Gamma-Amino Butyric Acid (GABA)-A Alpha2/3 Study
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Full description
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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
16 participants in 2 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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