Risperdal Consta for Bipolar Disorder
Condition: Bipolar I Disorder
MeSH terms: Bipolar Disorder
Intervention: Injectable Risperidone (Consta) or oral antipsychotic
Intervention description: Injectable Risperidone (Consta) from 12.5 to 50 mg q 2 weeks
Oral antipsychotic agents, olanzapine, quetiapine, ziprasidone, aripiprazole in doses approved in the US for bipolar disorder
Intervention MeSH terms: Olanzapine; Risperidone; Aripiprazole; Quetiapine Fumarate; Ziprasidone; Antipsychotic Agents
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Bipolar I Disorder; Risperidone Consta - Long Acting Injection; Oral second generation antipsychotic agents

Summary:

      We recruited 50 consenting adult subjects with DSM-IV TR diagnoses of bipolar disorder who
      were about to initiate or switch their current antipsychotic agent. Only 48 patients (23 in
      the risperidone LAI group and 25 in the oral AAP group) contributed data to the assessments.
      Patients were titrated and cross-tapered during a 3 month titration and stabilization phase.
      They were followed for an additional 12 months. Clinical outcomes such as study drop out,
      adverse events, worsening of symptoms, crisis interventions, need for additional medication,
      hospitalizations etc. were evaluated from months 3 to 15. The numbers of clinical events
      (pooled) will be used to evaluate if the long acting injectable form of risperidone has an
      advantage over the oral second generation antipsychotic agents in terms of treatment
      continuity and clinical stability.
    

Eligibility criteria:

        Inclusion Criteria:

          -  DSM-IV - TR diagnoses of bipolar disorder (I or II or NOS).

          -  Age 18 to 70 years

          -  Men or women

          -  Any Ethnicity

          -  Currently receiving or willing to receive treatment at sites associated with the
             Western Psychiatric Institute and Clinic -University of Pittsburgh Medical Center
             (inpatient or ambulatory) or Mon Yough Community Services, Inc. or at Mayview State
             Hospital, Bridgeville, PA (inpatient)

          -  Able to provide competent and sign an informed consent document

          -  It is clinically appropriate in the eligible individual to consider antipsychotic
             treatment for at least 15 months (clinician and investigator determined)

          -  It is clinically appropriate to switch antipsychotic treatment to one of the second
             generation antipsychotic agents being evaluated in this study.

          -  There is no known contraindication for the use of either risperidone or for more than
             two of the antipsychotic agents being considered in the study (Investigator
             determined)

          -  At entry (at the screening visit, and just prior to randomization) Y-MRS (Young-Mania
             rating scale, Young et al., 1978) total score > 15 in bipolar disorder patients
             entering in a manic or mixed or hypomanic or NOS episode.

          -  Either life-time or current comorbid substance abuse or dependence is permitted
             (unless the Investigator and referring physician opines the substance abuse is likely
             to significantly interfere with either the diagnosis of the Axis I condition or to
             compromise patients safety due to withdrawal issues (Investigator determined).

          -  Screening physical and laboratory/EKG procedures are within acceptable limits

        Exclusion Criteria:

          -  Actively suicidal or dangerous to others (Investigator opines that it is inappropriate
             to involve the potential subject in the study)

          -  Pregnant or lactating women

          -  Women in the reproductive age group who are not using any acceptable contraception
             (abstinence is not acceptable) or intend to become pregnant during the trial

          -  Subjects who are likely to face incarceration during the study duration (and for those
             already in the study, the continued participation of such subjects will be evaluated
             on a case-by-case basis)

          -  Patients currently receiving clozapine (or within six weeks prior to randomization)
             are ineligible for the study

          -  Subjects currently receiving a depot neuroleptic injectable agent, or within 2
             injection cycles of receiving the injection prior to randomization.

          -  Allergy or serious side effects (for instance - neuroleptic malignant syndrome) to
             either risperidone or to more than two of the other second-generation antipsychotic
             agents that have been approved for use in the U.S.A. (olanzapine, quetiapine,
             ziprasidone, aripiprazole-per investigator and referring clinician).

          -  Treatment resistance to either risperidone, or to more than two of the other
             antipsychotic agents in this trial (olanzapine, quetiapine, ziprasidone,
             aripiprazole).

          -  This is the first episode of mania, mixed or hypomania for patients.

          -  Current (or within one month prior to randomization) participation in an
             investigational drug/device study.

          -  Currently participating in another study that would confound the present study
             objectives (per investigator)