Major Depressive Disorder MedDRA version: 12.1 Level: LLT Classification code 10025453 Term: Major depressive disorder NOS MedDRA version: 12.1 Level: LLT Classification code 10025454 Term: Major depressive disorder, recurrent episode
Conditions
Interventions
Product Name: Lu AA21004
Product Code: NA
Pharmaceutical Form: Tablet
INN or Proposed INN: NA
CAS Number: NA
Current Sponsor code: Lu AA21004
Other descriptive name: NA
Concentration unit: mg milligra
Sponsors
H. Lundbeck A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The patient is able to read and understand the Informed Consent Form. 2. The patient has signed the new Informed Consent Form, which is separate from the signed informed consent obtained for the lead-in Study 13267A. No study-related procedures may be performed before the patient has signed the form. 3. The patients has completed the lead-in Study 13267A (Visit 9, end of Week 10) immediately prior to enrolment into this extension study. 4. The patient suffers from Major Depressive Disorder (MDD) according to DSM-IV-TR™ criteria (classification code 296.3x) at the entry into the lead-in Study 13267A. 5. The patient, if a woman, must: - agree not to try to become pregnant during the study, AND - use adequate, highly effective contraception, defined as those that result in a low failure rate (less than 1% per year), when used consistently and correctly, for example, implants, injectables, combined oral contraceptives, some intrauterine devices, sexual abstinence, vasectomised partner), OR - have had her last natural menstruation at least 24 months prior to the Baseline Visit, OR - have been surgically sterilised prior to the Baseline Visit, OR - have had a hysterectomy prior to the Baseline Visit. 6. The patient is willing and able to attend study appointments within the specified time windows. 7. The patient is judged to benefit from 52-week continuation treatment with Lu AA21004 according to the clinical opinion of the investigator. 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: 1. The patient has previously participated in this study. 2. The patient has been diagnosed with a psychiatric disorder other than MDD (mania, bipolar disorder,schizophrenia or any other) during the lead-in Study 13267A. 3. The patient has a clinically significant unstable illness diagnosed during the lead-in Study 13267A. 4. The patient, in the investigator’s clinical judgment, has a significant risk of suicide and/or a score of =5 points on item 10 (suicidal thoughts) of the Montgomery-Åsberg Depression Rating Scale (MADRS). 5. The patient has a moderate or severe ongoing adverse event related to study medication from the lead-inStudy 13267A considered of potential safety risk by the investigator. 6. The patient takes or has taken any disallowed recent or concomitant medication, specified in Appendix II - Or it is anticipated that the patient will require treatment with at least one of the disallowed concomitant medications during the study. 7. The patient has a disease or takes medication that could, in the investigator’s opinion, interfere with the assessments of safety, tolerability, or efficacy, or interfere with the conduct or interpretation of the study. 8. The patient has clinically significant abnormal vital signs at the Completion Visit (Visit 7, end of Week 8)of the lead-in Study 13267A considered of potential safety risk by the investigator. 9. The patient has one or more laboratory values outside the reference range, based on the blood or urine samples taken at the Completion Visit (Visit 7, end of Week 8) of the lead-in Study 13267A, that are, in the investigator’s opinion, of potential risk to the patient’s safety, or the patient has any of the following values at the Completion Visit (Visit 7, end of Week 8) of the lead-in Study 13267A: - a serum creatinine value >1.5 times the upper limit of the reference range - a serum total bilirubin value >1.5 times the upper limit of the reference range - a serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value >2 times the upper limitof the reference range. 10. The patient has, at the Completion Visit (Visit 7, end of Week 8) of the lead-in Study 13267A: - an abnormal ECG that is, in the investigator’s opinion, clinically significant - a PR interval >250 ms - a QRS interval >130 ms - a QTcF interval >450 ms (for men) or >470 ms (for women) (based on the Fridericia correction where QTcF = QT/RR 0.33). 11. The patient is a member of the site personnel or their immediate families. 12. The patient is pregnant or breast-feeding. 13. The patient has a history of severe drug allergy or hypersensitivity, or known hypersensitivity to Lu AA21004. 14. The patient is currently receiving formal cognitive or behavioural therapy or systematic psychotherapy except bereavement counselling, or planning to initiate such therapy during the study. 15. The patient is unlikely to be able to comply with the clinical protocol or is unsuitable for any other reason, in the opinion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the long-term safety and tolerability of flexible doses of Lu AA 21004 (15 and 20 mg/day) during 52-weeks treatment period in patients with Major Depressive Disorder (MDD) who have completed Study 13267A.;Secondary Objective: To evaluate the therapeutic effect of flexible doses of Lu AA21004 (15 and 20 mg/day) over a period of 52 weeks in patients with MDD as assessed by MADRS, CGI-S and HAM-A Additional Objectives of the trial are described in the protocol: To evaluate the effect of Lu AA21004 on: - health-related quality of life and satisfaction, related to various areas of functioning as assessed by Q-LES-Q (SF) - health-related quality of life, related to disability as assessed by SDS - health-related quality of life, related to health care utilization as assessed by HEA - health-related quality of life as assessed by EQ-5D health questionnaire - work productivity as assessed by WPAI - sexual function as assessed by ASEX - suicidal ideation and behaviour as assessed by C-SSRS To evaluate the population pharmacokinetics of Lu AA21004. To explore associations between biological parameters and clinical features such as disease symptoms, drug response and potential adverse events.;Primary end point(s): The primary endpoint is the change from baseline in MADRS total score ofter 52 weeks of treatment. | — |
Countries
Belgium, Estonia, Finland, Latvia, Lithuania, Sweden
Outcome results
None listed