Randomized, placebo-controlled trial of risperidone for acute treatment of bipolar anxiety

David V. Sheehan, Susan L. McElroy, Kathy Harnett-Sheehan, Paul E. Keck, Juris Janavs, Jamison Rogers, Robert Gonzalez, Geetha Shivakumar, Trisha Suppes

Research output: Contribution to journalArticle

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Abstract

Background: The treatment of bipolar disorder is often complicated by the presence of a co-occuring anxiety disorder. Although second generation antipsychotics are being used with increasing frequency in bipolar patients, their anxiolytic effects have not been well studied in this population. Methods: The anxiolytic effect of risperidone 0.5-4 mg/day was tested in an 8-week, double-blind, placebo-controlled, randomized clinical trial in 111 patients with bipolar disorder and a co-occuring panic disorder or generalized anxiety disorder (GAD). The primary outcome measure was the Clinician Global Improvement-21 Anxiety scale (CGI-21 Anxiety). Secondary measures included the Hamilton Anxiety Scale (HAM-A) and the Sheehan Panic Disorder Scale. Results: On the last-observation-carried forward analysis of repeated measures analysis of variance (ANOVA), risperidone was not more effective than placebo for the CGI-21 Anxiety score or the other anxiety outcome measures. Risperidone was well tolerated, with only two patients withdrawing because of adverse events. Limitations: The risperidone treated group had more patients with mixed states and lifetime panic disorder at randomization than the placebo group. The study was limited to 8 weeks and to individuals with bipolar and comorbid panic disorder or GAD. The results may not be applicable to risperidone as an add-on treatment to mood stabilizers, or to bipolar disorder comorbid with anxiety disorders other than panic disorder or GAD. Conclusions: Risperidone monotherapy was not an effective anxiolytic for bipolar patients with comorbid panic disorder or GAD in doses of 0.5-4 mg/day over 8 weeks of treatment. The efficacy of other second generation antipsychotics and mood stabilizers on anxiety in patients with bipolar disorder and a co-occuring anxiety disorder should be investigated in double-blind, placebo-controlled studies.

Original languageEnglish (US)
Pages (from-to)376-385
Number of pages10
JournalJournal of Affective Disorders
Volume115
Issue number3
DOIs
StatePublished - Jun 1 2009

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Risperidone
Anxiety Disorders
Panic Disorder
Anxiety
Randomized Controlled Trials
Placebos
Bipolar Disorder
Anti-Anxiety Agents
Therapeutics
Antipsychotic Agents
Outcome Assessment (Health Care)
Random Allocation
Analysis of Variance
Observation
Population

All Science Journal Classification (ASJC) codes

  • Clinical Psychology
  • Psychiatry and Mental health

Cite this

Sheehan, D. V., McElroy, S. L., Harnett-Sheehan, K., Keck, P. E., Janavs, J., Rogers, J., ... Suppes, T. (2009). Randomized, placebo-controlled trial of risperidone for acute treatment of bipolar anxiety. Journal of Affective Disorders, 115(3), 376-385. https://doi.org/10.1016/j.jad.2008.10.005
Sheehan, David V. ; McElroy, Susan L. ; Harnett-Sheehan, Kathy ; Keck, Paul E. ; Janavs, Juris ; Rogers, Jamison ; Gonzalez, Robert ; Shivakumar, Geetha ; Suppes, Trisha. / Randomized, placebo-controlled trial of risperidone for acute treatment of bipolar anxiety. In: Journal of Affective Disorders. 2009 ; Vol. 115, No. 3. pp. 376-385.
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Sheehan, DV, McElroy, SL, Harnett-Sheehan, K, Keck, PE, Janavs, J, Rogers, J, Gonzalez, R, Shivakumar, G & Suppes, T 2009, 'Randomized, placebo-controlled trial of risperidone for acute treatment of bipolar anxiety', Journal of Affective Disorders, vol. 115, no. 3, pp. 376-385. https://doi.org/10.1016/j.jad.2008.10.005

Randomized, placebo-controlled trial of risperidone for acute treatment of bipolar anxiety. / Sheehan, David V.; McElroy, Susan L.; Harnett-Sheehan, Kathy; Keck, Paul E.; Janavs, Juris; Rogers, Jamison; Gonzalez, Robert; Shivakumar, Geetha; Suppes, Trisha.

In: Journal of Affective Disorders, Vol. 115, No. 3, 01.06.2009, p. 376-385.

Research output: Contribution to journalArticle

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Sheehan DV, McElroy SL, Harnett-Sheehan K, Keck PE, Janavs J, Rogers J et al. Randomized, placebo-controlled trial of risperidone for acute treatment of bipolar anxiety. Journal of Affective Disorders. 2009 Jun 1;115(3):376-385. https://doi.org/10.1016/j.jad.2008.10.005