Status:
COMPLETED
Antidepressant Safety in Kids Study
Lead Sponsor:
Duke University
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Anxiety Disorders
Depressive Disorders
Eligibility:
All Genders
7-17 years
Brief Summary
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-specifi...
Detailed Description
The Antidepressant Safety in Kids (ASK) study is part of the Child and Adolescent Psychiatry Trials Network (CAPTN). Selective serotonin reuptake inhibitor (SSRI) and serotonin-norepinephrine reuptak...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
569 Patients enrolled
Trial Details
Trial ID
NCT00395213
Start Date
May 1 2007
End Date
July 1 2009
Last Update
April 17 2015
Active Locations (1)
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1
Child and Adolescent Psychiatry Trials Network (CAPTN)
Durham, North Carolina, United States, 27715