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The purpose of the study is to evaluate the efficacy of risperidone long-acting injectable in comparison with placebo in the prevention of a mood episode in treatment of patients with bipolar I disorder. This study tests the safety and effectiveness of a drug called risperidone Long Acting Injectable (LAI). Placebo treatment, and another drug called olanzapine are used to assess the validity of the study design. The purpose of this research study is to see if risperidone LAI can help keep patients who have bipolar disorder from having another mood episode. Risperidone LAI is injected into a muscle. The risperidone contained in the long acting injection slowly moves out of the spot where the injection was made and is taken up by the blood. Risperidone LAI has been approved by the FDA in the USA and health authorities in many European and other countries for use in patients with schizophrenia. Risperidone as a tablet has been approved for use in patients with the following conditions: schizophrenia and delaying relapse in schizophrenia and bipolar mania. Outside the United States risperidone has been approved for the treatment of mania in adults, behavioral and psychotic symptoms of dementia (BPSD), and conduct disorder in children and adults.
The primary objective of this study is to evaluate the efficacy of risperidone long-acting injectable (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. This is a randomized (patients are assigned different treatments based on chance), double-blind (neither the patient nor the physician knows whether drug or placebo is being taken, or at what dosage), double-dummy multicenter study with 3 parallel arms (risperidone LAI, placebo, and olanzapine) to evaluate the efficacy and safety of risperidone LAI in the prevention of a mood episode (recurrence event). This study includes 3 periods - the screening period (Period I, lasting up to 2 weeks); the open-label treatment period (Period II, lasting 12 weeks); and the double-blind treatment period (Period III, lasting up to 18 months and at least 9 months). In the open -label treatment period (Period II) treatment with risperidone LAI will be started with injection of a recommended dose of 25 mg in patients entering Period II. If judged clinically appropriate, patients may start with 37.5 mg. Injections are repeated every 14 days. Dosage can only be increased (up to a maximum dose of 50 mg every 14 days) if the CGI-S score has increased by => 1 over 2 consecutive assessments at least 2 weeks apart and if there is symptom exacerbation that cannot be treated adequately with short-term (14 days) benzodiazepine medication. If an increase in risperidone LAI dosage is necessary, oral risperidone (1 to 2 mg/day) needs to be added for 3 weeks after the first injection of the higher dosage. Patients experiencing an acute manic or mixed episode will additionally be treated with oral risperidone at whole-milligram dosages between 1 and 6 mg/day as needed to treat the symptoms of the acute episode for the first 3 weeks. Patients experiencing an acute episode who do not respond to treatment within 4 weeks will be discontinued from the study. Washout of all psychotropics other than risperidone must be completed by the end of the first week. Non-acute patients on an antipsychotic or mood stabilizer for at least 4 weeks will continue their previous treatment for the first 3 weeks. No changes will be made in the regimens of non-acute patients receiving an antipsychotic or mood stabilizer unless there is concern about efficacy or safety. Patients who do not show a response (acute patients at baseline) or do not maintain the efficacy (non-acute patients at baseline and acute patients after initial response) during the 12-week (3 month) open-label risperidone LAI stabilization period (Period II), will be discontinued from the study as soon as any one of the following criteria is met: The patient meets DSM-IV-TR criteria for a hypomanic, manic, mixed, or depressive episode; the patient needs treatment intervention with any mood stabilizer, antipsychotic medication (other than study drug), benzodiazepine (beyond the dosage allowed), or antidepressant medication; the patient requires hospitalization for any bipolar mood episode; the patient either has a YMRS score >12 in combination with CGI-S score =>4 or a MADRS score >12 in combination with a CGI-S score =>4. (If either of these criteria is fulfilled at an assessment but if the investigator assumes that this is only a temporary state that requires no action, the investigator is allowed to postpone the decision about maintenance or response by a maximum of 4 days. If after 4 days, the criteria are still met, the patient must be withdrawn from Period II.) Patients who show initial and maintained response (acute patients at baseline) or who maintain the efficacy (non-acute patients at baseline) during the 12-week (3-month) open-label risperidone LAI stabilization period (Period II), will be eligible for entering the double-blind treatment period (Period III). Patients who enter Period III will be randomized to receive intramuscular injections of risperidone LAI every 14 days (at the dosage achieved at the end of Period II) and oral placebo daily, or placebo injections every 14 days and oral placebo daily, or placebo injections every 14 days and oral olanzapine 10 mg/day. No supplementation with oral risperidone and no dosage titration will be allowed during this period of the study. Using the double-dummy design, all patients will receive an intramuscular injection every 14 days and will take oral medication every day. Patients who present with a recurrence during Period III, will be considered as meeting the end point of the study. Patients will remain in the double-blind treatment period until they meet recurrence criteria, until they withdraw consent, or are lost to follow-up, until the last patient completed at least 9 months without a mood episode in Period III, or until the study ends. The study will end when 158 patients have presented with a mood episode in Period III, or if the study is terminated based on the decision of the sponsor. Patients who are aged 18 to 65 years (inclusive) with a diagnosis of bipolar I disorder who are currently experiencing a manic or mixed episode or who are between mood episodes, who do not meet DSM-IV-TR criteria for a depressive episode, and who are in good physical health are eligible for the study if they meet the inclusion and exclusion criteria. Approximately 860 patients meeting the inclusion and exclusion criteria will be enrolled in this study, with the goal of observing at least 158 recurrence events in Period III. Safety evaluations will include adverse events, clinical laboratory tests - including blood glucose/lipid profile (fasting), prolactin, TSH, and urinalysis - vital signs (pulse and blood pressure) and ECG, physical examination, body weight and height, the Extrapyramidal Symptom Rating Scale, pregnancy testing, and urine drug screen. The patients will receive risperidone LAI (either 25, 37.5 or 50 mg equivalent) repeated every 14 days during the 12 week long open-label period. Patients who enter the double-blind period will be randomized to receive intramuscular injections of risperidone LAI every 14 days and oral placebo daily, or placebo injections every 14 days and oral placebo daily, or placebo injections every 14 days and oral olanzapine 10 mg/day. During the open-label period oral risperidone supplementation is used.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Bipolar I Disorder
Long-acting intramuscular injectable (LAI) risperidone; risperidone depot microspheres
Published on BioPortfolio: 2014-08-27T03:41:54-0400
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