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.
Investigators
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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