Proof of Concept Study of Cognitive Improvement in Patients With Schizophrenia (HALO)
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ClinicalTrials.gov Identifier: NCT00528905 |
Recruitment Status
:
Completed
First Posted
: September 12, 2007
Last Update Posted
: November 25, 2008
|
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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 |

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
|
- 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 ]
- UCSD Performance Based Skills Assessment (UPSA2) and on the Social Functioning Scale (SFS) [ Time Frame: Change from baseline to Week 12 ]

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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

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 ClinicalTrials.gov identifier (NCT number): NCT00528905

Study Director: | Larry Rodichok, MD | AstraZeneca |
Additional Information:
ClinicalTrials.gov 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:
Schizophrenia Cognitive Deficits |
Additional relevant MeSH terms:
Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Mental Disorders |