PER-114-06已完成未知
A randomized, double-blind, placebo- and active-controlled, parallel-group study to evaluate the efficacy and safety of risperidone long-acting injectable for the prevention of mood episodes in the treatment of subjects with bipolar I disorder
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 至 0（—）
入选标准
- •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.
排除标准
- •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.
研究者
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A randomized, double-blind, placebo- and active-controlled, parallel-group study to evaluate the efficacy and safety of risperidone long-acting injectable for theprevention of mood episodes in the treatment of subjects with bipolar I disorderSubjects 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-acuteYMRS<12 and CGI-S</=3 [mild]), who do meet DSM-IV-TR criteria for a depressive episodeMedDRA version: 8.1Level: LLTClassification code 10004939Term: Bipolar I disorderEUCTR2006-001490-15-DEJanssen-Cilag International N.V600
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