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ABBV-932

Phase 2

Generalized Anxiety Disorder (GAD) | Small molecule | Psychiatry |AbbVie Inc.|Last Updated: Jun 29, 2026

Success Probability
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Market & Valuation
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment419
FDA Designations
No designations recorded
Clinical trial landscape

ABBV-932 · 10 trials · 8 indications

Phase 2 3Phase 1 7
NCT07220460Study to Assess the Adverse Events of Oral ABBV-932 in Adult Participants With Depressive Episodes Associated With Bipolar I or II DisorderBipolar I or II Disorder
RECRUITING200 Analytics
NCT06846320Study to Assess Adverse Events and Change in Disease Activity When Oral ABBV-932 is Added to Antidepressant Therapies in Adult Participants With Generalized Anxiety DisorderGeneralized Anxiety Disorder (GAD)
RECRUITING315 Analytics
NCT06605599Study of Oral ABBV-932 to Assess Adverse Events and Change in Disease Activity in Adult Participants With Bipolar I or II DisorderBipolar I Disorder
COMPLETED161 Analytics
PHASE2RECRUITING
Study to Assess the Adverse Events of Oral ABBV-932 in Adult Participants With Depressive Episodes Associated With Bipolar I or II Disorder
Bipolar I or II DisorderUnlock trial analytics
PHASE2RECRUITING
Study to Assess Adverse Events and Change in Disease Activity When Oral ABBV-932 is Added to Antidepressant Therapies in Adult Participants With Generalized Anxiety Disorder
Generalized Anxiety Disorder (GAD)Unlock trial analytics
PHASE2COMPLETED
Study of Oral ABBV-932 to Assess Adverse Events and Change in Disease Activity in Adult Participants With Bipolar I or II Disorder
Bipolar I DisorderUnlock trial analytics
Study Endpoints
Primary Endpoints
Number of Participants Experiencing Adverse Events
Up to approximately 29 weeks

An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.

Number of Participants with Abnormal Change From Baseline in Vital Sign Measurements
Up to week 26

Number of participants with abnormal change from baseline in vital sign measurements like systolic and diastolic blood pressure will be assessed.

Number of Participants with Change from Baseline in Electrocardiogram (ECG)
Up to week 26

12-lead resting ECG will be recorded.

Number of Participants with Abnormal Change in Clinical Laboratory Test Results Like Hematology will be Assessed
Up to week 26

Number of participants with abnormal change in clinical laboratory test results like hematology will be assessed.

Change From Baseline in Simpson-Angus Scale (SAS)
Up to week 26

SAS (Simpson-Angus Scale): is a 10-item rating scale for assessment of antipsychotic-induced parkinsonism in both clinical practice and research settings. Minimum: 0 (no symptoms) Maximum: 40 (very severe symptoms; 10 items scored 0-4 each).

Change From Baseline in Abnormal Involuntary Movement Scale (AIMS)
Up to week 26

AIMS (Abnormal Involuntary Movement Scale): assesses abnormal involuntary movements, such as tardive dyskinesia, associated with antipsychotic drugs; it measures facial, oral, extremities, and trunk movements, as well as the participant's awareness of abnormal movements. Minimum: 0 (no abnormal movements) Maximum: 42 (most severe; 7 items scored 0-4 each), some versions use 0-4 on 10 items for a max of 40/40.

Change From Baseline in Barnes Akathisia Rating Scale (BARS)
Up to week 26

BARS (Barnes Akathisia Rating Scale): is a 4-item rating scale used to assess drug-induced akathisia. The scale comprises items for rating the observable restless movements that characterize the condition, the subjective awareness of restlessness, and any distress associated with the akathisia. Minimum: 0 (no akathisia) Maximum: 14 (severe akathisia; 4 items scored, most items 0-3 or 0-5)

Change from Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS)
Up to week 26

C-SSRS rates an individual's degree of suicidal ideation (SI) and behaviors on a scale, ranging from "wish to be dead" to "active suicidal ideation with specific plan and intent."

Change From Baseline in the Epworth Sleepiness Scale (ESS)
Up to week 26

ESS (Epworth Sleepiness Scale): is a scale that is intended to measure daytime sleepiness. Minimum: 0 (no sleepiness) Maximum: 24 (severe sleepiness; 8 items scored 0-3 each)

Change From Baseline in the Young Mania Rating Scale (YMRS)
Up to week 26

The YMRS (Young Mania Rating Scale): is an 11-item, clinician-rated scale that assesses manic symptoms based on the participant's perception of their condition over the previous 48 hours, as well as the physician's clinical observations during the interview. Minimum: 0 (no mania) Maximum: 60 (severe mania; 11 items, some scored 0-4, others 0-8)

Number of Participants with Abnormal Change in Ocular Examination
Up to week 26

Number of participants with abnormal change in ocular examinations in areas like best corrected visual acuity (BCVA), and refraction.

