Bipolar I Disorder Clinical Trial
Official title:
A Multiple Dose Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of MK-8189 in Participants With Bipolar I Disorder
The goal of this study is to evaluate the safety and tolerability of MK-8189 in participants with stable bipolar I disorder. There will be no hypothesis testing in this study.
| Status | Recruiting |
| Enrollment | 32 |
| Est. completion date | September 10, 2024 |
| Est. primary completion date | September 10, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 60 Years |
| Eligibility | 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 it's 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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Hassman Research Institute Marlton Site ( Site 0006) | Marlton | New Jersey |
| Lead Sponsor | Collaborator |
|---|---|
| Merck Sharp & Dohme LLC |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of Participants Who Experience One or More Adverse Events (AEs) | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. | Up to ~28 days | |
| Primary | Number of Participants Who Discontinue Study Treatment Due to an AE | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. | Up to ~14 days |
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