Gamma-Amino Butyric Acid (GABA)-A Alpha2/3 Study - Full Text View

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

Drug Information available for: gamma-Aminobutyric Acid

U.S. FDA Resources

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 as provided by University of Pittsburgh:

Primary Outcome Measures:

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

Enrollment:	15
Study Start Date:	August 2005
Study Completion Date:	January 2008
Primary Completion Date:	January 2008 (Final data collection date for primary outcome measure)

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00129441

Locations

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

Sponsors and Collaborators

University of Pittsburgh

Merck

Investigators

Principal Investigator:

David A Lewis, MD

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.

Publications indexed to this study:

Lewis DA, Cho RY, Carter CS, Eklund K, Forster S, Kelly MA, Montrose D. Subunit-selective modulation of GABA type A receptor neurotransmission and cognition in schizophrenia. Am J Psychiatry. 2008 Dec;165(12):1585-93. Epub 2008 Oct 15.

Study ID Numbers:	0502027
Study First Received:	August 10, 2005
Last Updated:	May 15, 2008
ClinicalTrials.gov Identifier:	NCT00129441
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Pittsburgh:

schizophrenia

Study placed in the following topic categories:

Schizophrenia
Mental Disorders
Gamma-Aminobutyric Acid
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
GABA Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009