Safety and Efficacy of Pyridoxal 5' -Phosphate in the Treatment of Tardive Dyskinesia
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||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|
- The primary outcome measure will be a reduction in the total AIMS score for items 1 through 7 (facial and oral movements, extremity movements and trunk movements) across treatment groups. . [ Time Frame: From baseline through to week 12 ] [ Designated as safety issue: No ]
- An AIMS score reduction (items 1-7) across arms over course of study amongst completers; determine whether the proportion of responders differs between treatment arms; a reduction in the AIMS score, items 1 - 7 total, across treatment arms. [ Time Frame: From baseline through to Week 12 and Baseline compared to Week 12 ] [ Designated as safety issue: Yes ]
|Study Start Date:||May 2009|
|Study Completion Date:||August 2014|
|Primary Completion Date:||August 2012 (Final data collection date for primary outcome measure)|
Experimental: Pyridoxal 5'-Phosphate
Pyridoxal 5'-Phosphate, enteric-coated 2x 250mgs po bid.
Drug: Pyridoxal 5'-Phosphate
Pyridoxal 5'-Phosphate 500mgs po bid for 12 weeks.
Placebo Comparator: Placebo
Placebo 2 pills, po bid.
Placebo 2 pills, po bid for 12 weeks.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00917293
|Canada, British Columbia|
|Vancouver Island Health Authority|
|Victoria, British Columbia, Canada, V8R 4Z3|
|Centre for Addiction and Mental Health|
|Toronto, Ontario, Canada, M5T 1R8|
|Windsor Regional Hospital|
|Windsor, Ontario, Canada, N9C 3Z4|
|Schizophrenia Research Foundation (SCARF) Mental Health Centre|
|Chennai, TamilNadu, India, 600101|
|Principal Investigator:||Gary J. Remington, MD, PhD||Centre for Addiction and Mental Health|