Number of Participants with Adverse Events (AEs)
Up to approximately 10 weeks

An AE is defined as any untoward medical occurrence in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.

Change from Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score
Up to approximately 6 weeks

The HAM-A is a 14-item, clinician-reported measure used to quantify and categorize the participant's anxiety over the past week. Items are rated on a 5-point Likert rating scale. The HAM-A total score ranges from 0 to 56, with higher scores indicating greater anxiety severity.

Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score
Up to Week 6

The MADRS is a 10-item, clinician-rated scale that evaluates the participant's depressive symptomatology. Each item is scored on a 7-point scale with a score of 0 reflecting no symptoms and a score of 6 reflecting symptoms of maximum severity.

Maximum Plasma Concentration (Cmax) of ABBV-932
Up to approximately 86 days

Cmax of ABBV-932

Time to Cmax (Tmax) of ABBV-932
Up to approximately 86 days

Tmax of ABBV-932

Terminal phase elimination rate constant (λz) of ABBV-932
Up to approximately 86 days
Terminal Phase Elimination Half-Life (t1/2) of ABBV-932
Up to approximately 86 days

Terminal phase elimination half-life of ABBV-932

Area Under the Concentration-Time Curve From Time 0 to Time t (AUCt) of ABBV-932
Up to approximately 86 days

AUCt of ABBV-932

Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of ABBV-932
Up to approximately 86 days

AUCinf of ABBV-932

Observed plasma concentration at the end of a dosing interval (Ctrough) of ABBV-932
Up to approximately 43 days

Ctrough of ABBV-932

Area under the plasma concentration-time curve from time 0 until the last measurable concentration (AUCtau) of Desmethyl Cariprazine ABBV-932
Up to approximately 43 days

AUCtau of ABBV-932

Maximum Plasma Concentration (Cmax) of DCAR
Up to approximately 43 days

Cmax of DCAR

Time to Cmax (Tmax) of DCAR
Up to approximately 43 days

Tmax of DCAR

Observed plasma concentration at the end of a dosing interval (Ctrough) of DCAR
Up to approximately 43 days

Ctrough of DCAR

Area under the plasma concentration-time curve from time 0 until the last measurable concentration (AUCtau) of Desmethyl Cariprazine (DCAR)
Up to approximately 43 days

AUCtau of DCAR

Maximum Plasma Concentration (Cmax) of Didesmethyl-Cariprazine (DDCAR)
Up to approximately 43 days

Cmax of DDCAR

Time to Cmax (Tmax) of DDCAR
Up to approximately 43 days

Tmax of DDCAR

Observed plasma concentration at the end of a dosing interval (Ctrough) of DDCAR
Up to approximately 43 days

Ctrough of DDCAR

Area under the plasma concentration-time curve from time 0 until the last measurable concentration (AUCtau) of DDCAR
Up to approximately 43 days

AUCtau of DDCAR

Maximum Plasma Concentration (Cmax) of ABBV-932 and active metabolites DCAR and DDCAR
Up to approximately 29 days

Cmax of ABBV-932 and active metabolites DCAR and DDCAR

Time to Cmax (Tmax) of ABBV-932 and active metabolites DCAR and DDCAR
Up to approximately 29 days

Tmax of ABBV-932 and active metabolites DCAR and DDCAR

Observed plasma concentration at the end of a dosing interval (Ctrough) of ABBV-932 and active metabolites DCAR and DDCAR
Up to approximately 29 days

Ctrough of ABBV-932 and active metabolites DCAR and DDCAR

Apparent terminal phase elimination rate constant (β) of ABBV-932 and active metabolites DCAR and DDCAR
Up to approximately 29 days

(β) of ABBV-932 and active metabolites DCAR and DDCAR

Terminal Phase Elimination Half-Life (t1/2) of ABBV-932 and active metabolites DCAR and DDCAR
Up to approximately 29 days

Terminal phase elimination half-life of ABBV-932 and active metabolites DCAR and DDCAR

Area Under the Concentration-Time Curve From Time 0 to Time t (AUCt) of ABBV-932 and active metabolites DCAR and DDCAR
Up to approximately 29 days

AUCt of ABBV-932 and active metabolites DCAR and DDCAR

Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of ABBV-932 and active metabolites DCAR and DDCAR
Up to approximately 29 days

AUCinf of ABBV-932 and active metabolites DCAR and DDCAR

Terminal Phase Elimination Rate Constant (Beta) of ABBV-932
Up to approximately 6 days

Terminal phase elimination rate constant (beta) of ABBV-932

Change in Dopamine Receptor Occupancy in Brain Measured by Positron Emission Tomography (PET)
Up to approximately 14 days

Dopamine D2 and D3 Receptor Occupancy in the brain up to Day 14 after multiple doses of ABBV-932 will be measured by PET. The occupancies will be determined by evaluating the difference in the binding potential (BPND) measured between baseline and post-dose scans in various brain regions.

