drugset / Trial / NCT01706965
Kuvan in People With Schizophrenia and Schizoaffective Disorder
Phase 1/2
Completed
27 enrolled
New York State Psychiatric Institute
Stanley Medical Research Institute · collab
RandomizedParallel-groupSingle-blindTreatment
Summary
Rater blinded trial of six weeks of Kuvan vs. multivitamin in 60 outpatients with schizophrenia or schizoaffective disorder. The aims are to evaluate an anticipated clinical response to Kuvan treatment including negative symptom and cognitive deficits, evaluate safety of Kuvan treatment for schizophrenic patients and evaluate the relationship of changes in plasma Kuvan levels and efficacy outcomes.
Timeline
- Start
- 2012-10
- Primary completion
- 2016-06
- Completion
- 2016-06
Outcome
Missed primary endpoint
registry analysis (superiority test); Kuvan vs Multivitamin; p = .38; ANOVA NCT01706965 ↗
registry analysis (superiority test); Kuvan vs Multivitamin; p = .99; ANOVA NCT01706965 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | sapropterin | Unknown | 20 mg/kg | — |