A Phase 3 interventional study of Vortioxetine and Placebo in Depression, sponsored by H. Lundbeck A/S. Terminated at 17 sites in 7 countries. Open to participants aged 7 Years to 11 Years. Per ClinicalTrials.gov, last updated 2023-01-05.
Sponsored by H. Lundbeck A/S · Phase 3, Interventional, and Treatment
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.
The study consists of a 12-week open-label, flexible-dose treatment period with vortioxetine, followed by a 26-week, randomized, double-blind, fixed-dose, placebo-controlled relapse-prevention period. There will be a safety follow up 4 weeks after the end of the 26-week double-blind treatment period.
The study population will include 'de novo' participants as well as 'rollover' participants from other paediatric vortioxetine studies 12709A (NCT02709655) and 12712A (NCT02871297), who, in the investigator's opinion, could benefit from continued treatment with vortioxetine.
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's enrollment of 35 is below the median of 84 across 6,720 interventional studies indexed under Depression.
Browse Depression studies →H. Lundbeck A/S is the lead sponsor of 218 studies on the registry; 10 are open to participants now.
Of its 33 completed or terminated interventional studies of FDA-regulated products, 10 (30%) have results posted.
Counted across the registry records on this site, refreshed daily.
De novo participants
Exclusion Criteria:
Other inclusion and exclusion criteria may apply.
Vortioxetine - 5, 10, 15, and 20 mg/day, film-coated tablets, orally once daily. Patients will receive a targeted dose of 10 mg/day vortioxetine, however the investigator has the possibility to adjust the dose in case of unsatisfactory response or in case of dose-limiting adverse events.
Drug: Vortioxetine
Vortioxetine - 5, 10, 15, and 20 mg/day, encapsulated film-coated tables, orally once daily. In the double-blind period, the patients will continue on the same fixed dose as during the end of the open label period
Drug: Vortioxetine
Placebo - encapsulated tablets, orally once daily.
Drug: Placebo
Tablets
Also known as: Brintellix, Trintellix
Tablets
Time to Relapse in the Double-blind Period
Relapse was defined as either a total score ≥40 on the Children Depression Rating Scale Revised Version (CDRS-R) with a history of 2 weeks of clinical deterioration, or clinical deterioration as judged by the clinician. The CDRS-R is rated by a clinician following interviews with the child and parent and consists of 17 items out of which 3 items rate nonverbal observations (listless speech, hypoactivity, and depressed affect). Fourteen items are rated on a 7-point scale from 1 to 7, and 3 items (sleep disturbance, appetite disturbance, and listless speech) are scored on a 5-point scale from 1 to 5. A rating of 1 indicates normal functioning and a higher number indicates a greater degree of depression. The total score ranges from 17 (normal) to 113 (severe depression).
Time frame: From randomization to Week 26 in the double-blind treatment period
Relapse Rate in the Double-blind Period: Percentage of Participants With Relapse
Relapse was defined as either a total score ≥40 on the CDRS-R with a history of 2 weeks of clinical deterioration, or clinical deterioration as judged by the clinician. The CDRS-R is rated by a clinician following interviews with the child and parent and consists of 17 items out of which 3 items rate nonverbal observations (listless speech, hypoactivity, and depressed affect). Fourteen items are rated on a 7-point scale from 1 to 7, and 3 items (sleep disturbance, appetite disturbance, and listless speech) are scored on a 5-point scale from 1 to 5. A rating of 1 indicates normal functioning and a higher number indicates a greater degree of depression. The total score ranges from 17 (normal) to 113 (severe depression).
Time frame: From randomization to Week 26 in the double-blind treatment period
Change From Baseline in Children's Depression Rating Scale - Revised Version (CDRS-R) Total Score at Week 26
The CDRS-R is a clinician-rated scale to measure the severity of depression in children and adolescents. The CDRS-R is rated by a clinician following interviews with the child and parent and consists of 17 items out of which 3 items rate nonverbal observations (listless speech, hypoactivity, and depressed affect). Fourteen items are rated on a 7-point scale from 1 to 7, and 3 items (sleep disturbance, appetite disturbance, and listless speech) are scored on a 5-point scale from 1 to 5. A rating of 1 indicates normal functioning and a higher number indicates a greater degree of depression. The total score ranges from 17 (normal) to 113 (severe depression).
Time frame: Baseline, Week 26
Change From Baseline in Clinical Global Impression - Severity of Illness (CGI-S) Score at Week 26
The CGI-S provides the clinician's impression of the participant's current state of mental illness. The clinician uses his or her clinical experience of this participant population to rate the severity of the participant's current mental illness on a 7-point scale ranging from 1 (normal - not at all ill) to 7 (among the most extremely ill participants).
Time frame: Baseline, Week 26
Clinical Global Impression - Global Improvement (CGI-I) Score at Week 26
The CGI-I provides the clinician's impression of the participant's improvement (or worsening). The clinician assesses the participant's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).
