CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 27 enrolled
Drug / intervention
Kuvan +1 moredrug
Likely dose
Kuvan 20mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01706965
NCT01706965Phase 2Completed
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6R-BH 4 in People With Schizophrenia and Schizoaffective Disorder

New York State Psychiatric Institute·interventional·Posted Oct 15, 2012·Updated Sep 13, 2017

In Brief

A Phase 2 clinical trial evaluating Kuvan and Multivitamin for Schizophrenia and Schizoaffective Disorder. Completed, enrolled 27 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia, Schizoaffective Disorder
CountriesUnited States
CollaboratorsStanley Medical Research Institute

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedOct 15, 2012
Enrollment StartOct 1, 2012
Primary CompletionJun 1, 2016
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 13.7 years ago

Interventions

Kuvandrug

20mg/kg using a daily dosing schedule. To increase tolerability, treatment will be initiated at 10mg/kg for the first week of the study. Given the short length of the trial, no dose adjustments will be made for changes in weight

Multivitamindrug

Multi-vitamin will be used as an active control in this study. Will be dosed daily