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Eleven drugs are approved by the US Food and Drug Administration (FDA) for acute mania. For bipolar maintenance, only lithium, aripiprazole, olanzapine, lamotrigine, and adjunctive quetiapine are FDA approved. The standard medications for acute mania include monotherapy and combined therapy. The standard medications for maintenance include lithium, valproate, carbamazepine and second-generation antipsychotics (SGAs). The other established acute and maintenance treatments include benzodiazepines, electroconvulsive therapy (ECT), clozapine and experimental antimanic treatments. All of the medications reviewed have potentially serious adverse consequences that obligate careful pretreatment and ongoing monitoring, and that call for personalized treatment selection. The traditional mood stabilizers, lithium, valproate, and carbamazepine, are teratogenic, particularly in the first trimester, although the risk of cardiovascular malformation with lithium is thought by some to have been over-estimated. In general first-generation antipsychotics (FGAs), SGAs, and, if necessary ECT, are preferred for mania in pregnancy.
In spite of the virtually ubiquitous nature of the initial 10-day placebo run-in period (IPR) in drug trials, there is little empirical data establishing its relevance.
Data from 593 subjects were examined retrospectively to determine whether or not the prognosis of subjects minimally improved during the IPR was different to those who were unimproved. The IPR period was single-blind and was followed by a six-week double-blind phase in all studies.
Twenty-six per cent of the subjects were minimally improved and 74% were unimproved. Approximately 10% of the subjects who were much improved were not followed systematically. Across a range of diagnosis, severity and chronicity subjects minimally improved (versus unimproved) after IPR had a more favourable prognosis whether assigned to drug or placebo.
Change during IPR appears to be a meaningful predictor. Stratification should be considered in future antidepressant studies.
We summarise a series of studies using a MAOI to help establish the validity of a subgroup of depressives referred to as atypical depressives. Patients with reactive mood meeting DSM-III criteria for depressive illness who had associated atypical features (which include hyperphagia, hypersomnolence, leaden paralysis, and rejection sensitivity) were randomised to imipramine, phenelzine and placebo. Non-responders were crossed over, and in all there were over 400 patient trials. Phenelzine consistently was found to be superior to imipramine. Only in trials which included patients lacking atypical, vegetative symptoms was imipramine found to equal phenelzine. We conclude that the researcher and the clinician should consider the relevance of the atypical depressive syndrome.
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