Treatment of Patients With Major Depressive Disorder With... | NCT00034983

Studies
Treatment of Patients With Major Depressive Disorder With MK0869 (0869-066)(COMPLETED)

NCT00034983

Sponsor

Merck Sharp & Dohme LLC

Status

Completed

Last Update Posted

Apr 26, 2017Actual

Enrollment

900Actual

Phase

Phase 3

Conditions

Major Depressive Disorder

Interventions

aprepitant
Comparator: paroxetine HCL

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 29, 2001Actual

Primary Completion Date

Dec 29, 2003Actual

Completion Date

Dec 29, 2003Actual

First Submitted Date

May 2, 2002

First Submission Date that Met QC Criteria

May 2, 2002

First Posted Date

May 3, 2002Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 24, 2017

Last Update Posted Date

Apr 26, 2017Actual

Description Module

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 1 year.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

900Actual

Name	Type	Description	Arm Group Labels	Other Names
aprepitant	Drug			MK0869
Comparator: paroxetine HCL	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Long-term safety and tolerability.		Duration of treatment

Secondary Outcomes

Measure	Description	Time Frame
Sexual dysfunction adverse experiences and gastrointestinal disturbance adverse experiences		Duration of treatment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Major Depressive Disorder

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Medical Monitor	Merck Sharp & Dohme LLC	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30373688	Derived	Snyder E, Cai B, DeMuro C, Morrison MF, Ball W. A New Single-Item Sleep Quality Scale: Results of Psychometric Evaluation in Patients With Chronic Primary Insomnia and Depression. J Clin Sleep Med. 2018 Nov 15;14(11):1849-1857. doi: 10.5664/jcsm.7478.

ID	Type	Description	Link
Formally-497B
MK0869-066
2006_407

ID	Term
D003866	Depressive Disorder
D019964	Mood Disorders
D001523	Mental Disorders

ID	Term
D009025	Morpholines
D010078	Oxazines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds