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Study to Evaluate the Safety and Efficacy of MEM 3454 as Adjunctive Treatment in Combination With a Preexisting Antipsychotic in Patients With Cognitive Impairment Associated With Schizophrenia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2008 by Memory Pharmaceuticals.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Memory Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00604760
First received: January 17, 2008
Last updated: December 5, 2008
Last verified: December 2008
History of Changes
  Purpose

To establish the proof of concept that MEM 3454, used as add-on pharmacotherapy, is a safe and effective treatment in patients with cognitive impairment associated with schizophrenia (CIAS).


Condition Intervention Phase
Cognitive Impairment Associated With Schizophrenia
 Drug: MEM 3454
Drug: Placebo for MEM 3454
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2a, Multi-Center, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Safety and Efficacy of MEM 3454 as Adjunctive Treatment in Combination With a Preexisting Antipsychotic in Patients With Cognitive Impairment Associated With Schizophrenia

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Further study details as provided by Memory Pharmaceuticals:

Primary Outcome Measures:
  • Change from baseline in the total composite score of the MATRICS cognitive battery at week 8. [ Time Frame: Change from baseline at wk 8. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in the total composite score of the MATRICS cognitive battery at Weeks 4 and 10 [ Time Frame: Change from baseline - weeks 4 and 10 ] [ Designated as safety issue: No ]
  • Change from baseline on the various cognition tests at Weeks 4, 8 and 10 [ Time Frame: Change from baseline at Weeks 4, 8 and 10 ] [ Designated as safety issue: No ]
  • Functional Assessments Change from baseline on the following tests at Week 8 and 10: UPSA-2 and PSP [ Time Frame: Change from baseline at weeks 8 and 10 ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: weeks 2, 4, 6, 8, 10 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 160
Study Start Date: December 2007
Estimated Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: MEM 3454
Capsule 5 mg once a day
Experimental: B Drug: MEM 3454
Capsule 15 mg once a day
Experimental: C Drug: MEM 3454
Capsule 50 mg once a day
Placebo Comparator: D Drug: Placebo for MEM 3454
Capsule once a day

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of schizophrenia (any subtype), assessed using a structured interview.
  • At least one month on the same dose of antipsychotic medication.
  • Clinically stable, as judged by the investigator, and in a non-acute phase for at least 12 weeks.
  • Able to provide informed consent.
  • Fluent in English.
  • Smokers and non-smokers.

Exclusion Criteria:

  • First 3 years of schizophrenia diagnosis.
  • Current risk of suicide, or history of suicidal behavior within the last 6 months.
  • Hospitalized for psychiatric symptoms in the past 3 months.
  • Other psychiatric diagnoses.
  • Substance abuse/dependence (other than nicotine or caffeine) within the last 6 months according.
  • Nicotine replacement therapy, smoking cessation medications or remedies, including Varenicline (Chantix).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00604760

  Show 44 Study Locations
Sponsors and Collaborators
Memory Pharmaceuticals
  More Information

Additional Information:
MATRICS Tests  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Amy S. Domanowski, Ph.D., Head Regulatory Affairs, Memory Pharmaceuticals Corp.
ClinicalTrials.gov Identifier: NCT00604760     History of Changes
Other Study ID Numbers: MEM 3454-101
Study First Received: January 17, 2008
Last Updated: December 5, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Schizophrenia
Cognition Disorders
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Antipsychotic Agents
Tranquilizing Agents
 Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on May 23, 2013