Therapeutic Drug Monitoring in Child and Adolescent Psychiatry (TDMKJP)
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ClinicalTrials.gov Identifier: NCT01057329 |
Recruitment Status :
Completed
First Posted : January 27, 2010
Last Update Posted : March 6, 2019
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Condition or disease | Intervention/treatment |
---|---|
Depression Anorexia Nervosa ADHD | Drug: Atomoxetine Drug: Duloxetine Drug: Olanzapine Drug: Aripiprazole |

Study Type : | Observational |
Actual 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 |
Actual Primary Completion Date : | March 5, 2019 |
Actual Study Completion Date : | March 5, 2019 |

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 |
Anorexia
36 severe anorexia nervosa patients treated with olanzapine
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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
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Drug: Atomoxetine
mg according to body weight |
Depressive disorder
30 depressed patients treated with duloxetine
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Drug: Duloxetine
30 mg / die |
- Blood level concentrations of the drugs in use; [ Time Frame: 5 weeks ]Blood level concentration of the druns in use
- Level of symtomatology [ Time Frame: 5 weeks ]symtomatology

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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 |
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

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 ClinicalTrials.gov identifier (NCT number): NCT01057329
Austria | |
Medical University of Vienna | |
Vienna, Austria, A-1090 |
Principal Investigator: | Andreas Karwautz, Prof | Medical University of Vienna |
Responsible Party: | Dr. Andreas Karwautz, Univ. Prof. Dr., Medical University of Vienna |
ClinicalTrials.gov Identifier: | NCT01057329 |
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: | March 6, 2019 |
Last Verified: | March 2019 |
TDM Drug Psychopharmacology children adolescents |
Anorexia Anorexia Nervosa Signs and Symptoms, Digestive Feeding and Eating Disorders Mental Disorders Duloxetine Hydrochloride Olanzapine Aripiprazole Atomoxetine Hydrochloride Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Antipsychotic Agents |
Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Serotonin Agents Antidepressive Agents Dopamine Agonists Dopamine Agents Serotonin 5-HT1 Receptor Agonists Serotonin Receptor Agonists Serotonin 5-HT2 Receptor Antagonists |