Major depressive disorder MedDRA version: 21.1 Level: PT Classification code 10057840 Term: Major depression System Organ Class: 10037175 - Psychiatric disorders
Conditions
Sponsors
H. Lundbeck A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - The patient has a primary diagnosis of single or recurrent MDD, diagnosed according to DSM-5®. The current major depressive episode (MDE) must be confirmed using the Mini International Neuropsychiatric Interview (MINI). - The patient has a Montgomery and Åsberg Depression Rating Scale (MADRS) total score =24 at screening and baseline. - The patient has had the current MDE for =3 months and =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - The patient has any other disorder for which the treatment takes priority over treatment of MDD or is likely to interfere with study treatment or impair treatment compliance. Other exclusion criteria may apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The purpose of this study is to compare the efficacy of vortioxetine versus desvenlafaxine after 8 weeks of treatment in patients that have tried one available treatment without getting the full benefit.;Secondary Objective: N/A;Primary end point(s): 1. Change in Montgomery and Åsberg Depression Rating Scale (MADRS) total score The Montgomery and Åsberg Depression Rating Scale (MADRS) is a 10-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Symptoms are rated on a 7-point scale from 0 (no symptom) to 6 (severe symptom). The total score of the 10 items ranges from 0 to 60, with higher values indicating worse outcome. ;Timepoint(s) of evaluation of this end point: 1. Time-frame: From baseline to Week 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 2. Remission (defined as a MADRS total score = 50% decrease from baseline in MADRS total score) 4. Change in MADRS anhedonia factor score 5. Change in Digital Symbol Substitution Test (DSST) total score 6. The proportion number of Hard Choice/number of High Reward trials and number of Low choice/number of Low Reward trials when performing the Effort- Expenditure for Rewards Task (EEfRT) 7. Change in Clinical Global Impression - Severity of Illness (CGI-S) score 8. Clinical Global Impression Scale- Global Improvement (CGI-I) score 9. Change in Functioning Assessment Short Test (FAST) total score 10. Change in FAST sub-domain scores 11. Change in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) total score 12. Change in Q-LES-Q work subscale 13. Change in Q-LES-Q household duties subscale 14. Change in Q-LES-Q school/course subscale 15. Change in Q-LES-Q leisure time activities subscale 16. Change in Q-LES-Q social relations subscale. ;Timepoint(s) of evaluation of this end point: 2. Time-frame: At Week 8 3. Time-frame: At Week 8 4. Time-frame: From baseline to Week 8 5. Time-frame: From baseline to Week 8 6. Time-frame: From baseline to Week 8 7. Time-frame: From baseline to Week 8 8. Time-frame: At Day 7,28,56 9. Time-frame: From baseline to Week 8 10. Time-frame: From baseline to Week 8 11. Time-frame: From baseline to Week 8 12. Time-frame: From baseline to Week 8 13. Time-frame: From baseline to Week 8 14. Time-frame: From baseline to Week 8 15. Time-frame: From baseline to Week 8 16. Time-frame: From baseline to Week 8 | — |
Countries
Argentina, Belgium, Bulgaria, Croatia, Czech Republic, Estonia, Finland, France, Latvia, Mexico, Russian Federation, Slovakia, Spain, Sweden, Ukraine
Contacts
Public ContactLundbeckClinicalTrials@lundbeck.com
H. Lundbeck A/S
Outcome results
None listed