A Study of Elpipodect (MK-8189) in Participants With Bipolar I Disorder (MK-8189-020) (NCT06273774) | Clinical Trial Compass
CompletedPhase 1
A Study of Elpipodect (MK-8189) in Participants With Bipolar I Disorder (MK-8189-020)
United States34 participantsStarted 2024-04-08
Plain-language summary
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.
Who can participate
Age range18 Years – 60 Years
SexALL
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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 prev…
What they're measuring
1
Number of Participants Who Experience One or More Adverse Events (AEs)
Timeframe: Up to 28 days
2
Number of Participants Who Discontinue Study Treatment Due to an AE