Trial record 1 of 1 for:
BIP2001 | United States
A Study of JNJ-55308942 in the Treatment of Bipolar Depression
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| ClinicalTrials.gov Identifier: NCT05328297 |
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Recruitment Status :
Recruiting
First Posted : April 14, 2022
Last Update Posted : March 2, 2023
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Sponsor:
Janssen Pharmaceutica N.V., Belgium
Information provided by (Responsible Party):
Janssen Pharmaceutica N.V., Belgium
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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 |
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 (Clinical Trial) |
| Estimated 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 : | June 3, 2022 |
| Estimated Primary Completion Date : | March 22, 2024 |
| Estimated Study Completion Date : | May 22, 2024 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Bipolar Disorder
| Arm | Intervention/treatment |
|---|---|
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Experimental: JNJ-55308942
Participants will receive a JNJ-55308942 capsule once daily for 6 weeks.
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Drug: JNJ-55308942
JNJ-55308942 capsules will be administered orally. |
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Placebo Comparator: Placebo
Participants will receive a matching placebo capsule once daily for 6 weeks.
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Drug: Placebo
Matching placebo capsules will be administered orally. |
Primary Outcome Measures :
- Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 6 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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 Vital Signs [ Time Frame: 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.
- Number of Participants with Abnormalities in Clinical Laboratory Tests [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: Up to Week 8 ]Number of participants with abnormalities in ECG will be reported.
- Change from Baseline in Young Mania Rating Scale (YMRS) Score [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Baseline up to Week 6 ]Change from baseline in CGI-S scale score will be reported.
- Plasma Concentrations of JNJ-55308942 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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. [ Time Frame: Baseline up to Week 6 ]Change from baseline in GAD-7 score will be reported.
- Percentage of Participants with Response at Week 6 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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.
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years to 64 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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)
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05328297
Contacts
| Contact: Study Contact | 844-434-4210 | Participate-In-This-Study@its.jnj.com |
Locations
Show 51 study locations
Sponsors and Collaborators
Janssen Pharmaceutica N.V., Belgium
Investigators
| Study Director: | Janssen Pharmaceutica N.V., Belgium Clinical Trial | Janssen Pharmaceutica N.V., Belgium |
| Responsible Party: | Janssen Pharmaceutica N.V., Belgium |
| ClinicalTrials.gov Identifier: | NCT05328297 |
| Other Study ID Numbers: |
CR109116 2021-004790-31 ( EudraCT Number ) 55308942BIP2001 ( Other Identifier: Janssen Pharmaceutica N.V., Belgium ) |
| First Posted: | April 14, 2022 Key Record Dates |
| Last Update Posted: | March 2, 2023 |
| Last Verified: | March 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| 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 |
| URL: | https://www.janssen.com/clinical-trials/transparency |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Bipolar Disorder Bipolar and Related Disorders Mental Disorders JNJ-55308942 Purinergic P2X Receptor Antagonists Purinergic P2 Receptor Antagonists |
Purinergic Antagonists Purinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |