Safety and Efficacy of Pyridoxal 5' -Phosphate in the Treatment of Tardive Dyskinesia
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.
|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|
|Estimated Study Completion Date:||September 2013|
|Estimated Primary Completion Date:||June 2013 (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.
|Contact: George R. Thomas, PhDemail@example.com|
|Contact: Michael C. Janzen, PhDfirstname.lastname@example.org|
|Canada, British Columbia|
|Vancouver Island Health Authority||Recruiting|
|Victoria, British Columbia, Canada, V8R 4Z3|
|Principal Investigator: Richard Williams, MBBS, FRCPC|
|Centre for Addiction and Mental Health||Recruiting|
|Toronto, Ontario, Canada, M5T 1R8|
|Contact: Steve Mann 1-416-535-8501 ext 4104|
|Contact: Carol Borlido 1-416-525-8501 ext 4321|
|Principal Investigator: Gary J. Remington, MD, PhD|
|Windsor Regional Hospital||Recruiting|
|Windsor, Ontario, Canada, N9C 3Z4|
|Principal Investigator: Leonardo Cortese, MD|
|Schizophrenia Research Foundation (SCARF) Mental Health Centre||Recruiting|
|Chennai, TamilNadu, India, 600101|
|Contact: Sujit John, MA 91 44 26153971 ext 1073 email@example.com|
|Principal Investigator: Rangaswamy Thara, MD, PhD|
|Principal Investigator:||Gary J. Remington, MD, PhD||Centre for Addiction and Mental Health|