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A 17-Week, Phase 2, Multicenter, Randomized, Double-Blind Study of Treatment With LY2140023 Combined With Standard of Care (SOC) Compared to Placebo With SOC in the Treatment of Patients With Prominent Negative Symptoms of Schizophrenia
The purpose of this study is to determine whether LY2140023, when added to standard-of-care antipsychotic treatment, will improve negative symptoms.
Details
| Lead sponsor | Denovo Biopharma LLC |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 167 |
| Start date | 2010-01 |
| Completion | 2012-06 |
Conditions
- Schizophrenia
Interventions
- LY2140023
- Placebo
- Standard of Care
Primary outcomes
- Change From Baseline in the 16-Item Negative Symptoms Assessment (NSA-16) — Baseline, randomization treatment Week 16
The NSA-16 scale is used to help clinicians rate behaviors (not psychopathology) commonly associated with negative symptoms of schizophrenia. The scale rates participants on 16 "anchors". Each item ("anchor") is rated from 1 (better) to 6 (worse). The total score is the sum of the 16 specific items and ranges from 16 to 96. Higher scores indicate greater severity of illness. The Mixed Model Repeated Measure (MMRM) analysis was used to calculate Least Squares (LS) mean and standard error. LS mean values are controlled for visit, pooled investigative site, treatment, standard of care (SOC) type, baseline positive symptom stratum, treatment\*visit, baseline NSA-16 total score, and baseline NSA-16 total score\*visit.
Countries
United States, Israel, Italy, Spain