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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Duke University
- Enrollment
- 569
- Locations
- 1
- Primary Endpoint
- Clinician Patient Access to Electronic Records System
Study Overview
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-specified anxiety disorder, depressive disorder, eating disorder, or obsessive-compulsive disorder.
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 reuptake inhibitor (SNRI) medications are prescribed to approximately 2 to 3% of American children. Evidence suggests that these medications are beneficial for treating obsessive-compulsive disorder (OCD), anxiety disorders, and major depressive disorder. Following hearings in February and September of 2004, the FDA mandated Black Box warnings for all antidepressants, cautioning prescribers about the risk of treatment-emergent suicidal tendency in children and adolescents treated with these drugs. Although prescribing waned somewhat following the warning, many children continue to receive SSRIs and SNRIs for a variety of conditions that do not have empirically validated alternative treatments. Therefore, there is a pressing need to clearly understand the safety, tolerability, and effectiveness of SSRIs and SNRIs in children and adolescents.
Specific Aim:
The purpose of this study is to evaluate the safety, tolerability, and effectiveness of SSRI and SNRI medications for children and adolescents with anxiety disorders, depressive disorders, eating disorders, or obsessive-compulsive disorder. The study will characterize predictors of outcome, including demographic, disease severity, comorbidity, concomitant treatment, and genetic variation. This information will help clinicians to better understand the balance of risk and benefit associated with antidepressants and to answer the question of which treatment is best for which child.
Three specific aims include the following:
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 7 Years to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
1
Children and adolescents with a pre-specified anxiety disorder, depressive disorder, eating disorder, or obsessive-compulsive disorder
Intervention: Selective serotonin reuptake inhibitor (SSRI) and serotonin-norepinephrine reuptake inhibitor (SNRI) medications (Drug)
Outcomes
Primary Outcomes
Clinician Patient Access to Electronic Records System
Time Frame: Measured at every visit
Score on the Clinical Global Impression Improvement scale (CGI-I)
Time Frame: Measured at Months 3, 6, and 9
CAPTN Serious Adverse Events (SAE)/Harm-related adverse events form
Time Frame: Measured at every visit
Secondary Outcomes
- Parent Coping Strategies Questionnaire (CSQ)(Measured at every visit)
- Youth Coping Strategies Questionnaire (CSQ)(Measured at every visit)
- Score on the Children's Global Assessment Scale (CGAS)(Measured at Months 3, 6, and 9)
- Score on the Clinical Global Impression Severity scale (CGI-S)(Measured at Months 3, 6, and 9)