The Treatment for Adolescents with Depression Study (TADS): Long-term effectiveness and safety outcomes

John S. March, Susan Silva, Stephen Petrycki, John Curry, Karen Wells, John Fairbank, Barbara Burns, Marisa Domino, Steven McNulty, Benedetto Vitiello, Joanne Severe, Charles Casat, Jeanette Kolker, Karyn Riedal, Norah Feeny, Robert Findling, Sheridan Stull, Susan Baab, Elizabeth B. Weller, Michele RobinsRonald A. Weller, Naushad Jessani, Bruce Waslick, Michael Sweeney, Randi Dublin, John Walkup, Golda Ginsburg, Elizabeth Kastelic, Hyung Koo, Christopher J Kratochvil, Diane May, Randy LaGrone, Brigette Vaughan, Anne Marie Albano, Glenn S. Hirsch, Elizabeth Podniesinki, Mark Reinecke, Bennett Leventhal, Gregory Rogers, Rachel Jacobs, Sanjeev Pathak, Jennifer Wells, Sarah Arszman, Arman Danielyan, Paul Rohde, Anne Simons, James Grimm, Stephenie Frank, Graham Emslie, Beth Kennard, Carroll Hughes, Taryn L. Mayes, David Rosenberg, Nili Benazon, Michael Butkus, Marla Bartoi, Kelly Posner, James Rochon

Research output: Contribution to journalArticle

346 Citations (Scopus)

Abstract

Context: The Treatment for Adolescents With Depression Study evaluates the effectiveness of fluoxetine hydrochloride therapy, cognitive behavior therapy (CBT), and their combination in adolescents with major depressive disorder. Objective: To report effectiveness outcomes across 36 weeks of randomized treatment. Design and Setting: Randomized, controlled trial conducted in 13 academic and community sites in the United States. Cognitive behavior and combination therapies were not masked, whereas administration of placebo and fluoxetine was double-blind through 12 weeks, after which treatments were unblinded. Patients assigned to placebo were treated openly after week 12, and the placebo group is not included in these analyses by design. Participants: Three hundred twenty-seven patients aged 12 to 17 years with a primary DSM-IV diagnosis of major depressive disorder. Interventions: All treatments were administered per protocol. Main Outcome Measures: The primary dependent measures rated blind to treatment status by an independent evaluator were the Children's Depression Rating Scale-Revised total score and the response rate, defined as a Clinical Global Impressions-Improvement score ofmuchor very much improved. Results: Intention-to-treat analyses on the Children's Depression Rating Scale-Revised identified a significant time X treatment interaction (P<.001). Rates of response were 73% for combination therapy, 62% for fluoxetine therapy, and 48% for CBT at week 12; 85% for combination therapy, 69% for fluoxetine therapy, and 65% for CBT at week 18; and 86% for combination therapy, 81% for fluoxetine therapy, and 81% for CBT at week 36. Suicidal ideation decreased with treatment, but less so with fluoxetine therapy than with combination therapy or CBT. Suicidal events were more common in patients receiving fluoxetine therapy (14.7%) than combination therapy (8.4%) or CBT (6.3%). Conclusions: In adolescents with moderate to severe depression, treatment with fluoxetine alone or in combination with CBT accelerates the response. Adding CBT to medication enhances the safety of medication. Taking benefits and harms into account, combined treatment appears superior to either monotherapy as a treatment for major depression in adolescents. Trial Registration: clinicaltrials.gov Identifier: NCT00006286.

Original languageEnglish (US)
Pages (from-to)1132-1144
Number of pages13
JournalArchives of general psychiatry
Volume64
Issue number10
DOIs
StatePublished - Oct 1 2007

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Depression
Safety
Cognitive Therapy
Fluoxetine
Therapeutics
Placebos
Major Depressive Disorder
Suicidal Ideation
Intention to Treat Analysis
Diagnostic and Statistical Manual of Mental Disorders
Randomized Controlled Trials

ASJC Scopus subject areas

  • Arts and Humanities (miscellaneous)
  • Psychiatry and Mental health

Cite this

March, J. S., Silva, S., Petrycki, S., Curry, J., Wells, K., Fairbank, J., ... Rochon, J. (2007). The Treatment for Adolescents with Depression Study (TADS): Long-term effectiveness and safety outcomes. Archives of general psychiatry, 64(10), 1132-1144. https://doi.org/10.1001/archpsyc.64.10.1132

