MK0249 for the Treatment of Cognitive Impairment in Patients With Schizophrenia (0249-016)

NCT00506077 | Completed Phase 2 Results

• 2 other identifiers: 0249-0162007_522
• Study Type: interventional
• Target: 55
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to determine the safety and effectiveness of an investigational drug MK0249 for the treatment of the cognitive impairment in patients with schizophrenia.

Conditions

Paranoid Schizophrenia

Keywords

Undifferentiated schizophrenia; residual schizophrenia

Outcome Measures

Primary Outcomes (1)

• Mean Change From Baseline at 4 Weeks of Treatment in Total Cognitive Score on the Brief Assessment of Cognition in Schizophrenia (BACS) Battery.

  The mean change from baseline after 4 weeks of treatment in total cognitive score on the BACS was calculated as a weighted average of T-scores (normalized for age) from BACS subtests including Verbal Memory, Digit Sequencing, Token Motor, Symbol Coding, Semantic Fluency, Letter Fluency, and Tower of London. The minimum and maximum values possible for this composite T-score of the change from baseline were -131 and 131, respectively. Higher values (positive changes from baseline) indicate better performance.

  Baseline and 4 weeks of treatment

Secondary Outcomes (3)

• Mean Change From Baseline at 4 Weeks of Treatment in Attention/Processing Speed Composite Score

  Baseline and 4 weeks of treatment

• Mean Change From Baseline at 4 Weeks of Treatment in Episodic Memory Composite Score

  Baseline and 4 weeks of treatment

• Mean Change From Baseline at 4 Weeks of Treatment in Working Memory Composite Score

  Baseline and 4 weeks of treatment

Other Outcomes (4)

• Pre-randomization Baseline: Total Cognitive Score on the Brief Assessment of Cognition in Schizophrenia (BACS) Battery.

  Pre-randomization Baseline

• Pre-randomization Baseline: Attention/Processing Speed Composite Score

  Pre-randomization Baseline

• Pre-randomization Baseline: Episodic Memory Composite Score

  Pre-randomization Baseline

Study Arms (2)

MK0249

EXPERIMENTAL

Drug: MK0249

Placebo

PLACEBO COMPARATOR

Drug: Comparator: Placebo (unspecified)

Interventions

MK0249 DRUG

MK0249 10mg (2 x 5 mg) tablet daily (qd) for 28 days.

MK0249

Comparator: Placebo (unspecified) DRUG

MK0249 10mg (2 x 5 mg) Pbo tablet qd for a 28 day treatment period.

Placebo

Eligibility Criteria

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

You may qualify if:

• Patient is clinically stable, on current antipsychotic medication for at least 3 months and current dose for 2 months
• Patient has a 6th grade reading level or better
• Females are not pregnant, and those who can have children agree to remain abstinent or use acceptable birth control throughout the study
• Patient has had a stable living arrangement for at least 3 months prior to study start
• Patient is in general good health based on screening assessments
• Patient has total Positive and Negative Syndrome Scale (PANSS) score between 36 and 75 at screening and at the first baseline visit
• Patient has a Clinical Global Impressions - Severity (CGI-S) score less than or equal to 4 at screening and at the first baseline visit

You may not qualify if:

• Patient has a major disease/disorder that may interfere with cognitive testing (such as mental retardation) and/or pose a risk upon study participation
• Patient has a history of head trauma with loss of consciousness greater than 15 minutes
• Patient has had warfarin treatment, MAO inhibitors, clonazepam or clozapine within 1 month of screening
• Patient has had ECT treatment within 6 months of screening
• Patient requires treatment with antihistamines or certain other medications listed in the protocol
• Patient has a history of liver disease that has been active within the last 2 years, or a history of cancer within the past 5 years
• Patient has a history of alcohol or drug dependence within the past year or alcohol or drug abuse within 3 months of screening

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• F Egan M, Zhao X, Gottwald R, Harper-Mozley L, Zhang Y, Snavely D, Lines C, Michelson D. Randomized crossover study of the histamine H3 inverse agonist MK-0249 for the treatment of cognitive impairment in patients with schizophrenia. Schizophr Res. 2013 May;146(1-3):224-30. doi: 10.1016/j.schres.2013.02.030. Epub 2013 Mar 22.

  PMID: 23523692 DERIVED

MeSH Terms

Conditions

Schizophrenia, Paranoid

Interventions

MK-0249

Condition Hierarchy (Ancestors)

Schizophrenia; 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: July 24, 2007
• First Posted: July 25, 2007
• Study Start: December 1, 2007
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: August 3, 2015
• Results First Posted: March 7, 2011

Record last verified: 2015-07