Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006286
Status:
COMPLETED
Last Update Posted:
2014-04-17
First Post:
2000-09-14
Brief Title:
Treatment for Adolescents With Depression Study TADS
Sponsor:
National Institute of Mental Health NIMH
Organization:
National Institute of Mental Health NIMH
Study Overview
Official Title:
Treatment for Adolescents With Depression Study TADS
Status:
COMPLETED
Status Verified Date:
2005-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 eg 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
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 eg 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
Detailed Description:
TADS is a randomized controlled clinical trial that will compare the effectiveness of established treatments---cognitive-behavioral psychotherapy medication management and their combination---for adolescents suffering from major depressive disorder MDD
The experimental design consists of three treatment stages and a follow-up phase Stage I 12 weeks is a four-group randomized comparison of four treatments antidepressant medication alone Fluoxetine psychotherapy alone CBT a combination of the medication and psychotherapy Comb and a placebo control medication condition Pbo Stage II six weeks is a treatment consolidation phase in which we ask whether longer treatment in responders and higher intensity treatment in partial responders to their Stage I treatment would be helpful Non-responders at the end of Stage I will be referred to open community treatment or for ethical and practical reasons in the case of non-responders to Placebo to open treatment of their choice with one of the three active study treatments administered by the study team Responders at the end of Stage I advance to 6 weeks of maintenance treatment in their assigned arm Partial responders to CBT receive an additional 6 weeks of CBT in their assigned arm partial responders to Fluoxetine may receive a higher dose for six weeks Partial responders to the Comb treatment will receive an additional 6 weeks of CBT and may receive a higher dose of medication for six weeks Stage III 18 weeks is a treatment maintenance phase for those teenagers who have continued to respond well Treatment will be continued and progress will be monitored Stage IV one year is an assessment-only follow-up phase to help us understand the long-term benefits of the treatments
The recruitment strategy is designed to enter into treatment a volunteer clinical sample of 432 teenagers both males and females ages 12 to 17 at ten sites A multiple gating procedure will be used in which patients will be screened assessed for study eligibility and if eligible consented before randomization to one of the four treatment groups Patients will be selected without regard to race gender or ethnicity and it is expected that the sample will match patients seen in general clinical practice Patients will be recruited from multiple sources including mental health identified children ie children already coming to a clinic primary care identified children pediatric and family physicians teacher or school identified children ie school refers through the parents or primary caretaker and families who self-refer
The experimental design consists of three treatment stages and a follow-up phase Stage I 12 weeks is a four-group randomized comparison of four treatments antidepressant medication alone Fluoxetine psychotherapy alone CBT a combination of the medication and psychotherapy Comb and a placebo control medication condition Pbo Stage II six weeks is a treatment consolidation phase in which we ask whether longer treatment in responders and higher intensity treatment in partial responders to their Stage I treatment would be helpful Non-responders at the end of Stage I will be referred to open community treatment or for ethical and practical reasons in the case of non-responders to Placebo to open treatment of their choice with one of the three active study treatments administered by the study team Responders at the end of Stage I advance to 6 weeks of maintenance treatment in their assigned arm Partial responders to CBT receive an additional 6 weeks of CBT in their assigned arm partial responders to Fluoxetine may receive a higher dose for six weeks Partial responders to the Comb treatment will receive an additional 6 weeks of CBT and may receive a higher dose of medication for six weeks Stage III 18 weeks is a treatment maintenance phase for those teenagers who have continued to respond well Treatment will be continued and progress will be monitored Stage IV one year is an assessment-only follow-up phase to help us understand the long-term benefits of the treatments
The recruitment strategy is designed to enter into treatment a volunteer clinical sample of 432 teenagers both males and females ages 12 to 17 at ten sites A multiple gating procedure will be used in which patients will be screened assessed for study eligibility and if eligible consented before randomization to one of the four treatment groups Patients will be selected without regard to race gender or ethnicity and it is expected that the sample will match patients seen in general clinical practice Patients will be recruited from multiple sources including mental health identified children ie children already coming to a clinic primary care identified children pediatric and family physicians teacher or school identified children ie school refers through the parents or primary caretaker and families who self-refer
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DSIR CT | None | None | None |