Department of Psychiatry, University of Minnesota Medical School, Minneapolis, MN, USA
McLean Hospital, Harvard Medical School, Boston, MA, USA
Halliwick Unit, St Anns Hospital, Barnet, Enfield and Haringey Mental Health Trust, London, UK
Department of Psychosomatic Medicine, Central Institute of Mental Health, University of Heidelberg, Germany
Lilly Research Laboratories, Indianapolis, IN, USA
Lilly Research Laboratories, Belgium
Lilly Research Laboratories, Indianapolis, IN, USA
Correspondence: Dr S. Charles Schulz, Department of Psychiatry, Medical School, F282/2A West, 2450 Riverside Avenue, Minneapolis, MN 55454, USA. Email: scs{at}umn.edu
This study was sponsored by Eli Lilly. S.C.S. has received honorarium from Eli Lilly, AstraZeneca and Bristol-Meyers Squibb; grant fees from Eli Lilly, AstraZeneca, Abbott, MIND Institute and the NIMH; and consultation fees from Eli Lilly, AstraZeneca and Vanda. H.C.D., Q.T., Y.T., D.L. and S.C. are employed by Lilly Research Laboratories.
Background
Despite the prevalence and clinical significance of borderline personality disorder, its treatment remains understudied.
Aims
To evaluate treatment with variably dosed olanzapine in individuals with borderline personality disorder.
Method
In this 12-week randomised, double-blind trial, individuals received olanzapine (2.5–20 mg/day; n=155) or placebo (n=159) (trial registry: NCT00091650). The primary efficacy measure was baseline to end-point change on the Zanarini Rating Scale for Borderline Personality Disorder (ZAN–BPD) using last-observation-carried-forward methodology.
Results
Both olanzapine and placebo groups showed significant improvements but did not differ in magnitude at end-point (–6.56 v. –6.25, P=0.661). Response rates (50% reduction in ZAN–BPD) were 64.7% with olanzapine and 53.5% with placebo (P=0.062); however, time to response was significantly shorter for olanzapine (P=0.022). Weight gain was significantly greater (2.86 v. –0.35 kg, P<0.001), with higher incidence of treatment-emergent abnormal high levels of prolactin for the olanzapine group.
Conclusions
Individuals treated with olanzapine and placebo showed significant but not statistically different improvements on overall symptoms of borderline personality disorder. The types of adverse events observed with olanzapine treatment appeared similar to those observed previously in adult populations.
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