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

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

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.

Study Overview

• Status: Completed
• Conditions: Bipolar Disorder
• Intervention / Treatment: Drug: JNJ-55308942; Drug: Placebo

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 an 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, adverse events, electrocardiogram (ECG), vital signs, clinical safety laboratory assessments, and suicidal ideation and behavior risk monitoring. Total duration of this study will be up to 12 weeks.

• Study Type: Interventional
• Enrollment (Actual): 116
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • West Vancouver, British Columbia, Canada, V7T 1C5
      • The Medical Arts Health Research Group
  • Ontario
    • Chatham, Ontario, Canada, N7L 1C1
      • Chatham-Kent Clinical Trials Research Centre
• Poland
  • Bialystok, Poland, 15 272
    • Uniwersytecki Szpital Kliniczny w Bialymstoku Klinika Psychiatrii
  • Bydgoszcz, Poland, 85-133
    • PROMENTE Sp. z o.o.
  • Gdansk, Poland, 80 546
    • Centrum Badan Klinicznych PI House sp z o o
  • Gorlice, Poland, 30073
    • Specjalistyczna Praktyka Lekarska Piotr Zalitacz
  • Katowice, Poland, 40-568
    • Centrum Medyczne Care Clinic Katowice
  • Lodz, Poland, 90-009
    • Indywidualna Praktyka Lekarska Kinga Bobinska
  • Poznan, Poland, 60 744
    • Filip Rybakowski Specjalistyczna Praktyka Lekarska
  • Poznan, Poland, 61-485
    • Centrum Medyczne HCP Sp. z o.o. Osrodek Badan Klinicznych
  • Siemianowice Slaskie, Poland, 41-100
    • Samodzielny Publiczny Zespol Lecznictwa Psychiatrycznego w Siemianowicach Slaskich
  • Suchy Las, Poland, 62-002
    • Indywidualna Specjalistyczna Praktyka Lekarska Agnieszka Remlinger Molenda
  • Warszawa, Poland, 02957
    • Instytut Psychiatrii i Neurologii
  • Warszawa, Poland, 00-774
    • Szpital Nowowiejski Osrodek Badan Klinicznych
  • Wroclaw, Poland, 50-227
    • Przychodnia Lekarsko-Psychologiczna Persona
  • Wroclaw, Poland, 50-414
    • Ginemedica Sp. z o.o.
• Spain
  • Barcelona, Spain, 08003
    • Hosp. Del Mar
  • Barcelona, Spain, 08025
    • Institucion Hosp Hestia Palau
  • Barcelona, Spain, 08036
    • Hosp Clinic de Barcelona
  • Madrid, Spain, 28034
    • Hosp. Univ. Ramon Y Cajal
  • Oviedo, Spain, 33013
    • Centro Salud Mental La Eria
  • Pamplona, Spain, 31008
    • Clinica Univ. de Navarra
  • Ponferrada, Spain, 24404
    • Hosp. El Bierzo
  • Valencia, Spain, 46026
    • Hosp. Univ. I Politecni La Fe
  • Vigo, Spain, 36213
    • Hosp. Alvaro Cunqueiro
  • Vitoria Gasteiz, Spain, 1006
    • Hosp. Psiquiatrico Alava
• United States
  • Alabama
    • Huntsville, Alabama, United States, 35801
      • UAB Huntsville Regional Medical Campus
  • Arkansas
    • Little Rock, Arkansas, United States, 72211
      • Preferred Research Partners
  • California
    • Lemon Grove, California, United States, 91945
      • Synergy East
    • Torrance, California, United States, 90504
      • Collaborative Neuroscience Network
  • Florida
    • Jacksonville, Florida, United States, 32256
      • Clinical Neuroscience Solutions Inc
    • Orlando, Florida, United States, 23801
      • Clinical Neuroscience Solutions
  • Illinois
    • Skokie, Illinois, United States, 60076
      • Psychiatric Medicine Associates LLC
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University
  • New Jersey
    • Cherry Hill, New Jersey, United States, 08002
      • Center for Emotional Fitness
  • North Carolina
    • Raleigh, North Carolina, United States, 27609-9148
      • Richard H. Weisler, MD & Associates
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Case Western Reserve School of Medicine
    • Columbus, Ohio, United States, 43210
      • The Ohio State University
  • Pennsylvania
    • Media, Pennsylvania, United States, 19063
      • Suburban Research Associates
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Clinical Neuroscience Solutions Inc
  • Texas
    • Austin, Texas, United States, 78712-1873
      • The University of Texas at Austin Department of Psychiatry, Dell Medical School
    • Fort Worth, Texas, United States, 76104
      • North Texas Clinical Trials
    • Houston, Texas, United States, 77054
      • The University of Texas Health Science Center at Houston
  • Washington
    • Bellevue, Washington, United States, 98007
