JNJ-55308942 for Bipolar Depression

Recruiting at 59 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

116 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new medication called JNJ-55308942 to see if it can help people with bipolar disorder who are currently very depressed. The medication aims to improve mood by balancing brain chemicals.

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.

What data supports the effectiveness of the drug JNJ-55308942 for treating bipolar depression?

Research shows that lamotrigine, a drug used in similar conditions, was more effective than a placebo in improving symptoms of bipolar depression, with significant improvements seen in patients after three weeks. ^{1 2 3 4 5}

Research Team

Janssen Pharmaceutica N.V., Belgium Clinical Trial

Principal Investigator

Janssen Pharmaceutica N.V., Belgium

Eligibility Criteria

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)

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

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

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

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)

Treatment Details

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.

Participant Groups

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

Biljana Naumovic

Janssen Pharmaceutica N.V., Belgium

Chief Medical Officer since 2019

MD from Belgrade University Medical School, Executive Education from London Business School

References

1. United States pubmed.ncbi.nlm.nih.gov

A pooled analysis of 2 placebo-controlled 18-month trials of lamotrigine and lithium maintenance in bipolar I disorder. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Lamotrigine in the treatment of bipolar depression. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Recent placebo-controlled acute trials in bipolar depression: focus on methodology. [2016]

4. United States pubmed.ncbi.nlm.nih.gov

Placebo effect in randomized, controlled maintenance studies of patients with bipolar disorder. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Melancholic Symptoms in Bipolar II Depression and Responsiveness to Lamotrigine in an Exploratory Pilot Study. [2018]