Time frame: Week 26
Change From Baseline in Paediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) Total Score (Items 1 to 14) at Week 26
The PQ-LES-Q is a participant-rated scale designed to assess satisfaction with life. It is an adaptation of the Quality of Life Enjoyment and Satisfaction Questionnaire, which is used to measure quality of life in adults. The PQ-LES-Q consist of 15 items, item 1 to 14 assess the degree of satisfaction experienced by participants in various areas of daily functioning, and item 15 allows participants to summarise their experience in a global rating. Each item is rated on a 5-point scale from 1 (very poor) to 5 (very good). The total score range of item 1 to 14 is 14 to 70, with higher scores indicating greater satisfaction.
Time frame: Baseline, Week 26
Plasma Concentration of Vortioxetine
Time frame: From randomization to Week 26 in the double-blind treatment period
The study population included de novo participants as well as rollover participants from other paediatric vortioxetine studies (Studies 12709A \[NCT02709655\] and 12712A \[NCT02871297\]) who, in the investigator's opinion, would benefit from continued treatment with vortioxetine.
| Milestone | Open-Label Treatment: Vortioxetine | Double-Blind Relapse Prevention: Vortioxetine | Double-Blind Relapse Prevention: Placebo |
|---|---|---|---|
| Started | 33 | 0 | 0 |
| Received at least 1 dose of study drug | 33 | 0 | 0 |
| Completed | 5 | 0 | 0 |
| Not completed | 28 | 0 | 0 |
| Withdrew: Adverse event | 1 | 0 | 0 |
| Withdrew: Lack of efficacy | 1 | 0 | 0 |
| Withdrew: Withdrawal by subject | 2 | 0 | 0 |
| Withdrew: Based on sponsor information of results from vortioxetine study | 15 | 0 | 0 |
| Withdrew: Sponsor decision | 4 | 0 | 0 |
| Withdrew: Study terminated by sponsor | 5 | 0 | 0 |
| Milestone | Open-Label Treatment: Vortioxetine | Double-Blind Relapse Prevention: Vortioxetine | Double-Blind Relapse Prevention: Placebo |
|---|---|---|---|
| Started | 0 | 2 | 2 |
| Received at least 1 dose of study drug | 0 | 2 | 2 |
| Completed | 0 | 1 | 0 |
| Not completed | 0 | 1 | 2 |
| Withdrew: Study terminated by sponsor | 0 | 0 | 1 |
| Withdrew: Based on sponsor information of results from vortioxetine study | 0 | 1 | 1 |
Relapse was defined as either a total score ≥40 on the Children Depression Rating Scale Revised Version (CDRS-R) with a history of 2 weeks of clinical deterioration, or clinical deterioration as judged by the clinician. The CDRS-R is rated by a clinician following interviews with the child and parent and consists of 17 items out of which 3 items rate nonverbal observations (listless speech, hypoactivity, and depressed affect). Fourteen items are rated on a 7-point scale from 1 to 7, and 3 items (sleep disturbance, appetite disturbance, and listless speech) are scored on a 5-point scale from 1 to 5. A rating of 1 indicates normal functioning and a higher number indicates a greater degree of depression. The total score ranges from 17 (normal) to 113 (severe depression).
No measurements were reported for this outcome.
Relapse was defined as either a total score ≥40 on the CDRS-R with a history of 2 weeks of clinical deterioration, or clinical deterioration as judged by the clinician. The CDRS-R is rated by a clinician following interviews with the child and parent and consists of 17 items out of which 3 items rate nonverbal observations (listless speech, hypoactivity, and depressed affect). Fourteen items are rated on a 7-point scale from 1 to 7, and 3 items (sleep disturbance, appetite disturbance, and listless speech) are scored on a 5-point scale from 1 to 5. A rating of 1 indicates normal functioning and a higher number indicates a greater degree of depression. The total score ranges from 17 (normal) to 113 (severe depression).
No measurements were reported for this outcome.
The CDRS-R is a clinician-rated scale to measure the severity of depression in children and adolescents. The CDRS-R is rated by a clinician following interviews with the child and parent and consists of 17 items out of which 3 items rate nonverbal observations (listless speech, hypoactivity, and depressed affect). Fourteen items are rated on a 7-point scale from 1 to 7, and 3 items (sleep disturbance, appetite disturbance, and listless speech) are scored on a 5-point scale from 1 to 5. A rating of 1 indicates normal functioning and a higher number indicates a greater degree of depression. The total score ranges from 17 (normal) to 113 (severe depression).
No measurements were reported for this outcome.
The CGI-S provides the clinician's impression of the participant's current state of mental illness. The clinician uses his or her clinical experience of this participant population to rate the severity of the participant's current mental illness on a 7-point scale ranging from 1 (normal - not at all ill) to 7 (among the most extremely ill participants).
No measurements were reported for this outcome.
The CGI-I provides the clinician's impression of the participant's improvement (or worsening). The clinician assesses the participant's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).
No measurements were reported for this outcome.
