Controlled, dose-response study of sertindole and haloperidol in the treatment of schizophrenia. Sertindole Study Group.

OBJECTIVE: This multicenter, double-blind, placebo-controlled study evaluated the efficacy and safety of three doses of sertindole (12, 20, and 24 mg/day) and haloperidol (4, 8, and 16 mg/day) in the treatment of psychotic symptoms for 497 hospitalized patients with schizophrenia. METHOD: The patients were randomly assigned to one of the medication groups and received treatment for 8 weeks. Changes in Positive and Negative Syndrome Scale, Scale for the Assessment of Negative Symptoms, Brief Psychiatric Rating Scale, and Clinical Global Impression scores were used as evaluations of treatment efficacy. Three rating scales were used to assess extrapyramidal symptoms as well as the occurrence of adverse events and the use of medications related to extrapyramidal symptoms. RESULTS: Both sertindole and haloperidol were comparably effective in the treatment of psychosis, and all dose levels were significantly more effective than placebo. For the treatment of negative symptoms, only sertindole, 20 mg/day, was significantly more effective than placebo. For all extrapyramidal symptom measures, sertindole was clinically and statistically indistinguishable from placebo, and rates of extrapyramidal symptoms were not dose related. All dose levels of haloperidol produced significantly more extrapyramidal symptoms than placebo or sertindole. Adverse events associated with sertindole treatment were mild in severity. CONCLUSIONS: Sertindole is a new antipsychotic agent effective for the treatment of both the positive and negative symptoms of schizophrenia, with motor side effects that are indistinguishable from those associated with placebo.

Sertindole in the treatment of psychosis in schizophrenia: efficacy and safety.

Evidence from clinical trials supports the claim that sertindole is a potent antipsychotic drug at a dose of 12-24 mg/day. Its action against positive symptoms is as potent as that of the traditional antipsychotic haloperidol. Its action against negative symptoms is significantly different from that of placebo and quantitatively larger than that of haloperidol. Its most distinctive characteristic is a reduction in motor side effects over a whole range of comparable drug and comparator doses. More work is needed to determine whether sertindole's actions against negative symptoms influence the primary or the secondary negative system. There are insufficient data at present to compare sertindole with the highly efficacious drug clozapine or the other new antipsychotic olanzapine.

Hooked on hormones? An anabolic steroid addiction hypothesis.

Widespread illicit anabolic steroid use has recently been reported. A review of available evidence suggests that elevations of serum levels of steroid hormones, including anabolic steroids, have profound psychological effects. Long-term, high-dose anabolic steroid use may lead to a preoccupation with drug use, difficulty stopping despite psychological side effects, and drug craving. Reductions in serum levels of steroid hormones appear to result in acute hyperadrenergic withdrawal symptoms that respond to steroid replacement or to agents that also ameliorate withdrawal symptoms in alcohol and opioid dependence. A delayed depression syndrome when serum steroid levels drop precipitously has been reported that appears similar to that observed in withdrawing cocaine-dependent individuals. We conclude that a proportion of anabolic steroid abusers may develop a previously unrecognized sex steroid hormone-dependence disorder and that treatment should be based on research into steroid effects on opioid and aminergic neurotransmission systems and relapse prevention.