Overview

Antidepressant Safety in Kids Study

Status:
Completed
Trial end date:
2009-07-01
Target enrollment:
0
Participant gender:
All
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-specified anxiety disorder, depressive disorder, eating disorder, or obsessive-compulsive disorder.
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Duke University
Collaborator:
National Institute of Mental Health (NIMH)
Treatments:
Antidepressive Agents
Norepinephrine
Serotonin
Serotonin Uptake Inhibitors
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