None listed
Conditions
Interventions
GROUP 1 Type of group
This group will be treated with Risperidone at a dose of 25 mg, IV, every 14 days for a period of 12 weeks, the dose can be adjusted according to the clinical response (Open Treatment Period). After this period, they will continue with Risperidone with the dose established in the previous period and will start with Olanzapine Placebo, PO, QD
This group will be treated with Risperidone at a dose of 25 mg, IV, every 14 days for a period of 12 weeks, the dose can be adjusted according to the clinical response (Open Treatment Period). After this period, they will continue with Risperidone Placebo, IV, every 14 days + Olanzapine at a dose of 10 mg, PO, QD
this scheme will continue at least 9 months and up to 18 months.
Sponsors
JANSSEN-CILAG,
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects can be male or female and must be between 18 and 65 years of age. 2. Subjects must have a diagnosis of bipolar I disorder. 3. Subjects must be currently experiencing a manic or mixed episode or must be between episodes of mood change. 4. The subjects must have had at least 2 episodes of bipolar mood, excluding the current episode, during the last year. 5. Subjects who qualify as non-acute who are currently receiving an antipsychotic other than risperidone or a mood stabilizer must have received this other medication at the same dose for a minimum of 4 weeks and must be experiencing safety or security problems or tolerability with the antipsychotic or mood stabilizer or request a change of medication. 6. Only voluntary inpatients. 7. Outpatients should not be dangerous to themselves or to others. 8. Subjects with a history of attention deficit hyperactivity disorder (ADHD), anxiety disorder, or panic disorder are acceptable if this is not the primary diagnosis. 9. Women should be surgically sterile, abstinent or, if sexually active, be using an effective contraceptive method. 10. Women must have obtained a negative result from a pre-pregnancy pregnancy test. 11. Subjects must have been previously treated with oral risperidone or must have tolerated a trial dose of risperidone orally in two subsequent 2 days prior to the first injection of risperidone lAP. 12. Subjects must have signed an informed consent document indicating that they understand the purpose of the study and the procedures required for the study and that they are willing to participate in the study.
Exclusion criteria
Exclusion criteria: 1. Subjects with a history of more than 4 episodes of change in mood each year during the last 2 years prior to the preselection. 2. Subjects who have received an experimental drug or used an experimental medical device within 30 days prior to the preselection. 3. Subjects with a history of attention deficit hyperactivity disorder (ADHD), anxiety disorder, or panic disorder as the primary diagnosis. 4. Subjects that meet the DSM-IV-TR criteria for a hypomanic or depressive episode. 5. Subjects that meet the DSM-IV-TR criteria for any comorbid or active Axis I disorder other than those specifically allowed in the Inclusion Criteria. 6. Subjects that meet the DSM-IV-TR criteria for antisocial or borderline personality disorder. 7. Women who are pregnant or breastfeeding. 8. Subjects who have a chronic or severe general medical illness, including liver, kidney, respiratory, cardiovascular, endocrine, neurological, or hematologic disease. 9. Subjects that have a clinically significant abnormality in the thyroid function test in the preselection. 10. Subjects with known risk of narrow-angle glaucoma. 11. Subjects who have a known or suspected history of substance dependence within the last 6 months. 12. Subjects with a history of chronic use of stimulants within 4 weeks prior to preselection 13. Subjects who have received clozapine within 3 months prior to prescreening, or who have a known or suspected history of bipolar symptoms resistant to clozapine treatment. 14. Subjects who have received any deposit antipsychotic within the period of a treatment cycle prior to prescreening. 15. Subjects who have received any antidepressant medication within 2 weeks prior to prescreening. 16. Subjects who have had any other result in the analysis of biochemistry, hematology or urine that are not within the reference range of the central laboratory. 17. Subjects that present a significant risk of damaging themselves or others or causing significant damage to property. 18. Subjects with a history of severe allergy to drugs or known hypersensitivity to risperidone or olanzapine or to any of the components of the products. 19. Subjects with evidence of moderate or severe tardive dyskinesia. 20. Subjects who are employees of the researcher or center in charge of the study, with direct participation in the proposed study or in other studies conducted by said researcher or center in charge of the study, or who are members of the family of an employee or investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Medical evaluation of recurrence, which is defined by: 1) The subject meets the DSM-IV-TR criteria for a hypomanic, manic, mixed, or depressive episode. 2) The subject requires treatment intervention with a mood stabilizer, an antipsychotic medication, benzodiazepine or an antidepressant medication. 3) Subject requires hospitalization due to any episode of bipolar mood. 4) The subject has either a YMRS score of> 12 + CGI-S of ≥ 4 OR MADRS of> 12 + CGI-S of ≥ 4. 5) At the discretion of the investigator, an increase or supplementation of the dose is required. oral risperidone or other antipsychotic or mood stabilizer. Measure:Time to recurrence in the double-blind period (Period III). Timepoints:Between 9-18 months (Period III). | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Criteria 1 and 3: Clinical evaluation to determine if the patient meets the criteria of a high mood (manic, hypomanic or mixed) or a depressive episode, according to the criteria DSM-IV-TRa. Criterion 2: Determination of time to premature discontinuation, including recurrence. Criterion 4: The 36-item SF-36 questionnaire will be used. the clinically significant deterioration will be determined with a decrease of ≥ 5 points with respect to the baseline. Criterion 5: Application of the Young Mania Rating Scale (YMRS), Montgomery-Asberg Depression Rating Scale (MADRS), Clinical Global Severity Impression Scale (CGI-S). Criterion 6: Summary of the Mental Health Component, Summary of the Physical Component of the Short Form of the Medical Results Study-36 (SF-36), and change in the Personal and Social Performance Scale (PSP). Criterion 7: Determination of the number of responders / responders maintained after the open treatment period. Measure:Secondary efficacy: 1) Time to recurrence in Period III of an episode of elevated mood and time to recurrence in Period III of a depressive episode. 2) Time until the premature discontinuation of the medication due to any reason. 3) Time until the recurrence of an episode of change in mood. 4) Time to clinically relevant deterioration of mental health status in Period III. 5) Change in the YMRS, MADRS, and CGI-S scores during Periods II and III. 6) Change in the scores corresponding to the 8 domains during Period II and Period III. 7) Number and percentage of responders / respondents maintained in Period II. Timepoints:In Period II (12 weeks) and Period III (9-18 months). ; Outcome name:Criterion 1: Evaluation of any adverse medical event that occurs after the administration of the investigational medication. Criterion 2: Hematology and serum chemistry panels, urine test. Criterion 3: Blood pressure and pulse will be measured. Criterion 4: 12-lead electrocardiogram a | — |
Countries
Germany, Greece, Peru
Outcome results
None listed