Subjects with a diagnosos of bipolar I disorder who are currently experiencing a manic or mixed episode (YMRS>20 and CGI-S>/= 4 [moderate]) or who are between mood episodes (non-acute
Conditions
Interventions
Trade Name: Risperdal
Product Name: Risperdal 1 mg
Product Code: F005
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: RISPERIDONE
CAS Number: 106266062
Current Sponsor code: R064766
Conce
Sponsors
Janssen-Cilag International N.V
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects may be male or female and must be between the ages of 18 and 65 years, inclusive. Subjects must have a 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.). Subjects 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. Subjects must be currently experiencing a manic or mixed episode (YMRS >20 and CGI-S ³4 [moderate]) or must be between mood episodes (non-acute; YMRS =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Having a history of more than 4 mood episodes each year (rapid cycling) during the last 2 years prior to screening. Having received an experimental drug or used an experimental medical device within 30 days prior to screening. Having a history of ADHD, anxiety disorder, or panic disorder as the primary diagnosis. Meeting DSM-IV-TR criteria for a hypomanic or depressive episode. Meeting DSM-IV-TR criteria for any comorbid or active Axis I disorder other than those specifically allowed in the Inclusion Criteria. Meeting DSM-IV-TR criteria for antisocial or borderline personality disorder.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of risperidone long-acting injectable (LAI) versus placebo in the prevention of a mood episode (recurrence event) in subjects with bipolar I disorder after a 12-week (3-month) stabilazion period on risperidone LAI, as measured by the time to recurrence of any mood episode.;Secondary Objective: To evaluate the prevention of a mood episode with risperidone LAI versus placebo To evaluate overall duration of treatment of risperidone LAI versus placebo To evaluate the sustained efficacy of maintenance treatment with risperidone LAI versus placebo. To perform exploratory comparisons between risperidone LAI and olanzapine as well as between olanzapine and placebo with regard to all items mentioned above To evaluate the long-term safety of risperidone LAI in subjects with bipolar I disorder;Primary end point(s): A recurrence with a mood episode. The study will end when at least 142 subjects have a recurrence with a mood episode in Period III. | — |
Countries
Germany, Greece
Outcome results
None listed