Long-term, Open-label, Flexible-dose, Extension Study of Vortioxetine in Child and Adolescent Patients With Major Depressive Disorder (MDD) From 7 to 18 Years of Age
Status: | Enrolling by invitation |
---|---|
Conditions: | Depression, Depression, Major Depression Disorder (MDD) |
Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
Healthy: | No |
Age Range: | 7 - 18 |
Updated: | 12/1/2018 |
Start Date: | August 2016 |
End Date: | September 2019 |
Evaluation of the long-term safety and tolerability of vortioxetine in child and adolescent
patients with a Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5™)
diagnosis of MDD
patients with a Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5™)
diagnosis of MDD
Inclusion Criteria:
- The patient is a male or female child aged ≥7 and <12 years or 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.
- For patients aged ≥7 and ≤17 years at the Baseline visit; the patient is able to
understand the Informed Assent Form, and parent(s)/legal representative(s) are able to
read and understand the Informed Consent Form.
- For patients who turned 18 years during the lead-in study 12710A; the patient has
signed the Informed Consent Form.
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.
Other protocol-defined inclusion and exclusion criteria may apply
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