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ABBV-932 for Generalized Anxiety Disorder

Phase 1
Recruiting
Research Sponsored by AbbVie
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
For healthy volunteer cohort: Individuals between 18 and 65 years of age inclusive at the time of screening.
For patients with generalized anxiety disorder (GAD) cohort(s): Patients with GAD between 18 and 65 years of age, inclusive at time of screening meet the following criteria: Patients with DSM-5 Primary diagnosis of GAD as confirmed by MINI, and a HAM-A score ≥ 15 (at least moderate anxiety) and CGI-Severity Score ≥ 3 (mildly ill) at screening.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to day 129
Awards & highlights

Study Summary

This trial will investigate the effects of ABBV-932 on healthy adults and those with GAD, looking at safety, effectiveness, and tolerability.

Who is the study for?
This trial is for healthy adults, and patients with Generalized Anxiety Disorder (GAD) or Schizophrenia (SCZ), aged 18-65 with a BMI of 18.0 to 32.0 kg/m2. GAD patients must have moderate anxiety and be mildly ill at minimum. Exclusions include recent significant illness, hospitalization, surgery, major depression in the past 3 months, other psychiatric disorders besides GAD and MDD, or substance abuse within the last six months.Check my eligibility
What is being tested?
The study tests ABBV-932 against a placebo to see how the body processes it and its safety profile when given multiple times orally to healthy individuals as well as those with GAD or SCZ.See study design
What are the potential side effects?
While specific side effects are not listed here, participants will be monitored for any adverse reactions related to ABBV-932 compared to placebo which could range from mild discomforts like headaches or nausea to more serious conditions depending on individual responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 65 years old.
Select...
I am 18-65 with GAD, have moderate anxiety, and am at least mildly ill.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to day 129
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to day 129 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area under the Plasma Concentration-time Curve from Time Zero to the End of the Dosing Interval (AUCtau)
Maximum Observed Plasma Concentration (Cmax)
Number of Participants with Adverse Events (AEs)
+2 more

Trial Design

6Treatment groups
Experimental Treatment
Group I: Part C, Placebo for ABBV-932Experimental Treatment1 Intervention
Participants will receive placebo for ABBV-932 QD for 28 days.
Group II: Part C, ABBV-932Experimental Treatment1 Intervention
Participants will receive ABBV-932 QD for 28 days.
Group III: Part B, Placebo for ABBV-932Experimental Treatment1 Intervention
Participants will receive placebo for ABBV-932 QD for 28 days.
Group IV: Part B, ABBV-932Experimental Treatment1 Intervention
Participants will receive ABBV-932 QD for 28 days.
Group V: Part A, Placebo for ABBV-932Experimental Treatment1 Intervention
Participants will receive placebo for ABBV-932 QD for 14 days.
Group VI: Part A, ABBV-932Experimental Treatment1 Intervention
Participants will receive ABBV-932 once daily (QD) for 14 days.

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

AbbVieLead Sponsor
958 Previous Clinical Trials
502,326 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
397 Previous Clinical Trials
147,045 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current size of the patient pool undertaking this experimental research?

"Affirmative. According to the information on clinicaltrials.gov, this research initiative is actively recruiting participants and was initially made available on August 31st 2023; it has since been updated as of September 20th 2023. This evaluation seeks 56 patients from a single site."

Answered by AI

Are enrollees currently being accepted for this experiment?

"Indeed, per the data on clinicaltrials.gov it is apparent that enrollment for this trial is currently in progress. This study was launched at the end of August and underwent an update a few weeks later."

Answered by AI

Is it possible to join this research project?

"To participate in this research, individuals should meet the criteria of being 18 months to 65 years old and have a clinical diagnosis of generalized anxiety disorder (GAD). The total number of patients needed is 56."

Answered by AI

What potential adverse effects could patients experience when taking Part 1, ABBV-932?

"The limited amount of evidence surrounding the safety and efficacy of ABBV-932 has lead our team to conservatively assign it a score of 1."

Answered by AI

Does this medical trial encompass participants of senior age?

"The requirements for this clinical trial demand that participants to be aged between 18 months and 65 years. For those under the age of 18, there are 123 studies available while 292 more research projects are accessible to individuals over 65."

Answered by AI

Who else is applying?

What site did they apply to?
CenExel HRI /ID# 260271
Cenexel CNS /ID# 260270
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of ABBV-932 in Healthy Adult Participants, Participants With Generalized Anxiety Disorder (GAD) and Participants With Bipolar Disorder (BPD)
2023. "A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of ABBV-932 in Healthy Adult Participants, Participants With Generalized Anxiety Disorder (GAD) and Participants With Bipolar Disorder (BPD)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06024239.
All > Anxiety Disorder
~27 spots leftby Nov 2024
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