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

NCT ID: NCT02305797

Last Updated: 2018-09-26

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

495 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2016-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Generalized Anxiety Disorder (GAD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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EDG004

EDG004 - Extended release lorazepam capsules

Group Type EXPERIMENTAL

Extended-release lorazepam

Intervention Type DRUG

Extended-release lorazepam capsules

Placebo

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo capsules

Interventions

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Extended-release lorazepam

Extended-release lorazepam capsules

Intervention Type DRUG

Placebo

Placebo capsules

Intervention Type DRUG

Other Intervention Names

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EDG004

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Edgemont Pharmaceuticals, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Multiple Investigational Sites

Multiple Locations, California, United States

Site Status

Countries

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United States

Other Identifiers

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EDG004-003

Identifier Type: -

Identifier Source: org_study_id

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