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Therapeutic Drug Monitoring in Child and Adolescent Psychiatry (TDMKJP)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Medical University of Vienna.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01057329
First received: January 26, 2010
Last updated: NA
Last verified: January 2010
History: No changes posted
  Purpose

The investigators aim to analyse in adolescents with mental illness effectiveness, side effects, and serum level concentrations of antipsychotics (olanzapine and aripiprazole), antidepressants (Duloxetine, Atomoxetine) by means of "Therapeutic Drug Monitoring" (TDM) in order to optimize dosage - effect relations and minimize unwanted side effects.


Condition Intervention
Depression
Anorexia Nervosa
ADHD
 Drug: Atomoxetine
Drug: Duloxetine
Drug: Olanzapine
Drug: Aripiprazole

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Therapeutic Drug Monitoring (TDM) in Child & Adolescent Psychiatry

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • Blood level concentrations of the drugs in use; [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Level of symtomatology [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: January 2010
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Anorexia nervosa
36 severe AN patients treated with aripiprazole
 Drug: Aripiprazole
5 mg from week 1, 10 mg from week 2
Anorexia
36 severe anorexia nervosa patients treated with olanzapine
 Drug: Olanzapine
5mg 1 wwek and 10 mg from second week
Drug: Aripiprazole
5 mg from week 1, 10 mg from week 2
Attention Deficit Hyperactivity Disorder
30 ADHD patients treated with atomoxetine
 Drug: Atomoxetine
mg according to body weight
Depressive disorder
30 depressed patients treated with duloxetine
 Drug: Duloxetine
30 mg / die

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   10 Years to 19 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

university clinic population

Criteria

Inclusion Criteria:

  • appropriate diagnosis and severity of the disorder of interest
  • age range 10-19

Exclusion Criteria:

  • below 10 yrs of age
  • no written informed consent possible due to intelligence or no willingness by parents to include minor
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01057329

Contacts
Contact: Andreas FK Karwautz, Prof, MD, FAED 0043-1-40400- ext 3057 andreas.karwautz@meduniwien.ac.at
Contact: Julia Huemer, MD 0043-1-40400 ext 3057 julia.huemer@meduniwien.ac.at

Locations
Austria
Medical University of Vienna Recruiting
Vienna, Austria, A-1090
Contact: Andreas Karwautz, Prof     0043-1-40400 ext 3057     andreas.karwautz@meduniwien.ac.at    
Contact: Julia Huemer, MD     0043-1-40400- ext 2747     julia.huemer@meduniwien.ac.at    
Sub-Investigator: Julia Huemer, MD            
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Andreas Karwautz, Prof Medical University of Vienna
  More Information

Additional Information:
Eating Disorders and Research Site with links to all projects  This link exits the ClinicalTrials.gov site
TDM in C&A Psych  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Karwautz Andreas, MD; FAED, Medical University of Vienna, Deprt Child a Adoelscent Psychiatry
ClinicalTrials.gov Identifier: NCT01057329     History of Changes
Other Study ID Numbers: 223/2008/TDM, MUW223/2008/2010TDM, MUW223/2008/2010/TDM
Study First Received: January 26, 2010
Last Updated: January 26, 2010
Health Authority: Austria: Ethikkommission

Keywords provided by Medical University of Vienna:
TDM
Drug
Psychopharmacology
children
adolescents

Additional relevant MeSH terms:
Anorexia
Anorexia Nervosa
Depression
Depressive Disorder
Signs and Symptoms, Digestive
Signs and Symptoms
Eating Disorders
Mental Disorders
Behavioral Symptoms
Mood Disorders
Atomoxetine
Duloxetine
Olanzapine
Aripiprazole
Adrenergic Uptake Inhibitors
 Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Serotonin Uptake Inhibitors
Serotonin Agents
Antiemetics

ClinicalTrials.gov processed this record on June 18, 2013