A study to evaluate the long-term safety and tolerability of a product named vortioxetine (used in depression) in children and adolescents.

Phase 1

• Conditions: Major Depressive Disorder; MedDRA version: 21.1Level: PTClassification code 10057840Term: Major depressionSystem Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2008-005356-25-BG
• Lead Sponsor: H. Lundbeck A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-04-27
• Last Update Posted: 16 May 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 696

Inclusion Criteria

- The patient is a male or female child aged =7 and <12 years or an adolescent aged =12 and =18 years in the lead-in study (12709A and 12710A).
- The patient must have completed Study 12709A or 12710A (Visit 12, Completion Visit) immediately prior to enrolment into this extension study.
- The patient had a primary diagnosis of MDD at entry in study 12709A or 12710A, diagnosed according to DSM-5™.
- The patient is indicated for long-term treatment with vortioxetine according to the clinical opinion of the Investigator.
Are the trial subjects under 18? yes
Number of subjects for this age range: 696
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- The patient has been diagnosed with another psychiatric disorder (for example mania, bipolar disorder, schizophrenia or any psychotic disorder) during study 12709A or 12710A.
- The patient has an attention-deficit/hyperactivity disorder (ADHD) that requires a pharmacological treatment other than a stimulant medication.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified