Awarded Trial: 03-STN-001
900 mg t.i.d.
Secondary Drug Intervention
Duration of Study Period for Each Subject
PANSS, Cognitive Battery, Calgary Depression Scale, Quality of Life Scale
105 patients were randomized and 95 completed the four-week trial. CX516 was associated with a small (effect size 0.32) improvement in the composite cognitive score compared to placebo, which was not statistically significant. Performance was not significantly improved on any cognitive test, nor were any symptom ratings improved with CX516. The PANSS total score was significantly reduced in the placebo group compared to CX516. CX516 was well-tolerated, although associated with a significantly greater incidence of insomnia, fatigue and gastrointestinal complaints.
Freedom Trail Clinic, Department of Psychiatry
Massachusetts General Hospital
Lindemann Mental Health Center, 25 Staniford Street
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