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

NCT02305797 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 495

Last updated 2018-09-26

Study results available
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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.

Conditions

  • Generalized Anxiety Disorder (GAD)

Interventions

DRUG

Extended-release lorazepam

Extended-release lorazepam capsules

DRUG

Placebo

Placebo capsules

Sponsors & Collaborators

  • Edgemont Pharmaceuticals, LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2016-05-31
Completion
2016-05-31

Countries

  • United States

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02305797 on ClinicalTrials.gov