Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Merck Sharp & Dohme LLC
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Meets the diagnostic criteria for moderate-to-severe major depressive disorder (MDD) without psychotic features according to Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria at Visit 1 (Screening)
Is currently experiencing an episode of moderate-to-severe MDD
Had an inadequate response to 1 to 4 different courses of antidepressant therapy for the current episode of moderate-to-severe MDD
Has been on a stable course of antidepressant therapy for ≥4 weeks before Visit 1 (Screening)
Has not initiated psychotherapy for depressive symptoms in the last 3 months before Visit 1 (Screening) and agrees not to initiate a new psychotherapy for depressive symptoms or to modify their current regimen of psychotherapy for depressive symptoms from Visit 1 (Screening) to Visit 9 (Post-dose Follow-up Visit)
A female participant is eligible to participate if she is not a woman of childbearing potential (WOCBP) or a WOCBP who is not pregnant, breastfeeding, or within 3 months from postpartum. WOCBP should use contraceptive methods that are highly effective as per the study specifications or be abstinent from heterosexual intercourse as their preferred and usual lifestyle, have a negative pregnancy test at screening, immediately prior to the first dosing event, and at regular intervals during the study period, and abstain from breastfeeding during the study intervention period and for at least 7 days after last study intervention
Has a reliable contact person
You may not be if
Has an ongoing episode of MDD that started more than 2 years before Visit 1 (Screening)
Has a current or prior history of one or more of the following: a) diagnosis of a psychotic disorder b) chronic convulsive disorder, except febrile seizures during childhood c) neurodegenerative disorder, traumatic brain injury causing ongoing cognitive difficulties, or any chronic organic disease of the central nervous system d) intellectual disability of a severity that would affect the ability of the participant to participate in the study e) bipolar and related disorders, MDD with psychosis f) MDD with mixed features g) posttraumatic stress disorder if not in remission for at least 5 years before Visit 1 (Screening) h) obsessive-compulsive disorder i) autism spectrum disorder
Meets criteria for substance abuse or dependence disorder currently or within the 12 months before Visit 1 (Screening)
Has a known allergy or intolerance to the active or inert ingredients in MK-1942
Has a history of malignancy ≤3 years before Visit 1 (Screening) except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer
Has a Body Mass Index (BMI) \>40 kg/m2
Has HIV or nonstable hypothyroidism, diabetes, cardiovascular disease, or respiratory disease
Failed to adequately respond to treatment with ketamine or esketamine for the current or a prior episode of MDD
Previously received electroconvulsive therapy within the past 10 years, deep brain stimulation, or vagal nerve stimulation for treatment of depression
Is imminent risk for self harm or harm to others
Is currently participating in or has previously participated in an interventional clinical study within the 2 months before Visit 1 (Screening), or has participated in \>4 interventional clinical studies within the 2 years before Visit 1 (Screening)
Has known renal disease or is experiencing renal insufficiency
Routinely consumes \>3 alcoholic drinks per day. One standard drink is defined as any beverage containing 14 gram (g) of pure alcohol
Requires use of a language interpreter to participate in the study
Had major surgery or donated or lost \>1 unit of blood within the 4 weeks before Visit 1 (Screening)
Is pregnant or is currently breastfeeding or plans to breastfeed during the course of the study
Is a woman with \<12 months of amenorrhea and is receiving hormone replacement therapy (HRT) or an estrogen-based contraceptive
Is or has an immediate family member who is investigational site or Sponsor staff directly involved with this study
Clareo Health | Efficacy and Safety of MK-1942 When Added to Stable Antidepressant Therapy in Participants With Treatment-Resistant Depression (TRD) (MK-1942-006)
