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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00848484 | Treatment of Cognitive Impairment in Men With Schizophrenia (MK5757-005)(COMPLETED) | PHASE2 | COMPLETED | 54 | — | — | Oct 1, 2008 | Jun 1, 2009 | Nov 2, 2015 | - | — |
The Brief Assessment of Cognition in Schizophrenia (BACS) was used to evaluate cognitive impairment, as measured by the mean change from baseline after 2 weeks of treatment in the composite score. The BACS composite score was calculated by averaging scores from the BACS subtests, including Verbal Memory, Digit Sequencing, Token Motor, Symbol Coding, Verbal Fluency (Semantic Fluency and Letter Fluency) and Tower of London. The possible minimum and maximum scores for change from baseline at two weeks of treatment for the endpoint are -111.5 and 111.5, respectively.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | MK5757 |
| 2 | PLACEBO_COMPARATOR | Placebo |
| Name | Type | Description |
|---|---|---|
| MK5757 | DRUG | This is a 2 period, cross-over study. In each of the two treatment periods, each patient will receive the following: Days 1 and 28 MK5757 25 mg capsules three times a day (tid). Days 2 through 14 and Days 29 through 42 MK5757 50 mg capsules tid. Study drug is taken 3 times daily. Each treatment period is 14 days |
| Comparator: Placebo | DRUG | This is a 2 period, cross-over study. In each of the two treatment periods, each patient will receive the following: Days 1 and 28 MK5757 one placebo capsules three times a day (tid). Days 2 through 14 and Days 29 through 42 two MK5757 placebo capsules tid. Study drug is taken 3 times daily. Each treatment period is 14 days. |
Inclusion Criteria: * Patient is male between 21 and 55 years of age * Duration of the illness must be longer than 1 year * Patient's current antipsychotic medication regimen must be stable * Patient is negative for selected drugs of abuse at Screening * Must be in a stable living arrangement for a...