Olanzapine for the treatment of borderline personality disorder: variable dose 12-week randomised double-blind placebo-controlled study

Schulz, S. Charles; Zanarini, Mary C.; Bateman, Anthony; Bohus, Martin; Detke, Holland C.; Trzaskoma, Quynh; Tanaka, Yoko; Lin, Daniel; Deberdt, Walter; Corya, S.

doi:10.1192/bjp.bp.107.037903

Cited by 100 publications

(47 citation statements)

References 38 publications

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“…Of note, two studies 31,33 of olanzapine-treated groups had a significantly lower degree of amelioration of recurrent suicidal ideation as compared to the placebo groups. No significant differences were found in the comparison of olanzapine with fluoxetine and olanzapine with haloperidol for any pathology-related outcome.…”

Section: Olanzapinementioning

confidence: 99%

“…The intervention times ranged from 12 weeks to 6 months. The trials by Zanarini and colleagues 33,35,38 were supported in part by a grant from Eli Lilly (Indianapolis, IN), the maker of olanzapine.…”

Section: Olanzapinementioning

confidence: 99%

“…Six of these studies compared olanzapine to placebo. These studies are Bogenschutz and Nurnberg 31 (n = 40); Linehan et al 32 (olanzapine was added to psychotherapy, n = 24); Schulz et al 33 (n = 314); Soler et al 34 (all patients were in DBT, n = 60); Zanarini and Frankenberg 35 (n = 28); and Eli Lilly 36 (n = 301). Of the remaining three studies, one compared olanzapine to haloperidol (Shafti and Shahveisi, 37 n = 28); one compared olanzapine to sertraline (Jariani et al, 10 n = 120 [all patients were on methadone maintenance therapy]); and one with three different arms of treatment 38 compared olanzapine to fluoxetine (n = 30), then olanzapine to olanzapine plus fluoxetine (n = 31), and finally fluoxetine to fluoxetine and olanzapine (n = 29).…”

Section: Olanzapinementioning

confidence: 99%

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The Efficacy of Pharmacotherapy for Borderline Personality Disorder: A Review of the Available Randomized Controlled Trials

Francois¹,

Roth²,

Klingman³

2015

Psychiatric Annals

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Although there are no medications approved by the US Food and Drug Administration for the treatment of borderline personality disorder (BPD), polypharmacy is commonly encountered in individuals with BPD. This review summarizes the results of randomized controlled trials on the efficacy of pharmacologic agents in BPD. Pharmacotherapy in BPD is an adjunctive treatment aimed at stabilizing symptoms and behavior in a crisis situation, and it should be avoided whenever possible. Further studies are needed, including large, randomized controlled trials with long-term follow up, to examine the efficacy of psychiatric medications in patients with BPD. ANTIDEPRESSANTS Selective Serotonin Reuptake InhibitorsSalzman et al. 7 described the results of a 13-week, double-blind, placebocontrolled study of the effects of fluoxetine on anger in patients with BPD or BPD traits. Thirteen patients received fluoxetine and nine received placebo. All patients began with a single 20-mg capsule or identical placebo, and doses were titrated up to a maximum of 60 mg/day. The authors found a reduction in anger among the fluoxetine recipients but no reduction in depression.In 2004, the therapeutic effect of fluoxetine added to dialectical behavior therapy (DBT) for the treatment of BPD was examined by Simpson et al. 8 in a 12-week, randomized, doubleblind, placebo-controlled study. Of the 20 patients that completed treatment, 9 were randomly assigned to receive up to 40 mg/day of fluoxetine and 11 were randomly assigned to placebo. The result showed no significant group differences in scores from pretreatment to posttreatment on any measure. Rinne et al.9 conducted a doubleblind, placebo-controlled, randomized trial of fluvoxamine (mean dose 150 mg/day) for 6 weeks followed by a blind half-crossover for 6 weeks and an open follow-up for another 12 weeks in 38 women with BPD. Fluvoxamine improved rapid mood shifts (standardized mean changes [SMD], -0.646) but not impulsivity and aggression.Jariani et al. 10 compared sertraline (50-100 mg/day) to olanzapine (5-10 mg/day) for the treatment of BPD in 120 patients on methadone maintenance therapy for heroin dependence who were also diagnosed as having BPD. The results (evaluation of Symptom Checklist-90 questionnaire before treatment and in the 4th, 8th, and 12th weeks of treatment) indicated that both drugs could generally ameliorate depression, anxiety, hypersensitivity in interpersonal relationships, aggression, obsession, and somatization symptoms in a 12-week treatment. Sertraline was more effective in decreasing symptoms of depression, hypersensitivity in interpersonal relationships, and obsession. Olanzapine was more useful for anxiety, aggression, and paranoia symptoms. There was no difference in decreasing somatization symptoms between both drugs. In regard to selfmutilation, there was a significant difference in the olanzapine group.