      • Northwest Clinical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score up to Week 6	Change from baseline in MADRS total score up to Week 6 were reported. MADRS was a clinician-rated scale designed to measure depression severity and detect changes due to antidepressant (AD) treatment. The MADRS evaluated reported sadness, apparent sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. The scale consisted of 10 items, each of which was scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms),with higher score indicating a more severe condition. The MADRS total score was the sum of scores from individual question items and it ranged from 0 to 60, with higher scores indicated more severe conditions. Negative change in MADRS total score indicated improvement.	From Baseline (Day 1) up to Week 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Snaith-Hamilton Pleasure Scale (SHAPS) Total Score up to Week 6	Change from baseline in SHAPS total score up to Week 6 were reported. The SHAPS was a reliable, valid, and unidimensional instrument used to assess hedonic capacity in adults with Major Depressive Disorder. It is a 14-item, self-report tool with a completion time below 5 minutes. Each of the items had a set of 4 response categories: 1 = definitely agree/strongly agree, 2 = agree, 3 = disagree, and 4 = strongly disagree. The SHAPS total score was the sum of the 14 item scores, which ranged from 14 to 56. A higher SHAPS total score indicated higher levels of current anhedonia. Negative changes in the SHAPS total score indicated improvement.	From Baseline (Day 1) up to Week 6
Change From Baseline in MADRS Total Score up to Week 6 (Genetic Subgroup Analysis)	Genetic subgroup analysis included participants with bipolar depression and who were with P2RX7 Gain of Function single nucleotide polymorphism (P2RX7 GoF SNP) mutation genotype: heterozygous or homozygous. MADRS was a clinician-rated scale designed to measure depression severity and detect changes due to AD treatment. The MADRS evaluated reported sadness, apparent sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. The scale consisted of 10 items, each of which was scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms),with higher score indicating a more severe condition. The MADRS total score was the sum of scores from individual question items and it ranged from 0 to 60, with higher scores indicated more severe conditions. Negative change in MADRS total score indicated improvement.	From Baseline (Day 1) up to Week 6
Change From Baseline in MADRS Total Score up to Week 6 (Diagnosis Subgroup Analysis)	Change from baseline in MADRS total score up to Week 6 (Diagnosis Subgroup Analysis) were reported. Diagnosis subgroup analysis included participants with bipolar type 1 or II. MADRS was a clinician-rated scale designed to measure depression severity and detect changes due to AD treatment. The MADRS evaluated reported sadness, apparent sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. The scale consisted of 10 items, each of which was scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms),with higher score indicating a more severe condition. The MADRS total score was the sum of scores from individual question items and it ranged from 0 to 60, with higher scores indicated more severe conditions. Negative change in MADRS total score indicated improvement.	From Baseline (Day 1) up to Week 6
Change From Baseline in MADRS Total Score up to Week 6 (Biomarker Subgroup Analysis)	Biomarker subgroup analysis included specific (3-Marker Model [3MM]) biomarker profile: Yes or No. 3MM biomarker profile was defined as serum C-reactive protein >3 mg/Liter(L) and soluble interleukin-6 receptor >25 micrograms(mcg)/L or tumor necrosis factor >4 nanograms(ng)/L at baseline. MADRS was a clinician-rated scale designed to measure depression severity and detect changes due to AD treatment. MADRS evaluated reported sadness, apparent sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Scale consist of 10 items each of which was scored from 0(item not present or normal) to 6(severe or continuous presence of the symptoms),with higher score indicating a more severe condition. MADRS total score was sum of scores from individual question items, ranged from 0 to 60,with higher scores indicated more severe conditions. Negative change in MADRS total score indicated improvement.	From Baseline (Day 1) up to Week 6
