depression MedDRA version: 14.1 Level: LLT Classification code 10066555 Term: Chronic depression System Organ Class: 100000004873
Conditions
Interventions
Product Name: MK-6096
Product Code: MK-6096
Pharmaceutical Form: Tablet
Current Sponsor code: MK-6096
Other descriptive name: MK-6096
Concentration unit: mg milligram(s)
Concentration type: equal
Conc
Sponsors
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Demographic • Men and women between 21 and =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Demographic • Patient has history of transmeridian travel (across > 3 time zones) or shift work (permanent night shift or rotating day/night shift work) within past 2 wks or will have to travel (across > 3 time zones) at any time during the study. Diagnostic • Patient’s current depressive episode is his/her first major depressive episode. • Patient has a current primary diagnosis (ie, a diagnosis designated by the investigator as the primary source of current distress and functional impairment) of an Axis I disorder other than MDD. • Patient has a lifetime diagnosis of bipolar disorder, schizophrenia, schizoaffective disorder, or other psychotic disorder, as determined by the investigator. Note that a history of psychotic features in the context of a previous depressive episode is permitted; however psychotic features associated with the current episode are exclusionary. • Patient has a known or suspected personality dysfunction that could, in the investigator's opinion, interfere with trial participation or efficacy evaluation. A patient with known antisocial or borderline personality disorder should be excluded. • Patient has a diagnosis of mental retardation, a history of traumatic brain injury causing ongoing cognitive difficulties, Alzheimer's Disease or another form of dementia, or any chronic organic disease of the central nervous system. • Patient is at imminent risk of self-harm, based on clinical interview and responses on the Columbia Suicidality Severity Rating Scale (C-SSRS), or of harm to others in the opinion of the investigator. Patients must be excluded if they report suicidal ideation with intent, with or without a plan (i.e., MADRS item 10 = 3 and/or Type 4 or 5 on the C-SSRS) in the past 1 month or suicidal behavior in the past 6 months. • Patient currently (within the past year) meets criteria for alcohol or other substance abuse or dependence (excluding nicotine), posttraumatic stress disorder (PTSD), obsessive compulsive disorder (OCD), or eating disorder. • Patient has a positive screening urine drug screen (e.g., positive for benzodiazepines, cannabinoids, cocaine, etc.). Medications and Treatments • Patient has an inadequate response to up to 3 antidepressant trials for current episode, in the investigator's opinion. • Patient uses anxiolytic or sedative-hypnotic agents chronically (=4 times/wk). • Patient is taking a prohibited medication (see protocol Table 2-2) within the specified washout period and during the study. • Patient has a history of hypersensitivity or idiosyncratic reaction to more than two pharmacologic classes of drugs, including prescriptions and over-the-counter medications. Medical • If female: pregnant, breastfeeding, or expecting to conceive within duration of study • Patient has a Body Mass Index > 40 kg/m2. • Patient has a history or current evidence of any clinically significant disease that according to the investigator might confound the results of the study, complicate the interpretation of the study results, interfere with the patient’s participation for the full duration of the study, or pose an additional undue risk to the patient.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: (1) To evaluate the efficacy of MK-6096 in comparison with placebo as treatment augmentation for patients with MDD, based on change from baseline to week 6 in MADRS total score. (2) To assess the safety and tolerability of MK-6096 as augmentation therapy for patients with MDD. ;Secondary Objective: The secondary objectives are to assess the efficacy of MK-6096 in comparison with placebo as treatment augmentation for patients with MDD, based on the following: 1. Change from baseline to week 6 in the MADRS total score excluding the sleep item; 2. Change from baseline to week 6 in the HAM-D Bech subscale score; 3. HAM-D17 remission (HAM-D17 total score = 7) rate at week 6. ;Primary end point(s): Change from baseline to week 6 in MADRS total score;Timepoint(s) of evaluation of this end point: 6 weeks from baseline (randomization) visit | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): ) 1. Change from baseline to week 6 in the MADRS total score excluding the sleep item; 2. Change from baseline to week 6 in HAM-D Bech subscale score; 3. HAM-D17 remission (HAM-D17 total score = 7) rate at week 6 ;Timepoint(s) of evaluation of this end point: 6 weeks from baseline (randomization) visit | — |
Countries
Finland, France, Germany, Norway, Sweden
Contacts
Public ContactSandra Marzodko-Denzler
Merck Sharp & Dohme GmbH
Outcome results
None listed