CompletedPhase 3

Study of Risperidone Monotherapy in Ambulatory Bipolar Disorder With Concurrent Moderately Severe Anxiety and Lifetime Panic or Generalized Anxiety Disorder

United States111 participantsStarted 2004-02

Plain-language summary

The purpose of this research study is to evaluate the safety, tolerability, and efficacy (how well the drug works) of risperidone compared to placebo (an inactive drug) in the treatment of bipolar disorder with panic disorder or generalized anxiety disorder. Risperidone is currently approved by the United States Food and Drug Administration (FDA) for the treatment of schizophrenia and bipolar mania. Risperidone is not currently FDA approved for the treatment of bipolar hypomania with or without panic disorder or generalized anxiety disorder (the condition being investigated in this study).

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Subjects must be 18 years of age or older.
✓. Subjects must have lifetime bipolar I, II, or NOS disorder as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria.
✓. Subjects must have lifetime panic disorder or generalized anxiety disorder (GAD) as defined by DSM-IV criteria (except clause "does not occur exclusively during a mood disorder" of Criterion F for GAD) .
✓. Subjects' bipolar symptoms must be no more than moderately severe, defined as a CGI-BP \< 4.
✓. Subjects' anxiety symptoms must be at least moderately severe, defined as a CGI-S \> 4.
✓. Subjects must not be receiving mood stabilizing, antidepressant, antipsychotic, or anxiolytic medication for \> one week prior to baseline. Patients receiving fluoxetine or depot antipsychotics should be off these medications for \> four weeks prior to baseline.
✓. Subjects or their legally authorized representative must sign the Informed Consent Document after the nature of the trial has been fully explained.
✓. If female, subjects must be:

Exclusion criteria

What they're measuring

Clinical Global Improvement-21 Anxiety scale (CGI-21 Anxiety)

Timeframe: weekly

Trial details

NCT IDNCT00277654

SponsorLindner Center of HOPE

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2009-03

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