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

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Schizophrenia

Treatments: Drug: AZD3480

Study type: Interventional

Funder types: Industry

Identifiers

NCT00528905

D3690C00011

Details and patient eligibility

About

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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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400 participants in 3 patient groups, including a placebo group

1

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: AZD3480

2

Experimental group

Description:

AZD3480 oral

Treatment:

Drug: AZD3480

3

Experimental group

Description:

AZD3480 oral dose

Treatment:

Drug: AZD3480