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

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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


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
We found this trial at
6
sites
Baltimore, Maryland
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Cincinnati, Ohio
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Cincinnati, OH
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Cleveland, Ohio
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Targovishte,
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Targovishte,
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1333 East 2nd Street
Tucson, Arizona 85719
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Tucson, AZ
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Wichita, Kansas
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Wichita, KS
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