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Clinical Trial: GABA-A alpha2/3 Study

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Purpose
Eligibility
Location and Contact Information
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This study is currently recruiting patients.
Verified by University of Pittsburgh July 2005

Sponsors and Collaborators:	University of Pittsburgh Merck
Information provided by:	University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT00129441

Purpose

The purpose of this research study is to determine whether a short-term administration of an investigational study drug may provide evidence of improvement in cognitive functioning in a group of stable male subjects with schizophrenia.

Condition	Intervention	Phase
Schizophrenia	Drug: Merck L-830982	Phase II

MedlinePlus related topics: Schizophrenia

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Official Title: Treatment of Cognitive Disability in Schizophrenia with a GABA-A alpha2/3 Receptor Agonist

Further Study Details:

Primary Outcomes: To determine if the investigational study drug will be associated with improvement on measures of executive control and working memory and if a greater response is associated with a longer exposure to higher doses of the study drug.
Expected Total Enrollment: 15

Study start: August 2005

Eligibility

Ages Eligible for Study: 18 Years - 50 Years, Genders Eligible for Study: Male

Criteria

Inclusion Criteria:

Male participants
Between the ages of 18 and 50
Meet diagnostic criteria for schizophrenia or schizoaffective disorder
Are clinically stable for a minimum of 3 months on current dose of medication
Are unemployed (i.e., work less than 20 hours per week at competitive employment)

Exclusion Criteria:

Psychoactive substance dependence within the past 6 months or substance abuse within the past month
History of head trauma or other neurological disorder
Medical illness or medications, such as benzodiazepine treatment or HIV medications, that may be affected by study participation (the study doctor will discuss this with potential subjects.)
Mental retardation
Seizure disorder
History of a heart attack, arrhythmia, or other heart disease

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier NCT00129441

Kevin Eklund, RN 412-586-9009 eklundkd@upmc.edu
David A Lewis, MD 412-624-2924 lewisda@upmc.edu

Pennsylvania
University of Pittsburgh, Pittsburgh, Pennsylvania, 15213, United States; Recruiting

David A Lewis, MD 412-624-3934 lewisda@upmc.edu
David A Lewis, MD, Principal Investigator
Cameron S Carter, MD, Sub-Investigator
Raymond Y Cho, MD, Sub-Investigator

Study chairs or principal investigators

David A Lewis, MD, Principal Investigator, University of Pittsburgh

More Information

Publications

Lewis DA, Hashimoto T, Volk DW. Cortical inhibitory neurons and schizophrenia. Nat Rev Neurosci. 2005 Apr;6(4):312-24. Review.

Lewis DA, Volk DW, Hashimoto T. Selective alterations in prefrontal cortical GABA neurotransmission in schizophrenia: a novel target for the treatment of working memory dysfunction. Psychopharmacology (Berl). 2004 Jun;174(1):143-50. Epub 2003 Dec 9. Review.

Study ID Numbers: 0502027
Last Updated: August 11, 2005
Record first received: August 10, 2005
ClinicalTrials.gov Identifier: NCT00129441
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-08-23

Source: ClinicalTrials.gov
Cache Date: August 24, 2005

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GABA-A alpha2/3 Study - Article

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Clinical Trial: GABA-A alpha2/3 Study

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GABA-A alpha2/3 Study - Article

General Topics A-Z

Clinical Trial: GABA-A alpha2/3 Study

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Eligibility

Location and Contact Information

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