A Study of MK0777 Gel Extrusion Module (GEM) in the Treatment of Outpatients With Generalized Anxiety Disorder (0777-019)

The study will look at the effectiveness of MK0777 in patients with Generalized Anxiety Disorder.

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Key information

Conditions

Generalized Anxiety Disorder Anxiety Disorders Mental Disorders

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Male or Female
Current diagnosis of Generalized Anxiety Disorder
Age 18 - 70

Exclusion criteria

Women who are pregnant, or breast-feeding
Use of illicit drugs
History of drug or alcohol dependence

Treatment and study plan

MK0777

Drug

Days 1-3 3mg MK0777, Days 4-7 6 mg MK0777, Days 8-28 3, 6 or 9 mg MK0777

Placebo (unspecified)

Drug

matching placebo

Primary outcomes

Measure the reduction of anxiety

Time frame: after 4 weeks and at end of study

Secondary outcomes

Safety and efficacy

Time frame: throughout study and at end of study

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Double-Blind, Multicenter, Placebo-Controlled Study of MK0777 Gel Extrusion Module (GEM) 1.5 mg b.i.d. in the Treatment of Outpatients With Generalized Anxiety Disorder

Important dates

Study start: 2002
Primary completion: 2003
Study completion: 2003
First posted: Jun 24, 2008
Registry last updated: Nov 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed