Major Depressive Disorder (MDD) MedDRA version: 9.1 Level: LLT Classification code 10025463 Term: Major depressive disorder, single episode
Conditions
Interventions
Product Code: LuAA21004 10mg
Pharmaceutical Form: Capsule*
Current Sponsor code: LuAA21004
Other descriptive name: 1-[2-(2,4-Dimethyl-phenylsulfanyl)-phenyl]-piperazine
Concentration unit: mg milligra
Sponsors
Takeda Global Research & Development Centre (Europe) Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 ;Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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 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;Exclusion criteria: 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to evaluate the efficacy of 3 fixed doses of Lu AA21004 (1, 5 and 10 mg once daily) versus placebo after 8 weeks of treatment in subjects with MDD.;Secondary Objective: The secondary objectives of this study are: • To evaluate the efficacy of Lu AA21004 (1, 5 and 10 mg daily) compared with placebo during the 8-week, double-blind treatment. • To evaluate the proportion of subjects who respond to Lu AA21004 during the 8-week treatment period. • To evaluate the proportion of subjects who are in remission after 8 weeks of treatment with Lu AA21004 compared with placebo. • To evaluate the effect of Lu AA21004 on assessments of depression, anxiety, quality of life, and disability. • To evaluate the effects of Lu AA21004 on healthcare resource utilization. • To evaluate the population pharmacokinetics of Lu AA21004 and its metabolites Lu AA34443 and Lu AA39835 in subjects with MDD. • To evaluate the safety and tolerability of Lu AA21004 (1, 5 and 10 mg daily) compared with placebo during the course of treatment. Exploratory Objective: • To assess the treatment effect (Lu AA21004 or placebo) on suicidal ideation and behavior. ;Primary end point(s): The primary endpoint for this study is the least squares (LS) mean change from Baseline in the 24-item Hamilton Depression Scale (HAM-D 24) total score after 8 weeks of treatment. Secondary Endpoints Secondary efficacy endpoints for this study are: • LS mean change from baseline HAM-D 24 total score at each week assessed. • Response rates at each week assessed, with response defined as a =50% decrease in the HAM-D 24 total score from Baseline. • Sustained response from Week 1 for Lu AA21004 compared with placebo, with sustained response defined as at least a 20% decrease from Baseline in HAM-D 24 total score obtained at Week 1 and sustained through Week 7 and at least 50% decrease from baseline at Week 8. • Remission rates at Week 8, with remission defined as a MADRS total | — |
Countries
France, Germany, Latvia, Lithuania, Netherlands, Poland, United Kingdom
Contacts
Public Contact; ;
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Outcome results
None listed