Phase 2
N=54
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)
Depression
Bottom Line
View on ClinicalTrials.gov: NCT00610649 ↗Enrolled (actual)
54
Serious AEs
0.0%
Results posted
Jul 2014
Primary outcome: Primary: Part 1: Number of Participants With Moderate Intensity Adverse Events (AEs) — 2; 0; 1; 2 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- MK-8777 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Nov 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Part 1: Number of Participants With Moderate Intensity Adverse Events (AEs) |
2; 0; 1; 2; 4; 0 | — |
| PRIMARY Part 1: Number of Participants With Serious Adverse Events (SAEs) |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Part 1: Number of Participants With AEs Leading to Discontinuation of Study Drug |
1; 0; 0; 0; 0; 0 | — |
| PRIMARY Part 2: Number of Participants With AEs |
10; 9; 9 | — |
| PRIMARY Part 2: Number of Participants With AEs Leading to Discontinuation of Study Drug |
0; 0; 1 | — |
| SECONDARY Part 1: Change From Baseline in the Montgomery-Ashberg Depression Rating Scale (MADRS) |
-10.00; -24.50; -13.50; -7.00; -10.25; -9.50 | — |
| SECONDARY Part 2: Change From Baseline in the MADRS |
-15.40; -13.70; -13.30 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00610649). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.