Number of Participants With Treatment-emergent Clinically Important Abnormalities in Vital Signs	Vital signs parameters included pulse rate (abnormally low [AL]: <50 beats per minute [bpm] and with >15 bpm decrease from baseline and abnormally high [AH]: >100 bpm and with >15 bpm increase from baseline), Systolic blood pressure (SBP) (AL: <90 millimeters of mercury [mmHg] and with >20 mmHg decrease from baseline and AH: >180 mmHg and with >20 mmHg increase from baseline), Diastolic blood pressure (DBP) (AL: <50 mmHg and with >15 mmHg decrease from baseline and AH: >105 mmHg and with >15 mmHg increase from baseline) , temperature (AL:<35.5 and AH:>37.5 degree Celsius [C]), respiratory rate (AH :>20 breaths per minute), and weight (AL: decrease from baseline >7% and AH: increase from baseline >7%). Weight was planned to analyzed at Weeks 6 and 8 only. Treatment-emergent concluded if postbaseline value was above/below upper/lower limit and baseline value was below/above the upper/lower limit.	Weeks 1, 2, 4, 6, and 8 (Follow-up/Early Withdrawal)
Change From Baseline in Clinical Laboratory Values in Male Hormone: Inhibin B	Change from baseline in clinical laboratory values in male hormone (Inhibin B) were reported.	Baseline (Day 1), Week 4, 6, and 8 (Follow-up/Early Withdrawal)
Change From Baseline in Clinical Laboratory Values in Male Hormone: Luteinizing Hormone	Change from baseline in clinical laboratory values in male hormone (luteinizing hormone) were reported.	Baseline (Day 1), Week 4, 6, and 8 (Follow-up/Early Withdrawal)
Change From Baseline in Clinical Laboratory Values in Male Hormone: Prolactin	Change from baseline in clinical laboratory values in male hormone (prolactin) were reported.	Baseline (Day 1), Week 4, 6, and 8 (Follow-up/Early Withdrawal)
Change From Baseline in Clinical Laboratory Values in Male Hormones: Sex Hormone Binding Globulin, Testosterone (Free), Testosterone (High Sensitivity), and Testosterone (Low Sensitivity)	Change from baseline in clinical laboratory values in male hormones (sex hormone binding globulin, testosterone [free], testosterone [high sensitivity], and testosterone [low sensitivity]) were reported.	Baseline (Day 1), Week 4, 6, and 8 (Follow-up/Early Withdrawal)
Number of Participants With Abnormal Laboratory Values: Serum Chemistry	Number of participants with abnormal laboratory values: serum chemistry were reported. It included: aspartate aminotransferase (high), alanine aminotransferase (high), bilirubin (high/low), and alkaline phosphatase (high/low). Only categories with data were reported.	Weeks 2, 4, 6, and 8 (Follow-up/Early Withdrawal)
Number of Participants With Clinically Significant Abnormal Laboratory Values: Hematology	Number of participants with clinically significant abnormal laboratory values: hematology were reported.	Weeks 2, 4, 6, and 8 (Follow-up/Early Withdrawal)
Number of Participants With Clinically Significant Abnormal Laboratory Values: Urinalysis	Number of participants with clinically significant abnormal laboratory values: urinalysis were reported.	Weeks 2, 4, 6, and 8 (Follow-up/Early Withdrawal)
Number of Participants With Treatment-emergent Adverse Events (TEAEs)	Number of participants with TEAEs were reported. An adverse event (AE) is any untoward medical occurrence in a clinical study participants who administered a medicinal (investigational or non-investigational) product and does not necessarily have a causal relationship with the treatment. A TEAE defined as an AE that occurred at or after the first dose administration up to day of the last dose plus 30 days.	Day 1 (Week 0) up to 30 days after the last dose (up to 11 weeks)
Number of Participants With Treatment-emergent Abnormalities in Electrocardiograms (ECGs)	Number of participants with treatment-emergent abnormalities in ECGs were reported. It included ECG mean heart rate (abnormally low [AL]: <50 and abnormally high [AH]: >100 beats per minute [bpm]), PR Interval (AL: <120 and AH: >200 milliseconds [msec]), QRS Duration (AL: <60 and AH: >120 msec), and QT Interval (AL: <200 and AH: >500 msec). A treatment-emergent abnormalities in ECGs are defined as those abnormalities that occurred at or after the first dose administration.	Weeks 1, 2, 4, 6, and 8 (Follow-up/Early Withdrawal)
Change From Baseline in Young Mania Rating Scale (YMRS) Total Score	Change from baseline in YMRS total score were reported. The YMRS was designed to measure the severity of manic symptoms, to gauge the effect of treatment on mania severity, and to detect a return of manic symptoms (for example relapse or recurrence). YMRS had 11 items : 4 items (irritability, speech, thought content, and disruptive/aggressive behavior) were graded on a scale of 0 to 8 and the remaining 7 items (elevated mood, increased motor activity, sexual interest, sleep, language-thought disorder, appearance, and insight) were graded on a scale of 0 to 4. Higher scores indicated greater symptom severity. Responses were summed to yield YMRS total score ranged from 0 to 60 , with higher scores reflecting greater severity of mania.	From Baseline (Day 1) up to Week 6
