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

NCT ID: NCT00129441

Last Updated: 2011-10-17

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-31

Study Completion Date

2008-01-31

Brief Summary

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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.

Detailed Description

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The goal of this study is to determine whether the short-term (4 week), double-blind administration of Merck L-830982 provides evidence of improvement in cognitive functioning in stable male subjects with schizophrenia. This initial, small sample size study (n=9 on L-830982 and n=6 on placebo) is restricted to males in order to reduce the variance that might be attributable to the well-documented sex differences in the clinical features of schizophrenia.

Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Merck L-830982

Group Type EXPERIMENTAL

Merck L-830982

Intervention Type DRUG

The initial dose of L-830982 was 3.0 mg twice daily (b.i.d.) the dosage increased to 5.0 mg b.i.d. at the end of week 1 and 8.0 mg b.i.d. at the end of week 2, which was continued for the remaining 2 weeks of the trial. Medications were dispensed weekly in blister packs by the hospital pharmacy.

Sugar pill

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Medications were dispensed weekly in blister packs by the hospital pharmacy, using the same number of pills as those on active drug.

Interventions

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Merck L-830982

The initial dose of L-830982 was 3.0 mg twice daily (b.i.d.) the dosage increased to 5.0 mg b.i.d. at the end of week 1 and 8.0 mg b.i.d. at the end of week 2, which was continued for the remaining 2 weeks of the trial. Medications were dispensed weekly in blister packs by the hospital pharmacy.

Intervention Type DRUG

Placebo

Medications were dispensed weekly in blister packs by the hospital pharmacy, using the same number of pills as those on active drug.

Intervention Type DRUG

Other Intervention Names

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MK-0777

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

University of Pittsburgh

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David A Lewis, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

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University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

References

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Lewis DA, Hashimoto T, Volk DW. Cortical inhibitory neurons and schizophrenia. Nat Rev Neurosci. 2005 Apr;6(4):312-24. doi: 10.1038/nrn1648.

Reference Type BACKGROUND
PMID: 15803162 (View on PubMed)

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. doi: 10.1007/s00213-003-1673-x. Epub 2003 Dec 9.

Reference Type BACKGROUND
PMID: 15205885 (View on PubMed)

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. doi: 10.1176/appi.ajp.2008.08030395. Epub 2008 Oct 15.

Reference Type RESULT
PMID: 18923067 (View on PubMed)

Other Identifiers

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0502027

Identifier Type: -

Identifier Source: org_study_id