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Treatment of Adolescent Suicide Attempters (TASA)

Primary Purpose

Depression, Suicide, Attempted

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
fluoxetine
sertraline
citalopram
escitalopram
bupropion
mirtazapine
venlafaxine
lithium
Cognitive Behavioral Therapy
Sponsored by
New York State Psychiatric Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Dysthymic Disorder, Adolescent

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: At least one suicide attempt or interrupted attempt within the past 45 days Continuously reside with a primary caretaker (parent, legal guardian, foster parent) for at least 6 months that can provide legal consent

Sites / Locations

  • Johns Hopkins University
  • New York University Child Study Center
  • Columbia University at the New York State Psychiatric Institute
  • Duke University Medical Center
  • University of Pittsburgh - Western Psychiatric Institute and Clinic
  • University of Texas, Southwestern Medical Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
March 24, 2004
Last Updated
June 18, 2020
Sponsor
New York State Psychiatric Institute
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00080158
Brief Title
Treatment of Adolescent Suicide Attempters (TASA)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New York State Psychiatric Institute
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to compare the effects of three types of treatments for depressed teenagers who have attempted suicide.
Detailed Description
Suicide is the third leading cause of death in adolescents and is a major public health problem. Depression is the most common diagnosis for adolescent suicide attempts. Little is known about what treatment is best for these adolescents since they are usually excluded from participation in research studies. Participants in this study will be randomly assigned to receive carefully monitored antidepressant medication with routine support and management, cognitive behavioral therapy (CBT), or a combination of antidepressant medication plus CBT.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Suicide, Attempted
Keywords
Dysthymic Disorder, Adolescent

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
fluoxetine
Intervention Type
Drug
Intervention Name(s)
sertraline
Intervention Type
Drug
Intervention Name(s)
citalopram
Intervention Type
Drug
Intervention Name(s)
escitalopram
Intervention Type
Drug
Intervention Name(s)
bupropion
Intervention Type
Drug
Intervention Name(s)
mirtazapine
Intervention Type
Drug
Intervention Name(s)
venlafaxine
Intervention Type
Drug
Intervention Name(s)
lithium
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: At least one suicide attempt or interrupted attempt within the past 45 days Continuously reside with a primary caretaker (parent, legal guardian, foster parent) for at least 6 months that can provide legal consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laurence Greenhill, MD
Official's Role
Study Chair
Facility Information:
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
New York University Child Study Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Columbia University at the New York State Psychiatric Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
University of Pittsburgh - Western Psychiatric Institute and Clinic
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
University of Texas, Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19730274
Citation
Brent DA, Greenhill LL, Compton S, Emslie G, Wells K, Walkup JT, Vitiello B, Bukstein O, Stanley B, Posner K, Kennard BD, Cwik MF, Wagner A, Coffey B, March JS, Riddle M, Goldstein T, Curry J, Barnett S, Capasso L, Zelazny J, Hughes J, Shen S, Gugga SS, Turner JB. The Treatment of Adolescent Suicide Attempters study (TASA): predictors of suicidal events in an open treatment trial. J Am Acad Child Adolesc Psychiatry. 2009 Oct;48(10):987-996. doi: 10.1097/CHI.0b013e3181b5dbe4.
Results Reference
derived
PubMed Identifier
19730273
Citation
Stanley B, Brown G, Brent DA, Wells K, Poling K, Curry J, Kennard BD, Wagner A, Cwik MF, Klomek AB, Goldstein T, Vitiello B, Barnett S, Daniel S, Hughes J. Cognitive-behavioral therapy for suicide prevention (CBT-SP): treatment model, feasibility, and acceptability. J Am Acad Child Adolesc Psychiatry. 2009 Oct;48(10):1005-1013. doi: 10.1097/CHI.0b013e3181b5dbfe.
Results Reference
derived

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Treatment of Adolescent Suicide Attempters (TASA)

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