A Study to Evaluate the Efficacy and Safety of Risperidone for the Prevention of Mood Episodes in the Treatment of Patients With Bipolar I Disorder
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Intervention: Olanzapine; Placebo; Risperidone Long Acting Injectable (LAI)
Intervention description: Intramuscular injections of placebo every 2 weeks and oral olanzapine 10 mg daily; Intramuscular injections of placebo every 2 weeks and oral placebo daily; Intramuscular injections of risperidone LAI (25, 37.5, or 50 mg) every 2 weeks and oral placebo daily
Intervention MeSH terms: Olanzapine; Risperidone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 585.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Bipolar I Disorder; Intramuscular injection; prevention of mood episodes; long acting injectable; risperidone

Summary:

      The purpose of this randomized, double blind, double dummy, multicenter study was to evaluate
      the efficacy of risperidone long-acting injectable (LAI) monotherapy in comparison with
      placebo in the prevention of a mood episode in treatment of patients with bipolar I disorder.
      Oral olanzapine was used to assess the validity of the study design. The primary objective of
      this study is to evaluate the efficacy of risperidone LAI versus placebo in the prevention of
      a mood episode (recurrence event) in patients with bipolar I disorder after a 12-week (3
      month) stabilization period on risperidone LAI, as measured by the time to recurrence of any
      mood episode. Risperidone LAI has been approved by the FDA in the USA for the treatment of
      patients with schizophrenia and for the prevention of mood recurrences in bipolar I disorder,
      as monotherapy or add-on treatment. It is approved at EMEA and other European and
      non-European health authorities for the treatment of patients with schizophrenia, too.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of bipolar I disorder as defined by DSM-IV-TR criteria. All diagnoses will
             be confirmed by the Mini International Neuropsychiatric Interview (M.I.N.I.). Patients
             who present with additional signs or symptoms compatible with Axis I diagnoses of
             social anxiety disorder or generalized anxiety disorder are acceptable. All other
             comorbid or active Axis I diagnoses are excluded. Personality disorders as defined by
             DSM IV TR criteria are acceptable, with the exception of antisocial and borderline
             personality disorders

          -  Must be currently experiencing a manic or mixed episode (acute

          -  YMRS >20 and CGI-S =>4 [moderate]) or must be between mood episodes (non-acute

          -  YMRS <12 and CGI-S=<3 [mild])

          -  Must have had at least 2 bipolar mood (manic, mixed manic, or depressed) episodes,
             exclusive of the current episode (if applicable), during the last year. For non-acute
             subjects (YMRS <12 and CGI-S=<3 [mild]), one manic episode must have occurred within 4
             months of enrollment

          -  Patients who are non-acute (YMRS <12 and CGI-S =<3 [mild]) and are currently receiving
             an antipsychotic other than risperidone or a mood stabilizer must have received this
             other medication at the same dosage for a minimum of 4 weeks and must be either
             experiencing problems of safety or tolerability with the antipsychotic or mood
             stabilizer or request a change of medication

        Exclusion Criteria:

          -  No history of more than 4 mood episodes each year (rapid cycling) during the last 2
             years prior to screening

          -  No history of ADHD, anxiety disorder, or panic disorder as the primary diagnosis

          -  Not meeting DSM-IV-TR criteria for a hypomanic or depressive episode

          -  Not meeting DSM-IV-TR criteria for any comorbid or active Axis I disorder other than
             those specifically allowed in the Inclusion Criteria

          -  Not meeting DSM-IV-TR criteria for antisocial or borderline personality disorder

          -  Not having a chronic or serious general medical illness, including hepatic, renal,
             respiratory, cardiovascular, endocrine, neurologic (including seizure disorder), or
             hematologic disease as determined by the clinical judgment of the investigator