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Trial record 3 of 4 for:    MEM3454

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 safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00604760
Recruitment Status : Unknown
Verified December 2008 by Memory Pharmaceuticals.
Recruitment status was:  Active, not recruiting
First Posted : January 30, 2008
Last Update Posted : December 8, 2008
Sponsor:
Information provided by:
Memory Pharmaceuticals

Brief Summary:
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 or disease Intervention/treatment Phase
Cognitive Impairment Associated With Schizophrenia Drug: MEM 3454 Drug: Placebo for MEM 3454 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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
Study Start Date : December 2007
Estimated Primary Completion Date : February 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Change from baseline in the total composite score of the MATRICS cognitive battery at week 8. [ Time Frame: Change from baseline at wk 8. ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. Adverse events [ Time Frame: weeks 2, 4, 6, 8, 10 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00604760


  Hide Study Locations
Locations
United States, California
Telecare-Cresta Loma
Lemon Grove, California, United States, 91945
Newport Bay Hospital
Newport Beach, California, United States, 92663
Excell Research
Oceanside, California, United States, 92056
Pasadena Research Institute
Pasadena, California, United States, 91107
BHC Alhambra Hospital
Rosemead, California, United States, 91770
California Clinical Trials Medical Group
San Diego, California, United States, 92123
Neuropsychiatric Research Center of Orange County
Santa Ana, California, United States, 92701
Coastal Communities Hospital
Santa Ana, California, United States, 92704
Collaborative NeuroScience Network, Inc.
Torrance, California, United States, 90502
United States, Florida
Aventura Hospital
Aventura, Florida, United States, 33180
Fort Lauderdale Hospital
Fort Lauderdale, Florida, United States, 33301
Aventura Hospital
Miami, Florida, United States, 33180
TuKoi Clinical Research
Miami, Florida, United States, 33180
Professional Clinical Research, Inc. c/o Segal Institute for Clinical Research
North Miami, Florida, United States, 33161
Scientific Clinical Research, Inc.
North Miami, Florida, United States, 33161
United States, Georgia
Atlanta Center for Medical Research
Atlanta, Georgia, United States, 30308
United States, Illinois
Berwyn Rehabilitation Center
Berwyn, Illinois, United States, 60402
Alexian Brothers Behavioral Health Hospital
Hoffman Estates, Illinois, United States, 60169
Alexian Brothers Center for Psychiatric Research
Hoffman Estates, Illinois, United States, 60169
Chinmay K. Patel, DO
Hoffman Estates, Illinois, United States, 60169
American Medical Research, Inc.
Oak Brook, Illinois, United States, 60523
United States, Kansas
Clinical Research Institute
Wichita, Kansas, United States, 67207
United States, Mississippi
Parkwood Behavioral Health System
Olive Branch, Mississippi, United States, 38654
United States, Missouri
St. Louis Clinical Trials, LC
St. Louis, Missouri, United States, 63118
United States, New Jersey
CRI Worldwide, LLC at Lourdes Medical Center of Burlington County
Willingboro, New Jersey, United States, 08046
CRI Worldwide, LLC
Willingboro, New Jersey, United States, 08046
United States, Oklahoma
Sooner Clinical Research
Oklahoma City, Oklahoma, United States, 73112
United States, Pennsylvania
Arthur P. Noyes Research Foundation
Norristown, Pennsylvania, United States, 19401
CRC Worldwide, LLC
Philadelphia, Pennsylvania, United States, 19139
United States, South Carolina
Carolina Clinical Trials, Inc.
Charleston, South Carolina, United States, 29405
United States, Tennessee
Centerstone
Madison, Tennessee, United States, 37115
Research Strategies of Memphis, LLC
Memphis, Tennessee, United States, 38117
Vogelfanger and Struble Clinic
Memphis, Tennessee, United States, 38119
Lakeside Behavioral Health System
Memphis, Tennessee, United States, 38133
Centerstone - Ella Hayes Center
Nashville, Tennessee, United States, 37208
Vanderbilt Psychiatric Hospital
Nashville, Tennessee, United States, 37212-8645
Centerstone - Frank Luton Center
Nashville, Tennessee, United States, 37217
United States, Texas
Texas NeuroRehab Center, Pecos Unit
Austin, Texas, United States, 78745
Community Clinical Reserarch, Inc.
Austin, Texas, United States, 78754
FutureSearch Trials
Austin, Texas, United States, 78756
University Hills Clinical Research
Irving, Texas, United States, 75062
United States, Virginia
Poplar Springs Hospital
Petersburg, Virginia, United States, 23805
International Clinical Research Associates, LLC
Richmond, Virginia, United States, 23229
United States, Washington
Pacific Institute of Medical Sciences
Bothell, Washington, United States, 98011
Sponsors and Collaborators
Memory Pharmaceuticals

Additional Information:
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
First Posted: January 30, 2008    Key Record Dates
Last Update Posted: December 8, 2008
Last Verified: December 2008

Additional relevant MeSH terms:
Schizophrenia
Cognitive Dysfunction
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Cognition Disorders
Neurocognitive Disorders
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs