Proof of Concept Study of Cognitive Improvement in Patients With Schizophrenia
HALO
A Multi-Center Randomized, Placebo-Controlled, Double-Blind, Parallel Group, Phase IIb Proof of Concept Study With 3 Oral Groups of AZD3480 During 12 Weeks Treatment of Cognitive Deficits in Patients With Schizophrenia
1 other identifier
interventional
400
2 countries
80
Brief Summary
The purpose of this study is to demonstrate that AZD3480 improves cognition in patients with stable schizophrenia who are being treated with an atypical antipsychotic and who are active cigarette smokers, to assess the safety and tolerability of AZD3480 and to define the optimal dose(s) to be used in future trials.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 schizophrenia
Started Aug 2007
80 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2007
CompletedFirst Submitted
Initial submission to the registry
September 10, 2007
CompletedFirst Posted
Study publicly available on registry
September 12, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2008
CompletedNovember 25, 2008
November 1, 2008
1.2 years
September 10, 2007
November 21, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Domain scores for Attention/Vigilance, Working Memory, Verbal Learning, Speed of Processing and Verbal Fluency as measured on the IntegNeuro computerized test battery of cognitive function
Change from baseline to Week 12
Secondary Outcomes (1)
UCSD Performance Based Skills Assessment (UPSA2) and on the Social Functioning Scale (SFS)
Change from baseline to Week 12
Study Arms (3)
1
PLACEBO COMPARATORPlacebo
2
EXPERIMENTALAZD3480 oral
3
EXPERIMENTALAZD3480 oral dose
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of schizophrenia
- Outpatient at the time of screening and randomization
- Stable housing defined as having a place to live in the community (ie, not in a hospital or nursing home)
- Active cigarette smoking (10 or more cigarettes per day
You may not qualify if:
- Any significant psychiatric or neurological disease other than schizophrenia, or current diagnosis of major depressive disorder
- Known or suspected drug or alcohol abuse within the 6 months or urine toxicology test positive for illegal or non-prescribed substances
- Impaired vision and/or hearing making cognitive testing difficult
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (80)
Research Site
Little Rock, Arkansas, United States
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Anaheim, California, United States
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Cerritos, California, United States
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Costa Mesa, California, United States
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Escondido, California, United States
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Garden Grove, California, United States
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Long Beach, California, United States
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Los Angeles, California, United States
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Oceanside, California, United States
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Pasadena, California, United States
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Pico Rivera, California, United States
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San Diego, California, United States
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Santa Ana, California, United States
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New Britain, Connecticut, United States
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New Haven, Connecticut, United States
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Washington D.C., District of Columbia, United States
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Boca Raton, Florida, United States
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Coral Gables, Florida, United States
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North Miami, Florida, United States
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Orlando, Florida, United States
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Tampa, Florida, United States
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Atlanta, Georgia, United States
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Augusta, Georgia, United States
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Marietta, Georgia, United States
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Chicago, Illinois, United States
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Joliet, Illinois, United States
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Schaumburg, Illinois, United States
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Indianapolis, Indiana, United States
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New Orleans, Louisiana, United States
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Glen Burnie, Maryland, United States
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Haverhill, Massachusetts, United States
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Pittsfield, Massachusetts, United States
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Minneapolis, Minnesota, United States
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St Louis, Missouri, United States
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Las Vegas, Nevada, United States
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Nashua, New Hampshire, United States
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Cherry Hill, New Jersey, United States
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Clementon, New Jersey, United States
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East Orange, New Jersey, United States
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Newark, New Jersey, United States
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Paramus, New Jersey, United States
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Brooklyn, New York, United States
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Cedarhurst, New York, United States
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Elmsford, New York, United States
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Glen Oaks, New York, United States
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Jamaica, New York, United States
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New York, New York, United States
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Rochester, New York, United States
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Staten Island, New York, United States
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Cincinnati, Ohio, United States
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Columbus, Ohio, United States
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Kettering, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Allentown, Pennsylvania, United States
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DuBois, Pennsylvania, United States
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Norristown, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Charleston, South Carolina, United States
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Memphis, Tennessee, United States
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Austin, Texas, United States
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DeSoto, Texas, United States
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Houston, Texas, United States
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Irving, Texas, United States
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San Antonio, Texas, United States
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Richmond, Virginia, United States
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Spokane, Washington, United States
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Calgary, Alberta, Canada
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Red Deer, Alberta, Canada
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Penticton, British Columbia, Canada
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Victoria, British Columbia, Canada
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Winnipeg, Manitoba, Canada
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Halifax, Nova Scotia, Canada
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Sydney, Nova Scotia, Canada
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Burlington, Ontario, Canada
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Greater Sudbury, Ontario, Canada
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Mississauga, Ontario, Canada
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Orléans, Ontario, Canada
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Toronto, Ontario, Canada
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Windsor, Ontario, Canada
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Montreal, Quebec, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Larry Rodichok, MD
AstraZeneca
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 10, 2007
First Posted
September 12, 2007
Study Start
August 1, 2007
Primary Completion
October 1, 2008
Study Completion
November 1, 2008
Last Updated
November 25, 2008
Record last verified: 2008-11