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Proof of Concept Study of Cognitive Improvement in Patients With Schizophrenia (HALO)

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
AZD3480
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Cognitive Deficits

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

1

2

3

Arm Description

Placebo

AZD3480 oral

AZD3480 oral dose

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

UCSD Performance Based Skills Assessment (UPSA2) and on the Social Functioning Scale (SFS)

Full Information

First Posted
September 10, 2007
Last Updated
November 21, 2008
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00528905
Brief Title
Proof of Concept Study of Cognitive Improvement in Patients With Schizophrenia
Acronym
HALO
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

2. Study Status

Record Verification Date
November 2008
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
November 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
AstraZeneca

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia, Cognitive Deficits

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Placebo Comparator
Arm Description
Placebo
Arm Title
2
Arm Type
Experimental
Arm Description
AZD3480 oral
Arm Title
3
Arm Type
Experimental
Arm Description
AZD3480 oral dose
Intervention Type
Drug
Intervention Name(s)
AZD3480
Intervention Description
oral capsule
Primary Outcome Measure Information:
Title
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
Time Frame
Change from baseline to Week 12
Secondary Outcome Measure Information:
Title
UCSD Performance Based Skills Assessment (UPSA2) and on the Social Functioning Scale (SFS)
Time Frame
Change from baseline to Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Larry Rodichok, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Little Rock
State/Province
Arkansas
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United States
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Anaheim
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California
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United States
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Cerritos
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California
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United States
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Costa Mesa
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California
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United States
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Escondido
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California
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United States
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Garden Grove
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California
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United States
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Long Beach
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California
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United States
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Los Angeles
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California
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United States
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Oceanside
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California
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United States
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Pasadena
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California
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United States
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Pico Rivera
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California
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United States
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San Diego
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California
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United States
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Santa Ana
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California
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United States
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New Britain
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Connecticut
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United States
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New Haven
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Connecticut
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United States
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Washington
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District of Columbia
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United States
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Boca Raton
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Florida
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United States
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Coral Gables
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Florida
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United States
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North Miami
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United States
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Orlando
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Florida
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United States
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Tampa
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United States
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Atlanta
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Georgia
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United States
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Augusta
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Georgia
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United States
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Marietta
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United States
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Chicago
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Illinois
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United States
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Joliet
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Schaumburg
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Indianapolis
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Indiana
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New Orleans
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Glen Burnie
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United States
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Haverhill
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Pittsfield
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Minneapolis
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St. Louis
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Las Vegas
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Nashua
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United States
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Cherry Hill
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United States
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Clementon
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East Orange
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Newark
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United States
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Paramus
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United States
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Brooklyn
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Cedarhurst
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Elmsford
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Glen Oaks
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Jamaica
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New York
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New York
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Rochester
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United States
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Staten Island
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New York
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Cincinnati
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Columbus
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United States
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Kettering
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Ohio
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United States
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Oklahoma City
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Oklahoma
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United States
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Allentown
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Pennsylvania
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United States
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Dubois
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United States
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Norristown
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United States
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Philadelphia
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Charleston
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South Carolina
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United States
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Memphis
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Tennessee
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United States
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Austin
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United States
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Desoto
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Houston
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Irving
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San Antonio
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Richmond
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Virginia
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Spokane
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Calgary
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Alberta
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Canada
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Red Deer
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Alberta
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Canada
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Penticton
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British Columbia
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Canada
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Victoria
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British Columbia
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Canada
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Winnipeg
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Manitoba
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Canada
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Halifax
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Nova Scotia
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Canada
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Sydney
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Nova Scotia
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Canada
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Burlington
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Ontario
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Canada
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Mississauga
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Ontario
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Canada
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Orleans
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Ontario
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Canada
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Sudbury
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Ontario
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Canada
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Toronto
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Ontario
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Canada
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Windsor
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Ontario
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Canada
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Montreal
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Quebec
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Canada

12. IPD Sharing Statement

Learn more about this trial

Proof of Concept Study of Cognitive Improvement in Patients With Schizophrenia

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