WHO ICTRP trial
A study to evaluate the long-term safety and tolerability of a product named…
EUCTR2015-002658-11-BE · EU Clinical Trials Register · Not Recruiting
Key facts
| Trial ID | EUCTR2015-002658-11-BE |
|---|---|
| Public title | A study to evaluate the long-term safety and tolerability of a product named vortioxetine (used in depression) in children and adolescents. |
| Scientific title | Long-term, open-label, flexible-dose, continuation extension study with vortioxetine in child and adolescent patients with Major Depressive Disorder (MDD) from 7 to 17 years of age |
| Primary sponsor | H. Lundbeck A/S |
| Registry | EU Clinical Trials Register |
| Recruitment status | Not Recruiting |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no |
| Countries | Estonia;Slovakia;Finland;Spain;Ireland;Lithuania;Austria;United Kingdom;Italy;France;Hungary;Poland;Belgium;Romania;Denmark;South Africa;Bulgaria;Netherlands;Germany;Latvia;Sweden |
| 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] |
| Interventions | Trade Name: Brintellix 5 mg film-coated tablets Pharmaceutical Form: Film-coated tablet INN or Proposed INN: VORTIOXETINE CAS Number: 508233-74-7 Current Sponsor code: Lu AA21004 Concentration unit: mg milligram(s) Concentration type: equal… |
| Registration date | Apr 4, 2016 |
| Target size | 175 |
| Secondary IDs | 12712B |
| Registry page | clinicaltrialsregister.eu |
At a glance
- Yes Results available
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About WHO ICTRP trial registrations
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: