A study to evaluate the effect of a product named vortioxetine (used in depression) in adolescents. These effects will be compared to those induced by a marketed comparator and a placebo. Investigator and subjects will be blinded.

Phase 1

• Conditions: Major Depressive Disorder; MedDRA version: 18.1 Level: PT Classification code 10057840 Term: Major depression System Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2008-005354-20-DE
• Lead Sponsor: H. Lundbeck A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-03-07
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 750

Inclusion Criteria

- The patient is a male or female, aged =12 and =17 years at screening (patients who turn 18 years during the study will be allowed to continue in the study).
- The patient has Major depressive disorder (MDD), diagnosed according to DSM-5™.
- The patient has a CDRS-R total score =45 at the Screening Visit and at the Baseline Visit.
- The patient has a CGI-S score =4 at the Screening Visit and at the Baseline Visit.
- The patient has provided assent to participation and parent(s)/legal representative(s) signed the Informed Consent Form.
Are the trial subjects under 18? yes
Number of subjects for this age range: 750
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 participated in a clinical study <30 days prior to the Screening Visit.

Study & Design

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