Major Depressive Disoder
Conditions
Interventions
Trade Name: Brintellix 20 mg encapsulated film-coated tablets
Product Name: Vortioxetine
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: VORTIOXETINE
CAS Number: 508233-74-7
Concentration
Sponsors
H. Lundbeck A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: De novo patients • The patient has a primary diagnosis of MDD according to DSM-5™ although co-morbid anxiety disorders will be permitted (except Post Traumatic Stress Disorder (PTSD) and Obsessive Compulsive Disorder (OCD)). •The patient has a CDRS-R total score =45 at the Screening and Baseline Visits. • The patient has a Clinical Global Impression – Severity of Illness (CGI-S) =4 at the Screening and Baseline Visit Are the trial subjects under 18? yes Number of subjects for this age range: 150 F.1.2 Adults (18-64 years) no 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: De novo patients and roll over patients from studies 12709A and 12712A • The patient receives ongoing current psychotherapy that is planned to be intensified. Interpersonal psychotherapy (IPT) or cognitive behavioural therapy (CBT) are not allowed. • The patient presents with, or has a history of, an Axis I (DSM-5TM) diagnosis of Bipolar Disorder, PTSD, OCD, Autism, Pervasive Developmental Disorder (PDD), or Schizophrenia or Schizoaffective Disorder. • The patient has a diagnosis of attention-deficit/hyperactivity disorder (ADHD) and is not maintained on a stable dose of a methylphenidate or amphetamine for a minimum of 4 weeks prior to the study treatment. • The patient has attempted suicide or is at significant risk of suicide.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The purpose of this study is to find out if vortioxetine is better than placebo (sugar pills) in preventing depression in children who improved when treated with vortioxetine.;Secondary Objective: N/A;Primary end point(s): Time to relapse Relapse defined as either a total score =40 on the Children Depression Rating Scale Revised Version (CDRS-R) total score with a history of 2 weeks of clinical deterioration, or clinical deterioration as judged by the clinician;Timepoint(s) of evaluation of this end point: Baseline/Randomization to week 26 in the double-blind treatment period | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Relapse rate (Relapse defined as either a total score =40 on the Children Depression Rating Scale Revised Version (CDRS-R) total) score with a history of 2 weeks of clinical deterioration, or clinical deterioration as judged by the clinician 2. Change from baseline to Week 26 in the CDRS-R total score 3. Change from baseline to Week 26 in the Clinical Global Impression - Severity of Illness (CGI-S) score 4. Clinical Global Impression - Global Improvement (CGI-I) score at Week 26 5. Change from baseline in Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) - Patient rated 6. Plasma concentration of vortioxetine;Timepoint(s) of evaluation of this end point: 1. Baseline/Randomization to week 26 in the double-blind treatment period 2. Baseline/Randomization to week 26 in the double-blind treatment period 3. Baseline/Randomization to week 26 in the double-blind treatment period 4. Week 26 in the double-blind treatment period 5. Baseline/Randomization to week 26 in the double-blind treatment period 6. Baseline/Randomization to week 26 in the double-blind treatment period | — |
Countries
Argentina, Bulgaria, Colombia, Latvia, Mexico, Poland, Russian Federation, Serbia, Spain, Ukraine, United States
Contacts
Public ContactLundbeckClinicalTrials@lundbeck.com
H. Lundbeck A/S
Outcome results
None listed