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Trial record 62 of 1550 for:    child psychiatry

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
Sponsor:
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

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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

Resource links provided by the National Library of Medicine


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
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 ]
    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
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

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 ClinicalTrials.gov identifier (NCT number): NCT01057329


Locations
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Austria
Medical University of Vienna
Vienna, Austria, A-1090
Sponsors and Collaborators
Medical University of Vienna
Investigators
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Principal Investigator: Andreas Karwautz, Prof Medical University of Vienna

Additional Information:
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Responsible Party: Dr. Andreas Karwautz, Univ. Prof. Dr., Medical University of Vienna
ClinicalTrials.gov 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: March 6, 2019
Last Verified: March 2019
Keywords provided by Dr. Andreas Karwautz, Medical University of Vienna:
TDM
Drug
Psychopharmacology
children
adolescents
Additional relevant MeSH terms:
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Anorexia
Anorexia Nervosa
Signs and Symptoms, Digestive
Signs and Symptoms
Feeding and Eating Disorders
Mental Disorders
Duloxetine Hydrochloride
Olanzapine
Aripiprazole
Atomoxetine Hydrochloride
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Dopamine D2 Receptor Antagonists
Dopamine Antagonists
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents