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LY2140023 withdrawal study in schizophrenia
NCT01452919Phase 3
Key facts
- Status
- Completed
- Start
- Nov 2011
- Primary completion
- Sep 2012
- Countries
- 2
- Sponsor
- Denovo Biopharma
- Modality
- Small Molecules
- Conditions
- schizophrenia
01
Overview
Phase 3, randomised, double-blind trial in schizophrenia comparing LY2140023 Continuation with Placebo Withdrawal (2 arms). Primary endpoint: Discontinuation Symptom Checklist-Modified Rickels Total Score at Week 2. Started Nov 2011; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
LY2140023 Continuation
Continue LY2140023
Placebo Withdrawal
Switch to Placebo
03
Who it enrols
Patients with DSM-IV-TR schizophrenia requiring modification or initiation of antipsychotic medication, excluding those with inadequate response to prior antipsychotics or recent clozapine use.
04
Endpoints
Primary
Discontinuation Symptom Checklist-Modified Rickels Total Score
Secondary
Clinical Institute Withdrawal Assessment of Alcohol Scale Total Score
Barnes Akathisia Scale Global Score
Simpson-Angus Scale Total Score
Abnormal Involuntary Movement Scale Total Score
Columbia Suicide Severity Rating Scale
Clinical Global Impression-Severity Scale
Brief Psychiatric Rating Scale Total Scores
05
Results
Not all primary endpoints met
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