ABBV-932
DrugOral Capsule
NCT Number: NCT06846320
Generalized anxiety disorder (GAD) is usually treated with antidepressant therapy (ADT); however, sometimes ADTs alone are not enough to adequately treat GAD. The purpose of this study is to assess how safe and effective ABBV-932 is when added to the antidepressant therapies in adult participants with GAD who have had an inadequate response ADTs.
ABBV-932 is an investigational drug being developed for the adjunctive treatment of GAD. Participants will be randomly assigned to receive ABBV-932 or Placebo in addition to their currently prescribed ADTs. There is 1 in 3 chance of participants assigned to Placebo. Approximately 315 adult participants with GAD and inadequate response to ADTs will be enrolled in approximately 50 sites in the United States and Puerto Rico.
Participants will receive oral capsules of ABBV-932 or matching placebo in addition to their prescribed ADT for 6 weeks and then will be followed for an additional 4 week follow-up period.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular 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.
Interested in participating?
Request Info18 year–65 year
All sexes
Interventional
Phase 2
BDH Research /ID# 267787, San Juan, Puerto Rico
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Oral Capsule
Oral Capsule
Standard of care
Time frame: 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.
Time frame: 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.
Time frame: Up to approximately 6 weeks
The PSWQ-10 is a 10-item, participant-reported measure of the tendency of an individual to worry, the excessiveness or intensity of worry, and the tendency for the worry to be generalized and not restricted to a small number of situations. Items are rated from 0 to 6 (0, never; 6, almost always). Total scores range from 0 to 60, with higher scores indicating greater worry.
Time frame: Up to approximately 6 weeks
The CGI-S GAD is a single, clinician-reported item that measures the clinician's impression of a participant's current anxiety severity considering their total clinical experience with the participant population. The measure uses a 7-point Likert rating scale, with higher scores indicating greater anxiety severity.
Time frame: Up to approximately 4 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.
Time frame: Up to approximately 6 weeks
The MADRS is a 10-item, clinician-rated scale that evaluates the participant's depressive symptomatology during the past week. Participants are rated on items assessing feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty in concentration, and lack of interest. 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.
Time frame: Up to approximately 6 weeks
Remission is defined as HAM-A total score <=7.
Time frame: Up to approximately 6 weeks
HAM-A response is defined as >= 50% reduction from baseline in HAM-A total score
Time frame: Up to approximately 6 weeks
The CGI-C GAD is a clinician-rated scale that measures the overall change in a participant's GAD symptoms since initial receipt of the study medication. The participant is rated on a 7-point Likert scale ranging from "Much better" (1) to "Much worse" (7).
Time frame: Up to approximately 6 weeks
The PGI-S GAD is a single, patient-reported item that assesses the subject's perceived level of GAD symptoms over the past 7 days. The measure uses a 5-point Likert rating scale with responses ranging from "no symptoms" (1) to "very severe" (5), with higher scores indicating greater severity of GAD symptoms.
Time frame: Up to approximately 6 weeks
The PGI-C GAD is a single, patient-reported item that assesses the subject's perceived overall change in their GAD symptoms since they started taking the study medication. The measure uses a 7-point Likert rating scale with responses ranging from "much better" (1) to "much worse" (7). Higher scores indicate worse GAD symptoms
Time frame: Up to approximately 6 weeks
The PGI-C Worry is a single, patient-reported item that assesses the subject's perceived overall change in their worry since they started taking the study medication. The measure uses a 7-point Likert rating scale with responses ranging from "much less worried" (1) to "much more worried" (7). Higher scores indicate more worry.
Time frame: Up to approximately 6 weeks
The PGI-C Worry is a single, patient-reported item that assesses the subject's perceived overall change in their worry since they started taking the study medication. The measure uses a 7-point Likert rating scale with responses ranging from "much less worried" (1) to "much more worried" (7). Higher scores indicate more worry.
Contact information is provided by the study sponsor or research team.
AbbVie
Industry
A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dose Study to Evaluate the Efficacy, Safety, and Tolerability of ABBV-932 as an Adjunct to Antidepressant Therapies in the Treatment of Subjects With Generalized Anxiety Disorder Who Have Had an Inadequate Response to Antidepressant Therapies
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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