary	Change from Baseline in Snaith-Hamilton Pleasure Scale (SHAPS) Total Score at Week 6	Change from baseline in SHAPS total score at Week 6 will be reported.	Baseline and Week 6
Secondary	Change from Baseline in MADRS Total Score at Week 6 (Genetic Subgroup Analysis)	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.	Baseline and Week 6
Secondary	Change from Baseline in MADRS Total Score at Week 6 (Diagnosis Subgroup Analysis)	Change from Baseline in MADRS total score at Week 6 in participants with bipolar disorder (BD) diagnostic subtypes (diagnosis subgroup analysis) will be reported.	Baseline and Week 6
Secondary	Change from Baseline in MADRS Total Score at Week 6 (Biomarker Subgroup Analysis)	Change from baseline in MADRS total score at Week 6 in subgroups of participants with specific biomarker profiles (biomarker subgroup analysis) will be reported.	Baseline and Week 6
Secondary	Number of Participants with Abnormalities in Vital Signs	Number of participants with abnormalities in vital signs (pulse/heart rate, systolic blood pressure [SBP], diastolic blood pressure [DBP], respiratory rate) will be reported.	Up to Week 8
Secondary	Number of Participants with Abnormalities in Clinical Laboratory Tests	Number of participants with abnormalities in clinical laboratory tests (chemistry, hematology, urinalysis) will be reported.	Up to Week 8
Secondary	Number of Participants with Adverse Events (AEs)	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.	Up to Week 8
Secondary	Number of Participants with Abnormalities in Electrocardiograms (ECGs)	Number of participants with abnormalities in ECG will be reported.	Up to Week 8
Secondary	Change from Baseline in Young Mania Rating Scale (YMRS) Score	Change from baseline in YMRS score will be reported. The YMRS is a rating scale used to assess manic symptoms.	Baseline up to Week 6
Secondary	Change from Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Score	Change from baseline in C-SSRS score will be reported.	Baseline up to Week 8
Secondary	Change from Baseline in Clinical Global Impression-Severity Scale (CGI-S) Score	Change from baseline in CGI-S scale score will be reported.	Baseline up to Week 6
Secondary	Plasma Concentrations of JNJ-55308942	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.	Days 1, 8, 15, 29, 43
Secondary	Change from Baseline in Patient Reported Outcome Measurement (PROMIS) Score - Ability to Participate in Social Roles and Activities Scores	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.	Baseline, up to Week 6
Secondary	Change from Baseline in Patient Health Questionnaire (PHQ-9) Score	Change from baseline in PHQ-9 will be reported. PHQ-9 score used to assess the severity of depression in the participants.	Baseline up to Week 6
Secondary	Change from Baseline in Generalized Anxiety Disorder 7 (GAD-7) Score.	Change from baseline in GAD-7 score will be reported.	Baseline up to Week 6
Secondary	Percentage of Participants with Response at 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.	Week 6
Secondary	Number of Participants with Remission at Week 6	Number of participants with remission (MADRS total score less than or equal to [<=] 12) at Week 6 will be reported.	Week 6
Secondary	Change from Baseline in MADRS Total Score at Week 6 (Subgroup of Participants with Messenger Ribonucleic Acid [mRNA] Transcript Levels)	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.	Baseline and Week 6
Secondary	Change from Baseline in MADRS Total Score at Week 6 (Mood Stabilizer Subgroup Analysis)	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.	Baseline and Week 6