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
18–50
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
18 to 50 years of age at Screening
Male
Female not of reproductive potential (e.g., postmenopausal or has had a hysterectomy), or agrees to practice abstinence or use acceptable contraception
Meets the diagnostic criteria for schizophrenia according to the DSM-5 criteria, or has a past diagnosis of schizophrenia with the onset of the first episode being \>=1 year prior to study entry, and has illness duration of \<=20 years
Is confirmed to be experiencing an acute episode of schizophrenia
Minimum PANSS score \>= 80 at Screening
Has a score of \>=4 in 3 or more of the following items (delusions, conceptual disorganization, hallucinatory behavior, grandiosity, suspiciousness/persecution) in the positive subscale of the PANSS at Screening
Has a CGI-S score \>= 4 at Screening
Is able to taper off psychotropic medications without significant destabilization or increased suicidality
Has responded positively to an antipsychotic medication other than clozapine in a prior psychotic episode
Has an identified responsible external contact person who has regular contact (no less than once per week) with the participant
You may not be if
Is currently under involuntary commitment because he/she is considered a danger to himself/herself or others
Is unwilling to remain hospitalized for the duration of trial treatment
Is currently participating in or has participated in an interventional clinical research study \<=6 months prior to Screening, or has participated in more than one interventional clinical trial research study within 12 months prior to Screening
Is unwilling to allow audio/video taping of the Mini International Neuropsychiatric Interview for Schizophrenia and Psychotic Disorders (MINI) and/or PANSS interview at Screening and Baseline
Is currently being treated with and benefiting from medications with a moderate or strong inhibiting or inducing effect on Cytochrome P450 (CYP) 3A and/or CYP2C9 and/or sensitive substrates of CYP2B6
Has a history of malignancy \<= 5 years except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer
Has a body mass index \<18.5 or \>40 kg/m˄2
Has a history of treatment-resistant schizophrenia
Has a prolactin laboratory value of \>= 5 times the upper limit of normal at Screening
Has a known history or clinical evidence of clinically significant hepatic, cardiovascular, or renal disease, or of untreated narrow-angle glaucoma- Has ever been diagnosed with epilepsy or had any seizure disorder beyond one childhood febrile seizure
Has known serological evidence of human immunodeficiency virus (HIV) antibody
Has a history of neuroleptic malignant syndrome
Has a current diagnosis other than schizophrenia, or a comorbid diagnosis primarily responsible for current symptoms and functional impairment
Has a known history of borderline personality disorder, antisocial personality disorder, or bipolar disorder
Has a known history of traumatic brain injury, or Alzheimer's disease or another form of dementia
Currently meets DSM-5 criteria for substance abuse or alcohol use disorder
Is at imminent risk of self-harm or harm to others
Clareo Health | An Active-Controlled Early Phase Study of Elpipodect (MK-8189) in Adults With Schizophrenia (MK-8189-005)
