Neuroleptic trials design

For newer agents, defining the plasma level or dose-response relationship should be a priority to avoid using excessive doses for prolonged periods of time. This information may also be relevant for designing clinical trials using appropriate doses of neuroleptics for comparison trials against novel antipsychotics (i.e., parallel dose-response studies). 

There is enormous interest in the effectiveness of neuroleptic drugs in conditions other than schizophrenia, such as autism (1) and psychosis in patients with dementia (2). Neuroleptic medication for treatment of psychosis and agitation in patients with dementia was generally effective in double-blind, placebo-controlled trials mean improvement rates were 61% with neuroleptic drugs and 35 % with placebo. However, the number of well-designed studies in this area has been small so far. 

The patients with schizophrenia performed 100 xlly tasks, 200 x22y tasks and eventually 300 x33y tasks. The reason of this design was that the index finger performed approximately 100 trials within each task. This was necessary to make the evaluations of the various tasks comparable to each other. The patients with schizophrenia had first rank symptoms in their history but were without productive symptoms now. All had negative symptoms like deficiency of emotion and concentration. All were treated with neuroleptics. The age of the patients lay between 20 and 40 years. 

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