ABBV-932 for Bipolar Disorder

Recruiting at 34 trial locations

Overseen By ABBVIE CALL CENTER

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: AbbVie

Disqualifiers: Schizophrenia, Psychotic disorders, Substance use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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

Compensation: Varies

Number of Visits: 1

Duration: 26 weeks

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of an experimental drug called ABBV-932 for treating depressive episodes in individuals with bipolar I or II disorder. Participants will take ABBV-932 capsules for about six months and must attend regular hospital or clinic visits for check-ups and assessments. The trial seeks adults diagnosed with bipolar I or II disorder who are currently experiencing a depressive episode lasting between 4 weeks and 12 months. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important early-stage research.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the study team or your doctor to understand how your current medications might interact with the trial.

Is there any evidence suggesting that ABBV-932 is likely to be safe for humans?

Research has shown that ABBV-932 has been studied for its safety in treating depressive episodes in bipolar disorder. In these studies, participants have generally tolerated ABBV-932 well. Although some side effects have been reported, the studies focus on tracking and managing these effects.

One study specifically examined the safety of ABBV-932 when taken in increasing doses by healthy individuals. This study found that ABBV-932 was tolerated without major safety issues. However, results for healthy individuals might differ from those with bipolar disorder.

The current study is in Phase 2, focusing on both safety and efficacy. Phase 2 trials usually suggest some early evidence of safety, but more information is needed for certainty. Participants in this trial will be closely monitored for any side effects, which is standard for this stage of research. ^{1 2 3 4 5}

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

ABBV-932 is unique because it represents a new approach to treating bipolar disorder, potentially offering benefits over traditional medications like mood stabilizers and antipsychotics. Unlike these standard treatments, ABBV-932 may work through a novel mechanism, targeting specific pathways in the brain that are not addressed by existing drugs. Researchers are excited about ABBV-932 because it could provide more effective symptom management with fewer side effects, ultimately improving the quality of life for people with bipolar disorder.

What evidence suggests that ABBV-932 might be an effective treatment for bipolar disorder?

Research has shown that ABBV-932 is under investigation as a potential treatment for depression in individuals with bipolar disorder. Although limited information exists from human studies, this new drug targets brain areas that influence mood. Early results suggest that ABBV-932 might reduce depression symptoms in those with bipolar I or II disorder. Further studies are underway to confirm its efficacy and safety. ^{1 2 3 6 7}

Who Is on the Research Team?

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

This trial is for adults with bipolar I or II disorder currently experiencing a depressive episode. Participants will be treated with ABBV-932, an investigational drug, over a 26-week period followed by a safety follow-up. The study requires regular hospital or clinic visits for medical assessments and questionnaires.

Inclusion Criteria

Must have no history of psychiatric hospitalization in the past 3 months, no lifetime history of schizophrenia, other psychotic disorders, dissociative disorders, or neurocognitive disorders, and no history of moderate or severe substance use disorder (except nicotine) in the past 6 months

Body Mass Index (BMI) must be ≥ 18.0 to ≤ 40.0 kg/m^2

I have bipolar disorder and am currently in a depressive phase lasting between 4 weeks and 12 months.

Exclusion Criteria

Total score greater than 12 on the Young Mania Rating Scale (YMRS) at baseline

History of allergic reaction or significant sensitivity to constituents of the study drug or other products in the same class

I don't have any health conditions that could affect the study or my safety.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive oral ABBV-932 for a 26-week treatment period

26 weeks

Regularly scheduled visits at a hospital or clinic

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• ABBV-932

Trial Overview

The study tests the safety and effectiveness of ABBV-932 in treating depressive episodes associated with bipolar disorder. Around 200 participants at about 50 sites across the U.S. and Puerto Rico will take oral capsules of ABBV-932 and undergo evaluations through blood tests and side effect monitoring.

How Is the Trial Designed?

Group I: ABBV-932 Experimental Treatment 1 Intervention

Participants will receive oral ABBV-932 for a 26-week treatment period followed by a 30-day follow-up

Who Is Running the Clinical Trial?

AbbVie

Lead Sponsor

Trials

1,079

Recruited

535,000+

Founded

2013

Headquarters

North Chicago, USA

Known For

Immunology treatments

Top Products

Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06605599

NCT06605599 | Study of Oral ABBV-932 to Assess ...

This study will assess how safe and effective ABBV-932 is in treating participants with bipolar I or II disorder.

2.

abbvieclinicaltrials.com

abbvieclinicaltrials.com/study/?id=M23-894

Study of Oral ABBV-932 to Assess Adverse Events and ...

This study will assess how safe and effective ABBV-932 is in treating participants with bipolar I or II disorder.

3.

ctv.veeva.com

ctv.veeva.com/study/study-to-assess-the-adverse-events-of-oral-abbv-932-in-adult-participants-with-depressive-episodes-a

Study to Assess the Adverse Events of Oral ABBV-932 in Adult ...

The purpose of this study is to assess how safe and effective ABBV-932 is in treating participants with depressive episodes associated with ...

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07220460

Study to Assess the Adverse Events of Oral ABBV-932 in ...

The purpose of this study is to assess how safe and effective ABBV-932 is in treating participants with depressive episodes associated with ...

5.

theglobeandmail.com

theglobeandmail.com/investing/markets/stocks/ABBV/pressreleases/30767023/abbvies-abbv-932-study-a-new-hope-for-bipolar-disorder-treatment/

AbbVie's ABBV-932 Study: A New Hope for Bipolar ...

' The study aims to assess the safety and effectiveness of ABBV-932, an investigational drug, in treating depressive episodes in adults with ...

6.

patlynk.com

patlynk.com/trial/NCT07220460

ABBV-932 for Depressive Episodes in Bipolar I or II Disorder

This study focuses on evaluating the long-term safety and how well ABBV-932 works in treating depressive episodes in people with Bipolar I ...

7.

abbvieclinicaltrials.com

abbvieclinicaltrials.com/study/?id=M23-893

A Study to Evaluate the Pharmacokinetics, Safety, and ...

The purpose of this study is to assess the pharmacokinetics, safety, and tolerability following multiple ascending oral doses of ABBV-932 or placebo in healthy ...