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Section: Olanzapinementioning

confidence: 99%

Section: Olanzapinementioning

confidence: 99%

Section: Olanzapinementioning

confidence: 99%

See 1 more Smart Citation

The Efficacy of Pharmacotherapy for Borderline Personality Disorder: A Review of the Available Randomized Controlled Trials

Francois¹,

Roth²,

Klingman³

2015

Psychiatric Annals

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“…In another RCT performed by Schulz et al, 314 patients were randomly assigned to olanzapine (2.5-20 mg/day) or placebo for 12 weeks [47]. Both groups showed a sig nificant improvement of BPD symptomatology (Zanarini Rating Scale for BPD) and did not differ at end point.…”

Section: Olanzapinementioning

confidence: 99%

Recent approaches to pharmacotherapy of personality disorders

Bellino

Rinaldi²,

Bozzatello³

et al. 2011

Neuropsychiatry

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Recent approaches to pharmacotherapy of personality disorders Practice pointsPharmacotherapy of personality disorders should be considered a symptom-focused treatment, targeting dimensions of affective dysregulation, impulsive-behavioral dyscontrol and cognitive-perceptual symptoms.To date, randomized controlled trials have been performed in samples of patients with antisocial personality disorder, schizotypal personality disorder and borderline personality disorder (BPD). However, the great majority of these trials have been conducted in samples with BPD.There is some evidence that mood stabilizers (topiramate, valproate and lamotrigine), second-generation antipychotics (olanzapine, aripiprazole), and omega-3 fatty acids can be useful for the treatment of affective symptoms and impulsive-behavioral dyscontrol in BPD patients.Antipsychotics produced an improvement of psychotic-like symptoms both in patients with BPD and schizotypal personality disorder.Selective serotonin reuptake inhibitors were found to be effective in decreasing depressed mood, anxiety, and anger in BPD patients, mainly with a comorbid major depressive episode. However, recent evidence no longer supports their use as first-line treatment of affective symptoms and impulsive-behavioral dyscontrol in BPD.Present studies suffer from important methodological limitations. Thus, further investigations are needed to confirm available findings. SUMMARY A growing number of studies on pharmacotherapy of personality disorders have been performed. This article considers controlled trials conducted between 1990 and 2010, and is directed toward the treatment of personality disorders. Data on borderline personality disorder (BPD), antisocial personality disorder and schizotypal personality disorder (STPD) were collected and discussed, in order to provide indications for clinical practice. Concerning antisocial personality disorder and STPD, available evidence is too sparse to propose treatment recommendations. As for BPD, there is some evidence that mood stabilizers (topiramate, valproate, and lamotrigine), second-generation antipsychotics (olanzapine, aripiprazole), and omega-3 fatty acids can be useful to treat affective symptoms For reprint orders, please contact: reprints@futuremedicine.comNeuropsychiatry (2011) 1(3) future science group 260Review Bellino, Rinaldi, Bozzatello & Bogetto Personality disorders (PDs) are defined as endur ing patterns of inner experience and behavior causing distress, which lead to maladaptive functioning in the areas of emotion, cognition, interpersonal relationships and impulse con trol [1]. Since the 1980s there has been increas ing recognition that PDs can be considered as syndromes of interacting dimensional traits that arise from psychosocial development and/or biological vulnerability [2]. Personality dimen sions acquired through social and cultural learning are termed character, whereas those believed to have a biological origin, genetically determined or acquired from overt injury to the CNS, are traditionally referr...

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“…To date, ten RCTs have been conducted in samples with BPD to assess the efficacy of olanzapine versus placebo [13,16,23,19,21], versus active drugs [14,17,20], or versus placebo in a combined treatment with psychotherapy (dialectical behavioral therapy) [15,18]. The majority of accumulated evidence suggests that olanzapine is efficacious in treating cognitive-perceptual symptoms (psychotic-like symptoms), and in producing significant reduction in mood instability and impulsive behavioral dyscontrol.…”

Section: Introductionmentioning

confidence: 99%

Efficacy and Tolerability of Asenapine Compared with Olanzapine in Borderline Personality Disorder: An Open-Label Randomized Controlled Trial

et al. 2017

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ObjectiveThe present open label randomised controlled trial aimed to evaluate the efficacy and tolerability of asenapine in comparison with olanzapine, the most broadly studied antispychotic in BPD. Methods51 outpatients aged between 18 and 50 years, with a diagnosis of BPD based on DSM-5 criteria were assigned for 12 weeks to: (1) asenapine (5-10 mg/day) or (2) olanzapine (5-10 mg/day).Participants were assessed at baseline and after 12 weeks with: Clinical Global Impression Scale, Severity item (CGI-S), Hamilton Depression Rating Scale (HAM-D), Hamilton Anxiety Rating Scale (HAM-A), Social Occupational Functioning Assessment Scale (SOFAS), Borderline Personality Disorder Severity Index (BPDSI), Barratt Impulsiveness Scale, version 11 (BIS-11), Modified Overt Aggression Scale (MOAS), Self Harm Inventory (SHI), and Dosage Record and Treatment Emergent Symptom Scale (DOTES).Analysis of variance repeated measures was performed. Intention to treat analysis with last observation carried forward was conducted. ResultsDrop-outs were 11 (21.57%): six patients taking asenapine and five patients receiving olanzapine.Two patients who received asenapine stopped the drug, one due to oral hypoesthesia and the other due to moderate anxiety. Two patients receiving olanzapine discontinued the treatment for a significant weight gain ( ≥ 3 Kg). The remaining seven drop-outs resulted from the lack of compliance with the trial prescription. Forty out of the 51 patients (78%) completed the trial: 19 3 patients received asenapine, while 21 patients received olanzapine.We found a significant withinsubjects effect (trial duration) for all rating scales, except from the HAM-D, the MOAS, and two items of the BPDSI: namely, "identity disturbance" and "parasuicidal behaviors". A significant effect between subjects was found for the two items of the BPDSI: "affective instability" and "dissociation/paranoid ideation". Asenapine was found superior to olanzapine in reducing the affective instability score (P = 0.001), whereas olanzapine was found superior to asenapine in reducing dissociation/paranoid ideation (P = 0.012). However, the study was found to be underpowered to detect a difference between the drugs on the dissociation/paranoid ideation item of the BPDSI. Two patients receiving asenapine experienced akathisia and another two restlessness/anxiety, while three patients receiving olanzapine reported somnolence and two fatigue. ConclusionsAsenapine and olanzapine were demonstrated to have a similar efficacy. While asenapine was found to be more efficacious than olanzapine in treating affective instability, olanzapine was superior to asenapine in treating paranoid ideation and dissociation. However, the study was underpowered to detect a difference between groups on the dissociation/paranoid ideation item.Both medications were well tolerated, with asenapine being related to a higher frequency of oral hypoaestesia and akathisia, and olanzapine being prone to induce weight gain.The open label study design, lack of a placebo group, and smal...

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Olanzapine for the treatment of borderline personality disorder: variable dose 12-week randomised double-blind placebo-controlled study

Cited by 100 publications

References 38 publications

The Efficacy of Pharmacotherapy for Borderline Personality Disorder: A Review of the Available Randomized Controlled Trials

The Efficacy of Pharmacotherapy for Borderline Personality Disorder: A Review of the Available Randomized Controlled Trials

Recent approaches to pharmacotherapy of personality disorders

Efficacy and Tolerability of Asenapine Compared with Olanzapine in Borderline Personality Disorder: An Open-Label Randomized Controlled Trial

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