NCT00917293

Safety and Efficacy of Pyridoxal 5' -Phosphate in the Treatment of Tardive Dyskinesia

A Randomized, Double-Blind, Placebo-Controlled, Comparative Study to Evaluate the Safety and Efficacy of Pyridoxal 5' -Phosphate in the Treatment of Tardive Dyskinesia in Patients With Schizophrenia and Schizoaffective Disorders

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Medicure · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The primary objective is to assess the safety and effectiveness of Pyridoxal 5'-Phosphate on the reduction of expressed symptoms of tardive dyskinesia in patients with schizophrenia and schizoaffective disorders.

Detailed description

This study will assess the effect of Pyridoxal 5'-Phosphate on the reduction of expressed symptoms of moderate to severe tardive dyskinesia in patients with schizophrenia and schizoaffective disorders who are on a stable dose, and regime, of either a long acting (i.e. depot/IM) or oral antipsychotic medication, as compared to placebo. Symptoms will be assessed through the administration and scoring of Abnormal Involuntary Movement Scale (AIMS), specifically on items 1 through 7 (facial and oral movements, extremity movements and trunk movements) at each visit.

Conditions

• Tardive Dyskinesia

Interventions

Type	Name	Description
DRUG	Pyridoxal 5'-Phosphate	Pyridoxal 5'-Phosphate 500mgs po bid for 12 weeks.
DRUG	Placebo	Placebo 2 pills, po bid.

Timeline

• Start date: 2009-05-01
• Primary completion: 2012-08-01
• Completion: 2014-08-01
• First posted: 2009-06-10
• Last updated: 2019-02-15

Locations

4 sites across 2 countries: Canada, India