Maximum Observed Plasma Concentration (Cmax)
Up to Day 28

Cmax will be assessed.

Time to Cmax (Tmax)
Up to Day 28

Tmax will be assessed.

Plasma Concentrations at Pre-dose or at the End of a Dosing Interval (Ctrough)
Up to Day 28

Ctrough will be assessed.

Area under the Plasma Concentration-time Curve from Time Zero to the End of the Dosing Interval (AUCtau)
Up to Day 28

AUCtau will be assessed.

Terminal Phase Elimination Rate Constant (Beta) of DCAR
Up to approximately 5 days

Terminal phase elimination rate constant (beta) of DCAR.

Terminal Phase Elimination Half-Life (t1/2) of DCAR
Up to approximately 5 days

Terminal phase elimination half-life of DCAR.

Area Under the Concentration-Time Curve From Time 0 to Time t (AUCt) of DCAR
Up to approximately 5 days

AUCt of DCAR.

Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of DCAR
Up to approximately 5 days

AUCinf of DCAR.

Maximum Plasma Concentration (Cmax) of DDCAR
Up to approximately 5 days

Cmax of DDCAR.

Terminal Phase Elimination Rate Constant (Beta) of DDCAR
Up to approximately 5 days

Terminal phase elimination rate constant (beta) of DDCAR.

Terminal Phase Elimination Half-Life (t1/2) of DDCAR
Up to approximately 5 days

Terminal phase elimination half-life of DDCAR.

Area Under the Concentration-Time Curve From Time 0 to Time t (AUCt) of DDCAR
Up to approximately 5 days

AUCt of DDCAR.

Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of DDCAR
Up to approximately 5 days

AUCinf of DDCAR.

Secondary Endpoints
Change from Baseline in Penn State Worry Questionnaire-10 (PSWQ-10) Total Score
Up to approximately 6 weeks
Change from Baseline in Clinical Global Impression of Severity Scale (CGI-S) Generalized Anxiety Disorder (GAD)
Up to approximately 6 weeks
Change from Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score
Up to approximately 4 weeks
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ABBV-932EXPERIMENTALParticipants will receive oral ABBV-932 for a 26-week treatment period followed by a 30-day follow-up
ABBV-932 Dose AEXPERIMENTALParticipants will receive ABBV-932 dose A in addition to prescribed antidepressant therapies (ADTs).
ABBV-932 Dose BEXPERIMENTALParticipants will receive ABBV-932 dose B in addition to prescribed antidepressant therapies (ADTs).
Placebo for ABBV-932PLACEBO_COMPARATORParticipants will receive placebo for ABBV-932 in addition to prescribed antidepressant therapies (ADTs).
ABBV-932 Dose CEXPERIMENTALParticipants will receive ABBV-932 Dose C.
ABBV-932 or Placebo Part AEXPERIMENTALParticipants will receive oral ABBV-932 or placebo once daily (QD) for 14 days.
ABBV-932 or Placebo Part BEXPERIMENTALParticipants will receive oral ABBV-932 or placebo QD for 14 days.
ABBV-932 or Placebo Part CEXPERIMENTALParticipants will receive oral ABBV-932 or placebo QD 42 days.
ABBV-932 with ItraconazoleEXPERIMENTALParticipants will receive ABBV-932 in Period 1 followed by Itraconalzole in combination with ABBV-932 in Period 2.
ABBV-932: Arm AEXPERIMENTALParticipants will receive a single dose of ABBV-932 Arm A on day 1 under fasting conditions.
ABBV-932: Arm BEXPERIMENTALParticipants will receive a single dose of ABBV-932 Arm B on day 1 under fasting conditions.
ABBV-932: Arm CEXPERIMENTALParticipants will receive a single dose of ABBV-932 Arm C on day 1 under fasting conditions.
ABBV-932: Arm DEXPERIMENTALParticipants will receive a single dose of ABBV-932 Arm D on day 1 with a high-fat meal.
ABBV-932: Arm EEXPERIMENTALParticipants will receive a single dose of ABBV-932 Arm E on day 1 with a high-fat meal.
ABBV-932: Arm FEXPERIMENTALParticipants will receive a single dose of ABBV-932 Arm F on day 1 under fasting conditions.
ABBV-932: Arm GEXPERIMENTALParticipants will receive a single dose of ABBV-932 Arm G on day 1 with a high-fat meal.
ABBV-932: Arm HEXPERIMENTALParticipants will receive a single dose of ABBV-932 Arm H on day 1 under fasting conditions.
Part A, ABBV-932EXPERIMENTALParticipants will receive ABBV-932 once daily (QD) for 14 days.
Part A, Placebo for ABBV-932EXPERIMENTALParticipants will receive placebo for ABBV-932 QD for 14 days.
Part B, ABBV-932EXPERIMENTALParticipants will receive ABBV-932 QD for 28 days.
Part B, Placebo for ABBV-932EXPERIMENTALParticipants will receive placebo for ABBV-932 QD for 28 days.
Part C, ABBV-932EXPERIMENTALParticipants will receive ABBV-932 QD for 28 days.
Part C, Placebo for ABBV-932EXPERIMENTALParticipants will receive placebo for ABBV-932 QD for 28 days.
Part D, ABBV-932EXPERIMENTALParticipants will receive ABBV-932 QD for 42 days.
Part D, Placebo for ABBV-932EXPERIMENTALParticipants will receive placebo for ABBV-932 QD for 42 days.
Part 1: ABBV-932EXPERIMENTALParticipants will receive ABBV-932 on Day 1 and followed for 30 days.
Part 1: PlaceboPLACEBO_COMPARATORParticipants will receive placebo on Day 1 and followed for 30 days.
Part 2: Sequence 1EXPERIMENTALParticipants will receive ABBV-932 on Day 1 in Period 1 under fasting conditions and followed for 30 days. Participants will receive ABBV-932 with food on Day 1 in Period 2 and followed for 30 days.
Part 2: Sequence 2EXPERIMENTALParticipants will receive ABBV-932 with food on Day 1 in Period 1 and followed for 30 days. Participants will receive ABBV-932 on Day 1 in Period 2 under fasting conditions and followed for 30 days.
Part 3: Japanese Participants: ABBV-932EXPERIMENTALJapanese participants will receive ABBV-932 on Day 1 in Period 1 and followed for 30 days.
Part 3: Japanese Participants: PlaceboPLACEBO_COMPARATORJapanese participants will receive placebo on Day 1 in Period 1 and followed for 30 days.
Part 3: Han-Chinese Participants: ABBV-932EXPERIMENTALHan-Chinese participants will receive placebo on Day 1 in Period 1 and followed for 30 days.
Interventions
NameTypeDescription
ABBV-932DRUGOral Capsule
Placebo for ABBV-932DRUGOral Capsule
Antidepressant Therapy (ADT)DRUGStandard of care
ItraconazoleDRUGOral Capsule
PlaceboDRUGOral Capsule
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Eligibility Criteria
Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites49

