Phase 3
Completed N=784
Active Reference (Fluoxetine) Fixed-dose Study of Vortioxetine in Paediatric Patients Aged 12 to 17 Years With Major Depressive Disorder (MDD)
Depressive Disorder, Major
Source: ClinicalTrials.gov NCT02709746 ↗
Enrolled (actual)
784
Serious AEs
2.0%
Results posted
Aug 2020
Primary outcomePrimary: Change in Children Depression Rating Scale - Revised (CDRS-R) Total Score After Treatment — -17.09; -18.94; -21.95; -18.22 units on a scale — p=0.4702
◆ Published Evidence
Established
37citations · ~9 / year
Vortioxetine for Major Depressive Disorder in Adolescents: 12-Week Randomized, Placebo-Controlled, Fluoxetine-Referenced, Fixed-Dose Study.
Summary
Evaluating the efficacy of vortioxetine 10 mg/day and 20 mg/day versus placebo on depressive symptoms in adolescents (age ≥12 and ≤17 years) with a DSM-5™ (Diagnostic and Statistical Manual of Mental Disorders, 5th edition) diagnosis of Major depressive disorder (MDD).
Linked Publications
-
Vortioxetine for Major Depressive Disorder in Adolescents: 12-Week Randomized, Placebo-Controlled, Fluoxetine-Referenced, Fixed-Dose Study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Children Depression Rating Scale - Revised (CDRS-R) Total Score After Treatment |
-17.09; -18.94; -21.95; -18.22; -18.01 | 0.4702 |
| SECONDARY Change in CDRS-R Total Score During Treatment (at Week 2) |
-9.58; -10.15; -10.34; -8.83 | — |
| SECONDARY Change in CDRS-R Total Score During Treatment (at Week 4) |
-14.32; -15.03; -16.25; -13.71 | — |
| SECONDARY Change in CDRS-R Total Score During Treatment (at Week 6) |
-15.43; -17.78; -19.20; -16.71 | — |
| SECONDARY Change in CDRS-R Mood Score |
-5.05; -5.47; -6.53; -5.32 | — |
| SECONDARY Change in CDRS-R Somatic Score |
-5.63; -6.03; -6.79; -5.78 | — |
| SECONDARY Change in CDRS-R Subjective Score |
-2.41; -2.63; -3.23; -2.66 | — |
| SECONDARY Change in CDRS-R Behaviour Score |
-4.32; -4.90; -5.52; -4.73 | — |
| SECONDARY CDRS-R Response |
53; 60; 68; 49 | — |
| SECONDARY CDRS-R Remission |
21; 24; 32; 20 | — |
| SECONDARY Change in General Behaviour Inventory (GBI) Depression Sub Scale Score Assessed by the Parents |
-6.23; -6.48; -8.00; -6.62 | — |
| SECONDARY Change General Behaviour Inventory (GBI) Depression Subscale Score Assessed by the Child |
-5.48; -5.55; -6.30; -6.03 | — |
| SECONDARY Parent Global Assessment-Global Improvement (PGA) Score |
2.80; 2.74; 2.49; 2.72 | — |
| SECONDARY Change in Symbol Digit Modalities Test (SDMT) |
3.75; 2.64; 2.69; 2.41 | — |
| SECONDARY Change in Clinical Global Impression Severity of Illness (CGI-S) Score |
-1.23; -1.38; -1.59; -1.21 | — |
| SECONDARY Clinical Global Impression - Global Improvement (CGI-I) Score |
2.81; 2.69; 2.50; 2.73 | — |
| SECONDARY CGI-S Remission |
26; 33; 36; 24 | — |
| SECONDARY Change in Children's Global Assessment Scale (CGAS) Score |
12.24; 13.89; 16.43; 14.52 | — |
| SECONDARY Change in Pediatric Quality of Life Inventory (PedsQL) Visual Analogue Scales (VAS): Afraid or Scared (Anxiety) Score |
-0.47; -0.76; -0.78; -0.71 | — |
| SECONDARY Change in PedsQL VAS: Sad or Blue (Sadness) Score |
-1.90; -1.71; -2.45; -2.12 | — |
| SECONDARY Change in PedsQL VAS: Angry Score |
-0.51; -0.70; -1.01; -0.59 | — |
| SECONDARY Change in PedsQL VAS: Worry Score |
-0.96; -1.17; -0.91; -1.33 | — |
| SECONDARY Change in PedsQL VAS: Tired (Fatigue) Score |
-1.18; -1.40; -1.55; -1.27 | — |
| SECONDARY Change in PedsQL VAS: Pain or Hurt Score |
-1.12; -0.97; -0.83; -0.76 | — |
| SECONDARY Change in PedsQL VAS Total Average Score |
-1.00; -1.13; -1.33; -1.14 | — |
| SECONDARY Change in PedsQL Emotional Distress Summary Average Score |
-0.93; -1.09; -1.33; -1.18 | — |
| SECONDARY Change in Paediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) Total Scores |
7.62; 7.56; 9.26; 7.06 | — |
| SECONDARY Change in PQ-LES-Q Overall Score |
0.54; 0.43; 0.67; 0.51 | — |
Eligibility Criteria
Inclusion Criteria
- The patient is a male or female, aged ≥12 and ≤17 years at Screening (patients who turn 18 years during the study will be allowed to continue in the study).
- The patient has Major depressive disorder (MDD), diagnosed according to DSM-5™.
- The patient has a Children Depression Rating Scale - Revised (CDRS-R) total score ≥45 at the Screening Visit and at the Baseline.
- The patient has a Clinical Global Impression - Severity of Illness (CGI-S) score ≥4 at the Screening Visit and at the Baseline
- The patient has provided assent to participation and parent(s)/legal representative (s) signed the Informed Consent Form.
Exclusion Criteria
- The patient has participated in a clinical study <30 days prior to the Screening Visit.
Other protocol defined inclusion and exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT02709746) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.