Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00827918 | A Study to Test the Safety and Efficacy of MK-8998 in Acutely Psychotic Participants With Schizophrenia (MK-8998-004) | PHASE2 | COMPLETED | 216 | — | — | Mar 1, 2009 | Apr 1, 2010 | Oct 21, 2015 | - | — |
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 ...