Inclusion 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 Neur...

Countries:United StatesPuerto RicoJapanNetherlandsChinaUnited Kingdom
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Recent Changes (Last 90 Days)
MEDIUMJul 5, 2026NCT06849791TRIAL_REMOVED: changed
MEDIUMJul 5, 2026NCT06849791TRIAL_REMOVED: changed
MEDIUMJul 5, 2026NCT06849791TRIAL_REMOVED: changed
MEDIUMJun 29, 2026NCT06953934Status: RECRUITING → ACTIVE_NOT_RECRUITING
MEDIUMJun 29, 2026NCT06953934Status: RECRUITING → ACTIVE_NOT_RECRUITING
LOWJun 18, 2026NCT07220460lastUpdatePostDate: changed
LOWJun 18, 2026NCT06846320lastUpdatePostDate: changed
LOWJun 18, 2026NCT07220460lastUpdatePostDate: changed
LOWJun 18, 2026NCT06846320lastUpdatePostDate: changed
LOWJun 18, 2026NCT07220460lastUpdatePostDate: changed
LOWJun 18, 2026NCT06846320lastUpdatePostDate: changed
LOWJun 18, 2026NCT06846320lastUpdatePostDate: changed
HIGHJun 4, 2026NCT06849791Status: ACTIVE_NOT_RECRUITING → COMPLETED
HIGHJun 4, 2026NCT06849791Status: ACTIVE_NOT_RECRUITING → COMPLETED
HIGHJun 4, 2026NCT06849791Status: ACTIVE_NOT_RECRUITING → COMPLETED
HIGHJun 4, 2026NCT06849791Status: ACTIVE_NOT_RECRUITING → COMPLETED
MEDIUMJun 2, 2026NCT06953934Status: NOT_YET_RECRUITING → RECRUITING
MEDIUMJun 2, 2026NCT06953934Status: NOT_YET_RECRUITING → RECRUITING
MEDIUMJun 2, 2026NCT06953934Status: NOT_YET_RECRUITING → RECRUITING
LOWMay 26, 2026NCT07220460primaryCompletionDate: changed