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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00528905
First received: September 10, 2007
Last updated: November 21, 2008
Last verified: November 2008
  Purpose

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 Intervention Phase
Schizophrenia
Drug: AZD3480
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

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 [ Time Frame: Change from baseline to Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • UCSD Performance Based Skills Assessment (UPSA2) and on the Social Functioning Scale (SFS) [ Time Frame: Change from baseline to Week 12 ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: August 2007
Study Completion Date: November 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
Placebo
Drug: AZD3480
oral capsule
Experimental: 2
AZD3480 oral
Drug: AZD3480
oral capsule
Experimental: 3
AZD3480 oral dose
Drug: AZD3480
oral capsule

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00528905

  Show 80 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Larry Rodichok, MD AstraZeneca
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00528905     History of Changes
Other Study ID Numbers: D3690C00011
Study First Received: September 10, 2007
Last Updated: November 21, 2008
Health Authority: United States: Food and Drug Administration
Canada: Canadian Institutes of Health Research

Keywords provided by AstraZeneca:
Schizophrenia
Cognitive Deficits

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on September 18, 2014