EUCTR2010-018860-17-EE进行中（未招募）不适用
A Multicenter, 52-week, Open-label Study to Assess the Safety and Tolerability of an Oral Aripiprazole/Escitalopram Combination Therapy in Patients with Major Depressive Disorder - ACES 257
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,500
研究概览
简要总结
暂无简介。
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. Subjects who are able to provide written informed consent and/or consent obtained from a legally acceptable representative (as required by IRB/IEC), prior to the initiation of any protocol-required procedures.
- •2. Ability, in the opinion of the principal investigator, to understand the nature of the study and follow protocol requirements, including the prescribed dosage regimens, tablet/capsule ingestion, and discontinuation of prohibited concomitant medication; to read and understand the written word in order to complete subject-reported outcomes measures; and to be reliably rated on assessment scales.
- •3. Male or female outpatients 18 to 66 years of age, inclusive, at the time of informed consent.
- •4. Subjects who have participated in Protocol 31-08-255, 31-08-256 or 31-08-263 and who, in the opinion of the investigator, could potentially benefit form the administration of oral aripiprazole/escitalopram combination therapy. Eligible subjects include those who:
- •a) completed participation in the Randomization Phase (Phase C, Week 14 Visit) or
- •b) met criteria for a response at the end of the Prospective treatment Phase (Phase B, Week 8 Visit) and at the end of Phase B+ (Week 14 Visit) did not meet criteria for remission (defined as a MADRS Total Score =<10).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 1500
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Sex and Reproductive Status
- •1. Sexually active males or females of childbearing potential who are not practicing two different methods of birth control during the study and for 90 or 30 days respectively after the last dose of study medication or who will not remain abstinent during the study and for 90 or 30 days respectively after the last dose. (*)
- •2. Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving study drug.
- •Target Disease
- •3. Subjects with a current need for involuntary commitment or who have been hospitalized <= 28 days of the Baseline Visit for the current major depressive episode.
- •4. Subjects with a current Axis I (DSM-IV-TR) diagnosis of any of the disorders listed in the protocol (*)
- •5. Subjects with a clinically significant current Axis II (DSM-IV-TR) diagnosis of borderline, antisocial, paranoid, schizoid, schizotypal or histrionic personality disorder.
- •6. Subjects experiencing hallucinations, delusions or any psychotic symptomatology in the current depressive episode.
- •Medical History and Concurrent Diseases
- •7. Subjects with a significant risk of committing suicide based on history, investigator’s judgement, and/or evaluation based on the C-SSRS.
- •8. Subjects who have met DSM-IV-TR criteria for substance abuse in the past 6 months (prior to the Baseline Visit) and/or dependence up to and including the past 12 months (prior to Baseline Visit), including alcohol and benzodiazepines, but excluding caffeine and nicotine. (*)
- •9. Subjects with hypothyroidism or hyperthyroidism (unless condition has been stabilized with medications for at least 90 days prior to the Baseline Visit). (*)
- •10. Subjects who currently have clinically significant neurological, hepatic, renal, metabolic, haematological, immunological, cardiovascular, pulmonary, or gastrointestinal disorders. (*)
- •11. Subjects with insulin-dependant diabetes mellitus (IDDM) are excluded. Subjects with non-IDDM may be eligible for the study if their condition is stable as determined by satisfying ALL of the criteria in protocol. (*)
- •12. Subjects with epilepsy or significant history of seizure disorders, except a single childhood febrile seizure, posttraumatic, etc. An alcohol withdrawal seizure up to and including 24 months of the Baseline Visit is exclusionary.
- •Physical and Laboratory Results
- •13. Subjects with two positive drug screens for cocaine or other drugs of abuse (excluding stimulants and other prescribed medications and marijuana) (*)
- •14. The following laboratory test are exclusionary: Platelets =< 75,000/mm3; Hemoglobin =< 9 g/dL; Neutrophils, absolute =< 1000/mm3; AST > 3x upper limit of normal as defined by the central laboratory; ALT > 3x upper limit of normal as defined by the central laboratory; Creatinine >= 2 mg/dL; (*)
- •Prohibited Therapies or Medications
- •15. Subjects who would be likely to require prohibited prior or concomitant therapy during the trial (*)
- •16. Anticipated need for diphenylhydramine or hydroxyzine during the study and other antihistamines for the treatment of agitation, anxiety or insomnia.
- •Allergies and Adverse Drug Reactions
- •17. History of allergy or hypersensitivity to aripiprazole or escitalopram.
- •18. Subjects with a history of neuroleptic malignant syndrome or serotonin syndrome.
- •19. Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (eg. infectious disease) illness must not b
研究者
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