ABBV-932 for Bipolar Disorder

(CANTO Trial)

Not currently recruiting at 2 trial locations

Overseen By ABBVIE CALL CENTER

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: AbbVie

Must not be taking: Antipsychotics, Antidepressants, Anticonvulsants, others

Disqualifiers: Positive drug screen, Investigational drug, others

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

Compensation: Varies

Number of Visits: 10

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, ABBV-932, to determine its safety and effectiveness in treating depressive episodes in individuals with bipolar I or II disorder. Participants will join one of four groups, with the possibility of receiving either the drug or a placebo (a look-alike pill with no active ingredient). The trial aims to assess the drug's efficacy and any potential side effects. Ideal participants are adults currently experiencing a depressive episode lasting between 4 weeks and 12 months. Participants must be prepared for regular hospital or clinic visits for check-ups and assessments over a 6-week treatment period, followed by a 4-week safety follow-up. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

Yes, you will need to stop taking any antipsychotic, antidepressant, anticonvulsant, mood stabilizer, herb, or over-the-counter medication with psychoactive potential at least 1 week before starting the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that ABBV-932 is being tested for safety and effectiveness in treating depressive episodes in individuals with bipolar I or II disorder. Earlier studies with healthy participants found that ABBV-932 was generally well-tolerated, with most side effects being mild and temporary, such as headaches or nausea. These findings suggest that ABBV-932 might be safe for individuals with bipolar disorder, but further research is necessary to confirm this. This trial aims to provide more insight into how individuals with bipolar disorder respond to the treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about ABBV-932 for bipolar disorder because it offers a new approach compared to traditional treatments like mood stabilizers and antipsychotics. Most current treatments work by balancing neurotransmitters such as serotonin and dopamine. However, ABBV-932 appears to target different pathways in the brain, potentially offering benefits for those who don't respond well to existing options. This unique mechanism could provide faster or more effective relief from symptoms, making it a promising candidate in the ongoing search for better bipolar disorder treatments.

What evidence suggests that this trial's treatments could be effective for bipolar disorder?

Research shows that ABBV-932 is undergoing testing to determine its effectiveness in alleviating depressive episodes in individuals with bipolar I or II disorder. The trial includes different arms where participants receive varying doses of ABBV-932 or a placebo. Researchers are studying this drug because it might alter brain chemicals that influence mood. Early results suggest that ABBV-932 could help relieve depressive symptoms, which many people with bipolar disorder find challenging. The ongoing studies aim to confirm its safety and efficacy in improving mood stability. While more information is needed, the initial results are promising and indicate potential for those dealing with bipolar depression. ^{1 2 3 6 7}

Who Is on the Research Team?

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

Adults with bipolar I or II disorder, currently experiencing a depressive episode lasting between 4 weeks and 12 months. Participants must score at least 20 on the HAMD-17 depression scale and no more than 12 on the YMRS mania scale.

Exclusion Criteria

Are you currently taking Antipsychotic medication?

Are you currently taking Mood Stabilizers?

Are you currently taking an antidepressant?

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive oral capsules of ABBV-932 or matching placebo once daily

6 weeks

6 visits (in-person, weekly)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

4 visits (in-person, weekly)

What Are the Treatments Tested in This Trial?

Interventions

• ABBV-932

Trial Overview The trial is testing ABBV-932, a new oral medication for treating depressive episodes in adults with bipolar disorder. Patients are randomly assigned to one of four groups, including a placebo group. The treatment lasts for six weeks followed by four weeks of safety follow-up.

How Is the Trial Designed?

Group I: ABBV-932 Dose C Experimental Treatment 1 Intervention

Participants will receive ABBV-932 Dose C.

Group II: ABBV-932 Dose B Experimental Treatment 1 Intervention

Participants will receive ABBV-932 Dose B.

Group III: ABBV-932 Dose A Experimental Treatment 1 Intervention

Participants will receive ABBV-932 Dose A.

Group IV: Placebo for ABBV-932 Placebo Group 1 Intervention

Participants will receive placebo.

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. 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 ...

4. 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 ...

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 ...