Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MK-8998 · 1 trial · 1 indication
PANSS is a medical scale used for measuring symptom severity of participants with schizophrenia. PANSS measure is composed of 3 scales: Positive scale, Negative scale, and General Psychopathology scale. Positive scale assesses hallucinations, delusions and related symptoms; Negative scale assesses emotional withdrawal, lack of motivation, and similar symptoms; and General Psychopathology scale addresses other symptoms such as anxiety, somatic concern and disorientation. The PANSS has 30 items in its 3 scales and an anchored Likert scale from 1 to 7 is used to score each item. Values of 2 and above indicate the presence of progressively more severe symptoms. The Positive scale has 7 items with a score from 7 to 49, the Negative scale has 7 items with a score from 7 to 49, and the General Psychopathology scale has 16 items with a score from 16 to 112. A total score is the sum of the 3 scores for the 3 scales.
An adverse event (AE) is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the study drug.
An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the study drug.
| Arm | Type | Description |
|---|---|---|
| MK-8998 | EXPERIMENTAL | MK-8998, 6 mg twice a day (BID) for Days 1 to 7, and 8 mg BID thereafter for a 4-week total treatment period |
| Olanzapine | ACTIVE_COMPARATOR | Olanzapine, 5 mg BID for Day 1 to 7, and 15 mg (5 mg in the morning and 10 mg in the evening) thereafter for a 4-week total treatment period |
| Placebo | PLACEBO_COMPARATOR | Placebo Comparator to MK-8998 or olanzapine |
| Name | Type | Description |
|---|---|---|
| MK-8998 | DRUG | MK-8998 6 mg capsules twice daily with food on Days 1 through 7. On Day 8, dosage will be increased to 8 mg capsules twice daily. Treatment period is 4 weeks. There will be a period of time when all participants will receive placebo. |
| Comparator: Olanzapine | DRUG | Olanzapine 5 mg tablets twice daily with food on Days 1 through 7. On Day 8, dosage will be increased to 5 mg tablets in the morning and 10 mg tablets in the evening. Treatment period is 4 weeks. There will be a period of time when all participants will receive placebo. |
| Comparator: Placebo | DRUG | Placebo tablets matching olanzapine tablets and MK-8998 capsules |
Inclusion Criteria: * Patient's age is 18 to 55 * Patient meets DSM-IV/DSM-IV-TR criteria for a primary diagnosis of schizophrenia * The duration of the patients schizophrenia diagnosis must be greater than 1 year * Patient has an acute exacerbation of psychotic symptoms (of at least 3 days but no ...
MK-8998 is an investigational small molecule being developed for the treatment of schizophrenia. It is intended for use in acutely psychotic participants with the condition. The drug is currently in clinical development and has not been approved by regulatory authorities.
MK-8998 is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug for schizophrenia.
MK-8998 is in Phase 2 clinical development. A Phase 2 study has been completed to test the safety and efficacy of the drug in acutely psychotic participants with schizophrenia. The drug remains investigational and has not received regulatory approval.
MK-8998 has one completed clinical trial registered as NCT00827918, titled "A Study to Test the Safety and Efficacy of MK-8998 in Acutely Psychotic Participants With Schizophrenia (MK-8998-004)." This Phase 2 study enrolled 216 participants and was placebo-controlled, randomized, and double-blind.
MK-8998 is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for schizophrenia. A completed Phase 2 trial has evaluated its safety and efficacy, but the drug has not yet received marketing authorization from regulatory agencies.