Antidepressant Safety in Kids Study - Full Text View

Sponsor:	National Institute of Mental Health (NIMH)
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	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 IV

Study Type:	Observational
Study Design:	Cohort, 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:

MedlinePlus related topics: Antidepressants Anxiety Depression Eating Disorders Obsessive-Compulsive Disorder

Drug Information available for: Serotonin Norepinephrine Norepinephrine bitartrate

U.S. FDA Resources

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

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	2420
Study Start Date:	May 2007
Estimated Study Completion Date:	July 2009
Estimated 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

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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

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

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:

John S. March, MD, MPH

Duke University School of Medicine

More Information

Additional 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:

March JS, Silva SG, Compton S, Anthony G, DeVeaugh-Geiss J, Califf R, Krishnan R. The Child and Adolescent Psychiatry Trials Network (CAPTN). J Am Acad Child Adolesc Psychiatry. 2004 May;43(5):515-8.

March JS, Silva SG, Compton S, Shapiro M, Califf R, Krishnan R. The case for practical clinical trials in psychiatry. Am J Psychiatry. 2005 May;162(5):836-46.

Responsible Party:	Duke University Medical Center ( John S. March, MD, MPH )
Study ID Numbers:	P30 MH066386, DSIR CTM, 3159; 8067-06-1
Study First Received:	October 31, 2006
Last Updated:	April 6, 2009
ClinicalTrials.gov Identifier:	NCT00395213 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):

Anxiety
Major Depression
Anorexia
Bulimia

OCD
Antidepressant
SSRI
SNRI

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Adrenergic Agonists
Pathologic Processes
Mental Disorders
Therapeutic Uses
Vasoconstrictor Agents
Antidepressive Agents
Obsessive-Compulsive Disorder
Eating Disorders
Disease

Depression
Adrenergic alpha-Agonists
Sympathomimetics
Cardiovascular Agents
Depressive Disorder
Serotonin Uptake Inhibitors
Serotonin
Pharmacologic Actions
Behavioral Symptoms
Serotonin Agents
Anxiety Disorders
Autonomic Agents
Norepinephrine
Mood Disorders
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on November 05, 2009