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L-Dopa augmentation for negative symptoms in schizophrenia
NCT01636037Phase 2
Key facts
- Status
- Completed
- Start
- Sep 2012
- Primary completion
- Dec 2015
- Countries
- 1
- Modality
- Small Molecules
- Drugs
- levodopa + carbidopa
- Conditions
- schizophrenia
01
Overview
Phase 2, open-label, single-arm trial of levodopa + carbidopa in schizophrenia, sponsored by Center for Addiction and Mental Health. Primary endpoint: Schedule for the Assessment of Negative Symptoms at 8 weeks. Started Sep 2012; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
L-Dopa (Sinemet)
Augmentation of current antipsychotic treatment with oral L-Dopa (levodopa/carbidopa)
03
Who it enrols
Patients with SCID-confirmed schizophrenia, ages 18-55, on stable antipsychotic medication. Excludes substance abuse, serious neurological/medical conditions (Parkinson's, epilepsy, cardiac, renal, hepatic), and pregnancy.
04
Endpoints
Primary
Schedule for the Assessment of Negative Symptoms
Secondary
MATRICS Consensus Cognitive Battery
Brief Psychotic Rating Scale
Schedule for the Assessment of Positive Symptoms
Brief Negative Symptoms Scale
Clinical Global Impression - Severity
Quality of Life Scale
Calgary Depression Scale
Simpson Angus Scale
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