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
- Conditions
- Cognitive Impairment Associated With Schizophrenia
- Interventions
- Drug: Placebo for MEM 3454
- Registration Number
- NCT00604760
- Lead Sponsor
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 160
- 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.
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A MEM 3454 - B MEM 3454 - C MEM 3454 - D Placebo for MEM 3454 -
- Primary Outcome Measures
Name Time Method Change from baseline in the total composite score of the MATRICS cognitive battery at week 8. Change from baseline at wk 8.
- Secondary Outcome Measures
Name Time Method Change from baseline in the total composite score of the MATRICS cognitive battery at Weeks 4 and 10 Change from baseline - weeks 4 and 10 Change from baseline on the various cognition tests at Weeks 4, 8 and 10 Change from baseline at Weeks 4, 8 and 10 Functional Assessments Change from baseline on the following tests at Week 8 and 10: UPSA-2 and PSP Change from baseline at weeks 8 and 10 Adverse events weeks 2, 4, 6, 8, 10
Trial Locations
- Locations (43)
CRI Worldwide, LLC at Lourdes Medical Center of Burlington County
🇺🇸Willingboro, New Jersey, United States
Neuropsychiatric Research Center of Orange County
🇺🇸Santa Ana, California, United States
CRC Worldwide, LLC
🇺🇸Philadelphia, Pennsylvania, United States
California Clinical Trials Medical Group
🇺🇸San Diego, California, United States
Newport Bay Hospital
🇺🇸Newport Beach, California, United States
Berwyn Rehabilitation Center
🇺🇸Berwyn, Illinois, United States
Professional Clinical Research, Inc. c/o Segal Institute for Clinical Research
🇺🇸North Miami, Florida, United States
Fort Lauderdale Hospital
🇺🇸Fort Lauderdale, Florida, United States
Centerstone
🇺🇸Madison, Tennessee, United States
Collaborative NeuroScience Network, Inc.
🇺🇸Torrance, California, United States
Atlanta Center for Medical Research
🇺🇸Atlanta, Georgia, United States
Aventura Hospital
🇺🇸Miami, Florida, United States
TuKoi Clinical Research
🇺🇸Miami, Florida, United States
BHC Alhambra Hospital
🇺🇸Rosemead, California, United States
Telecare-Cresta Loma
🇺🇸Lemon Grove, California, United States
Excell Research
🇺🇸Oceanside, California, United States
Pasadena Research Institute
🇺🇸Pasadena, California, United States
Clinical Research Institute
🇺🇸Wichita, Kansas, United States
St. Louis Clinical Trials, LC
🇺🇸St. Louis, Missouri, United States
Alexian Brothers Behavioral Health Hospital
🇺🇸Hoffman Estates, Illinois, United States
American Medical Research, Inc.
🇺🇸Oak Brook, Illinois, United States
Research Strategies of Memphis, LLC
🇺🇸Memphis, Tennessee, United States
Sooner Clinical Research
🇺🇸Oklahoma City, Oklahoma, United States
Parkwood Behavioral Health System
🇺🇸Olive Branch, Mississippi, United States
Carolina Clinical Trials, Inc.
🇺🇸Charleston, South Carolina, United States
CRI Worldwide, LLC
🇺🇸Willingboro, New Jersey, United States
Arthur P. Noyes Research Foundation
🇺🇸Norristown, Pennsylvania, United States
Vogelfanger and Struble Clinic
🇺🇸Memphis, Tennessee, United States
Centerstone - Ella Hayes Center
🇺🇸Nashville, Tennessee, United States
Vanderbilt Psychiatric Hospital
🇺🇸Nashville, Tennessee, United States
Texas NeuroRehab Center, Pecos Unit
🇺🇸Austin, Texas, United States
Poplar Springs Hospital
🇺🇸Petersburg, Virginia, United States
Centerstone - Frank Luton Center
🇺🇸Nashville, Tennessee, United States
Coastal Communities Hospital
🇺🇸Santa Ana, California, United States
FutureSearch Trials
🇺🇸Austin, Texas, United States
University Hills Clinical Research
🇺🇸Irving, Texas, United States
Pacific Institute of Medical Sciences
🇺🇸Bothell, Washington, United States
Scientific Clinical Research, Inc.
🇺🇸North Miami, Florida, United States
Alexian Brothers Center for Psychiatric Research
🇺🇸Hoffman Estates, Illinois, United States
Chinmay K. Patel, DO
🇺🇸Hoffman Estates, Illinois, United States
Lakeside Behavioral Health System
🇺🇸Memphis, Tennessee, United States
Community Clinical Reserarch, Inc.
🇺🇸Austin, Texas, United States
International Clinical Research Associates, LLC
🇺🇸Richmond, Virginia, United States