Phase 3
Completed N=683
Active Reference (Fluoxetine) Fixed-dose Study of Vortioxetine in Paediatric Participants Aged 7 to 11 Years With Major Depressive Disorder (MDD)
Depressive Disorder, Major
Source: ClinicalTrials.gov NCT02709655 ↗
Enrolled (actual)
683
Serious AEs
1.1%
Results posted
Sep 2022
Primary outcomePrimary: Change From Baseline in Children Depression Rating Scale - Revised (CDRS-R) Total Score at Week 8 of Phase B — -17.48; -19.20; -19.94; -20.78 units on a scale — p=0.0937
◆ Published Evidence
Emerging
2citations · ~2 / year
Vortioxetine for Major Depressive Disorder in Children: 12-Week Randomized, Placebo-Controlled Study.
Summary
Investigation of the efficacy and safety of a new potential treatment of Major depressive disorder (MDD) in paediatric participants (age 7 to 11 years).
Linked Publications
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Vortioxetine for Major Depressive Disorder in Children: 12-Week Randomized, Placebo-Controlled Study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Children Depression Rating Scale - Revised (CDRS-R) Total Score at Week 8 of Phase B |
-17.48; -19.20; -19.94; -20.78; -19.57 | 0.0937 |
| SECONDARY Change From Baseline in CDRS-R Total Score at Weeks 2, 4, and 6 of Phase B |
-9.20; -9.54; -10.30; -10.17; -13.15; -14.56 | — |
| SECONDARY Change From Baseline in CDRS-R Subscores (Mood, Somatic, Subjective, and Behaviour) at Weeks 2, 4, 6, and 8 of Phase B |
-2.82; -3.10; -3.47; -3.02; -3.69; -4.39 | — |
| SECONDARY Percentage of Participants With CDRS-R Response |
7.8; 10.2; 11.6; 16.3; 20.7; 23.4 | — |
| SECONDARY Percentage of Participants With CDRS-R Remission |
2.0; 5.4; 2.7; 3.8; 9.0; 9.5 | — |
| SECONDARY Change From Baseline in General Behaviour Inventory (GBI) Depression Subscale Score, Using the 10-Item Depression Subscale Assessed by Parent (PGBI-10D) and Child (CGBI-10D) at Weeks 2, 4, 6, and 8 of Phase B |
-3.33; -3.38; -3.78; -3.78; -4.11; -4.72 | — |
| SECONDARY Parent Global Assessment (PGA) Score |
3.31; 3.25; 3.18; 3.13; 2.97; 2.90 | — |
| SECONDARY Change From Baseline in Clinical Global Impression - Severity of Illness (CGI-S) Score at Weeks 1, 2, 3, 4, 6, and 8 of Phase B |
-0.25; -0.27; -0.28; -0.22; -0.50; -0.60 | — |
| SECONDARY Clinical Global Impression - Global Improvement (CGI-I) Score |
3.66; 3.63; 3.60; 3.72; 3.32; 3.30 | — |
| SECONDARY Percentage of Participants With CGI-S Remission |
0; 0.7; 0; 0; 0.7; 3.4 | — |
| SECONDARY Change From Baseline in Children's Global Assessment Scale (CGAS) Score at Weeks 4 and 8 of Phase B |
8.93; 9.84; 8.73; 10.54; 12.71; 12.98 | — |
| SECONDARY Change From Baseline in Pediatric Quality of Life Inventory (PedsQL) Visual Analogue Scales (VAS): Afraid or Scared (Anxiety) Score at Weeks 4 and 8 of Phase B |
-0.48; -0.51; -0.48; -0.41; -0.73; -1.07 | — |
| SECONDARY Change From Baseline in PedsQL VAS: Sad or Blue (Sadness) Score at Weeks 4 and 8 of Phase B |
-1.20; -1.65; -1.78; -1.42; -1.72; -2.23 | — |
| SECONDARY Change From Baseline in PedsQL VAS: Angry Score at Weeks 4 and 8 of Phase B |
-0.98; -1.36; -1.33; -1.22; -1.24; -1.98 | — |
| SECONDARY Change From Baseline in PedsQL VAS: Worry Score at Weeks 4 and 8 of Phase B |
-0.63; -1.48; -1.21; -1.27; -1.08; -1.82 | — |
| SECONDARY Change From Baseline in PedsQL VAS: Tired (Fatigue) Score at Weeks 4 and 8 of Phase B |
-1.22; -1.19; -1.63; -0.94; -1.39; -1.32 | — |
| SECONDARY Change From Baseline in PedsQL VAS: Pain or Hurt Score at Weeks 4 and 8 of Phase B |
-0.22; -0.81; -0.45; -0.50; -0.70; -0.79 | — |
| SECONDARY Change From Baseline in PedsQL VAS Total Average Score at Weeks 4 and 8 of Phase B |
-0.81; -1.19; -1.17; -1.01; -1.17; -1.55 | — |
| SECONDARY Change From Baseline in PedsQL Emotional Distress Summary Average Score at Weeks 4 and 8 of Phase B |
-0.84; -1.28; -1.22; -1.13; -1.22; -1.80 | — |
| SECONDARY Change From Baseline in Paediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) Total Score (Items 1 to 14) at Weeks 4 and 8 of Phase B |
3.94; 4.90; 4.90; 4.36; 6.22; 7.08 | — |
| SECONDARY Change From Baseline in PQ-LES-Q Overall Evaluation Score (Item 15) at Weeks 4 and 8 of Phase B |
0.28; 0.37; 0.43; 0.24; 0.41; 0.49 | — |
Eligibility Criteria
Inclusion Criteria
- The participant has MDD, diagnosed according to Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5™).
- The participant has a CDRS-R total score ≥45 at the Screening Visit and the Baseline.
- The participant has a CGI-S score ≥4 at the Screening Visit and the Baseline.
- The participant is a boy or girl, aged ≥7 and <12 years at Screening Visit
- The participant has provided assent to participation and parent(s)/legal representative (s) signed the Informed Consent Form.
Exclusion Criteria
- The participant has participated in a clinical study <30 days prior to the Screening Visit.
- The participant has previously participated in a study with vortioxetine.
Other protocol defined inclusion and exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT02709655) 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.