The purpose of this study is to compare the effects of three types of treatments for depressed teenagers who have attempted suicide...
Date First Received: March 24, 2004
Last Updated: July 17, 2008
Verified by: National Institute of Mental Health (NIMH), July 2008
Clinical Trial Phase: Phase 2/Phase 3 | Start Date: March 2004
Overall Status: Completed
Estimated Enrollment: 120
Brief Summary
Condition Keyword(s):
The purpose of this study is to compare the effects of three types of treatments for depressed teenagers who have attempted suicide.
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Detailed Clinical Trial 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.
Intervention(s) in this Clinical Trial
- Drug: fluoxetine
- Drug: sertraline
- Drug: citalopram
- Drug: escitalopram
- Drug: bupropion
- Drug: mirtazapine
- Drug: venlafaxine
- Drug: lithium
- Behavioral: Cognitive Behavioral Therapy
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 12 Years
Maximum Age for this Clinical Trial: 18 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: National Institute of Mental Health (NIMH)
Overall Clinical Trial Officials and Contacts
Laurence Greenhill, MD Study Chair
Additional Information
Information obtained from ClinicalTrials.gov on November 18, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00080158
Study ID Number: U10 MH66762
ClinicalTrials.gov Identifier: NCT00080158
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
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