Therapeutic Use of Piracetam for Treatment of Patients Suffering From Tardive Dyskinesia: a Double Blind, Placebo-Controlled Crossover Study

We intend to examine 40 inpatients, aged 18-75 years old, suffering from TD and its variants. Criteria for inclusion into the study will be: a) DSM-IV diagnosis of tardive dyskinesia; b) stable psychotropic regimen of a month prior to entry into the study; c) duration of TD of at least 1 year; d) all patients had to be hospitalized.

Exclusion criteria will be: a) evidence of family history of Huntington's disease; b) evidence of substance or alcohol abuse; c) patients who received any form of vitamin medication; d) patients with concurrent medical illness or neurological disorders that may have influenced up the diagnosis of tardive dyskinesia.

The study design will be a double blind, randomized crossover group study and will be last for 8 weeks. This period provided an opportunity to exclude the influence of spontaneous fluctuations in the severity of TD. Full physical and laboratory examinations were performed on all inpatients in the beginning and at the end of the trial. Psychotropic medication will be maintained at fixed doses throughout the duration of study. The capsules preparations will be made by a professional pharmacist in the same size and color capsules in individual number-coded packages. The capsules will be added to the patients' usual medications and will be given by nurses.

Assessments for tardive dyskinesia and its variants will be done using Extrapyramidal Symptom Rating Scale (ESRS) at baseline and repeated every week, prior crossover, and then every week. This scale was developed by G. Chouinard and A. Ross-Chouinard (15) and was designed to rate three types of extrapyramidal symptoms: parkinsonian, dystonic and dyskinetic. Although the scale may be applied to non-drug-induced extrapyramidal symptoms, its sensitivity has been most often assessed in the evaluation of drug-induced extrapyramidal symptoms. The dose of piracetam or placebo will be increased every week on 2000 mg up to 8000 mg/day in dependence on the changes of movement disorders. The doses of their neuroleptic medications not will be change a month before and during the research. The patients will take piracetam or placebo as addition to their constant medication.

It should be emphasized again that improvement of TD symptoms after piracetam addition was appeared through very short period (3-7 days) in comparison to other medications used for treatment of TD. Moreover, if efficacy of piracetam will be proved in our study, clinicians obtain a new, effective, safe drug for TD treatment with rapid onset of the action.