Phase 2
Completed N=15
Gamma-Amino Butyric Acid (GABA)-A Alpha2/3 Study
Source: ClinicalTrials.gov NCT00129441 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Oct 2011
Primary outcomePrimary: N-back Task - Reaction Time — 786; 684 msec — p=0.16
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY N-back Task - Reaction Time |
786; 684 | 0.16 |
| PRIMARY N-back Task - Error Rate |
0.239; 0.297 | 0.162 |
| PRIMARY AX Continuous Performance Test Task D-prime |
1.9; 0.7 | 0.12 |
| PRIMARY Preparing to Overcome Prepotency (POP) Task - Reaction Time |
57; 66 | 0.05 |
| PRIMARY Preparing to Overcome Prepotency Task - Error Rate |
0.042; 0.031 | 0.249 |
| SECONDARY Brief Psychiatric Rating Scale Total Score |
26.3; 27.0 | 0.01 sig |
| SECONDARY Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Total Score |
76.7; 70.8 | <0.05 sig |
| SECONDARY Repeatable Battery for the Assessment of Neuropsychological Status - Delayed Memory Subindex |
85.3; 63.8 | <0.05 sig |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00129441). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.