Therapeutic Drug Monitoring in Child and Adolescent Psychiatry (TDMKJP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01057329
Recruitment Status : Recruiting
First Posted : January 27, 2010
Last Update Posted : October 2, 2017
Information provided by (Responsible Party):
Dr. Andreas Karwautz, Medical University of Vienna

Brief Summary:
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 or disease Intervention/treatment
Depression Anorexia Nervosa ADHD Drug: Atomoxetine Drug: Duloxetine Drug: Olanzapine Drug: Aripiprazole

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Therapeutic Drug Monitoring (TDM) in Child & Adolescent Psychiatry
Study Start Date : January 2010
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : February 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
Anorexia nervosa
36 severe AN patients treated with aripiprazole
Drug: Aripiprazole
5 mg from week 1, 10 mg from week 2
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

Primary Outcome Measures :
  1. Blood level concentrations of the drugs in use; [ Time Frame: 5 weeks ]
    Blood level concentration of the druns in use

Secondary Outcome Measures :
  1. Level of symtomatology [ Time Frame: 5 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
university clinic population

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01057329

Contact: Andreas FK Karwautz, Prof,MD,FAED 0043-1-40400- ext 3057
Contact: Julia Huemer, MD 0043-1-40400 ext 3057

Medical University of Vienna Recruiting
Vienna, Austria, A-1090
Contact: Andreas Karwautz, Prof    0043-1-40400 ext 3057   
Contact: Julia Huemer, MD    0043-1-40400- ext 2747   
Sub-Investigator: Julia Huemer, MD         
Sponsors and Collaborators
Medical University of Vienna
Principal Investigator: Andreas Karwautz, Prof Medical University of Vienna

Additional Information:
Responsible Party: Dr. Andreas Karwautz, Univ. Prof. Dr., Medical University of Vienna Identifier: NCT01057329     History of Changes
Other Study ID Numbers: 223/2008/TDM
MUW223/2008/2010TDM ( Other Identifier: MUW )
MUW223/2008/2010/TDM ( Other Identifier: Medical University of Vienna )
First Posted: January 27, 2010    Key Record Dates
Last Update Posted: October 2, 2017
Last Verified: September 2017

Keywords provided by Dr. Andreas Karwautz, Medical University of Vienna:

Additional relevant MeSH terms:
Anorexia Nervosa
Signs and Symptoms, Digestive
Signs and Symptoms
Feeding and Eating Disorders
Mental Disorders
Duloxetine Hydrochloride
Atomoxetine Hydrochloride
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Serotonin and Noradrenaline Reuptake Inhibitors
Sensory System Agents
Antidepressive Agents
Dopamine Agents