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New treatment option for Bipolar I or II Disorder
Official title Study to Assess the Adverse Events of Oral ABBV-932 in Adult Participants With Depressive Episodes Associated With Bipolar I or II Disorder
ClinicalTrials.gov ID: NCT07220460
What this study is testing
What is ABBV-932?
ABBV-932 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for bipolar i or ii disorder.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Bipolar disorder is a severe chronic mood disorder that affects up to 4% of the adult population in the United States. The purpose of this study is to assess how safe and effective ABBV-932 is in treating participants with depressive episodes associated with bipolar I or II disorder.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Body Mass Index (BMI) \>= 18.0 to \<= 40.0 kg/m\^2, inclusive.
- Participants who currently meet the Diagnostic and Statistical Manual of Mental Disorders treatment (DSM-5-TR) criteria for bipolar I or II disorder...
- Normal physical examination findings, clinical laboratory test results, vital signs, and 12-lead ECG results at screening or abnormal results that...
- Participant with the following psychiatric history:
- No history of psychiatric hospitalization (inpatient or intensive outpatient) in the past 3 months prior to screening.
You likely can't join if
- A total score greater than 12 on the Young Mania Rating Scale (YMRS) at baseline.
- History of an allergic reaction or significant sensitivity to constituents of the study drug (and its excipients) and/or other products in the same...
- A concurrent medical condition that might interfere with the conduct of the study, confound the interpretation of the study results, or endanger the...
See the full eligibility criteria
- Body Mass Index (BMI) \>= 18.0 to \<= 40.0 kg/m\^2, inclusive.
- Participants who currently meet the Diagnostic and Statistical Manual of Mental Disorders treatment (DSM-5-TR) criteria for bipolar I or II disorder without psychotic features based on the Mini International...
- Normal physical examination findings, clinical laboratory test results, vital signs, and 12-lead ECG results at screening or abnormal results that are judged not clinically significant by the investigator and documented...
- Participant with the following psychiatric history:
- No history of psychiatric hospitalization (inpatient or intensive outpatient) in the past 3 months prior to screening.
- No lifetime history of schizophrenia, other psychotic disorders, dissociative disorders, or neurocognitive disorders.
- No history of moderate or severe substance use disorder (except nicotine) in the past 6 months prior to screening.
- History of stable psychiatric comorbidities (e.g., PTSD, OCD) may be included provided these conditions have not required intervention with a prohibited medication within the past 12 months prior to Screening.
- A total score greater than 12 on the Young Mania Rating Scale (YMRS) at baseline.
- History of an allergic reaction or significant sensitivity to constituents of the study drug (and its excipients) and/or other products in the same class.
- A concurrent medical condition that might interfere with the conduct of the study, confound the interpretation of the study results, or endanger the subject's well-being. This includes any unstable condition, history or...
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Anaheim, California, United States
- Colton, California, United States
- Garden Grove, California, United States
- Imperial, California, United States
- Lemon Grove, California, United States
- Long Beach, California, United States
- Los Angeles, California, United States
- Oceanside, California, United States
- Temecula, California, United States
- Walnut Creek, California, United States
- Cromwell, Connecticut, United States
- Jacksonville, Florida, United States
- Miami, Florida, United States
- Miami Lakes, Florida, United States
- Orlando, Florida, United States
- Tamarac, Florida, United States
- West Palm Beach, Florida, United States
- Atlanta, Georgia, United States
- Elgin, Illinois, United States
+ 24 more site(s).
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Anaheim, California, United States; Colton, California, United States; Garden Grove, California, United States; Imperial, California, United States; Lemon Grove, California, United States and 38 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.