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
- Conditions
- Major Depressive Disorder (MDD)MedDRA version: 9.1Level: LLTClassification code 10025463Term: Major depressive disorder, single episode
- Registration Number
- EUCTR2008-001580-11-GB
- Lead Sponsor
- Takeda Global Research & Development Centre (Europe) Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 560
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
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 (ALT), aspartate aminotransferase (AST), or total bilirubin level >1.5 times the upper limit 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 Screeni;
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 (ALT), aspartate aminotransferase (AST), or total bilirubin level >1.5 times the upper limit 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 Screeni
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method