Children's National

Active Reference (Fluoxetine) Fixed-dose Study of Vortioxetine in Paediatric Participants Aged 7 to 11 Years With Major Depressive Disorder (MDD)

Purpose

Investigation of the efficacy and safety of a new potential treatment of Major depressive disorder (MDD) in paediatric participants (age 7 to 11 years).

Condition

Depressive Disorder, Major

Eligibility

Eligible Ages: Between 7 Years and 11 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

Inclusion Criteria

The participant has MDD, diagnosed according to Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5™). 2. The participant has a CDRS-R total score ≥45 at the Screening Visit and the Baseline. 3. The participant has a CGI-S score ≥4 at the Screening Visit and the Baseline. 4. The participant is a boy or girl, aged ≥7 and <12 years at Screening Visit 5. 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. 2. The participant has previously participated in a study with vortioxetine. Other protocol defined inclusion and exclusion criteria may apply

Study Design

Phase: Phase 3
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: Double (Participant, Investigator)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Vortioxetine 10 mg/day		Drug: Vortioxetine 10 mg/day 10 mg/day, encapsulated tablet, orally (with addition of lower initial dose levels). Based on tolerability the dose may be reduced by 5 mg/day. No dose increase will be allowed Other names: Brintellix ® Lu AA21004
Experimental Vortioxetine 20 mg/day		Drug: Vortioxetine 20 mg/day 20 mg/day, encapsulated tablet, orally (with addition of lower initial dose levels). Based on tolerability the dose may be reduced by 5 mg/day. No dose increase will be allowed Other names: Brintellix ® Lu AA21004
Active Comparator Fluoxetine 20 mg/day,	A decision has been taken to stop recruitment into this treatment arm.	Drug: Fluoxetine 20mg/day 20 mg/day, encapsulated tablet, orally (with addition of lower initial dose levels). Based on tolerability the dose may be reduced by 10 mg/day. No dose increase will be allowed
Placebo Comparator Placebo		Other: Placebo Encapsulated tablet, orally

Recruiting Locations

More Details

NCT ID: NCT02709655
Status: Completed
Sponsor: H. Lundbeck A/S

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.