Status:
COMPLETED
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)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Depression
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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.
Detailed Description
This is a randomized, placebo-controlled, safety and tolerability study examining MK-8777 in participants with major depressive disorder. In Part I of the trial, four different cohorts of six particip...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 20 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 10 2008
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT00610649
Start Date
September 20 2007
End Date
December 10 2008
Last Update
November 6 2018
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