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

Edgemont Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Generalized Anxiety Disorder (GAD)

Treatments: Drug: Placebo; Drug: Extended-release lorazepam

Study type: Interventional

Funder types: Industry

Identifiers

NCT02305797

EDG004-003

Details and patient eligibility

About

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.

Enrollment: 495 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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495 participants in 2 patient groups, including a placebo group

EDG004

Experimental group

Description:

EDG004 - Extended release lorazepam capsules

Treatment:

Drug: Extended-release lorazepam

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo