Depression Clinical Trial
Official title:
Treatment for Adolescents With Depression Study (TADS)
TADS is designed to compare the effectiveness of established treatments for teenagers
suffering from major depressive disorder (MDD). The treatments are: psychotherapy ("talking
therapy"); medication; and the combination of psychotherapy and medication. Altogether, 432
teenagers (both males and females) ages 12 to 17, will take part in this study at 12 sites
in the United States.
The TADS design will provide answers to the following questions: What is the long-term
effectiveness of medication treatment of teenagers who have major depression? What is the
long-term effectiveness of a specific psychotherapy ("talking therapy) in the treatment of
teenagers who have major depression? How does medication treatment compare with
psychotherapy in terms of effectiveness, tolerability and teenager and family acceptance?
And, What is the cost-effectiveness of medication, psychotherapy and combined treatments?
The medication being used in this study is called fluoxetine. Fluoxetine is also known as
Prozac. Research has shown that medications like Prozac help depression in young persons.
Fluoxetine has been approved by the FDA for use in the treatment of child and adolescent
(ages 7 to 17 years) depression.
The psychotherapy or "talking therapy" being used in this study is called Cognitive
Behavioral Therapy (CBT). CBT is a talking therapy that will teach both the teenager and his
or her family member (e.g., parent) new skills to cope better with depression. Specific
topics include education about depression and the causes of depression, setting goals,
monitoring mood, increasing pleasant activities, social problem-solving, correcting negative
thinking, negotiation, compromise and assertiveness. CBT sessions may also help with
resolving disagreements as they affect families.
Status | Completed |
Enrollment | 432 |
Est. completion date | March 2004 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 12 Years to 17 Years |
Eligibility |
Inclusion Criteria: - Primary diagnosis DSM-IV of Major Depressive Disorder, pervasive and stable; Children's Depression Rating Scale-R total score at least 45; Ages 12-17 inclusive; Grade in school: 6-12; Full-Scale IQ at least 80; Medication-free before start of study; Outpatient; Parent (or family member) involvement Exclusion Criteria: - Bipolar disorder; Severe Conduct Disorder; Substance Use/Abuse/Dependence; Pervasive Developmental Disorders; Thought Disorder; Suicidality or homicidality; Concurrent treatment with psychotropic drug (stable stimulant for ADHD permitted) or psychotherapy outside study; Two previous failed SSRI trials or a failed trial of CBT for depression; Intolerance to fluoxetine; Non-English speaking patient; Pregnancy or breastfeeding; No phone in home; Lack of parent or family member)involvement. |
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Johns Hopkins Hospital | Baltimore | Maryland |
United States | Behavioral Health Center | Charlotte | North Carolina |
United States | Northwestern University | Chicago | Illinois |
United States | Children's Hospital Medical Center | Cincinnati | Ohio |
United States | Case Western Reserve University | Cleveland | Ohio |
United States | University of Texas Southwestern Medical Center at Dallas | Dallas | Texas |
United States | Wayne State University | Detroit | Michigan |
United States | University of Oregon | Eugene | Oregon |
United States | New York State Psychiatric Institute | New York | New York |
United States | New York University Medical Center | New York | New York |
United States | University of Nebraska Medical Center | Omaha | Nebraska |
United States | Children's Hospital of Philadelphia | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
National Institute of Mental Health (NIMH) |
United States,
Curry J, Rohde P, Simons A, Silva S, Vitiello B, Kratochvil C, Reinecke M, Feeny N, Wells K, Pathak S, Weller E, Rosenberg D, Kennard B, Robins M, Ginsburg G, March J; TADS Team. Predictors and moderators of acute outcome in the Treatment for Adolescents — View Citation
Emslie G, Kratochvil C, Vitiello B, Silva S, Mayes T, McNulty S, Weller E, Waslick B, Casat C, Walkup J, Pathak S, Rohde P, Posner K, March J; Columbia Suicidality Classification Group; TADS Team. Treatment for Adolescents with Depression Study (TADS): sa — View Citation
Glass RM. Treatment of adolescents with major depression: contributions of a major trial. JAMA. 2004 Aug 18;292(7):861-3. — View Citation
Herman KC, Ostrander R, Walkup JT, Silva SG, March JS. Empirically derived subtypes of adolescent depression: latent profile analysis of co-occurring symptoms in the Treatment for Adolescents with Depression Study (TADS). J Consult Clin Psychol. 2007 Oct; — View Citation
Kennard B, Silva S, Vitiello B, Curry J, Kratochvil C, Simons A, Hughes J, Feeny N, Weller E, Sweeney M, Reinecke M, Pathak S, Ginsburg G, Emslie G, March J; TADS Team. Remission and residual symptoms after short-term treatment in the Treatment of Adolesc — View Citation
Kratochvil C, Emslie G, Silva S, McNulty S, Walkup J, Curry J, Reinecke M, Vitiello B, Rohde P, Feeny N, Casat C, Pathak S, Weller E, May D, Mayes T, Robins M, March J; TADS Team. Acute time to response in the Treatment for Adolescents with Depression Stu — View Citation
March J, Silva S, Petrycki S, Curry J, Wells K, Fairbank J, Burns B, Domino M, McNulty S, Vitiello B, Severe J; Treatment for Adolescents With Depression Study (TADS) Team. Fluoxetine, cognitive-behavioral therapy, and their combination for adolescents wi — View Citation
March J, Silva S, Vitiello B; TADS Team. The Treatment for Adolescents with Depression Study (TADS): methods and message at 12 weeks. J Am Acad Child Adolesc Psychiatry. 2006 Dec;45(12):1393-403. — View Citation
March JS, Silva S, Petrycki S, Curry J, Wells K, Fairbank J, Burns B, Domino M, McNulty S, Vitiello B, Severe J. The Treatment for Adolescents With Depression Study (TADS): long-term effectiveness and safety outcomes. Arch Gen Psychiatry. 2007 Oct;64(10): — View Citation
Treatment for Adolescents with Depression Study (TADS) Team. The Treatment for Adolescents With Depression Study (TADS): demographic and clinical characteristics. J Am Acad Child Adolesc Psychiatry. 2005 Jan;44(1):28-40. Review. — View Citation
Treatment for Adolescents With Depression Study Team. Treatment for Adolescents With Depression Study (TADS): rationale, design, and methods. J Am Acad Child Adolesc Psychiatry. 2003 May;42(5):531-42. — View Citation
Vitiello B, Rohde P, Silva S, Wells K, Casat C, Waslick B, Simons A, Reinecke M, Weller E, Kratochvil C, Walkup J, Pathak S, Robins M, March J; TADS Team. Functioning and quality of life in the Treatment for Adolescents with Depression Study (TADS). J Am — View Citation
* Note: There are 12 references in all — Click here to view all references
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