Completed

Treatment of Adolescent Suicide Attempters (TASA)

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What is being tested

fluoxetine

+ sertraline
+ citalopram
Drug
Behavioral
Who is being recruted

Depression

+ Suicide, Attempted
From 12 to 18 Years
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: March 2004

Summary

Principal SponsorNew York State Psychiatric Institute
Last updated: June 22, 2020
Sourced from a government-validated database.Claim as a partner
Study start date: March 1, 2004Actual date on which the first participant was enrolled.

The purpose of this study is to compare the effects of three types of treatments for depressed teenagers who have attempted suicide. 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.

Official TitleTreatment of Adolescent Suicide Attempters (TASA) 
Principal SponsorNew York State Psychiatric Institute
Last updated: June 22, 2020
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
120 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation
: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

None (Single-arm trial)
: If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment
: Everyone gets the same treatment.

Cross-over assignment
: Participants switch between treatments during the study.

Factorial assignment
: Participants receive different combinations of treatments.

Sequential assignment
: Participants receive treatments one after another in a specific order, possibly based on individual responses.

Other assignment
: Treatment assignment does not follow a standard or predefined design.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Double-blind
: Neither participants nor researchers know which treatment is given.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 12 to 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Depression
Suicide, Attempted
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



Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 6 locations
Suspended
Johns Hopkins UniversityBaltimore, United StatesSee the location
Suspended
New York University Child Study CenterNew York, United States
Suspended
Columbia University at the New York State Psychiatric InstituteNew York, United States
Suspended
Duke University Medical CenterDurham, United States

Completed6 Study Centers