Expired Study
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Titusville, New Jersey 08560


Purpose:

The purpose of this research study is to determine the effectiveness of 2 target doses of R228060 in comparison with placebo during 6 weeks of treatment in moderately to severely depressed adult subjects with major depressive disorder. Approximately 488 subjects will be involved in the study.


Criteria:

- Generally healthy adults on the basis of a physical examination, medical history, ECG and laboratory work-up. - Subject needs to meet criteria for diagnosis of moderate or severe major depression as defined by the protocol. - The subject also needs to be an outpatient to participate in this study.


Study is Available At:


Original ID:

CR004339


NCT ID:

NCT00073203


Secondary ID:


Study Acronym:


Brief Title:

A 6 Week Study to Determine the Effectiveness of R228060 in Adult Subjects With Major Depressive Disorder


Official Title:

A 6- Week, Randomized, Double-Blind, Parallel-Group, Active-and Placebo-Controlled Trial to Assess the Efficacy of R228060 in Adult Subjects With Major Depressive Disorder (MDD)


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

65 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

488


Enrollment Type:


Study Dates

Completion Date:May 2004
Verification Date:May 2004
Last Changed Date:August 27, 2009
First Received Date:November 17, 2003

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Name:R228060
Intervention Type:Drug
Name:Placebo and Paroxetine

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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