Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 63 of 1486 for:    child psychiatry
Previous Study | Return to List | Next Study

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. Read our disclaimer for details.
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

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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 Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Layout table for location information
Austria
Medical University of Vienna
Vienna, Austria, A-1090
Sponsors and Collaborators
Medical University of Vienna
Investigators
Layout table for investigator information
Principal Investigator: Andreas Karwautz, Prof Medical University of Vienna
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations 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

Layout table for additonal information
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:
Layout table for MeSH terms
Anorexia
Anorexia Nervosa
Signs and Symptoms, Digestive
Signs and Symptoms
Feeding and Eating Disorders
Mental Disorders
Aripiprazole
Duloxetine Hydrochloride
Olanzapine
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