Major Depressive Disorder
Conditions
Interventions
Product Name: AA21004
Product Code: AA21004
Pharmaceutical Form: Capsule, hard
Current Sponsor code: AA21004
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Phar
Sponsors
H. Lundbeck A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A patient who meets all the following criteria, both at the Screening Visit and at the Baseline Visit, is eligible for inclusion in this study: 1. The patient is able to read and understand the Subject Information Sheet. 2. The patient has signed the Informed Consent Form. No study-related procedures may be performed before the patient has signed the form. 3. The patient suffers from a major depressive episode (MDE) as primary diagnosis according to DSM-IV-TR criteria (classification code 296.xx). 4. The reported duration of the current Major Depressive Episode is at least 3 months and less than 12 months at screening. 5. The patient has a MADRS total score >=30. 6. The patient is an outpatient, man or woman, aged between 18 and 65 years (extremes included). 7. 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 screening, OR - have been surgically sterilised prior to screening, OR - have had a hysterectomy prior to screening, OR - not be sexually active 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: 1.The patient has one or more of the following conditions (as defined in the DSM-IV-TR) - Any current psychiatric disorder other than Major Depressive Disorder. - 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. - Any substance disorder (except nicotine and caffeine) within the previous 6 months. - Presence or history of a clinically significant neurological disorder (including epilepsy). - Neurodegenerative disorder. - Any axis II disorder that might compromise the study. 2.The patient has a significant risk of suicide. 3.The patient has a history of lack of response to previous treatment with venlafaxine. 4.The current depressive symptoms of the patient are considered by the investigator to have been resistant to two adequate antidepressant treatments of at least 6 weeks duration. 5.The patient has a history of severe drug allergy or hypersensitivity, or known hypersensitivity to venlafaxine. 6. The patient has used/uses disallowed recent or concomitant medication (see protocol, 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 received electroconvulsive therapy within 6 months prior to screening. 8. The patient is currently receiving formal cognitive or behavioural therapy, systematic psychotherapy, or plans to initiate such therapy during the study. 9. The patient has a clinically significant unstable illness, for example, hepatic or renal insufficiency, or a cardiovascular, pulmonary, gastrointestinal, endocrine, neurological, infectious, neoplastic, skin and subcutaneous tissue disorders or metabolic disturbance. 10. The patient suffers from and/or is under treatment for hypertension 11. The patient has clinically significant abnormal vital signs. 12. The patient has one or more laboratory values 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. 13. The patient has a clinically significant abnormal ECG. 14. The patient has a disease or takes medication that, in the opinion of the investigator, could interfere with the assessments of safety, tolerability or efficacy. 15. The patient has been treated with any investigational medicinal product within 30 days or 5 half lives (whichever is longer) prior to screening. 16. The patient is pregnant or breast-feeding. 17. The patient, in the opinion of the investigator, is unlikely to comply with the clinical study protocol or is unsuitable for any reason. 18. The patient is a member of the site personnel or their immediate families. 19. The patient is under forced treatment. 20. The patient has previously participated in this study. 21. The patient has previously been exposed to Lu AA21004.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy, safety and tolerability of two fixed dosages of Lu AA21004 (5 and 10mg/day) versus placebo after 6 weeks of treatment in patients with Major Depressive Disorder;Secondary Objective: To evaluate the: - efficacy of Lu AA21004 (5 and 10mg/d) compared to placebo after 1 week of treatment. - safety, tolerability and efficacy of Lu AA21004 (5 and10mg/d) compared to placebo during the study. - proportion of patients who respond to Lu AA21004 at Week 6 compared to placebo (>=50% decrease in MADRS total score from baseline). - proportion of patients who are in sustained response (>=50% decrease in MADRS total score from baseline obtained at Week 1 and sustained throughout the treatment period) after 1 week of treatment with Lu AA21004 compared to placebo. - proportion of patients who are in remission (MADRS total score =<12) after 6 weeks of treatment with Lu AA21004 as compared to placebo. - effect of Lu AA21004 on Health Related Quality of Life. - population pharmacokinetics of Lu AA21004 and its metabolite and any relationship between exposure and efficacy/safety/tolerability. - effect of Lu AA21004 on the serotonin level.;Primary end point(s): Main endpoints of interest are MADRS total score at Week 6, MADRS total score at Week 1 and response rates at Week 1. Also, MADRS total score, HAM-D-24, HAM-A, CGI-S, CGI-I, SCL-90-R, SF-36, EuroQol and MADRS IVR version will be analysed at all time points. In addition safety is also an endpoint as measured by vital signs, ECGs, laboratory measurements, weight, physical examination, adverse events and withdrawal rates. | — |
Countries
Austria, Czech Republic, Finland, Italy, Spain, Sweden
Outcome results
None listed