NCT00703833

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2002

Shorter than P25 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2002

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2003

Completed
5.4 years until next milestone

First Submitted

Initial submission to the registry

June 22, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 24, 2008

Completed
Last Updated

November 2, 2015

Status Verified

October 1, 2015

Enrollment Period

5 months

First QC Date

June 22, 2008

Last Update Submit

October 30, 2015

Conditions

Generalized Anxiety Disorder

Outcome Measures

Primary Outcomes (1)

  • Measure the reduction of anxiety

    after 4 weeks and at end of study

Secondary Outcomes (1)

  • Safety and efficacy

    throughout study and at end of study

Study Arms (2)

1

EXPERIMENTAL

Drug

Drug: MK0777

2

PLACEBO COMPARATOR

Placebo

Drug: Placebo (unspecified)

Interventions

MK0777DRUG

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

1
Placebo (unspecified)DRUG

matching placebo

2

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Generalized Anxiety Disorder

Interventions

7-(1,1-dimethylethyl)-6-(2-ethyl-2H-1,2,4-triazol-3-ylmethoxy)-3-(2-fluorophenyl)-1,2,4-triazolo(4,3-b)pyridazine

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2008

First Posted

June 24, 2008

Study Start

September 1, 2002

Primary Completion

February 1, 2003

Study Completion

February 1, 2003

Last Updated

November 2, 2015

Record last verified: 2015-10