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USE OF VERY LOW DOSE ANTIPSYCHOTIC IN THE TREATMENT OF FIRST EPISODE PSYCHOSIS. IS IT FEASIBLE IN ROUTINE CLINICAL CARE? |
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McGregory PD, Cocks JT, Plowright D, Downin M, Longley T, Maude D, Edwards J |
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clinical trial examines the effects of very low dose neuroleptic treatment
(Risperidone) in young people aged 16 to 30 years experiencing a first
(non-affective) psychotic episode. The principle aim of the study is to
evaluate the efficacy of a once daily dose of Risperidone (2 miligrams)
over four weeks. In addition, the study aim to evaluate three treatment
options for participants not achieving a predefined level of response after
a four-week treatment period. Non-responders (slow responders) after 2
mg of Risperidone are randomized to remaining of 2 mg, increasing up to
4 mg, or receiving 2 mg Risperidone plus adjunctive Lithium therapy. Levels
of remission are assessed at 63 days after entry to the study. Time to
remission, and long term changes to clinical symptoms over 12 months will
also be explored. Participants are assessed at the beginning of the trial
using the Royal Park Multidiagnostic Instrument for Psychosis (RPMIP).
Changes in clinical symptoms are assessed over time using the Brief Psychiatric
Rating Scale (BPRS), the Scale for the Assessment of Negative Symptoms
(SANS), the Clinical Global Impression Scale (CGI), and the Subjective
Global Impression Scale (SGI).
To date, the majority of patients eligible for the study have agreed to participate (n=60) and have remained in the study in the acute phase. The initial response rate fast responders) has been higher than expected at 60-70%, though it is too early to draw conclusion regarding the relationship of dose to ultimate levels of remission. Preliminary date relating to the randomization phase of this study will also be presented. |
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Centre for Young People’s Mental Health Locked Bag 10, Parkville 3052, Australia |