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

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Design

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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

Outcome Measures

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 ]

Eligibility Criteria

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 55 Years (Adult)
Sexes Eligible for Study:	All
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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

  Show 80 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:	Larry Rodichok, MD	AstraZeneca

More Information

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Related Info 

ClinicalTrials.gov Identifier:	NCT00528905 History of Changes
Other Study ID Numbers:	D3690C00011
First Posted:	September 12, 2007
Last Update Posted:	November 25, 2008
Last Verified:	November 2008

Keywords provided by AstraZeneca:

Schizophrenia; Cognitive Deficits

Additional relevant MeSH terms:

Schizophrenia; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders