Major Depressive DisorderPhase 3NCT00006286
Treatment for Adolescents With Depression Study (TADS)
A Phase 3 study testing Fluoxetine and Psychotherapy in people with Major Depressive Disorder and Depression, run by National Institute of Mental Health (NIMH) at 12 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Major Depressive Disorder, Depression
- What is being tested?
- Fluoxetine and Psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 432 participants
- Where
- 12 sitesUnited States
- Study dates
- Sep 1998to Mar 2004
- Phase
- Phase 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 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Behavioral Health Center
Charlotte, North Carolina, 28203
Northwestern University
Chicago, Illinois, 60611
Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Case Western Reserve University
Cleveland, Ohio, 44106
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, 75235
Wayne State University
Detroit, Michigan, 48207
University of Oregon
Eugene, Oregon, 97403
New York University Medical Center
New York, New York, 10016
New York State Psychiatric Institute
New York, New York, 10032
University of Nebraska Medical Center
Omaha, Nebraska, 68198-5581
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
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?
Read more
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.
Read the 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, i.e., children already coming to a clinic; primary care identified children (pediatric and family physicians); teacher or school identified children (i.e., school refers through the parents or primary caretaker); and families who self-refer.
- Conditions
- Major Depressive Disorder, Depression
- Being tested
- Fluoxetine, Psychotherapy
- Keywords
- Depression, Major Depressive Disorder, Fluoxetine, Prozac, SSRI, Psychotherapy, CBT, Teenagers, Adolescents, Teens
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluoxetineDrug
PsychotherapyBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2000 (estimated)
- Study startSep 1998
- Study completionMar 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by National Institute of Mental Health (NIMH)The sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
- Enrolment
- 432 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Sponsor type
- US National Institutes of Health
- Investigators
- John March, Study director, Duke UniversityAnne Marie Albano, Principal investigator, NYU Langone HealthDavid Rosenberg, MD, Principal investigator, Wayne State UnivCharles Casat, Principal investigator, Carolinas Medical Center-RandlolphGraham Emslie, Principal investigator, University of Texas SoutwesternChristopher Kratochvil, Principal investigator, University of NebraskaPaul Rohde and Anne Simons, Principal investigator, University of OregonJohn Walkup, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006286
- Sponsor's protocol ID
- N01 MH80008
- Other IDs
- DSIR CT
- Status last verified
- Nov 2005
- First submitted
- 14 Sep 2000
- Last updated
- 17 Apr 2014
- Results posted
- No
Publications
Glass RM. Treatment of adolescents with major depression: contributions of a major trial. JAMA. 2004 Aug 18;292(7):861-3. doi: 10.1001/jama.292.7.861. No abstract available.
PubMed 15316001Treatment 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. doi: 10.1097/01.CHI.0000046839.90931.0D.
PubMed 12707557March 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 with depression: Treatment for Adolescents With Depression Study (TADS) randomized controlled trial. JAMA. 2004 Aug 18;292(7):807-20. doi: 10.1001/jama.292.7.807.
PubMed 15315995Treatment 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. doi: 10.1097/01.chi.0000145807.09027.82.
PubMed 15608541March 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. doi: 10.1097/01.chi.0000237709.35637.c0.
PubMed 17135984Emslie 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): safety results. J Am Acad Child Adolesc Psychiatry. 2006 Dec;45(12):1440-55. doi: 10.1097/01.chi.0000240840.63737.1d.
PubMed 17135989Curry 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 with Depression Study (TADS). J Am Acad Child Adolesc Psychiatry. 2006 Dec;45(12):1427-39. doi: 10.1097/01.chi.0000240838.78984.e2.
PubMed 17135988Kratochvil 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 Study (TADS). J Am Acad Child Adolesc Psychiatry. 2006 Dec;45(12):1412-8. doi: 10.1097/01.chi.0000237710.73755.14.
PubMed 17135986Kennard 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 Adolescents with Depression Study (TADS). J Am Acad Child Adolesc Psychiatry. 2006 Dec;45(12):1404-11. doi: 10.1097/01.chi.0000242228.75516.21.
PubMed 17135985Vitiello 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 Acad Child Adolesc Psychiatry. 2006 Dec;45(12):1419-26. doi: 10.1097/01.chi.0000242229.52646.6e.
PubMed 17135987March 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):1132-43. doi: 10.1001/archpsyc.64.10.1132.
PubMed 17909125Herman 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;75(5):716-28. doi: 10.1037/0022-006X.75.5.716.
