Major Depressive Disorder MedDRA version: 9.1 Level: LLT Classification code 10025453 Term: Major depressive disorder NOS
Conditions
Interventions
Product Name: Lu AA21004
Product Code: Not applicable
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: NA
Current Sponsor code: Lu AA21004
Concentration unit: mg milligram(s)
Concentration
Sponsors
H. Lundbeck A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A patient who meets all the following criteria, is eligible for inclusion in this study: 1.The patient is able to read and understand the Subject Information Sheet for the present study, different from the one for study 11984A. 2.The patient has signed the new Informed Consent Form, which is separate from the signed informed consent obtained for the study 11984A. 3.The patient must have completed study 11984A (Visit 7: Week 8) immediately prior to enrolment into the extension study. 4.The patient had a documented primary diagnosis of a Major Depressive Episode (MDE) at entry in study 11984A. 5.The patient, if female, must: -agree not to try to become pregnant during the study, AND -use adequate contraception (adequate contraception is defined as oral/systemic contraception, intrauterine device, diaphragm in combination with spermicide, or condom for male partner in combination with spermicide), OR -have had her last natural menstruation at least 24 months prior to baseline, OR -have been surgically sterilised prior to baseline, OR -have had a hysterectomy prior to baseline, OR -not be sexually active with men 6.The patient is indicated 12-month 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: In addition to the exclusion criteria applying for study 11984A (appendix V), and which are met at baseline visit, except criteria: -7 (increased intra-ocular pressure or at risk of acute narrow-angle glaucoma -9 (chronic liver disease) -11 (history of lack of response to previous adequate treatment with duloxetine) -17 (previous exposure to investigational drug) -22 (previous exposure to Lu AA21004) Patients who meet one or more of the following criteria are not eligible for inclusion in this study: 1.The patient with Major Depressive Disorder, for whom other psychiatric disorders (mania, bipolar disorder, schizophrenia or any psychotic disorder) have been diagnosed during study 11984A. 2.The patient, in the investigator’s opinion has a significant risk of suicide, and/or a score of 5 points or higher on item 10 (suicidal thoughts) of the MADRS. 3.The patient is in the opinion of the investigator, unlikely to be able to comply with the clinical trial protocol or is unsuitable for any other reasons. 4.The patient has a clinically significant, moderate or severe ongoing adverse event, related to study medication in study 11984A. 5.The patient has used/ uses disallowed recent or concomitant medication (specified in Appendix II, Recent and Concomitant medication).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: -to evaluate the long term safety and tolerability of flexible doses of Lu AA21004 (2.5mg, 5mg, or 10mg/day) over a period of 52 weeks in patients with Major Depressive Disorder, having completed the 8 week short-term treatment study 11984A.;Primary end point(s): Safety is the primary endpoint as measured by vital signs, ECGs, laboratory measurements, weight, physical examination, adverse events and withdrawal rates.;Secondary Objective: -to evaluate the maintenance of therapeutic effect of flexible doses of Lu AA21004 (2.5mg, 5mg, or 10mg/day) over a period of 52 weeks in patients with Major Depressive Disorder, having completed the short-term study 11984A. -to evaluate the effect of Lu AA21004 on Health Related Quality of Life, disability and health care resource utilisation. -to evaluate the population pharmacokinetics of Lu AA21004 and its metabolites Lu AA34443 and Lu AA39835. | — |
Countries
Bulgaria, Czech Republic, Estonia, Finland, France, Latvia, Lithuania, Slovakia, Spain
Outcome results
None listed