EDG004 Treatment of Adult Patients With Generalized Anxiety Disorder (GAD)

Completed · Phase 3 · Has a placebo group

Conditions studied: Generalized Anxiety Disorder (GAD)

In brief

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.

Key facts

Study ID

NCT02305797

Run by

Edgemont Pharmaceuticals, LLC

People needed

495

Starts

2015-01-01

Expected to finish

2016-05-01

Last updated by the study team

2018-09-26

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Men and women between the ages of 18-65 years and
• Diagnosed with GAD and
• No other psychiatric conditions, and are otherwise medically healthy.

You may not qualify if…

• Women who are pregnant or lactating.

Where it is running

• Multiple Investigational Sites — Multiple Locations, California, United States

Full record on ClinicalTrials.gov

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