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
NCT ID: NCT00604760
Last Updated: 2008-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE2
160 participants
INTERVENTIONAL
2007-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
A
MEM 3454
Capsule 5 mg once a day
B
MEM 3454
Capsule 15 mg once a day
C
MEM 3454
Capsule 50 mg once a day
D
Placebo for MEM 3454
Capsule once a day
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
MEM 3454
Capsule 5 mg once a day
MEM 3454
Capsule 15 mg once a day
MEM 3454
Capsule 50 mg once a day
Placebo for MEM 3454
Capsule once a day
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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).
18 Years
55 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Memory Pharmaceuticals
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Memory Pharmaceuticals Corp.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Telecare-Cresta Loma
Lemon Grove, California, United States
Newport Bay Hospital
Newport Beach, California, United States
Excell Research
Oceanside, California, United States
Pasadena Research Institute
Pasadena, California, United States
BHC Alhambra Hospital
Rosemead, California, United States
California Clinical Trials Medical Group
San Diego, California, United States
Neuropsychiatric Research Center of Orange County
Santa Ana, California, United States
Coastal Communities Hospital
Santa Ana, California, United States
Collaborative NeuroScience Network, Inc.
Torrance, California, United States
Aventura Hospital
Aventura, Florida, United States
Fort Lauderdale Hospital
Fort Lauderdale, Florida, United States
Aventura Hospital
Miami, Florida, United States
TuKoi Clinical Research
Miami, Florida, United States
Professional Clinical Research, Inc. c/o Segal Institute for Clinical Research
North Miami, Florida, United States
Scientific Clinical Research, Inc.
North Miami, Florida, United States
Atlanta Center for Medical Research
Atlanta, Georgia, United States
Berwyn Rehabilitation Center
Berwyn, Illinois, United States
Alexian Brothers Behavioral Health Hospital
Hoffman Estates, Illinois, United States
Alexian Brothers Center for Psychiatric Research
Hoffman Estates, Illinois, United States
Chinmay K. Patel, DO
Hoffman Estates, Illinois, United States
American Medical Research, Inc.
Oak Brook, Illinois, United States
Clinical Research Institute
Wichita, Kansas, United States
Parkwood Behavioral Health System
Olive Branch, Mississippi, United States
St. Louis Clinical Trials, LC
St Louis, Missouri, United States
CRI Worldwide, LLC at Lourdes Medical Center of Burlington County
Willingboro, New Jersey, United States
CRI Worldwide, LLC
Willingboro, New Jersey, United States
Sooner Clinical Research
Oklahoma City, Oklahoma, United States
Arthur P. Noyes Research Foundation
Norristown, Pennsylvania, United States
CRC Worldwide, LLC
Philadelphia, Pennsylvania, United States
Carolina Clinical Trials, Inc.
Charleston, South Carolina, United States
Centerstone
Madison, Tennessee, United States
Research Strategies of Memphis, LLC
Memphis, Tennessee, United States
Vogelfanger and Struble Clinic
Memphis, Tennessee, United States
Lakeside Behavioral Health System
Memphis, Tennessee, United States
Centerstone - Ella Hayes Center
Nashville, Tennessee, United States
Vanderbilt Psychiatric Hospital
Nashville, Tennessee, United States
Centerstone - Frank Luton Center
Nashville, Tennessee, United States
Texas NeuroRehab Center, Pecos Unit
Austin, Texas, United States
Community Clinical Reserarch, Inc.
Austin, Texas, United States
FutureSearch Trials
Austin, Texas, United States
University Hills Clinical Research
Irving, Texas, United States
Poplar Springs Hospital
Petersburg, Virginia, United States
International Clinical Research Associates, LLC
Richmond, Virginia, United States
Pacific Institute of Medical Sciences
Bothell, Washington, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Buchanan RW, Davis M, Goff D, Green MF, Keefe RS, Leon AC, Nuechterlein KH, Laughren T, Levin R, Stover E, Fenton W, Marder SR. A summary of the FDA-NIMH-MATRICS workshop on clinical trial design for neurocognitive drugs for schizophrenia. Schizophr Bull. 2005 Jan;31(1):5-19. doi: 10.1093/schbul/sbi020. Epub 2005 Feb 16.
Olincy A, Harris JG, Johnson LL, Pender V, Kongs S, Allensworth D, Ellis J, Zerbe GO, Leonard S, Stevens KE, Stevens JO, Martin L, Adler LE, Soti F, Kem WR, Freedman R. Proof-of-concept trial of an alpha7 nicotinic agonist in schizophrenia. Arch Gen Psychiatry. 2006 Jun;63(6):630-8. doi: 10.1001/archpsyc.63.6.630.
Related Links
Access external resources that provide additional context or updates about the study.
MATRICS Tests
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MEM 3454-101
Identifier Type: -
Identifier Source: org_study_id