major depressive disorder (MDD) MedDRA version: 12.1 Level: LLT Classification code 10025454 Term: Major depressive disorder, recurrent episode MedDRA version: 12.1 Level: LLT Classification code 10025463 Term: Major depressive disorder, single episode
Conditions
Interventions
Product Name: Lu AA21004
Pharmaceutical Form: Tablet
Current Sponsor code: Lu AA21004-HBr
Other descriptive name: 1-[2-(2,4-Dimethyl-phenylsulfanyl)-phenyl]-piperazine, hydrobromide
Concentration unit
Sponsors
Takeda Global Research and Development Centre (Europe) Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subject eligibility is determined according to the following criteria: 1. In the opinion of the investigator, the subject is capable of understanding and complying with protocol requirements. 2. The subject signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures. 3. The subject suffers from MDD as the primary diagnosis according to DSM-IV-TR criteria (classification code 296.2x and 296.3x). 4. The subject is a man or woman aged between 20 and 64 years at time of informed consent, inclusive. 5. The reported duration of the current major depressive episode is at least 3 months at the Screening Visit. 6. The subject has a MADRS total score =26 at the Screening and Baseline Visits. 7. The subject has a CGI-S score =4 at the Screening and Baseline Visits. 8. A female subject of childbearing potential* who is sexually active with a nonsterilized* male partner agrees to use routinely adequate contraception* from signing of informed consent throughout the duration of the study. 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) no 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 one or more of the following conditions: - Any current psychiatric disorder other than MDD as defined in the DSM-IV-TR (assessed by the Mini International Neuropsychiatric Interview: MINI). A subject who exhibits symptoms of anxiety is eligible unless the subject fulfills the diagnostic criteria for a current anxiety disorder per DSM-IV-TR. - Current diagnosis or 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. - Current diagnosis or history of any substance-related disorder (except nicotine and caffeine-related disorders) as defined in the DSM-IV-TR. Subject with confirmed positive urine drug screens will be excluded. - Presence or history of a clinically significant neurological disorder (including epilepsy). - Neurodegenerative disorder. (Alzheimer’s disease, Parkinson’s disease, multiple sclerosis, Huntington’s disease, etc.) - Any DSM-IV-TR axis II disorder that might compromise the study. 2. The subject has a chronic liver disease. 3. The subject has a history of severe drug allergy or hypersensitivity. 4. 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, neoplastic, skin and subcutaneous tissue disorders or metabolic disturbance. 5. 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. 6. The subject has received electroconvulsive, vagal nerve stimulation, or repetitive transcranial magnetic stimulation therapy within 6 months prior to the Screening Visit. 7. The subject is currently receiving formal cognitive or behavioral therapy, systematic psychotherapy, or plans to initiate such therapy during the study. 8. The subject is at significant risk of suicide or has a score =5 on Item 10 (suicidal thoughts) of the MADRS, or has attempted suicide within 6 months prior to the Screening Visit. 9. The subject takes or has taken disallowed recent or concomitant medication or it is anticipated that the subject will require treatment with at least one of the disallowed concomitant medications during the study. 10. The subject has received any investigational compound within 12 weeks prior to the first dose of the study drug (Day-84 ~). 11. The subject has clinically significant abnormal vital signs at the Screening Visit as determined by the investigator. 12. The subject has an abnormal ECG at the Screening Visit as determined clinically significant by the investigator. 13. The subject has one or more laboratory values outside the reference range, based on the blood or urine samples taken at the Screening Visit, that are, in the investigator’s opinion, of potential risk to the subject’s safety. 14. The subject has a value of thyroid stimulating hormone (TSH) outside the normal range at the Screening Visit and deemed clinically significant by the investigator. 15. If female, the subject is pregnant or lactating or intending to become pregnant before, during, or within 1 month after participating in this study;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate the efficacy of 3 fixed doses of Lu AA21004 (5, 10 and 20 mg QD) compared with placebo as assessed by the Montgomery-Åsberg Depression Rating Scale (MADRS) after 8 weeks of treatment in subjects with MDD.;Primary end point(s): The primary endpoint is change from baseline in the MADRS total score after 8 weeks (last observation carried forward: LOCF) of treatment.;Secondary Objective: To evaluate the efficacy of 3 fixed doses of Lu AA21004 QD compared with placebo based on other parameters of efficacy after 8 weeks of treatment. To evaluate the effect of 3 fixed doses of Lu AA21004 QD on subject functioning compared with placebo after 8 weeks of treatment. To evaluate the safety and tolerability of Lu AA21004 compared with placebo during the course of treatment. Additional Objectives: To evaluate the efficacy of 3 fixed doses of Lu AA21004 QD compared with placebo during the 8-week treatment period. To evaluate the effect of 3 fixed doses of Lu AA21004 QD on anxiety symptoms compared with placebo after 8 weeks of treatment. To evaluate potential discontinuation symptoms after the end of the treatment period. To assess the treatment effect (Lu AA21004 or placebo) on suicidal ideation and behavior. To analyze plasma concentrations of Lu AA21004 and its metabolites Lu AA34443 and Lu AA39835 in subjects with MDD for population pharmacokinetic analysis. | — |
Countries
Finland, Germany, Latvia, Romania
Outcome results
None listed