The Treatment for Adolescents with Depression Study (TADS) : Long-term effectiveness and safety outcomes. / March, John S.; Silva, Susan; Petrycki, Stephen; Curry, John; Wells, Karen; Fairbank, John; Burns, Barbara; Domino, Marisa; McNulty, Steven; Vitiello, Benedetto; Severe, Joanne; Casat, Charles; Kolker, Jeanette; Riedal, Karyn; Feeny, Norah; Findling, Robert; Stull, Sheridan; Baab, Susan; Weller, Elizabeth B.; Robins, Michele; Weller, Ronald A.; Jessani, Naushad; Waslick, Bruce; Sweeney, Michael; Dublin, Randi; Walkup, John; Ginsburg, Golda; Kastelic, Elizabeth; Koo, Hyung; Kratochvil, Christopher J; May, Diane; LaGrone, Randy; Vaughan, Brigette; Albano, Anne Marie; Hirsch, Glenn S.; Podniesinki, Elizabeth; Reinecke, Mark; Leventhal, Bennett; Rogers, Gregory; Jacobs, Rachel; Pathak, Sanjeev; Wells, Jennifer; Arszman, Sarah; Danielyan, Arman; Rohde, Paul; Simons, Anne; Grimm, James; Frank, Stephenie; Emslie, Graham; Kennard, Beth; Hughes, Carroll; Mayes, Taryn L.; Rosenberg, David; Benazon, Nili; Butkus, Michael; Bartoi, Marla; Posner, Kelly; Rochon, James.

In: Archives of general psychiatry, Vol. 64, No. 10, 01.10.2007, p. 1132-1144.

Research output: Contribution to journalArticle

March, JS, Silva, S, Petrycki, S, Curry, J, Wells, K, Fairbank, J, Burns, B, Domino, M, McNulty, S, Vitiello, B, Severe, J, Casat, C, Kolker, J, Riedal, K, Feeny, N, Findling, R, Stull, S, Baab, S, Weller, EB, Robins, M, Weller, RA, Jessani, N, Waslick, B, Sweeney, M, Dublin, R, Walkup, J, Ginsburg, G, Kastelic, E, Koo, H, Kratochvil, CJ, May, D, LaGrone, R, Vaughan, B, Albano, AM, Hirsch, GS, Podniesinki, E, Reinecke, M, Leventhal, B, Rogers, G, Jacobs, R, Pathak, S, Wells, J, Arszman, S, Danielyan, A, Rohde, P, Simons, A, Grimm, J, Frank, S, Emslie, G, Kennard, B, Hughes, C, Mayes, TL, Rosenberg, D, Benazon, N, Butkus, M, Bartoi, M, Posner, K & Rochon, J 2007, 'The Treatment for Adolescents with Depression Study (TADS): Long-term effectiveness and safety outcomes', Archives of general psychiatry, vol. 64, no. 10, pp. 1132-1144. https://doi.org/10.1001/archpsyc.64.10.1132
March, John S. ; Silva, Susan ; Petrycki, Stephen ; Curry, John ; Wells, Karen ; Fairbank, John ; Burns, Barbara ; Domino, Marisa ; McNulty, Steven ; Vitiello, Benedetto ; Severe, Joanne ; Casat, Charles ; Kolker, Jeanette ; Riedal, Karyn ; Feeny, Norah ; Findling, Robert ; Stull, Sheridan ; Baab, Susan ; Weller, Elizabeth B. ; Robins, Michele ; Weller, Ronald A. ; Jessani, Naushad ; Waslick, Bruce ; Sweeney, Michael ; Dublin, Randi ; Walkup, John ; Ginsburg, Golda ; Kastelic, Elizabeth ; Koo, Hyung ; Kratochvil, Christopher J ; May, Diane ; LaGrone, Randy ; Vaughan, Brigette ; Albano, Anne Marie ; Hirsch, Glenn S. ; Podniesinki, Elizabeth ; Reinecke, Mark ; Leventhal, Bennett ; Rogers, Gregory ; Jacobs, Rachel ; Pathak, Sanjeev ; Wells, Jennifer ; Arszman, Sarah ; Danielyan, Arman ; Rohde, Paul ; Simons, Anne ; Grimm, James ; Frank, Stephenie ; Emslie, Graham ; Kennard, Beth ; Hughes, Carroll ; Mayes, Taryn L. ; Rosenberg, David ; Benazon, Nili ; Butkus, Michael ; Bartoi, Marla ; Posner, Kelly ; Rochon, James. / The Treatment for Adolescents with Depression Study (TADS) : Long-term effectiveness and safety outcomes. In: Archives of general psychiatry. 2007 ; Vol. 64, No. 10. pp. 1132-1144.
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T1 - The Treatment for Adolescents with Depression Study (TADS)

T2 - Long-term effectiveness and safety outcomes

AU - March, John S.

