Vortioxetine to Prevent Return of Symptoms in Children With Depression

Depression Clinical Trial

Official title:

A Double-blind, Randomized, Placebo-controlled, Multicentre, Relapse-prevention Study of Vortioxetine in Paediatric Patients Aged 7 to 11 Years With Major Depressive Disorder

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05014919
• Other study ID #: 13546A
• Secondary ID: 2010-020493-42
• Status: Terminated
• Phase: Phase 3
• Start date: August 10, 2021
• Est. completion date: April 28, 2022

Study information

• Verified date: December 2022
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 35
• Est. completion date: April 28, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 11 Years

Eligibility

Inclusion Criteria:

De novo participants

• The participant 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 participant has a CDRS-R total score =45 at the Screening and Baseline Visits.

• The participant has a Clinical Global Impression - Severity of Illness (CGI-S) =4 at the Screening and Baseline Visit

Exclusion Criteria:

• The participant receives ongoing current psychotherapy that is planned to be intensified. Interpersonal psychotherapy (IPT) or cognitive behavioural therapy (CBT) are not allowed.

• The participant 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 participant 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 participant has attempted suicide or is at significant risk of suicide

Other inclusion and exclusion criteria may apply.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Drug:
• Vortioxetine
Tablets
• Placebo
Tablets

Locations

Country	Name	City	State
Colombia	Centro de Investigaciones y Proyectos en Neurociencias CIPNA LTDA IPS.	Barranquilla	Atlantico
Colombia	Centro de investigaciones del Sistema Nervioso SAS Grupo CISNE SAS	Bogota	DC
Colombia	Psynapsis Salud Mental S.A.	Pereira	Risaralda
Latvia	Linda Keruze's Psychiatric Center, LLC	Liepaja
Mexico	SINACOR - Centro para el Desarrollo de la Medicina Y De Asistencia Medica Especializada S.C	Culiacan De Rosales	Sinaloa
Mexico	CRI Centro Regiomontano de Investigacion SC	Monterrey	Nuevo Leon
Mexico	BIND Investigaciones S.C	San Luis Potosi	San Luis Potosí
Poland	Przychodnia Syntonia Izabela Chojnowska-Cwiakala	Kielce
Poland	Indywidualna Specjalistyczna Praktyka Lekarska	Poznan
Russian Federation	GUZ Engels Psychiatric Hospital	Engels
Russian Federation	Medicorehabilitation Research Center Phoenix	Rostov-On-Don	Rostov State
Russian Federation	Rostov State Medical University of the Minzdravsotsrazvitiya of Russia	Rostov-on-Don
Russian Federation	Nebbiolo LLC	Tomsk
Ukraine	Odessa Regional Psychiatry Hospital No. 2	Odessa
United States	Atlanta Center for Medical Research	Atlanta	Georgia
United States	Alliance for Research	Long Beach	California
United States	AIM Trials, LLC	Plano	Texas

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Countries where clinical trial is conducted

United States,  Colombia,  Latvia,  Mexico,  Poland,  Russian Federation,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	From randomization to Week 26 in the double-blind treatment period
Secondary	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).	From randomization to Week 26 in the double-blind treatment period
Secondary	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).	Baseline, Week 26
Secondary	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).	Baseline, Week 26
Secondary	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).	Week 26
Secondary	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.	Baseline, Week 26
Secondary	Plasma Concentration of Vortioxetine		From randomization to Week 26 in the double-blind treatment period