DepressionPhase 2/3NCT00080158
Treatment of Adolescent Suicide Attempters (TASA)
A Phase 2/3 study testing fluoxetine, sertraline and citalopram in people with Depression and Suicide, Attempted, run by New York State Psychiatric Institute at 6 sites in United States.
Trial summary
The purpose of this study is to compare the effects of three types of treatments for depressed teenagers who have attempted suicide. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Depression, Suicide, Attempted
- What is being tested?
- fluoxetine, sertraline and citalopram
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 120 participants
- Where
- 6 sitesUnited States
- Study dates
- Mar 2004to Jun 2007
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Johns Hopkins University
Baltimore, Maryland, 21287
University of Texas, Southwestern Medical Center
Dallas, Texas, 75235
Duke University Medical Center
Durham, North Carolina, 27705
New York University Child Study Center
New York, New York, 10016
Columbia University at the New York State Psychiatric Institute
New York, New York, 10032
University of Pittsburgh - Western Psychiatric Institute and Clinic
Pittsburgh, Pennsylvania, 15213
About this study
The purpose of this study is to compare the effects of three types of treatments for depressed teenagers who have attempted suicide.
Read the 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.
- Conditions
- Depression, Suicide, Attempted
- Being tested
- fluoxetine, sertraline, citalopram, escitalopram, bupropion
- Keywords
- Dysthymic Disorder, Adolescent
- Medical subject headings
- Depression, Suicide, Attempted, Dysthymic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluoxetineDrug
sertralineDrug
citalopramDrug
escitalopramDrug
bupropionDrug
mirtazapineDrug
venlafaxineDrug
lithiumDrug
Cognitive Behavioral TherapyBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2004 (estimated)
- Study startMar 2004
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Laurence Greenhill, MD, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00080158
- Sponsor's protocol ID
- #4623
- Other IDs
- U10MH066762, U10MH066775, U10MH066778, U10MH066769, U10MH066750, DDTR B4-ARD
- Status last verified
- Jun 2020
- First submitted
- 24 Mar 2004
- Last updated
- 22 Jun 2020
- Results posted
- No
Publications
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.
PubMed 19730274Stanley 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.
PubMed 19730273
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Adolescent Suicide Attempters (TASA)
- ClinicalTrials.gov ID
- NCT00080158
- Acronym / sponsor ID
- #4623
- Conditions
- Depression, Suicide, Attempted
- Keywords
- Dysthymic Disorder, Adolescent
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Mar 2004
- Study completion
- Jun 2007 (actual)
- First posted
- 26 Mar 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fluoxetine | Drug | – |
| sertraline | Drug | – |
| citalopram | Drug | – |
| escitalopram | Drug | – |
| bupropion | Drug | – |
| mirtazapine | Drug | – |
| venlafaxine | Drug | – |
| lithium | Drug | – |
| Cognitive Behavioral Therapy | Behavioural | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2020.
- Derived from this study: PubMed 19730274Brent 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.
- Derived from this study: PubMed 19730273Stanley 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurence Greenhill, MD study chair
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing fluoxetine, sertraline and citalopram in people with Depression and Suicide, Attempted, run by New York State Psychiatric Institute at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00080158, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2020; AzTrials last refreshed its copy on 8 Nov 2026.