Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
16 participants
INTERVENTIONAL
2005-08-31
2008-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Merck L-830982
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.
Sugar pill
Placebo
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.
Placebo
Medications were dispensed weekly in blister packs by the hospital pharmacy, using the same number of pills as those on active drug.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
50 Years
MALE
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
University of Pittsburgh
OTHER
Responsible Party
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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
Countries
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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.
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.
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.
Other Identifiers
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0502027
Identifier Type: -
Identifier Source: org_study_id