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Antidepressant Safety in Kids (ASK) Study

This study is currently recruiting participants.
Verified by National Institute of Mental Health (NIMH), August 2007

Sponsors and Collaborators: National Institute of Mental Health (NIMH)
Child and Adolescent Psychiatry Trials Network (CAPTN)
Information provided by: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00395213
  Purpose

This study will evaluate the risks and benefits of treatment with a selective serotonin reuptake inhibitor or serotonin-norepinephrine reuptake inhibitor in children and adolescents with a pre-specified anxiety disorder, depressive disorder, eating disorder, or obsessive-compulsive disorder.


Condition Phase
Anxiety Disorders
Depressive Disorders
Eating Disorders
Obsessive Compulsive Disorder
Phase IV

MedlinePlus related topics:   Anxiety   Eating Disorders   Mental Health   Obsessive-Compulsive Disorder  

U.S. FDA Resources

Study Type:   Observational
Study Design:   Psychosocial, Longitudinal, Defined Population, Prospective Study
Official Title:   Antidepressant Safety in Kids (ASK) Study: An Open-Label, Prospective, Cohort Study of Antidepressants in Children and Adolescents With Anxiety Disorders, Depressive Disorders, Eating Disorders, or Obsessive-Compulsive Disorder

Further study details as provided by National Institute of Mental Health (NIMH):

Estimated Enrollment:   2420
Study Start Date:   May 2007
Estimated Study Completion Date:   February 2010

 Show Detailed Description

  Eligibility
Ages Eligible for Study:   7 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • Receiving treatment in an outpatient, residential, or in-patient setting
  • Meets DSM-IV diagnostic criteria for at least one of the following disorders: anxiety disorder, depressive disorder, eating disorder, or obsessive-compulsive disorder
  • English- or Spanish-speaking

Exclusion Criteria:

  • Inpatient status IF the enrolling inpatient clinician will not continue to follow the patient for the duration of the study
  • Sibling that is already enrolled in the study
  • Imminently suicidal and unable to comply with a no-suicide contract or, in the opinion of the treating clinician, has inadequate family monitoring for suicidality
  • Acutely psychotic at study entry
  • A demonstrated lack of benefit from or intolerance to SSRI/SNRI antidepressants, as a class
  • Receiving treatment with a tricyclic antidepressant (TCA) at study enrollment, with the exception of low doses for enuresis for chronic pain. Patients may receive adjunctive TCA treatment during the study at the clinician's discretion.
  • Received a monoamine oxidase inhibitor (MAOI), such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate), within the past 30 days
  • Parasuicidal behavior or milder forms of suicidality or activation that do not meet the diagnostic criteria
  • Refusal to participate in the pharmacogenomic study
  • For bipolar depressed patients, a mixed- or manic-state at study entry without stable treatment with a mood stabilizer for manic symptoms
  • Patient or family is unable to comply with the protocol
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00395213

Contacts
Contact: Onur N. Karayal, MD, MPH     919-668-7823     onur.karayal@duke.edu    
Contact: John S. March, MD, MPH     919-416-2404     jsmarch@acpub.duke.edu    

Locations
United States, North Carolina
Child and Adolescent Psychiatry Trials Network (CAPTN)     Recruiting
      Durham, North Carolina, United States, 27715
      Contact: Onur N. Karayal, MD, MPH     919-668-7823     onur.karayal@duke.edu    
      Contact: John S. March, MD, MPH     919-416-2404     jsmarch@duke.edu    
      Principal Investigator: John S. March, MD, MPH            

Sponsors and Collaborators
National Institute of Mental Health (NIMH)
Child and Adolescent Psychiatry Trials Network (CAPTN)

Investigators
Principal Investigator:     John S. March, MD, MPH     Duke University School of Medicine    
  More Information

Click here for the Child and Adolescent Psychiatry Trials Network (CAPTN) Web site  This link exits the ClinicalTrials.gov site
 
Click here for the PARCA trial, a related study by the CAPTN network  This link exits the ClinicalTrials.gov site
 

Publications:

Study ID Numbers:   P30 MH66386, DSIR CTM, 3159; 8067-06-1
First Received:   October 31, 2006
Last Updated:   August 21, 2007
ClinicalTrials.gov Identifier:   NCT00395213
Health Authority:   United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
Anxiety  
Major Depression  
Anorexia  
Bulimia  
OCD
Antidepressant
SSRI
SNRI

Study placed in the following topic categories:
Depression
Anxiety Disorders
Bulimia
Mood Disorders
Anorexia
Depressive Disorder, Major
Depressive Disorder
Eating Disorders
Obsessive-Compulsive Disorder

Additional relevant MeSH terms:
Mental Disorders
Behavioral Symptoms

ClinicalTrials.gov processed this record on May 15, 2008