What side effects are associated with this type of intervention?

Common treatments for Bipolar Disorder include mood stabilizers like lithium and lamotrigine, antipsychotics such as risperidone and quetiapine, and antidepressants. Lithium can cause side effects like tremor, increased thirst, diarrhea, and potential thyroid and kidney issues. Lamotrigine is generally well-tolerated but can cause skin rashes and, rarely, severe skin reactions. Antipsychotics may lead to weight gain, metabolic syndrome, and extrapyramidal symptoms. Antidepressants, when used, can sometimes trigger manic episodes and may cause nausea, weight gain, and sexual dysfunction.

What prior FDA approvals exist?

JNJ-55308942 is a Selective Orexin-2 Receptor Antagonist, a class of drugs not yet widely represented in FDA-approved treatments for Bipolar Disorder. Most FDA-approved treatments for Bipolar Disorder include mood stabilizers like lithium, anticonvulsants such as valproate and lamotrigine, and second-generation antipsychotics like quetiapine, olanzapine, and aripiprazole. These medications primarily target neurotransmitter systems such as serotonin, dopamine, and glutamate rather than the orexin system. Therefore, JNJ-55308942 represents a novel approach in the pharmacotherapy of Bipolar Disorder.

What other types of research exist?

Promising novel alternatives to JNJ-55308942 for bipolar disorder patients include LY2216684, a highly selective norepinephrine reuptake inhibitor, which has shown efficacy in major depressive disorder. Additionally, treatments such as extended-release venlafaxine, mirtazapine, and paroxetine have been studied for treatment-resistant depression and may offer potential benefits for bipolar depression. Further research and clinical trials are needed to confirm their efficacy specifically for bipolar disorder.

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JNJ-55308942 for Bipolar Depression

Phase 2

Recruiting

Research Sponsored by Janssen Pharmaceutica N.V., Belgium

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up days 1, 8, 15, 29, 43

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects aren't specified here, but generally, medications like JNJ-55308942 could cause nausea, headache, dizziness, sleep disturbances or changes in appetite among others.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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).

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ days 1, 8, 15, 29, 43

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~days 1, 8, 15, 29, 43

This trial's timeline: 3 weeks for screening, Varies for treatment, and days 1, 8, 15, 29, 43 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 6

Secondary study objectives

Change from Baseline in Clinical Global Impression-Severity Scale (CGI-S) Score

Change from Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Score

Change from Baseline in Generalized Anxiety Disorder 7 (GAD-7) Score.

+16 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: JNJ-55308942Experimental Treatment1 Intervention

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

Group II: PlaceboPlacebo Group1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

JNJ-55308942

2018

Completed Phase 1

~20

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Bipolar Disorder include mood stabilizers, antipsychotics, and anticonvulsants. Lithium works by modulating neurotransmitter activity and stabilizing mood swings, while valproate increases levels of gamma-aminobutyric acid (GABA) to calm neural activity. Antipsychotics like aripiprazole act on dopamine and serotonin receptors to manage manic and depressive symptoms. Lamotrigine, an anticonvulsant, stabilizes mood by inhibiting glutamate release. These mechanisms are crucial as they help balance mood and prevent extreme highs and lows in Bipolar Disorder patients. JNJ-55308942, a Selective Orexin-2 Receptor Antagonist, targets the orexin system, which is involved in regulating arousal and wakefulness, potentially offering a novel approach to managing depressive episodes in Bipolar Disorder.

Recent advances in treatment of acute mania.Assessing cognitive function in bipolar disorder: challenges and recommendations for clinical trial design.Predictors of response to treatment of acute bipolar manic episodes with divalproex sodium or placebo in 2 randomized, controlled, parallel-group trials.