PubMed 17907854Aboustate N, Jureidini J, Woodman R, Le Noury J, Klau J, Abi-Jaoude E, Raven M. Restoring TADS: RIAT reanalysis of the Treatment for Adolescents with Depression Study. Int J Risk Saf Med. 2025 Nov;36(4):218-237. doi: 10.1177/09246479251337879. Epub 2025 May 27.
PubMed 40421808Jureidini J, Moncrieff J, Klau J, Aboustate N, Raven M. Treatment guesses in the Treatment for Adolescents with Depression Study: Accuracy, unblinding and influence on outcomes. Aust N Z J Psychiatry. 2024 Apr;58(4):355-364. doi: 10.1177/00048674231218623. Epub 2023 Dec 21.
PubMed 38126083Baumgartner N, Foster S, Emery S, Berger G, Walitza S, Haberling I. How Are Discrepant Parent-Child Reports Integrated? A Case of Depressed Adolescents. J Child Adolesc Psychopharmacol. 2021 May;31(4):279-287. doi: 10.1089/cap.2020.0116. Epub 2020 Dec 29.
PubMed 33373537
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment for Adolescents With Depression Study (TADS)
- ClinicalTrials.gov ID
- NCT00006286
- Acronym / sponsor ID
- N01 MH80008
- Conditions
- Major Depressive Disorder, Depression
- Keywords
- Depression, Major Depressive Disorder, Fluoxetine, Prozac, SSRI, Psychotherapy, CBT, Teenagers
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 432 participants
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Study start
- Sep 1998
- Study completion
- Mar 2004
- First posted
- 15 Sep 2000 (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.
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.
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, i.e., children already coming to a clinic; primary care identified children (pediatric and family physicians); teacher or school identified children (i.e., school refers through the parents or primary caretaker); and families who self-refer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
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 | – |
| Psychotherapy | 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 17 Apr 2014.
- Background: PubMed 15316001Glass RM. Treatment of adolescents with major depression: contributions of a major trial. JAMA. 2004 Aug 18;292(7):861-3. doi: 10.1001/jama.292.7.861. No abstract available.
- Background: PubMed 12707557Treatment 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. doi: 10.1097/01.CHI.0000046839.90931.0D.
- Results publication: PubMed 15315995March 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 with depression: Treatment for Adolescents With Depression Study (TADS) randomized controlled trial. JAMA. 2004 Aug 18;292(7):807-20. doi: 10.1001/jama.292.7.807.
- Results publication: PubMed 15608541Treatment 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. doi: 10.1097/01.chi.0000145807.09027.82.
- Results publication: PubMed 17135984March 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. doi: 10.1097/01.chi.0000237709.35637.c0.
- Results publication: PubMed 17135989Emslie 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): safety results. J Am Acad Child Adolesc Psychiatry. 2006 Dec;45(12):1440-55. doi: 10.1097/01.chi.0000240840.63737.1d.
- Results publication: PubMed 17135988Curry 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 with Depression Study (TADS). J Am Acad Child Adolesc Psychiatry. 2006 Dec;45(12):1427-39. doi: 10.1097/01.chi.0000240838.78984.e2.
- Results publication: PubMed 17135986Kratochvil 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 Study (TADS). J Am Acad Child Adolesc Psychiatry. 2006 Dec;45(12):1412-8. doi: 10.1097/01.chi.0000237710.73755.14.
- Results publication: PubMed 17135985Kennard 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 Adolescents with Depression Study (TADS). J Am Acad Child Adolesc Psychiatry. 2006 Dec;45(12):1404-11. doi: 10.1097/01.chi.0000242228.75516.21.
- Results publication: PubMed 17135987Vitiello 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 Acad Child Adolesc Psychiatry. 2006 Dec;45(12):1419-26. doi: 10.1097/01.chi.0000242229.52646.6e.
- Results publication: PubMed 17909125March 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):1132-43. doi: 10.1001/archpsyc.64.10.1132.
- Results publication: PubMed 17907854Herman 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;75(5):716-28. doi: 10.1037/0022-006X.75.5.716.
- NIMH Press ReleaseLink provided by the sponsor.
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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.
John March study director
Duke University
Anne Marie Albano principal investigator
NYU Langone Health
David Rosenberg, MD principal investigator
Wayne State Univ
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fluoxetine and Psychotherapy in people with Major Depressive Disorder and Depression, run by National Institute of Mental Health (NIMH) at 12 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 1 inclusion and 1 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 17 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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 phase mean?
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 NCT00006286, which also lists 26 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 17 Apr 2014.