Generalized Anxiety Disorder (GAD)
Conditions
Keywords
LEGATO - (GAD), Generalized Anxiety Disorder (GAD), ABBV-932
Brief summary
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.
Interventions
Sponsors
AbbVie
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria for generalized anxiety disorder (GAD) confirmed by the Mini International Neuropsychiatric Interview (MINI). * Currently taking protocol-specified antidepressant therapies (ADT) for GAD with an inadequate response to an adequate dose (per label) and duration (\>= 8 weeks) as verified by a baseline Hamilton Anxiety Rating Scale (HAM-A) total score \>= 20 and Clinical Global Impression of Severity Scale (CGI-S GAD) \>= 4.
Exclusion criteria
* Have a Montgomery-Åsberg Depression Rating Scale (MADRS) score \>= 20. * New diagnosis or exacerbation of major depression in the last 6 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Penn State Worry Questionnaire-10 (PSWQ-10) Total Score | 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. |
| Change from Baseline in Clinical Global Impression of Severity Scale (CGI-S) Generalized Anxiety Disorder (GAD) | 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. |
| Change from Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score | 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. |
| Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score | 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. |
| Percentage of Participants in Remission | Up to approximately 6 weeks | Remission is defined as HAM-A total score \<=7. |
| Percentage of Participants with HAM-A Response | Up to approximately 6 weeks | HAM-A response is defined as \>= 50% reduction from baseline in HAM-A total score |
| Percentage of Participants with Clinical Global Impression of Change (CGI-C) GAD Responder Status of "Much Better" or "Moderately Better" | 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). |
| Change from Baseline in Patient Global Impression of Severity Scale (PGI-S) Generalized Anxiety Disorder (GAD) | 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. |
| Percentage of Participants with Patient Global Impression of Change Scale (PGI-C) Generalized Anxiety Disorder (GAD) Responder Status of "Much Better" or "Moderately Better" | 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 |
| Change from Baseline in Patient Global Impression of Severity Scale (PGI-S) Worry | 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. |
| Percentage of Participants with Patient Global Impression of Change Scale (PGI-C) Worry Responder Status of "Much Better" or "Moderately Better" | 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. |
Countries
Puerto Rico, United States
Contacts
CONTACTABBVIE CALL CENTER
STUDY_DIRECTORABBVIE INC.
AbbVie
Outcome results
None listed