WHO ICTRP trial
Efficacy and safety of 2 doses of agomelatine (10mg, 25mg) given orally in…
EUCTR2015-002181-23-HU · EU Clinical Trials Register · Not Recruiting
Key facts
| Trial ID | EUCTR2015-002181-23-HU |
|---|---|
| Public title | Efficacy and safety of 2 doses of agomelatine (10mg, 25mg) given orally in children (from 7 to less than 12 years) and adolescents (from 12 to less than 18 years) with moderate to severe Major Depressive Disorder. |
| Scientific title | Efficacy and safety of 2 doses of agomelatine (10mg, 25mg) given orally in children (from 7 to less than 12 years) and adolescents (from 12 to less than 18 years) with moderate to severe Major Depressive Disorder. A 12-week, randomized, double-blind, active (fluoxetine 10 mg/day with potential… |
| Primary sponsor | Institut de Recherche International Servier |
| 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 | Hungary;Finland;Poland;Ukraine;Romania;Russian Federation;Bulgaria;South Africa;Germany |
| 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 | Product Code: S20098 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: AGOMELATINE CAS Number: 138112-76-2 Current Sponsor code: S20098 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10… |
| Registration date | May 11, 2015 |
| Target size | 484 |
| Secondary IDs | CL3-20098-076;2015-002181-23-FI |
| 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: