Multicentre trial in to investigate the usage of antidepressant and antipsychotics (with / without approval) in patients at the age of children and adolescents

Phase 1

• Conditions: therapeutic use in clinical practise; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2013-004881-33-DE
• Lead Sponsor: niversitätsklinikum Würzburg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05-06
• Study Completion: 2018-12-31
• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 710

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: age adjusted incidence of adverse drug reaction;Secondary Objective: Use of antidepressants and antipsychotics in clinical life with or without approval. <br>prescreption of medications in children and adolescents with a psychiatric diagnosis;Primary end point(s): Share of a defined study population, which suffer on (minimum) one severe adverse event after receiving an antidepressant or antipsychotics in off-label use in the period of time until FU 2 weeks.;Timepoint(s) of evaluation of this end point: In the period of time until „FU 2 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1. Share of a defined study population with a report of (minimum) one (severe or not severe) adverse event after receiving an antidepressant or antipsychotics in off-label use in the period of time until FU 2 weeks.<br>2. Time until occuring the first adverse event<br>3. share of patients with change of medication, defined as one of following events: <br>- stopping of a medication and readjustment of an alternative medication<br>- relevant change of dose of a current medication<br>- precription of an additional medication / an additional combination therapy <br>4. Time until first change of medication;Timepoint(s) of evaluation of this end point: In the space of time from 2 weeks after dismissal to 6 months after reaching steady state of the last dosed drug.