ABBV-932 for Bipolar Disorder

(CANTO Trial)

Recruiting at 7 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

1 Power Preferred Clinic 1 of this trial's clinic is considered top 20 on Power

Compensation: Varies

Number of Visits: 10

Duration: 6 weeks

160 Participants Needed

Trial Summary

What is the purpose of this trial?

Bipolar disorder is a severe chronic mood disorder that affects up to 4% of the adult population in the United States. This study will assess how safe and effective ABBV-932 is in treating participants with bipolar I or II disorder. ABBV-932 is an investigational drug being developed for the treatment of depressive episodes in adult participants with bipolar I or II disorder. Study doctors put participants in 1 of 4 groups, called treatment arms. There is a 1 in 4 chance that a participant will be assigned to placebo. Around 160 adult participants with bipolar I or II disorder will be enrolled in approximately 40 sites worldwide. Participants will receive oral capsules of ABBV-932 or matching placebo once daily for 6 weeks. The treatment period will be followed by a safety follow-up (SFU) period for 4 weeks. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular weekly visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

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.

Research Team

ABBVIE INC.

Principal Investigator

AbbVie

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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