JNJ-55308942 for Bipolar Depression

No longer recruiting at 62 trial locations

Overseen By Study Contact

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Janssen Pharmaceutica N.V., Belgium

Disqualifiers: Manic episode, Cannabis misuse, Malignancy, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, JNJ-55308942, to determine if it reduces depression symptoms in people with bipolar disorder during a major depressive episode. Participants will receive either the experimental treatment or a placebo (a pill with no active medicine) for six weeks. The trial suits individuals diagnosed with bipolar disorder (either Type I or II) who are currently experiencing depression but not mania. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinator or your doctor.

Is there any evidence suggesting that JNJ-55308942 is likely to be safe for humans?

Research has shown that JNJ-55308942 has undergone safety testing in people. Earlier studies examined its effects on individuals with bipolar disorder and found the treatment to be generally well-tolerated. Some participants experienced side effects, but these were mostly mild to moderate.

This trial is in the middle stages, indicating that JNJ-55308942 has already passed initial safety tests in smaller groups. This suggests it is safe enough for testing in larger groups. However, as with any new treatment, risks may exist, so discussing these with the trial team or a healthcare professional is important. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for bipolar depression?

Most treatments for bipolar depression, like mood stabilizers or antipsychotics, work by altering neurotransmitter levels. But JNJ-55308942 works differently, targeting the kappa opioid receptor in the brain. This novel mechanism of action is what has researchers excited because it could offer relief for symptoms of bipolar depression in a new way, potentially with fewer side effects than traditional medications. This unique approach gives hope for more effective management of bipolar depression for those who may not respond well to current treatments.

What evidence suggests that JNJ-55308942 might be an effective treatment for bipolar depression?

Research shows that JNJ-55308942, which participants in this trial may receive, may help reduce depression symptoms in people with bipolar disorder. Studies have found improvements in two key areas related to depression, suggesting that JNJ-55308942 could aid those experiencing major depressive episodes. While more research is necessary, early results indicate promising potential benefits. ^{1 2 3 6 7}

Who Is on the Research Team?

Janssen Pharmaceutica N.V., Belgium Clinical Trial

Principal Investigator

Janssen Pharmaceutica N.V., Belgium

Are You a Good Fit for This Trial?

This trial is for adults with Bipolar Disorder (Type I or II) who are currently not experiencing psychotic features. Participants must have a stable weight (BMI between 18 and 35) and be medically stable. Women of childbearing potential need to test negative for pregnancy. People can't join if they've had recent substance misuse issues, manic episodes, or certain brain stimulation treatments.

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

Your body mass index (BMI), which is a measure of your weight in relation to your height, should be between 18 and 35 kilograms per meter squared (kg/m^2).

Exclusion Criteria

You currently have symptoms that meet the criteria for a manic episode, as defined by the DSM-5.

I haven't had brain stimulation treatments like TMS or DBS in the last 6 weeks.

You have a recent history of heavy cannabis use that meets the DSM-5 criteria for moderate to severe misuse.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either JNJ-55308942 or placebo once daily for 6 weeks

6 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• JNJ-55308942
• Placebo

Trial Overview The study is testing the effectiveness of JNJ-55308942 in treating symptoms of depression in people with bipolar disorder during a major depressive episode. It's compared against a placebo over six weeks to see if it helps improve mood and other related symptoms.

How Is the Trial Designed?

Group I: JNJ-55308942 Experimental Treatment 1 Intervention

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

Group II: Placebo Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Janssen Pharmaceutica N.V., Belgium

Lead Sponsor

Trials

84

Recruited

31,600+

Joaquin Duato

Janssen Pharmaceutica N.V., Belgium

Chief Executive Officer since 2022

MBA from ESADE, Master of International Management from Thunderbird School of Global Management

Dr. Jijo James, MD

Janssen Pharmaceutica N.V., Belgium

Chief Medical Officer since 2014

MD from St. Johns Medical College, MPH from Columbia University

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05328297

A Study of JNJ-55308942 in the Treatment of Bipolar ... 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) ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6224414/

Neuropsychopharmacology of JNJ-55308942 - PubMed Central These data collectively suggest that JNJ-55308942 produced efficacy in two behavioral endpoints akin to depression; more importantly, to our knowledge, this ...

3. ctv.veeva.com ctv.veeva.com/study/a-study-of-jnj-55308942-in-the-treatment-of-bipolar-depression

A Study of JNJ-55308942 in the Treatment of Bipolar ... 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)

4. withpower.com withpower.com/trial/phase-2-bipolar-disorder-3-2022-667e2

JNJ-55308942 for Bipolar Depression · Info for Participants Research shows that lamotrigine, a drug used in similar conditions, was more effective than a placebo in improving symptoms of bipolar depression, with ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0022395624005879

Development progress of drugs for bipolar disorder The current phase II trial evaluates JNJ-55308942's efficacy in reducing depressive symptoms in bipolar disorder. In this randomized, double-blind, placebo- ...

6. fdaaa.trialstracker.net fdaaa.trialstracker.net/trial/NCT05328297/

NCT05328297: A reported trial by Janssen Pharmaceutica ... Full data ... A Randomized, Stratified, Double-blind, Placebo-Controlled Study to Investigate the Efficacy, Safety and Tolerability of JNJ-55308942 in Bipolar ...

7. nature.com nature.com/articles/s41398-023-02557-5

Characterization of the central nervous system penetrant ... This was a double-blind, placebo-controlled, randomized study to assess the safety and pharmacokinetics of JNJ-54175446 and explore its effects ...