Proof of Concept Study of Cognitive Improvement in Patients With Schizophrenia

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.

Completed

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Key information

Conditions

Schizophrenia Cognition Disorders Mental Disorders Neurocognitive Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Calgary, Alberta, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AZD3480

Drug

oral capsule

Primary outcomes

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 outcomes

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

Time frame: Change from baseline to Week 12

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Acronym: HALO

Important dates

Study start: 2007
Primary completion: 2008
Study completion: 2008
First posted: Sep 12, 2007
Registry last updated: Nov 25, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed