NCT00516932

Brief Summary

This study will identify variations in genes that may be involved in the development of suicidal events or certain behaviors in youth who are exposed to antidepressant medications.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
211

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2007

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 14, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 16, 2007

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

April 17, 2015

Status Verified

April 1, 2015

Enrollment Period

2.4 years

First QC Date

August 14, 2007

Last Update Submit

April 16, 2015

Conditions

Anxiety DisordersDepressionEating DisordersObsessive-Compulsive DisorderSuicide Prevention

Keywords

Suicidal EventBehavioral Activation

Outcome Measures

Primary Outcomes (1)

  • Suicidal Event(120 patients) Behavioral Activation(120 patients) Co-occurring Suicidal Event + Behavioral Activation (120 patients) Tolerant controls (at a control to case ratio of 3:1) no evidence of Suicidal Events or Behavioral Activation

    9 months

Eligibility Criteria

Age7 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Males and Females Age 7 -17 years Pre-specified disorder of anxiety disorder, depressive disorder, eating disorder, or obsessive-compulsive disorder.

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
  • Receiving a new prescription for an SSRI or SNRI to treat one of the above disorders
  • A confirmed diagnosis of a "Suicidal Event" or "Behavioral Activation" or both following SSRI or SNRI exposure of at least 3 days duration
  • Willing to provide a sample of saliva for DNA analysis
  • 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
  • Note: Tolerant controls will be ineligible if they have a past history of a treatment-emergent "Suicidal Event" or "Behavioral Activation"

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Child and Adolescent Psychiatry Trials Network (CAPTN)

Durham, North Carolina, 27715, United States

Location

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Salivary DNA retained at the Duke Center for Human Genetics

MeSH Terms

Conditions

Anxiety DisordersDepressionFeeding and Eating DisordersObsessive-Compulsive DisorderSuicide Prevention

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehaviorSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsSuicideSelf-Injurious Behavior

Study Officials

  • John S. March, MD, MPH

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 14, 2007

First Posted

August 16, 2007

Study Start

May 1, 2007

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

April 17, 2015

Record last verified: 2015-04

Locations

US(1)