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Long Term Treatment of Patients With Major Depressive Disorder With MK0869 (0869-065)(COMPLETED)

A Double-Blind, Placebo-Controlled, Multicenter Study of the Long-Term Efficacy of MK0869 in the Maintenance of Antidepressant Effect in Patients With Major Depressive Disorder

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00048594
Enrollment
800
Registered
2002-11-05
Start date
2002-01-03
Completion date
2003-12-22
Last updated
2017-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depressive Disorder

Brief summary

A clinical study to determine the efficacy and safety of an investigational medication (MK0869) in the treatment of depression.

Detailed description

The duration of treatment is 20 months.

Interventions

DRUGaprepitant
DRUGComparator: placebo (unspecified)

Sponsors

Merck Sharp & Dohme LLC
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Patients with Major Depressive Disorder

Design outcomes

Primary

MeasureTime frame
Total HAMD-17 score </= 10 after 10 weeks of treatment, time to relapse of depression over 6-10 monthsafter 10 weeks of treatment and over 6-10 months

Secondary

MeasureTime frame
CGI-S score change from Week 10 at Month 6; HAMD-17 total score change from Week 10 at Month 6; an HAMA total score change from week 10 at Month 6.Week 10 at Month 6

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026