Antidepressant Safety in Kids Study

Completed

Conditions studied: Anxiety Disorders, Depressive Disorders, Eating Disorders, Obsessive Compulsive Disorder

In brief

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.

Key facts

Study ID

NCT00395213

Run by

Duke University

People needed

569

Starts

2007-05-01

Expected to finish

2009-07-01

Last updated by the study team

2015-04-17

Who can join

Age: 7 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Child and Adolescent Psychiatry Trials Network (CAPTN) — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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