Phase 2
N=54
Treatment of Cognitive Impairment in Men With Schizophrenia (MK5757-005)(COMPLETED)
Schizophrenia
Bottom Line
View on ClinicalTrials.gov: NCT00848484 ↗Enrolled (actual)
54
Serious AEs
1.0%
Results posted
Dec 2010
Primary outcome: 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 T-score based on normative data — p=0.277
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- MK5757 (Drug); Comparator: Placebo (Drug)
- Age
- Adult · 21+ yrs
- Sex
- Male
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Jun 2009
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 |
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.
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.