Clinical trial NCT05328297: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Bipolar Disorder
Lead sponsor: Janssen Pharmaceutica N.V., Belgium
Sponsor class: INDUSTRY
First posted: 2022-04-14
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 6
timeFrame: Baseline and Week 6
Secondary outcomes:
measure: Change from Baseline in Snaith-Hamilton Pleasure Scale (SHAPS) Total Score at Week 6
timeFrame: Baseline and Week 6
measure: Change from Baseline in MADRS Total Score at Week 6 (Genetic Subgroup Analysis)
timeFrame: Baseline and Week 6
measure: Change from Baseline in MADRS Total Score at Week 6 (Diagnosis Subgroup Analysis)
timeFrame: Baseline and Week 6
measure: Change from Baseline in MADRS Total Score at Week 6 (Biomarker Subgroup Analysis)
timeFrame: Baseline and Week 6
measure: Number of Participants with Abnormalities in Vital Signs
timeFrame: Up to Week 8
measure: Number of Participants with Abnormalities in Clinical Laboratory Tests
timeFrame: Up to Week 8
measure: Number of Participants with Adverse Events (AEs)
timeFrame: Up to Week 8
measure: Number of Participants with Abnormalities in Electrocardiograms (ECGs)
timeFrame: Up to Week 8
measure: Change from Baseline in Young Mania Rating Scale (YMRS) Score
timeFrame: Baseline up to Week 6
measure: Change from Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Score
timeFrame: Baseline up to Week 8
measure: Change from Baseline in Clinical Global Impression-Severity Scale (CGI-S) Score
timeFrame: Baseline up to Week 6
measure: Plasma Concentrations of JNJ-55308942
timeFrame: Days 1, 8, 15, 29, 43
measure: Change from Baseline in Patient Reported Outcome Measurement (PROMIS) Score - Ability to Participate in Social Roles and Activities Scores
timeFrame: Baseline, up to Week 6
measure: Change from Baseline in Patient Health Questionnaire (PHQ-9) Score
timeFrame: Baseline up to Week 6
measure: Change from Baseline in Generalized Anxiety Disorder 7 (GAD-7) Score.
timeFrame: Baseline up to Week 6
measure: Percentage of Participants with Response at Week 6
timeFrame: Week 6
measure: Number of Participants with Remission at Week 6
timeFrame: Week 6
measure: Change from Baseline in MADRS Total Score at Week 6 (Subgroup of Participants with Messenger Ribonucleic Acid [mRNA] Transcript Levels)
timeFrame: Baseline and Week 6
measure: Change from Baseline in MADRS Total Score at Week 6 (Mood Stabilizer Subgroup Analysis)
timeFrame: Baseline and Week 6
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: UAB Huntsville Regional Medical Campus
state: Alabama
city: Little Rock
country: United States
facility: Preferred Research Partners
state: Arkansas
city: Lemon Grove
country: United States
facility: Synergy East
state: California
city: Torrance
country: United States
facility: Collaborative NeuroScience Network
state: California
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions Inc
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions
state: Florida
city: Skokie
country: United States
facility: Psychiatric Medicine Associates LLC
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Cherry Hill
country: United States
facility: Center for Emotional Fitness
state: New Jersey
city: Raleigh
country: United States
facility: Richard H. Weisler, MD & Associates
state: North Carolina
city: Cleveland
country: United States
facility: Case Western Reserve School of Medicine
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Media
country: United States
facility: Suburban Research Associates
state: Pennsylvania
city: Memphis
country: United States
facility: Clinical NeuroScience Solutions Inc
state: Tennessee
city: Austin
country: United States
facility: The University of Texas at Austin Department of Psychiatry, Dell Medical School
state: Texas
city: Fort Worth
country: United States
facility: North Texas Clinical Trials
state: Texas
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
city: Bellevue
country: United States
facility: Northwest Clinical Research Center
state: Washington
city: West Vancouver
country: Canada
facility: The Medical Arts Health Research Group
state: British Columbia
city: Chatham
country: Canada
facility: Chatham-Kent Clinical Trials Research Centre
state: Ontario
city: Bialystok
country: Poland
facility: Uniwersytecki Szpital Kliniczny w Bialymstoku Klinika Psychiatrii
city: Bydgoszcz
country: Poland
facility: PROMENTE Sp. z o.o.
city: Gdansk
country: Poland
facility: Centrum Badan Klinicznych PI House sp z o o
city: Gorlice
country: Poland
facility: Specjalistyczna Praktyka Lekarska Piotr Zalitacz
city: Katowice
country: Poland
facility: Centrum Medyczne Care Clinic Katowice
city: Lodz
country: Poland
facility: Indywidualna Praktyka Lekarska Kinga Bobinska
city: Poznan
country: Poland
facility: Filip Rybakowski Specjalistyczna Praktyka Lekarska
city: Poznan
country: Poland
facility: Centrum Medyczne HCP Sp. z o.o. Osrodek Badan Klinicznych
city: Siemianowice Slaskie
country: Poland
facility: Samodzielny Publiczny Zespol Lecznictwa Psychiatrycznego w Siemianowicach Slaskich
city: Suchy Las
country: Poland
facility: Indywidualna Specjalistyczna Praktyka Lekarska Agnieszka Remlinger Molenda
city: Warszawa
country: Poland
facility: Szpital Nowowiejski Osrodek Badan Klinicznych
city: Warszawa
country: Poland
facility: Instytut Psychiatrii I Neurologii
city: Wroclaw
country: Poland
facility: Przychodnia Lekarsko-Psychologiczna Persona
city: Wroclaw
country: Poland
facility: Ginemedica Sp. z o.o.
city: Barcelona
country: Spain
facility: Hosp. Del Mar
city: Barcelona
country: Spain
facility: Institucion Hosp Hestia Palau
city: Barcelona
country: Spain
facility: Hosp Clinic de Barcelona
city: Madrid
country: Spain
facility: Hosp. Univ. Ramon Y Cajal
city: Oviedo
country: Spain
facility: Centro Salud Mental La Eria
city: Pamplona
country: Spain
facility: Clinica Univ. de Navarra
city: Ponferrada
country: Spain
facility: Hosp. El Bierzo
city: Valencia
country: Spain
facility: Hosp. Univ. I Politecni La Fe
city: Vigo
country: Spain
facility: Hosp. Alvaro Cunqueiro
city: Vitoria Gasteiz
country: Spain
facility: Hosp. Psiquiatrico Alava
Study officials:
affiliation: Janssen Pharmaceutica N.V., Belgium
name: Janssen Pharmaceutica N.V., Belgium Clinical Trial
role: STUDY_DIRECTOR
References: