Clinical trial NCT00528905: Proof of Concept Study of Cognitive Improvement in Patients With Schizophrenia
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Schizophrenia
Keywords: Schizophrenia
Cognitive Deficits
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2007-09-12
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: 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
timeFrame: Change from baseline to Week 12
Secondary outcomes:
measure: UCSD Performance Based Skills Assessment (UPSA2) and on the Social Functioning Scale (SFS)
timeFrame: Change from baseline to Week 12
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Research Site
state: Arkansas
city: Anaheim
country: United States
facility: Research Site
state: California
city: Cerritos
country: United States
facility: Research Site
state: California
city: Costa Mesa
country: United States
facility: Research Site
state: California
city: Escondido
country: United States
facility: Research Site
state: California
city: Garden Grove
country: United States
facility: Research Site
state: California
city: Long Beach
country: United States
facility: Research Site
state: California
city: Los Angeles
country: United States
facility: Research Site
state: California
city: Oceanside
country: United States
facility: Research Site
state: California
city: Pasadena
country: United States
facility: Research Site
state: California
city: Pico Rivera
country: United States
facility: Research Site
state: California
city: San Diego
country: United States
facility: Research Site
state: California
city: Santa Ana
country: United States
facility: Research Site
state: California
city: New Britain
country: United States
facility: Research Site
state: Connecticut
city: New Haven
country: United States
facility: Research Site
state: Connecticut
city: Washington
country: United States
facility: Research Site
state: District of Columbia
city: Boca Raton
country: United States
facility: Research Site
state: Florida
city: Coral Gables
country: United States
facility: Research Site
state: Florida
city: North Miami
country: United States
facility: Research Site
state: Florida
city: Orlando
country: United States
facility: Research Site
state: Florida
city: Tampa
country: United States
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state: Florida
city: Atlanta
country: United States
facility: Research Site
state: Georgia
city: Augusta
country: United States
facility: Research Site
state: Georgia
city: Marietta
country: United States
facility: Research Site
state: Georgia
city: Chicago
country: United States
facility: Research Site
state: Illinois
city: Joliet
country: United States
facility: Research Site
state: Illinois
city: Schaumburg
country: United States
facility: Research Site
state: Illinois
city: Indianapolis
country: United States
facility: Research Site
state: Indiana
city: New Orleans
country: United States
facility: Research Site
state: Louisiana
city: Glen Burnie
country: United States
facility: Research Site
state: Maryland
city: Haverhill
country: United States
facility: Research Site
state: Massachusetts
city: Pittsfield
country: United States
facility: Research Site
state: Massachusetts
city: Minneapolis
country: United States
facility: Research Site
state: Minnesota
city: St. Louis
country: United States
facility: Research Site
state: Missouri
city: Las Vegas
country: United States
facility: Research Site
state: Nevada
city: Nashua
country: United States
facility: Research Site
state: New Hampshire
city: Cherry Hill
country: United States
facility: Research Site
state: New Jersey
city: Clementon
country: United States
facility: Research Site
state: New Jersey
city: East Orange
country: United States
facility: Research Site
state: New Jersey
city: Newark
country: United States
facility: Research Site
state: New Jersey
city: Paramus
country: United States
facility: Research Site
state: New Jersey
city: Brooklyn
country: United States
facility: Research Site
state: New York
city: Cedarhurst
country: United States
facility: Research Site
state: New York
city: Elmsford
country: United States
facility: Research Site
state: New York
city: Glen Oaks
country: United States
facility: Research Site
state: New York
city: Jamaica
country: United States
facility: Research Site
state: New York
city: New York
country: United States
facility: Research Site
state: New York
city: Rochester
country: United States
facility: Research Site
state: New York
city: Staten Island
country: United States
facility: Research Site
state: New York
city: Cincinnati
country: United States
facility: Research Site
state: Ohio
city: Columbus
country: United States
facility: Research Site
state: Ohio
city: Kettering
country: United States
facility: Research Site
state: Ohio
city: Oklahoma City
country: United States
facility: Research Site
state: Oklahoma
city: Allentown
country: United States
facility: Research Site
state: Pennsylvania
city: Dubois
country: United States
facility: Research Site
state: Pennsylvania
city: Norristown
country: United States
facility: Research Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Research Site
state: Pennsylvania
city: Charleston
country: United States
facility: Research Site
state: South Carolina
city: Memphis
country: United States
facility: Research Site
state: Tennessee
city: Austin
country: United States
facility: Research Site
state: Texas
city: Desoto
country: United States
facility: Research Site
state: Texas
city: Houston
country: United States
facility: Research Site
state: Texas
city: Irving
country: United States
facility: Research Site
state: Texas
city: San Antonio
country: United States
facility: Research Site
state: Texas
city: Richmond
country: United States
facility: Research Site
state: Virginia
city: Spokane
country: United States
facility: Research Site
state: Washington
city: Calgary
country: Canada
facility: Research Site
state: Alberta
city: Red Deer
country: Canada
facility: Research Site
state: Alberta
city: Penticton
country: Canada
facility: Research Site
state: British Columbia
city: Victoria
country: Canada
facility: Research Site
state: British Columbia
city: Winnipeg
country: Canada
facility: Research Site
state: Manitoba
city: Halifax
country: Canada
facility: Research Site
state: Nova Scotia
city: Sydney
country: Canada
facility: Research Site
state: Nova Scotia
city: Burlington
country: Canada
facility: Research Site
state: Ontario
city: Mississauga
country: Canada
facility: Research Site
state: Ontario
city: Orleans
country: Canada
facility: Research Site
state: Ontario
city: Sudbury
country: Canada
facility: Research Site
state: Ontario
city: Toronto
country: Canada
facility: Research Site
state: Ontario
city: Windsor
country: Canada
facility: Research Site
state: Ontario
city: Montreal
country: Canada
facility: Research Site
state: Quebec
Study officials:
affiliation: AstraZeneca
name: Larry Rodichok, MD
role: STUDY_DIRECTOR
References: