An Open-Label Trial of Risperidone Augmentation for Refractory Anxiety Disorders

Harvard University, Cambridge, Massachusetts, United States
The Journal of Clinical Psychiatry (Impact Factor: 5.5). 04/2006; 67(3):381-5. DOI: 10.4088/JCP.v67n0307
Source: PubMed


There is a paucity of data to support "next-step" treatments for the many patients with anxiety disorders who remain symptomatic after initial pharmacotherapy.
Thirty patients with a primary diagnosis of an anxiety disorder-panic disorder (PD), social anxiety disorder (SAD), or generalized anxiety disorder (GAD)-refractory to initial pharmacotherapy with an adequate (or maximally tolerated) antidepressant and/or benzodiazepine trial of at least 8 weeks' duration prior to study initiation received open-label augmentation with flexibly dosed risperidone for 8 weeks. Participants were diagnosed using the Structured Clinical Interview for DSM-IV.
Risperidone augmentation at a mean +/- SD dose of 1.12 +/- 0.68 mg/day (range, 0.25-3.00 mg/day) resulted in a significant reduction in anxiety symptoms across disorders as measured by the Clinical Global Impressions-Severity of Illness scale and Hamilton Rating Scale for Anxiety (HAM-A) scores and for each disorder-specific primary outcome measure-the Panic Disorder Severity Scale, the Liebowitz Social Anxiety Scale, and HAM-A-in the intent-to-treat sample. Seventy percent (21/30) of participants completed the 8-week trial, with premature discontinuation due primarily to sedation and weight gain.
Although conclusions are limited by the open-label, relatively brief nature of this trial, our data suggest that augmentation with low-dose risperidone may be a useful option for patients with PD, SAD, or GAD refractory to adequate initial intervention with antidepressants and/or benzodiazepines. Longer-term, controlled safety and efficacy data are needed to understand the place of risperidone augmentation in the algorithm of treatment options for refractory anxiety disorders.

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    • "Adjunctive risperidone was also reported to be effective in reducing symptoms of post-traumatic stress disorder as well as scores of the Ham-A and the positive subscale of the Positive and Negative Syndrome Scales (PANSS) in patients diagnosed with post-traumatic stress disorder [32]. Risperidone augmentation has been shown to be effective in reducing anxiety symptoms in a group of patients with a variety of anxiety disorders refractory to adequate treatment with antidepressants and/or benzodiazepines [55]. In a study of risperidone monotherapy, risperidone was reported to be more effective than placebo in reducing anxiety in women diagnosed with PTSD [56]. "
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    ABSTRACT: Because a large proportion of patients with panic attacks receiving approved pharmacotherapy do not respond or respond poorly to medication, it is important to identify additional therapeutic strategies for the management of panic symptoms. This article describes a randomized, rater-blind study comparing low-dose risperidone to standard-of-care paroxetine for the treatment of panic attacks. Fifty six subjects with a history of panic attacks were randomized to receive either risperidone or paroxetine. The subjects were then followed for eight weeks. Outcome measures included the Panic Disorder Severity Scale (PDSS), the Hamilton Anxiety Scale (Ham-A), the Hamilton Depression Rating Scale (Ham-D), the Sheehan Panic Anxiety Scale-Patient (SPAS-P), and the Clinical Global Impression scale (CGI). All subjects demonstrated a reduction in both the frequency and severity of panic attacks regardless of treatment received. Statistically significant improvements in rating scale scores for both groups were identified for the PDSS, the Ham-A, the Ham-D, and the CGI. There was no difference between treatment groups in the improvement in scores on the measures PDSS, Ham-A, Ham-D, and CGI. Post hoc tests suggest that subjects receiving risperidone may have a quicker clinical response than subjects receiving paroxetine. We can identify no difference in the efficacy of paroxetine and low-dose risperidone in the treatment of panic attacks. Low-dose risperidone appears to be tolerated equally well as paroxetine. Low-dose risperidone may be an effective treatment for anxiety disorders in which panic attacks are a significant component. Identifier: NCT100457106.
    Full-text · Article · Feb 2009 · BMC Psychiatry
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    • "Unsurprisingly, for treatment-resistant panic disorder, atypical antipsychotics were suggested . Olanzapine was studied in an open trial (Hollifield et al. 2005), followed by risperidone (Simon et al. 2006) . Papp (2006) found the anticonvulsant levetiracetam, to be useful in an open label, fixed-flexible dose study. "

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