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A Study of Elpipodect (MK-8189) in Participants With Bipolar I Disorder (MK-8189-020)
A Study of Elpipodect (MK-8189) in Participants With Bipolar I Disorder (MK-8189-020)

NCT06273774

CompletedPhase 1

Sponsor: Merck Sharp & Dohme LLC

Conditions: Bipolar I Disorder

Interventions: Elpipodect, Placebo

Countries: United States

The goal of this study is to evaluate the safety and tolerability of elpipodect in participants with stable bipolar I disorder. There was no hypothesis testing in this study.

Eligibility overview

Sex: ALL

Age: 18 Years to 60 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

* Meets diagnostic criteria for bipolar I disorder, manic or mixed features according to the Diagnostic and statistical manual of Mental Disorders TR (DSM-5 TR) and considered to be in a non-acute phase of their illness.
* History of receiving and tolerating antipsychotic medication within the usual dose range employed for bipolar I disorder.
* Body mass index is 18 and 40 kg/m\^2, inclusive.
* If currently taking an antipsychotic, is able to discontinue use at least 5 days prior to study start and the duration of the study.

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

* Untreated or uncompensated endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological abnormalities or diseases.
* Evidence or history of a primary DSM-5 axis I psychiatric diagnosis other than those specified for inclusion.
* History of cancer (malignancy).
* Evidence or history of mental retardation, borderline personality disorder, or organic brain syndrome.
* History of neuroleptic malignant syndrome or moderate to severe tardive dyskinesia.
* Substance-induced psychotic disorder or behavioral disturbance.
* DSM-5 TR defined substance use disorder within 3 months of screening.
* History of seizure disorder beyond childhood or is receiving treatment with any anticonvulsant to prevent seizures.
* Positive test(s) for hepatitis B surface antigen, hepatitis C antibodies or human immunodeficiency virus.
* Major surgery or donation/loss of 1 unit of blood within 4 weeks prior to screening.
* Received any vaccine starting from 30 days prior to study intervention or is scheduled to receive any vaccine through 30 days following study intervention.
Locations (3)
  • Little Rock, Arkansas, United States
  • Atlanta, Georgia, United States
  • Marlton, New Jersey, United States