Phase 3
Completed N=495
EDG004 Treatment of Adult Patients With Generalized Anxiety Disorder (GAD)
Generalized Anxiety Disorder (GAD)
Source: ClinicalTrials.gov NCT02305797 ↗
Enrolled (actual)
495
Serious AEs
0.4%
Results posted
Sep 2018
Primary outcomePrimary: Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score at Visit 7 (Day 42) — -9.01; -8.93 Score on scale
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
To evaluate the efficacy of EDG004 compared to placebo for the treatment of adult patients with GAD, diagnosed by Diagnostic and Statistical Manual of Mental Disorders, 5th Ed. (DSM-5) and confirmed by the Mini International Neuropsychiatric Interview (MINI 7.0). Efficacy will be measured by a statistically significant greater mean reduction from baseline compared to endpoint in anxiety symptoms as measured by the total score of the clinician-rated Hamilton Rating Scale for Anxiety (HAM-A) for the EDG004 treatment group compared to placebo.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score at Visit 7 (Day 42) |
-9.01; -8.93 | — |
| SECONDARY Change From Baseline in the Clinical Global Impression-Severity (CGI-S) Score at Visit 7 (Day 42) |
-1.14; -1.10 | — |
Eligibility Criteria
Inclusion Criteria
- Men and women between the ages of 18-65 years and
- Diagnosed with GAD and
- No other psychiatric conditions, and are otherwise medically healthy.
Exclusion Criteria
- Women who are pregnant or lactating.
Data sourced from ClinicalTrials.gov (NCT02305797). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.