Xenazine in Late Dyskinetic Syndrome With Neuroleptics
Status:
Completed
Trial end date:
2017-08-01
Target enrollment:
Participant gender:
Summary
Late dyskinetic syndrome with neuroleptics, or tardive dyskinesia, is the appearance of
abnormal involuntary movements (AIM) in patients treated with antipsychotics for at least
three months. This important public health issue arises for 15-20% of patients treated with
neuroleptics, the most prescribed psychotropic drugs in mental disorders in France, and
seriously impacts the patients' quality of life. In over 50% of cases, it is
irreversible-that is to say that he will persist despite discontinuation of the offending
drug.
Risk factors have been described: the age and female gender are established, a higher dosage
of antipsychotic, a long-term treatment, a psychiatric condition other than schizophrenia are
likely risk factors, intermittent treatment, previous acute dyskinesia, neuroleptics or
powerful, longer term use of corrective treatments including anticholinergics are still
discussed.
Apart from preventive treatment, which consists in using antipsychotics as being coerced,
support is disappointing: the etiological treatment, which is to stop the offending
antipsychotic, is effective only in less than 50% of cases, the syndrome is most often late
irreversible. Must still have the possibility to interrupt the treatment, which is usually
impossible in the risk of decompensation of the mental illness for which the neuroleptic was
prescribed. Remains symptomatic treatment: functional neurosurgery is only for extreme cases,
because it is not without risk, in terms of morbidity and mortality. So it's the medication
that is most often offered: many drugs have been proposed, a direct result of the
multiplicity of neurotransmitter systems implicated.
However, in the vast majority of cases, this approach is disappointing not to say
ineffective. The only exception is the tetrabenazine, marketed under the name of Xenazine®.
Empirically, neurologists specializing in pathology of the movement are almost unanimous: its
efficiency is very good, with good tolerance. Some preliminary studies have reinforced this
impression. However, their level of evidence remains low and that is why the investigators
propose to implement a prospective multicenter clinical trial, double-blind with placebo
which will include two groups of 27 patients.