Treatment of Cognitive Impairment in Men With Schizophrenia (MK5757-005)(COMPLETED)

NCT00848484 | Completed Phase 2 Results

• 2 other identifiers: 5757-0052007_603
• Study Type: interventional
• Target: 54
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

• Mean Change From Baseline in the Composite Score From the Brief Assessment of Cognition in Schizophrenia (BACS) Battery After 2 Weeks of Treatment

  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.

  Baseline and Week 2

Secondary Outcomes (5)

• 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 Executive Functioning 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 Working Memory 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

Study Arms (2)

1

EXPERIMENTAL

MK5757

Drug: MK5757

2

PLACEBO COMPARATOR

Placebo

Drug: Comparator: Placebo

Interventions

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

1

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.

2

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2009
• First Posted: February 20, 2009
• Study Start: October 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: November 2, 2015
• Results First Posted: December 15, 2010

Record last verified: 2015-10