EUCTR2008-001580-11-LT进行中（未招募）不适用
A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Fixed-Dose Study Comparing the Efficacy and Safety of 3 Doses of Lu AA21004 in Acute Treatment of Adults With Major Depressive Disorder
Takeda Global Research & Development Centre (Europe) Ltd.0 个研究点目标入组 560 人开始时间: 2008年7月8日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 560
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
- •Subject eligibility is determined according to the following criteria:
- •1. The subject suffers from a major depressive episode (MDE) as the primary diagnosis according to DSM-IV-TR criteria (classification code 296.xx).
- •2. The reported duration of the current MDE is at least 3 months.
- •3. The subject has a MADRS total score =26.
- •4. The subject is a man or woman aged between 18 and 75 years, inclusive.
- •5. The subject is capable of understanding and complying with protocol requirements.
- •6. A male subject, or a female subject of childbearing potential, who is sexually active agrees to use adequate contraception from Screening throughout the duration of the study and for 1 month after the last dose of study medication. Women NOT of childbearing potential are defined as those who have been surgically sterilized (documented hysterectomy, bilateral oophorectomy and/or tubal ligation) or who are postmenopausal (defined as at least 2 years without menses). (Acceptable methods of contraception are defined in the Contraception and Pregnancy Avoidance Procedure section of the protocol, Section 9.1.10.)
- •7. The subject has signed the Informed Consent Form. No study-related procedures may be performed before the subject has signed the form.
- •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
- •Subject eligibility is determined according to the following criteria:
- •1. The subject suffers from a major depressive episode (MDE) as the primary diagnosis according to DSM-IV-TR criteria (classification code 296.xx).
- •2. The reported duration of the current MDE is at least 3 months.
- •3. The subject has a MADRS total score =26.
- •4. The subject is a man or woman aged between 18 and 75 years, inclusive.
- •5. The subject is capable of understanding and complying with protocol requirements.
- •6. A male subject, or a female subject of childbearing potential, who is sexually active agrees to use adequate contraception from Screening throughout the duration of the study and for 1 month after the last dose of study medication. Women NOT of childbearing potential are defined as those who have been surgically sterilized (documented hysterectomy, bilateral oophorectomy and/or tubal ligation) or who are postmenopausal (defined as at least 2 years without menses). (Acceptable methods of contraception are defined in the Contraception and Pregnancy Avoidance Procedure section of the protocol, Section 9.1.10.)
- •7. The subject has signed the Informed Consent Form. No study-related procedures may be performed before the subject has signed the form.
- •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
- •Any subject who meets any of the following criteria will not qualify for entry into the study:
- •1. The subject has received any investigational compound <30 days before Screening or 5 half-lives prior to Screening.
- •2. The subject has received Lu AA21004 in a previous clinical study.
- •3. The subject is a study-site employee, or is an immediate family member (ie, spouse, parent, child, sibling) of a study site employee involved in conduct of this study.
- •4. The subject has 1 or more the following:
- •a) Any current psychiatric disorder other than MDD as defined in the DSM-IV-TR (as
- •assessed by the Mini International Neuropsychiatric Interview [MINI]).
- •b) Current or past history of: manic or hypomanic episode, schizophrenia or any other psychotic disorder, including major depression with psychotic features, mental retardation, organic mental disorders, or mental disorders due to a general medical condition as defined in the DSM-IV-TR.
- •c) Any substance disorder (except nicotine and caffeine) within the previous 6 months as defined in the DSM-IV-TR. (Subject must have negative urine drug screen prior to Baseline).
- •d) Presence or history of a clinically significant neurological disorder (including epilepsy).
- •e) Neurodegenerative disorder (Alzheimer disease, Parkinson disease, multiple sclerosis, Huntington disease, etc).
- •f) Any Axis II disorder that might compromise the study.
- •5. The subject is required to take excluded medications or it is anticipated that the subject will require treatment with at least 1 of the disallowed concomitant medications during the study (please refer to Excluded Medications, Section 7.3).
- •6. If female, the subject is pregnant or lactating.
- •7. The subject has a significant risk of suicide according to the investigator’s opinion or has a score =5 on item 10 (suicidal thoughts) of the MADRS or has made a suicide attempt in the previous 6 months.
- •8. The current depressive symptoms of the subject are considered by the investigator to have been resistant to 2 adequate antidepressant treatments of at least 6 weeks duration each.
