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Clinical Trials/EUCTR2013-004881-33-DE
EUCTR2013-004881-33-DE
Active, not recruiting
Phase 1

Pharmacovigilance in children and adolescents: clinical trial protocol, subproject 1:Large Simple Trial, IIIb on the (off-label-) use of antidepressants and antipsychotics - TDM-VIGI

niversitätsklinikum Würzburg0 sites710 target enrollmentMay 6, 2014
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Conditionstherapeutic use in clinical practiseTherapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
DrugsAbilifyZyprexaLeponexSeroquelRisperdalZeldoxMelneurinDipiperonSarotenCipramilAnafranilAponalCymbaltaCipralexFluctinFevarinTofranilLudiomilRemergil

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
therapeutic use in clinical practise
Sponsor
niversitätsklinikum Würzburg
Enrollment
710
Status
Active, not recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
May 6, 2014
End Date
December 31, 2018
Last Updated
last year
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
niversitätsklinikum Würzburg

Eligibility Criteria

Inclusion Criteria

  • •1\. patients at the age of children and adolescents (4\. until 18\. year of life) with an initiated drug therapy with antidepressants and antipsychotics (with / without approval)
  • •2\. Informed Consent
  • •Are the trial subjects under 18? yes
  • •Number of subjects for this age range: 1000
  • •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

  • •\- no informed consent
  • •\- absolute contraindication for administration investigational medicinal product
  • •\- participation in an other clinical trial

Outcomes

Primary Outcomes

Not specified

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