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Clinical Trials/EUCTR2013-004881-33-AT
EUCTR2013-004881-33-AT
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

Kompetenznetz TDM-KJP e.V.0 sites1,000 target enrollmentJune 26, 2014

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
Kompetenznetz TDM-KJP e.V.
Enrollment
1000
Status
Active, not recruiting
Last Updated
7 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
June 26, 2014
End Date
TBD
Last Updated
7 years ago
Study Type
Interventional clinical trial of medicinal product

Investigators

Sponsor
Kompetenznetz TDM-KJP e.V.

Eligibility Criteria

Inclusion Criteria

  • 1\. patients at the age of children and adolescents 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

Outcomes

Primary Outcomes

Not specified

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