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

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-004881-33-DE

Enrollment

1000

Registered

2014-05-06

Start date

2017-02-28

Completion date

Unknown

Last updated

2025-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

therapeutic use in clinical practise

Interventions

Trade Name: Abilify Pharmaceutical Form: Tablet INN or Proposed INN: ARIPIPRAZOLE CAS Number: 129722-12-9 Trade Name: Zyprexa Pharmaceutical Form: Tablet INN or Proposed INN: OLANZAPINE CAS Number: 1

Eligibility

Sex/Gender

All

Inclusion 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

Exclusion criteria: - no informed consent - absolute contraindication for administration investigational medicinal product - participation in an other clinical trial

Design outcomes

Primary

Measure	Time frame
Main Objective: age adjusted incidence of adverse drug reaction;Secondary Objective: Use of antidepressants and antipsychotics in clinical life with or without approval. 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“	—

Measure

Time frame

Main Objective: age adjusted incidence of adverse drug reaction;Secondary Objective: Use of antidepressants and antipsychotics in clinical life with or without approval. 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“

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Secondary

Measure	Time frame
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". 2. Time until occuring the first adverse event 3. share of patients with change of medication, defined as one of following events: - stopping of a medication and readjustment of an alternative medication - relevant change of dose of a current medication - precription of an additional medication / an additional combination therapy 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.	—

Measure

Time frame

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". 2. Time until occuring the first adverse event 3. share of patients with change of medication, defined as one of following events: - stopping of a medication and readjustment of an alternative medication - relevant change of dose of a current medication - precription of an additional medication / an additional combination therapy 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.

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Countries

Austria, Germany, Switzerland

Contacts

Public ContactClinical Trial Information Desk

KJPPP Universität Würzburg

egberts@kjp.uni-wuerzburg.de0049201201 78020

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 6, 2026