Antidepressant Safety in Kids Study (ASK)

April 16, 2015 updated by: Duke University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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:

  1. To evaluate the within-subject benefit of antidepressant treatment over acute (12 weeks) and maintenance (an additional 6 months) of treatment;
  2. To evaluate the adverse event profile for harm to self, harm to others, and psychiatric and nonpsychiatric adverse events;
  3. To evaluate potential moderators and mediators of benefits and adverse events.

Design:

This will be a prospective longitudinal cohort study of 2,420 consecutively enrolled patients who are prescribed an SSRI or SNRI (Citalopram [Celexa], Escitalopram [Lexapro], Fluoxetine [Prozac/Prozac Weekly], Fluvoxamine [Luvox], Paroxetine, [Paxil/Paxil-Cr], Sertraline [Zoloft], Venlafaxine [Effexor/Effexor XR], Duloxetine [Cymbalta]). Patients will be drawn from the practices of approximately 200 CAPTN participants in the United States and Canada.

Study Timeline:

This study will have two phases: 1) an acute treatment phase following initiation of treatment with any SSRI or SNRI of the clinician's choosing and 2) a long-term follow-up phase. The acute treatment phase will last 12 weeks and the long-term follow-up phase will occur 6 and 9 months after initiation of treatment.

Treatment:

Flexible upward titration of any of the commercially available SSRI or SNRI medications. As decided by the treating doctor, titration will depend on the severity of illness, degree of response, and adverse event profile. With few exceptions, concomitant treatments are permitted.

Assessment:

Study assessment milestones will occur at baseline, Week 12, and Months 6 and 9 or at study entry. CAPTN uses a "no query rule" electronic data capture system. The parent and child will complete a pen and paper workbook consisting primarily of the DISC Predictive Scales (DPS-IV) and the Pediatric Adverse Event Rating Scale (PAERS). Based on this information and on clinical interview, the treating clinician will complete the fully web-based EDC modules at baseline and at all treatment and end-of-study visits.

Study Type

Observational

Enrollment (Actual)

569

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27715
        • Child and Adolescent Psychiatry Trials Network (CAPTN)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 17 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children and adolescents age 7 to 17 years old.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Score on the Clinical Global Impression Improvement scale (CGI-I)
Time Frame: Measured at Months 3, 6, and 9
Measured at Months 3, 6, and 9
Clinician Patient Access to Electronic Records System
Time Frame: Measured at every visit
Measured at every visit
CAPTN Serious Adverse Events (SAE)/Harm-related adverse events form
Time Frame: Measured at every visit
Measured at every visit

Secondary Outcome Measures

Outcome Measure
Time Frame
Score on the Clinical Global Impression Severity scale (CGI-S)
Time Frame: Measured at Months 3, 6, and 9
Measured at Months 3, 6, and 9
Score on the Children's Global Assessment Scale (CGAS)
Time Frame: Measured at Months 3, 6, and 9
Measured at Months 3, 6, and 9
Parent Coping Strategies Questionnaire (CSQ)
Time Frame: Measured at every visit
Measured at every visit
Youth Coping Strategies Questionnaire (CSQ)
Time Frame: Measured at every visit
Measured at every visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

National Institute of Mental Health (NIMH)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (ACTUAL)

July 1, 2009

Study Completion (ACTUAL)

July 1, 2009

Study Registration Dates

First Submitted

October 31, 2006

First Submitted That Met QC Criteria

October 31, 2006

First Posted (ESTIMATE)

November 2, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

April 17, 2015

Last Update Submitted That Met QC Criteria

April 16, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00013655
  • P30MH066386 (NIH)
  • DSIR CTM
  • 3159; 8067-06-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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