- •9. The subject has received electroconvulsive therapy within 6 months prior to Screening.
- •10. The subject is currently receiving formal cognitive or behavioral therapy, systematic psychotherapy, or plans to initiate such therapy during the study.
- •11. The subject has a clinically significant unstable illness, for example hepatic impairment or renal insufficiency, or a cardiovascular, pulmonary, gastrointestinal, endocrine, neurological, rheumatologic, immunologic, infectious, skin and subcutaneous tissue disorder or metabolic disturbance).
- •12. The subject has an alanine aminotransferase, aspartate aminotransferase, or total bilirubin level >1.5 times the upper limits of normal (xULN).
- •13. The subject has a serum creatinine level >1.5 xULN.
- •14. The subject has a previous history of cancer that had been in remission for less than 5 years prior to the first dose of study medication. This criterion does not include those subjects with basal cell or stage I squamous cell carcinoma of the skin.
- •15. The subject has clinically significant abnormal vital signs as determined by the investigator.
- •16. The subject has 1 or more laboratory value outside the normal range, based on the blood or urine samples taken at the Screening Visit, that are considered by the investigator to be clinically significant.
- •17. The subject has a thyroid stimulating hormone (TSH) value outside the normal range at the Screening Visit an;
- •Any subject who meets any of the following criteria will not qualify for entry into the study:
- •1. The subject has received any investigational compound <30 days before Screening or 5 half-lives prior to Screening.
- •2. The subject has received Lu AA21004 in a previous clinical study.
- •3. The subject is a study-site employee, or is an immediate family member (ie, spouse, parent, child, sibling) of a study site employee involved in conduct of this study.
- •4. The subject has 1 or more the following:
- •a) Any current psychiatric disorder other than MDD as defined in the DSM-IV-TR (as
- •assessed by the Mini International Neuropsychiatric Interview [MINI]).
- •b) Current or past history of: manic or hypomanic episode, schizophrenia or any other psychotic disorder, including major depression with psychotic features, mental retardation, organic mental disorders, or mental disorders due to a general medical condition as defined in the DSM-IV-TR.
- •c) Any substance disorder (except nicotine and caffeine) within the previous 6 months as defined in the DSM-IV-TR. (Subject must have negative urine drug screen prior to Baseline).
- •d) Presence or history of a clinically significant neurological disorder (including epilepsy).
- •e) Neurodegenerative disorder (Alzheimer disease, Parkinson disease, multiple sclerosis, Huntington disease, etc).
- •f) Any Axis II disorder that might compromise the study.
- •5. The subject is required to take excluded medications or it is anticipated that the subject will require treatment with at least 1 of the disallowed concomitant medications during the study (please refer to Excluded Medications, Section 7.3).
- •6. If female, the subject is pregnant or lactating.
- •7. The subject has a significant risk of suicide according to the investigator’s opinion or has a score =5 on item 10 (suicidal thoughts) of the MADRS or has made a suicide attempt in the previous 6 months.
- •8. The current depressive symptoms of the subject are considered by the investigator to have been resistant to 2 adequate antidepressant treatments of at least 6 weeks duration each.
- •9. The subject has received electroconvulsive therapy within 6 months prior to Screening.
- •10. The subject is currently receiving formal cognitive or behavioral therapy, systematic psychotherapy, or plans to initiate such therapy during the study.
- •11. The subject has a clinically significant unstable illness, for example hepatic impairment or renal insufficiency, or a cardiovascular, pulmonary, gastrointestinal, endocrine, neurological, rheumatologic, immunologic, infectious, skin and subcutaneous tissue disorder or metabolic disturbance).
- •12. The subject has an alanine aminotransferase, aspartate aminotransferase, or total bilirubin level >1.5 times the upper limits of normal (xULN).
- •13. The subject has a serum creatinine level >1.5 xULN.
- •14. The subject has a previous history of cancer that had been in remission for less than 5 years prior to the first dose of study medication. This criterion does not include those subjects with basal cell or stage I squamous cell carcinoma of the skin.
- •15. The subject has clinically significant abnormal vital signs as determined by the investigator.
- •16. The subject has 1 or more laboratory value outside the normal range, based on the blood or urine samples taken at the Screening Visit, that are considered by the investigator to be clinically significant.
- •17. The subject has a thyroid stimulating hormone (TSH) value outside the normal range at the Screening Visit an
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