Number of Participants Who Reported Suicidal Ideation (SI) or Suicidal Behavior (SB) Using With Columbia Suicide Severity Rating Scale (C-SSRS) Score	C-SSRS is a clinician-rated instrument that reports severity of both suicidal ideation (SI) and suicidal behavior (SB). SI categories: 1 (wish to be dead), 2 (nonspecific active suicidal thoughts), 3 (active suicidal ideation with any methods [not plan] without intent to act), 4 (active SI with some intent to act, without specific plan), and 5 (active SI with specific plan and intent). SB categories: 6 (preparatory acts or behavior), 7 (aborted attempt), 8 (interrupted attempt), 9 (actual attempt), and 10 (suicide). An additional category for non-suicide: non-suicidal self-injurious behavior. SI/SB was indicated by a "yes" answer to any of the listed categories. Score of 0 (no SI or SB) was assigned. Maximum score of 1 to 10 was assigned if suicidal ideation or behavior was present. Scoring was grouped into 3 categories: No SI/SB (0), SI (score 1 to 5), and SB (score 6 to 10), with higher scores indicating more severe ideation/behavior.	From Baseline (Day 1) up to Week 8
Change From Baseline in Clinical Global Impression-Severity Scale (CGI-S) Score	Change from baseline in CGI-S score were reported. The CGI-S provides an overall clinician-determined summary measure of the severity of the participant's illness that takes into account all available information, including knowledge of the participant's history, psychosocial circumstances, symptoms, behavior, and the impact of the symptoms on the participant's ability to function. The CGI-S is a 7-point global assessment scale that measures the clinician's impression of the severity of mental illness exhibited by a participant, and rated on a scale of 1 to 7: 1=normal (not at all ill); 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; and 7=among the most extremely ill participants. Higher scores indicate worsening. Negative change in CGI-S score indicate improvement.	From Baseline (Day 1) up to Week 6
Plasma Concentrations of JNJ-55308942	Plasma concentrations of JNJ-55308942 were reported.	Predose, 1.5 hours and 4 hours post-dose on Week 0 (Day 1), Weeks 1 (Day 8), 2 (Day 15), 4 (Day 29), and 6 (Day 43)
Change From Baseline in Patient Reported Outcomes Measurement Information System (PROMIS) Score - Ability to Participate in Social Roles and Activities (APS) T-Scores	Change from baseline in PROMIS score - ability to participate in social roles and activities T-Scores were reported. The PROMIS - APS item bank assessed the perceived ability to perform one's usual social roles and activities. The item bank did not use a time frame (for example, over the past seven days) when assessing the APS. The Short Form 4a included 4 items that represent this concept. Each question had 5 response options ranging in value from 1 to 5 with higher scores indicating better social function. The total raw score for the short form was calculated by summing the values of the response to each question, so for the 4-item form, the lowest possible raw score was 4; the highest possible raw score was 20. The total raw score was converted to a T score with a mean of 50 and a standard deviation of 10. Higher T-scores indicate better social function.	Baseline (Day 1), Weeks 1, 2, 3, 4, 5, and 6
Change From Baseline in Patient Health Questionnaire-9 (PHQ-9) Total Score	Change from baseline in PHQ-9 total score were reported. PHQ-9 is 9-item, self-report scale assessed depressive symptoms. Each item was rated on 4-point scale (0=Not at all, 1=several days, 2=more than half days, 3=nearly every day. The participant's item responses were summed to provide PHQ-9 total score (range of 0 to 27) with higher scores indicating greater severity of depressive symptoms.	Baseline (Day 1), Weeks 1, 2, 3, 4, 5, and 6
Change From Baseline in Generalized Anxiety Disorder 7 (GAD-7) Total Score	Change from baseline in GAD-7 total score were reported. GAD-7 is a brief and validated 7-item self-reported questionnaire for assessment of overall GAD. Participants responded to each item using a 4-point scale with response categories of 0=not at all, 1=several days, 2=more than half the days, and 3=nearly every day, with a higher score representing a more severe condition. Item responses were summed to yield GAD-7 total score which ranged of 0 to 21, where higher scores indicated more anxiety.	Baseline (Day 1), Weeks 2, 4, and 6
