Antidepressant Safety in Kids Study (ASK)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00395213
First received: October 31, 2006
Last updated: April 10, 2014
Last verified: April 2014
  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 Intervention Phase
Anxiety Disorders
Depressive Disorders
Eating Disorders
Obsessive Compulsive Disorder
Drug: Selective serotonin reuptake inhibitor (SSRI) and serotonin-norepinephrine reuptake inhibitor (SNRI) medications
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Score on the Clinical Global Impression Improvement scale (CGI-I) [ Time Frame: Measured at Months 3, 6, and 9 ] [ Designated as safety issue: No ]
  • Clinician Patient Access to Electronic Records System [ Time Frame: Measured at every visit ] [ Designated as safety issue: No ]
  • CAPTN Serious Adverse Events (SAE)/Harm-related adverse events form [ Time Frame: Measured at every visit ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Score on the Clinical Global Impression Severity scale (CGI-S) [ Time Frame: Measured at Months 3, 6, and 9 ] [ Designated as safety issue: No ]
  • Score on the Children's Global Assessment Scale (CGAS) [ Time Frame: Measured at Months 3, 6, and 9 ] [ Designated as safety issue: No ]
  • Parent Coping Strategies Questionnaire (CSQ) [ Time Frame: Measured at every visit ] [ Designated as safety issue: No ]
  • Youth Coping Strategies Questionnaire (CSQ) [ Time Frame: Measured at every visit ] [ Designated as safety issue: No ]

Enrollment: 571
Study Start Date: May 2007
Estimated Study Completion Date: December 2014
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Children and adolescents with a pre-specified anxiety disorder, depressive disorder, eating disorder, or obsessive-compulsive disorder
Drug: Selective serotonin reuptake inhibitor (SSRI) and serotonin-norepinephrine reuptake inhibitor (SNRI) medications
Treatment with SSRIs or SNRIs

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   7 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Children and adolescents age 7 to 17 years old.

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
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, see Learn About Clinical Studies.

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

Locations
United States, North Carolina
Child and Adolescent Psychiatry Trials Network (CAPTN)
Durham, North Carolina, United States, 27715
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: John S. March, MD, MPH Duke University School of Medicine
  More Information

Additional Information:
Publications:
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00395213     History of Changes
Other Study ID Numbers: Pro00013655, P30MH066386, DSIR CTM, 3159; 8067-06-1
Study First Received: October 31, 2006
Last Updated: April 10, 2014
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Duke University:
Anxiety
Major Depression
Anorexia
Bulimia
OCD
Antidepressant
SSRI
SNRI

Additional relevant MeSH terms:
Anxiety Disorders
Depressive Disorder
Depression
Eating Disorders
Obsessive-Compulsive Disorder
Compulsive Personality Disorder
Mental Disorders
Mood Disorders
Behavioral Symptoms
Personality Disorders
Antidepressive Agents
Norepinephrine
Serotonin
Serotonin Uptake Inhibitors
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Vasoconstrictor Agents
Cardiovascular Agents
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Receptor Agonists

ClinicalTrials.gov processed this record on July 23, 2014