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
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
1 other identifier
interventional
160
1 country
44
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
44 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2007
CompletedFirst Submitted
Initial submission to the registry
January 17, 2008
CompletedFirst Posted
Study publicly available on registry
January 30, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2009
CompletedDecember 8, 2008
December 1, 2008
1.2 years
January 17, 2008
December 5, 2008
Conditions
Outcome Measures
Primary Outcomes (1)
Change from baseline in the total composite score of the MATRICS cognitive battery at week 8.
Change from baseline at wk 8.
Secondary Outcomes (4)
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
Study Arms (4)
A
EXPERIMENTALB
EXPERIMENTALC
EXPERIMENTALD
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (44)
Telecare-Cresta Loma
Lemon Grove, California, 91945, United States
Newport Bay Hospital
Newport Beach, California, 92663, United States
Excell Research
Oceanside, California, 92056, United States
Pasadena Research Institute
Pasadena, California, 91107, United States
BHC Alhambra Hospital
Rosemead, California, 91770, United States
California Clinical Trials Medical Group
San Diego, California, 92123, United States
Neuropsychiatric Research Center of Orange County
Santa Ana, California, 92701, United States
Coastal Communities Hospital
Santa Ana, California, 92704, United States
Collaborative NeuroScience Network, Inc.
Torrance, California, 90502, United States
Aventura Hospital
Aventura, Florida, 33180, United States
Fort Lauderdale Hospital
Fort Lauderdale, Florida, 33301, United States
Aventura Hospital
Miami, Florida, 33180, United States
TuKoi Clinical Research
Miami, Florida, 33180, United States
Professional Clinical Research, Inc. c/o Segal Institute for Clinical Research
North Miami, Florida, 33161, United States
Scientific Clinical Research, Inc.
North Miami, Florida, 33161, United States
Atlanta Center for Medical Research
Atlanta, Georgia, 30308, United States
Berwyn Rehabilitation Center
Berwyn, Illinois, 60402, United States
Alexian Brothers Behavioral Health Hospital
Hoffman Estates, Illinois, 60169, United States
Alexian Brothers Center for Psychiatric Research
Hoffman Estates, Illinois, 60169, United States
Chinmay K. Patel, DO
Hoffman Estates, Illinois, 60169, United States
American Medical Research, Inc.
Oak Brook, Illinois, 60523, United States
Clinical Research Institute
Wichita, Kansas, 67207, United States
Parkwood Behavioral Health System
Olive Branch, Mississippi, 38654, United States
St. Louis Clinical Trials, LC
St Louis, Missouri, 63118, United States
CRI Worldwide, LLC at Lourdes Medical Center of Burlington County
Willingboro, New Jersey, 08046, United States
CRI Worldwide, LLC
Willingboro, New Jersey, 08046, United States
Sooner Clinical Research
Oklahoma City, Oklahoma, 73112, United States
Arthur P. Noyes Research Foundation
Norristown, Pennsylvania, 19401, United States
CRC Worldwide, LLC
Philadelphia, Pennsylvania, 19139, United States
Carolina Clinical Trials, Inc.
Charleston, South Carolina, 29405, United States
Centerstone
Madison, Tennessee, 37115, United States
Research Strategies of Memphis, LLC
Memphis, Tennessee, 38117, United States
Vogelfanger and Struble Clinic
Memphis, Tennessee, 38119, United States
Lakeside Behavioral Health System
Memphis, Tennessee, 38133, United States
Centerstone - Ella Hayes Center
Nashville, Tennessee, 37208, United States
Vanderbilt Psychiatric Hospital
Nashville, Tennessee, 37212-8645, United States
Centerstone - Frank Luton Center
Nashville, Tennessee, 37217, United States
Texas NeuroRehab Center, Pecos Unit
Austin, Texas, 78745, United States
Community Clinical Reserarch, Inc.
Austin, Texas, 78754, United States
FutureSearch Trials
Austin, Texas, 78756, United States
University Hills Clinical Research
Irving, Texas, 75062, United States
Poplar Springs Hospital
Petersburg, Virginia, 23805, United States
International Clinical Research Associates, LLC
Richmond, Virginia, 23229, United States
Pacific Institute of Medical Sciences
Bothell, Washington, 98011, United States
Related Publications (2)
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.
PMID: 15888422BACKGROUNDOlincy 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.
PMID: 16754836BACKGROUND
Related Links
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 17, 2008
First Posted
January 30, 2008
Study Start
December 1, 2007
Primary Completion
February 1, 2009
Last Updated
December 8, 2008
Record last verified: 2008-12