A Phase IIa, Randomized, Double-Blind, Placebo-Controlled, Add-On Therapy, 2-Period Cross-Over Clinical Trial to Evaluate the Safety and Efficacy of MK5757 for the Treatment of Cognitive Impairment in Men With Schizophrenia
Overview
- Phase
- Phase 2
- Intervention
- MK5757
- Conditions
- Schizophrenia
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 54
- Primary Endpoint
- Mean Change From Baseline in the Composite Score From the Brief Assessment of Cognition in Schizophrenia (BACS) Battery After 2 Weeks of Treatment
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief 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.
Investigators
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
Arms & Interventions
1
MK5757
Intervention: MK5757
Outcomes
Primary Outcomes
Mean Change From Baseline in the Composite Score From the Brief Assessment of Cognition in Schizophrenia (BACS) Battery After 2 Weeks of Treatment
Time Frame: Baseline and Week 2
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.
Secondary Outcomes
- Mean Change From Baseline After 2 Weeks of Treatment in the CogState Composite Score(Baseline and week 2)
- Mean Change From Baseline After 2 Weeks of Treatment in the Attention/Processing Speed Composite Score(Baseline and Week 2)
- Mean Change From Baseline After 2 Weeks of Treatment in the Episodic Memory Composite Score(Baseline and Week 2)
- Mean Change From Baseline After 2 Weeks of Treatment in the Executive Functioning Composite Score(Baseline and Week 2)
- Mean Change From Baseline After 2 Weeks of Treatment in the Working Memory Composite Score(Baseline and Week 2)