Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 1:08 AM
Ignite Modification Date:
2025-12-25 @ 1:08 AM
NCT ID:
NCT00917293
Brief 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.
Study:
NCT00917293
Study Brief:
Protocol Section:
NCT00917293