A 12-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study ToEvaluate the Efficacy and Safety of Adjunctive Aripiprazole Therapy in the Treatment of Mania in Bipolar I Disorder Patients Treated with Valproate or Lithium and in Need of Further Clinical Improvement.Revised protocol 02, incorporating Administrative letters 01 and 02 and Amendment 02 (v2.0 dated 17-Oct-2008)

Bristol Myers Squibb International Corporation0 个研究点目标入组 485 人开始时间: 2008年6月19日最近更新: 2012年5月1日

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试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方: Bristol Myers Squibb International Corporation
入组人数: 485

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

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研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: All

入选标准

•1) Signed Written Informed Consent
•a) Subjects must be competent to understand the nature of the study, sign the informed consent, agree to comply with prescribed dosage regimens, discontinuation of prohibited concomitant medication, report for regularly scheduled visits, able to provide reliable information for safety, efficacy and Quality of Life assessments and communicate to the investigator about adverse events and concomitant medication use;
•b) The informed consent process must be documented by signing the informed consent form prior to any study-related procedures including alterations in medications in preparation for study entry and subject’s assignment via Interactive Voice Response System (IVRS).
•2) Target Population
•a) Subjects with Bipolar I Disorder Mania, manic or mixed episode, with or without psychotic features, as defined by DSM-IV-TR and confirmed by the M.I.N.I., presenting with ongoing treatment with lithium or valproate and based on the investigator’s clinical judgment could benefit from adjunctive treatment with aripiprazole.
•b) Subjects with therapeutic serum levels of lithium or valproate (as per local SmPC) and a YMRS Total Score of = 16 at screening and baseline and, in case of decrease, a = 35% decrease of YMRS score from the initial screening visit prior to randomization (YMRS to be assessed 14-28 days after blood draw confirming the therapeutic serum level of lithium or valproate).
•c) Subjects on lithium or valproate treatment combined with antipsychotic medication other than aripiprazole can be enrolled provided that the other antipsychotic medication is washed out at least 3 days prior to the blood draw for the therapeutic plasma levels of lithium and valproate determination. Long-acting antipsychotics must be washed out prior to entering the double-blind treatment as indicated in Section 5.5 of the protocol. Those subjects who are currently improving or stable on a lithium/valproate and antipsychotic combination treatment and who in Investigator's clinical judgment would not benefit from adjunctive treatment with aripiprazole should not be considered for the trial.
•3) Age and Sex
•a) Men and women, = 18 years of age
•Women of childbearing potential (WOCBP) must be using an adequate method of
•contraception to avoid pregnancy throughout the study and for up to 4 weeks after
•the last dose of investigational product in such a manner that the risk of pregnancy
•is minimized. WOCBP must have a negative serum or urine pregnancy test (minimum
•sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to the start of investigational product.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

排除标准

•1) Sex and Reproductive Status
•a) WOCBP who are unwilling or unable to use an acceptable method to avoid
•pregnancy for the entire study period and for up to 4 weeks after the last dose of
•investigational product. Acceptable methods include oral, injectable or
•implantable contraceptives, intrauterine devices or barrier methods such as
•condoms, diaphraghms;
•b) WOCBP using a prohibited contraceptive method. No specific contraceptive
•methods are prohibited in this study. Women practicing abstinence should use a
•reliable method of contraception if they choose to become sexually active during
•c) Women who are pregnant or breastfeeding;
•d) Women with a positive pregnancy test on enrollment or prior to investigational
•product administration.
•2) Target Disease Exceptions
•a) Subjects presenting clinically with a DSM-IV-TR diagnosis of: delirium,
•dementia, amnestic or other cognitive disorders, or a psychotic disorder (e.g.,
•schizophrenia or schizoaffective disorder).
•b) Subjects with a current Axis I (DSM-IV-TR) diagnosis of Bipolar II Disorder,
•Bipolar Disorder NOS, or any other primary psychiatric disorder other than
•Bipolar I Disorder Mania.
•3) Medical History and Concurrent Diseases
•a) Subjects considered treatment refractory by investigator judgment for manic
•b) Subjects previously nonresponsive (by investigator judgment) to aripiprazole for
•manic symptoms.
•c) Subjects with a significant risk of committing suicide based on history, mental
•status exam, or investigator’s judgment.
•d) Subjects who meet DSM-IV-TR criteria for cocaine dependence or abuse only
•within the past 3 months prior to screening.
•e) Subjects with thyroid pathology (i.e., hypothyroidism or hyperthyroidism) that in
•the investigator’s judgment may interfere with safety and efficacy assessments.
•f) Subjects with a history of neuroleptic malignant syndrome from antipsychotic
•agents, or subjects where - according to investigator’s judgment - neuroleptic
•malignant syndrome can not be ruled out in the presence of an increased CPK;
•g) Subjects who have a history or evidence of a medical condition that would expose
•them to an undue risk of a significant adverse event or interfere with assessments
•of safety or efficacy during the course of the trial, including but not limited to
•hepatic, renal, respiratory, cardiovascular, endocrine (e.g., Addison’s Disease),
•immune, neurologic, or hematologic disease as determined by the clinical
•judgment of the investigator;
•h) Subjects with a significant history of seizure disorder (e.g., epilepsy);
•4) Physical and Laboratory Test Findings
•a) The following laboratory test results, vital sign and ECG findings are
•exclusionary:
•? QTc > 475 msec
•? Platelets = 75,000/mm³
•? Hemoglobin = 9g/dL
•? Neutrophils, absolute = 1000/mm³
•? Subjects with detectable levels of cocaine in the drug screen.
•? AST (SGOT) or ALT (SGPT) > 3x upper limit of normal
•? Creatinine = 2 mg/dL [or = 177 µmol/L]
•? Diastolic blood pressure > 105 mmHg
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研究者

发起方

Bristol Myers Squibb International Corporation

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A 12-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study ToEvaluate the Efficacy and Safety of Adjunctive Aripiprazole Therapy in the Treatment of Mania in Bipolar I Disorder Patients Treated with Valproate or Lithium and in Need of Further Clinical Improvement.Estudio multicéntrico, aleatorizado, doble ciego y controlado con placebo, de 12 semanas de duración, para evaluar la eficacia y la seguridad de la terapia con aripiprazol como adyuvante en el tratamiento de la manía en pacientes con trastorno bipolar I tratados con valproato o litio y que precisan mejoría clínica adicionalBipolar I Mania (manic or mixed episode)Mania Bipolar I (episodio maníaco o mixto)MedDRA version: 9.1Level: LLTClassification code 10026749Term: Mania

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