Effect of the benzodiazepine derivative estazolam in patients with auditory hallucinations. A multicentre double-blind, cross-over study.

The main aim of this study was to test the effect of the triazolobenzodiazepine, estazolam, on auditory hallucinations. Fifty-eight patients (28 male, 30 female) with auditory hallucinosis that had responded poorly to neuroleptics alone, were included; most patients were chronic schizophrenics, and most patients were maintained on previous neuroleptic treatment during the trial. Each patient was treated for three consecutive 3-week periods, and randomly allocated to receive estazolam (1 + 1 + 4 mg) either in the first and third, or in the second period. Similar-looking placebo tablets were given in the control periods. These were seven drop-outs, three of them due to somnolence on estazolam. In both treatment groups there was a significant (but not significantly different) improvement during the first 3-week period, with regard to both global clinical state and auditory hallucinations. During the second and third periods, however, the two groups differed significantly, in that improvement of global state and hallucinosis was seen on estazolam, and deterioration on placebo. It is concluded that estazolam (as an addition to neuroleptics) had a significantly better effect than placebo on the global clinical state, on the frequency of, and attitude towards the hallucinations, and also on the single symptoms "Compulsive thoughts" and "Visual hallucinations" (items in the Comprehensive Psychopathological Rating Scale). There were few side effects except drowsiness. Possible pharmacokinetic and pharmacodynamic interactions between benzodiazepines and neuroleptics are discussed briefly.

RCT Entities:   Population Interventions Outcomes