Number of Participants Who Achieved Response at Week 6	Number of participants who achieved response at Week 6 were reported. Response was defined as greater than or equal to (>=)50% improvement in MADRS total score from baseline. MADRS was a clinician-rated scale designed to measure depression severity and detect changes due to AD treatment. The MADRS evaluated reported sadness, apparent sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. The scale consisted of 10 items, each of which was scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms),with higher score indicating a more severe condition. The MADRS total score was the sum of scores from individual question items and it ranged from 0 to 60, with higher scores indicated more severe conditions. Negative change in MADRS total score indicated improvement.	Week 6
Number of Participants Who Achieved Remission at Week 6	Number of participants who achieved remission at Week 6 were reported. Remission was defined as MADRS total score <=12. MADRS was a clinician-rated scale designed to measure depression severity and detect changes due to AD treatment. The MADRS evaluated reported sadness, apparent sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. The scale consisted of 10 items, each of which was scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms),with higher score indicating a more severe condition. The MADRS total score was the sum of scores from individual question items and it ranged from 0 to 60, with higher scores indicated more severe conditions. Negative change in MADRS total score indicated improvement.	Week 6
Change From Baseline in MADRS Total Score up to Week 6 (Subgroup of Participants With Messenger Ribonucleic Acid [mRNA] Transcript Levels)	Change from baseline in MADRS total score up to Week 6 (subgroup of participants with mRNA transcript levels) was planned to be reported. Subgroup included participants with mRNA transcript levels at baseline that exceeded the medium level for both P2RX7 and IL-1-beta. MADRS was a clinician-rated scale designed to measure depression severity and detect changes due to AD treatment. MADRS evaluated reported sadness, apparent sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. The scale consisted of 10 items, each of which was scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms),with higher score indicating a more severe condition. MADRS total score was the sum of scores from individual question items and it ranged from 0 to 60, with higher scores indicated more severe conditions. Negative change in MADRS total score indicated improvement.	From Baseline (Day 1) up to Week 6
Change From Baseline in MADRS Total Score up to Week 6 (Concomitant Medication Subgroup Analysis)	Change from baseline in MADRS total score up to Week 6 (concomitant medication subgroup analysis) was reported. Concomitant medication subgroup analysis included subjects with BD not taking any mood stabilizer or antipsychotic, taking a mood stabilizer alone, taking antipsychotic alone, and taking a combination of mood stabilizer and an antipsychotic. MADRS measures depression severity, detects changes due to AD treatment. It consists of 10 items (evaluate apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, suicidal thoughts), scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), summed to total possible score of 0 to 60. Higher scores indicate more severe conditions. Negative change in score indicates improvement.	From Baseline (Day 1) up to Week 6

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): June 3, 2022
• Primary Completion (Actual): May 17, 2024
• Study Completion (Actual): May 17, 2024

Study Registration Dates

• First Submitted: April 11, 2022
• First Submitted That Met QC Criteria: April 11, 2022
• First Posted (Actual): April 14, 2022

Study Record Updates

• Last Update Posted (Actual): July 11, 2025
• Last Update Submitted That Met QC Criteria: June 23, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bipolar and Related Disorders; Mental Disorders; Mood Disorders; Bipolar Disorder; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Agents; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Purinergic P2X Receptor Antagonists; JNJ-55308942
• Other Study ID Numbers: CR109116; 2021-004790-31 (EudraCT Number); 55308942BIP2001 (Other Identifier: Janssen Pharmaceutica N.V., Belgium)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No