Trial to Determine the Maximum Tolerated Dose (MTD) Based on Safety and Tolerability, of Org 26576 in Participants With Major Depressive Disorder (174001/P05704/MK-8777-001)

• Status: Completed
• Trial end date: 2008-12-10
• Target enrollment: 0
• Participant gender: All

Summary

Trial to determine the maximum tolerated dose (MTD) based on safety and tolerability of MK-8777 (Org 26576, SCH 900777) in participants with major depressive disorder.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.

Criteria

Inclusion Criteria:

• Female who is non-pregnant, nonlactating, using an acceptable method of birth control, or is not of child-bearing potential;

• be diagnosed with current major depressive disorder either mild or severe, as evidenced by a score of at least 9 but not more than 20 on the Quick Inventory of Depression Symptomatology - Clinician Rated (QIDS-C);

• be anti-depressant naïve;

• be able to refrain from all use of grapefruit containing products from the time of admission until the last assessment is performed at discharge;

• smokes less than or equal to 10 cigarettes or equivalent daily.

Exclusion Criteria:

• has any current and primary Axis I disorder other than major depressive disorder;

• has any history of bipolar I or II disorder, dysthymia, psychotic depression, psychotic disorders, posttraumatic stress disorder, borderline personality disorder, obsessive compulsive disorder, or eating disorder;

• the duration of the current depressive episode is longer than 2 years at screening;

• has any history of a significant suicide attempt, or poses a current risk of attempting suicide;

• is known to be human immunodeficiency virus (HIV) positive, or positive for hepatitis B surface antigen or hepatitis A antibodies or hepatitis C total antibodies;

• has any clinically significant concurrent endocrine, renal, respiratory, cardiovascular, hematological, immunological, cerebrovascular, neurological, malignancy, or any other concurrent medical condition, or has any history of diabetes mellitus;

• donation of blood within 60 days prior to the anticipated first dose of trial medication.