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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00528905
Recruitment Status : Completed
First Posted : September 12, 2007
Last Update Posted : November 25, 2008
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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.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: AZD3480 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : August 2007
Actual Primary Completion Date : October 2008
Actual Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: 1
Drug: AZD3480
oral capsule
Experimental: 2
AZD3480 oral
Drug: AZD3480
oral capsule
Experimental: 3
AZD3480 oral dose
Drug: AZD3480
oral capsule

Primary Outcome Measures :
  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 [ Time Frame: Change from baseline to Week 12 ]

Secondary Outcome Measures :
  1. UCSD Performance Based Skills Assessment (UPSA2) and on the Social Functioning Scale (SFS) [ Time Frame: Change from baseline to Week 12 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00528905

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Sponsors and Collaborators
Study Director: Larry Rodichok, MD AstraZeneca

Additional Information: Identifier: NCT00528905     History of Changes
Other Study ID Numbers: D3690C00011
First Posted: September 12, 2007    Key Record Dates
Last Update Posted: November 25, 2008
Last Verified: November 2008

Keywords provided by AstraZeneca:
Cognitive Deficits

Additional relevant MeSH terms:
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders