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

Sponsor

Janssen Pharmaceutica N.V., Belgium (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05328297

Collaborator

(none)

164

Enrollment

Locations

Arms

23.6

Anticipated Duration (Months)

3.6

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bipolar Disorder	Drug: JNJ-55308942 Drug: Placebo	Phase 2

Detailed Description

JNJ-55308942 is a potent, selective, and brain penetrant antagonist of the adenosine triphosphate (ATP) gated P2X7 receptor. The primary hypothesis that will be tested in this study is that JNJ-55308942, compared to placebo, results in a significant improvement in the reduction of the symptoms of depression in participants with BD in a MDE as assessed by change in Montgomery-Åsberg Depression Rating Scale (MADRS) total score. Efficacy assessment will include MADRS and safety assessment will include physical examination, electrocardiogram (ECG), vital signs, clinical safety laboratory assessments, and suicidal ideation and behavior risk monitoring. Total duration of this study will be up to 15 weeks.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

164 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 3, 2022

Anticipated Primary Completion Date :

Mar 22, 2024

Anticipated Study Completion Date :

May 22, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: JNJ-55308942 Participants will receive a JNJ-55308942 capsule once daily for 6 weeks.	Drug: JNJ-55308942 JNJ-55308942 capsules will be administered orally.
Placebo Comparator: Placebo Participants will receive a matching placebo capsule once daily for 6 weeks.	Drug: Placebo Matching placebo capsules will be administered orally.

Arm

Intervention/Treatment

Experimental: JNJ-55308942

Participants will receive a JNJ-55308942 capsule once daily for 6 weeks.

Drug: JNJ-55308942

JNJ-55308942 capsules will be administered orally.

Placebo Comparator: Placebo

Participants will receive a matching placebo capsule once daily for 6 weeks.

Drug: Placebo

Matching placebo capsules will be administered orally.

Outcome Measures

Primary Outcome Measures

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

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 (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.
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.
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.
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.
Number of Participants with Abnormalities in Vital Signs [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 [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) [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) [Up to Week 8]
Number of participants with abnormalities in ECG 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 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 Clinical Global Impression-Severity Scale (CGI-S) Score [Baseline up to Week 6]
Change from baseline in CGI-S scale score 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 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 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 (Mood Stabilizer Subgroup Analysis) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 64 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UAB Huntsville Regional Medical Campus	Huntsville	Alabama	United States	35801
2	Preferred Research Partners	Little Rock	Arkansas	United States	72211
3	Artemis Institute for Clinical Research	San Diego	California	United States	92103
4	Collaborative NeuroScience Network	Torrance	California	United States	90502
5	Clinical Neuroscience Solutions Inc	Jacksonville	Florida	United States	32256
6	Clinical Neuroscience Solutions	Orlando	Florida	United States	23801
7	Psychiatric Medicine Associates LLC	Skokie	Illinois	United States	60076
8	Indiana University	Indianapolis	Indiana	United States	46202
9	University of Iowa Hospitals & Clinics	Iowa City	Iowa	United States	52242
10	University of Louisville, Department of Psychiatry	Louisville	Kentucky	United States	40202
11	Center for Emotional Fitness	Cherry Hill	New Jersey	United States	08002
12	Richard H. Weisler, MD & Associates	Raleigh	North Carolina	United States	27609-9148
13	Case Western Reserve School of Medicine	Cleveland	Ohio	United States	44106
14	The Ohio State University	Columbus	Ohio	United States	43210
15	Suburban Research Associates	Media	Pennsylvania	United States	19063
16	Clinical NeuroScience Solutions, Inc	Memphis	Tennessee	United States	38119
17	The University of Texas at Austin Department of Psychiatry, Dell Medical School	Austin	Texas	United States	78712-1873
18	The University of Texas Health Science Center at Houston	Houston	Texas	United States	77054
19	Northwest Clinical Research Center	Bellevue	Washington	United States	98007
20	Foothills Hospital	Calgary	Alberta	Canada	T2N 4Z6
21	The Medical Arts Health Research Group	West Vancouver	British Columbia	Canada	V7T 1C5
22	Chatham-Kent Clinical Trials Research Centre	Chatham	Ontario	Canada	N7L 1C1
23	Queen's University	Kingston		Canada	K7L 4X3
24	PROMENTE Sp. z o.o.	Bydgoszcz		Poland	85-133
25	Uniwersyteckie Centrum Kliniczne	Gdansk		Poland	80-124
26	Centrum Badań Klinicznych PI-House sp. z o.o.	Gdansk		Poland	80-546
27	Specjalistyczna Praktyka Lekarska lek. Piotr Zalitacz	Gorlice		Poland	38-300
28	Centrum Medyczne Care Clinic Katowice	Katowice		Poland	40-568
29	Specjalistyczny Psychiatryczny Zespol Opieki Zdrowotnej w Lodzi Szpital im. J. Babinskiego	Lodz		Poland	91-229
30	Filip Rybakowski Specjalistyczna Praktyka Lekarska	Poznan		Poland	60-744
31	Samodzielny Publiczny Zespół Lecznictwa Psychiatrycznego w Siemianowicach Śląskich	Siemianowice Śląskie		Poland	41-100
32	Osrodek Badan Klinicznych CLINSANTE S.C.	Torun		Poland	87-100
33	Instytut Psychiatrii I Neurologii	Warszawa		Poland	02957
34	Centrum Medyczne Oporow	Wrocław		Poland	52-415
35	Hosp. Del Mar	Barcelona		Spain	08003
36	Institucion Hosp Hestia Palau	Barcelona		Spain	08025
37	Hosp. Univ. Vall D Hebron	Barcelona		Spain	08035
38	Hosp. Clinic I Provincial de Barcelona	Barcelona		Spain	08036
39	Hosp. Univ. Ramon Y Cajal	Madrid		Spain	28034
40	Centro Salud Mental La Eria	Oviedo		Spain	33013
41	Clinica Univ. de Navarra	Pamplona		Spain	31008
42	Hosp. El Bierzo	Ponferrada		Spain	24404
43	Hosp. Clinico Univ. de Valencia	Valencia		Spain	46010
44	Hosp. Univ. I Politecni La Fe	Valencia		Spain	46026
45	Hosp. Alvaro Cunqueiro	Vigo		Spain	36213
46	Hosp. Psiquiatrico Alava	Vitoria-Gasteiz		Spain	1006

Sponsors and Collaborators

Janssen Pharmaceutica N.V., Belgium

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Janssen Pharmaceutica N.V., Belgium

ClinicalTrials.gov Identifier:

NCT05328297

Other Study ID Numbers:

CR109116
2021-004790-31
55308942BIP2001

First Posted:

Apr 14, 2022

Last Update Posted:

Aug 18, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Bipolar Disorder

JNJ-55308942

Study Results

No Results Posted as of Aug 18, 2022