Phase 2
Completed N=54
Treatment of Cognitive Impairment in Men With Schizophrenia (MK5757-005)(COMPLETED)
Source: ClinicalTrials.gov NCT00848484 ↗Enrolled (actual)
54
Serious AEs
1.0%
Results posted
Dec 2010
Primary outcomePrimary: Mean Change From Baseline in the Composite Score From the Brief Assessment of Cognition in Schizophrenia (BACS) Battery After 2 Weeks of Treatment — 0.3; 1.5 T-score based on normative data — p=0.277
Summary
This study is to evaluate the safety and efficacy of the study drug compared to placebo in the treatment of cognitive impairment in men with schizophrenia.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in the Composite Score From the Brief Assessment of Cognition in Schizophrenia (BACS) Battery After 2 Weeks of Treatment |
0.3; 1.5 | 0.277 |
| SECONDARY Mean Change From Baseline After 2 Weeks of Treatment in the CogState Composite Score |
0.3; -0.5 | 0.686 |
| SECONDARY Mean Change From Baseline After 2 Weeks of Treatment in the Executive Functioning Composite Score |
0.9; 1.0 | 0.933 |
| SECONDARY Mean Change From Baseline After 2 Weeks of Treatment in the Episodic Memory Composite Score |
0.1; 0.8 | 0.686 |
| SECONDARY Mean Change From Baseline After 2 Weeks of Treatment in the Working Memory Composite Score |
-1.7; -0.1 | 0.686 |
| SECONDARY Mean Change From Baseline After 2 Weeks of Treatment in the Attention/Processing Speed Composite Score |
-0.2; -1.3 | 0.686 |
Eligibility Criteria
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 at least 3 months prior to screening (not a homeless shelter)
Exclusion Criteria
- Patient has mental retardation
- Undergone Electroconvulsive Therapy (ECT) treatment within 6 months prior to screening
- Has suicidal attempts or ideation within the last 12 months
- Patient has a history of alcohol/drug dependence within 1 year or alcohol/drug abuse within 12 months of starting the study
Data sourced from ClinicalTrials.gov (NCT00848484). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.