The PQ-LES-Q is a participant-rated scale designed to assess satisfaction with life. It is an adaptation of the Quality of Life Enjoyment and Satisfaction Questionnaire, which is used to measure quality of life in adults. The PQ-LES-Q consist of 15 items, item 1 to 14 assess the degree of satisfaction experienced by participants in various areas of daily functioning, and item 15 allows participants to summarise their experience in a global rating. Each item is rated on a 5-point scale from 1 (very poor) to 5 (very good). The total score range of item 1 to 14 is 14 to 70, with higher scores indicating greater satisfaction.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
Collected over Baseline (Week 0) up to Week 42. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Open-Label Treatment: Vortioxetine | 0/33 (0%) | 0/33 (0%) | 8/33 (24.2%) |
| Double-Blind Relapse Prevention: Placebo | 0/2 (0%) | 0/2 (0%) | 1/2 (50%) |
| Double-Blind Relapse Prevention: Vortioxetine | 0/2 (0%) | 0/2 (0%) | 0/2 (0%) |
| Event | Open-Label Treatment: Vortioxetine | Double-Blind Relapse Prevention: Placebo | Double-Blind Relapse Prevention: Vortioxetine |
|---|---|---|---|
| Respiratory tract infection viralInfections and infestations | 0/33 | 1/2 | 0/2 |
| NauseaGastrointestinal disorders | 6/33 | 0/2 | 0/2 |
| VomitingGastrointestinal disorders | 2/33 | 0/2 | 0/2 |
| Food poisoningGastrointestinal disorders | 1/33 | 0/2 | 0/2 |
| Coronavirus infectionInfections and infestations | 1/33 | 0/2 | 0/2 |
| InfluenzaInfections and infestations | 1/33 | 0/2 | 0/2 |
| Electrocardiogram QT prolongedInvestigations | 1/33 | 0/2 | 0/2 |
| DizzinessNervous system disorders | 1/33 | 0/2 | 0/2 |
| HeadacheNervous system disorders | 1/33 | 0/2 | 0/2 |
All-patients-enrolled (APES): all participants enrolled to the 12-week open-label treatment period who took at least 1 dose of study drug. Full analysis set (FAS): all participants randomized to the 26-week double-blind treatment period who took at least 1 dose of double-blind study drug.
| Age, Customized(Participants) | Open-Label Treatment: Vortioxetine | Double-Blind Relapse Prevention: Vortioxetine | Double-Blind Relapse Prevention: Placebo | Total |
|---|---|---|---|---|
| Open-Label Treatment — Children (2-11 years) | 27 | 0 | 0 | 27 |
| Open-Label Treatment — Adolescents (12-17 years) | 6 | 0 | 0 | 6 |
| Double-Blind Relapse Prevention — Children (2-11 years) | 0 | 2 | 2 | 4 |
| Double-Blind Relapse Prevention — Adolescents (12-17 years) | 0 | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Open-Label Treatment: Vortioxetine | Double-Blind Relapse Prevention: Vortioxetine | Double-Blind Relapse Prevention: Placebo | Total |
|---|---|---|---|---|
| Open-Label Treatment — Female | 18 | 0 | 0 | 18 |
| Open-Label Treatment — Male | 15 | 0 | 0 | 15 |
| Double-Blind Relapse Prevention — Female | 0 | 1 | 1 | 2 |
| Double-Blind Relapse Prevention — Male | 0 | 1 | 1 | 2 |
| Ethnicity (NIH/OMB)(Participants) | Open-Label Treatment: Vortioxetine | Double-Blind Relapse Prevention: Vortioxetine | Double-Blind Relapse Prevention: Placebo | Total |
|---|---|---|---|---|
| Open-Label Treatment — Hispanic or Latino | 18 | 0 | 0 | 18 |
| Open-Label Treatment — Not Hispanic or Latino | 15 | 0 | 0 | 15 |
| Open-Label Treatment — Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Double-Blind Relapse Prevention — Hispanic or Latino | 0 | 2 | 1 | 3 |
| Double-Blind Relapse Prevention — Not Hispanic or Latino | 0 | 0 | 0 | 0 |
| Double-Blind Relapse Prevention — Unknown or Not Reported | 0 | 0 | 1 | 1 |
| Race/Ethnicity, Customized(Participants) | Open-Label Treatment: Vortioxetine | Double-Blind Relapse Prevention: Vortioxetine | Double-Blind Relapse Prevention: Placebo | Total |
|---|---|---|---|---|
| Open-Label Treatment — White | 13 | 0 | 0 | 13 |
| Open-Label Treatment — Black or African American | 3 | 0 | 0 | 3 |
| Open-Label Treatment — Asian | 1 | 0 | 0 | 1 |
| Open-Label Treatment — Other | 16 | 0 | 0 | 16 |
| Double-Blind Relapse Prevention — White | 0 | 0 | 2 | 2 |
| Double-Blind Relapse Prevention — Black or African American | 0 | 0 | 0 | 0 |
| Double-Blind Relapse Prevention — Asian | 0 | 0 | 0 | 0 |
| Double-Blind Relapse Prevention — Other | 0 | 2 | 0 | 2 |
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H. Lundbeck A/S