AU - Silva, Susan

AU - Petrycki, Stephen

AU - Curry, John

AU - Wells, Karen

AU - Fairbank, John

AU - Burns, Barbara

AU - Domino, Marisa

AU - McNulty, Steven

AU - Vitiello, Benedetto

AU - Severe, Joanne

AU - Casat, Charles

AU - Kolker, Jeanette

AU - Riedal, Karyn

AU - Feeny, Norah

AU - Findling, Robert

AU - Stull, Sheridan

AU - Baab, Susan

AU - Weller, Elizabeth B.

AU - Robins, Michele

AU - Weller, Ronald A.

AU - Jessani, Naushad

AU - Waslick, Bruce

AU - Sweeney, Michael

AU - Dublin, Randi

AU - Walkup, John

AU - Ginsburg, Golda

AU - Kastelic, Elizabeth

AU - Koo, Hyung

AU - Kratochvil, Christopher J

AU - May, Diane

AU - LaGrone, Randy

AU - Vaughan, Brigette

AU - Albano, Anne Marie

AU - Hirsch, Glenn S.

AU - Podniesinki, Elizabeth

AU - Reinecke, Mark

AU - Leventhal, Bennett

AU - Rogers, Gregory

AU - Jacobs, Rachel

AU - Pathak, Sanjeev

AU - Wells, Jennifer

AU - Arszman, Sarah

AU - Danielyan, Arman

AU - Rohde, Paul

AU - Simons, Anne

AU - Grimm, James

AU - Frank, Stephenie

AU - Emslie, Graham

AU - Kennard, Beth

AU - Hughes, Carroll

AU - Mayes, Taryn L.

AU - Rosenberg, David

AU - Benazon, Nili

AU - Butkus, Michael

AU - Bartoi, Marla

AU - Posner, Kelly

AU - Rochon, James

PY - 2007/10/1

Y1 - 2007/10/1

N2 - Context: The Treatment for Adolescents With Depression Study evaluates the effectiveness of fluoxetine hydrochloride therapy, cognitive behavior therapy (CBT), and their combination in adolescents with major depressive disorder. Objective: To report effectiveness outcomes across 36 weeks of randomized treatment. Design and Setting: Randomized, controlled trial conducted in 13 academic and community sites in the United States. Cognitive behavior and combination therapies were not masked, whereas administration of placebo and fluoxetine was double-blind through 12 weeks, after which treatments were unblinded. Patients assigned to placebo were treated openly after week 12, and the placebo group is not included in these analyses by design. Participants: Three hundred twenty-seven patients aged 12 to 17 years with a primary DSM-IV diagnosis of major depressive disorder. Interventions: All treatments were administered per protocol. Main Outcome Measures: The primary dependent measures rated blind to treatment status by an independent evaluator were the Children's Depression Rating Scale-Revised total score and the response rate, defined as a Clinical Global Impressions-Improvement score ofmuchor very much improved. Results: Intention-to-treat analyses on the Children's Depression Rating Scale-Revised identified a significant time X treatment interaction (P<.001). Rates of response were 73% for combination therapy, 62% for fluoxetine therapy, and 48% for CBT at week 12; 85% for combination therapy, 69% for fluoxetine therapy, and 65% for CBT at week 18; and 86% for combination therapy, 81% for fluoxetine therapy, and 81% for CBT at week 36. Suicidal ideation decreased with treatment, but less so with fluoxetine therapy than with combination therapy or CBT. Suicidal events were more common in patients receiving fluoxetine therapy (14.7%) than combination therapy (8.4%) or CBT (6.3%). Conclusions: In adolescents with moderate to severe depression, treatment with fluoxetine alone or in combination with CBT accelerates the response. Adding CBT to medication enhances the safety of medication. Taking benefits and harms into account, combined treatment appears superior to either monotherapy as a treatment for major depression in adolescents. Trial Registration: clinicaltrials.gov Identifier: NCT00006286.

AB - Context: The Treatment for Adolescents With Depression Study evaluates the effectiveness of fluoxetine hydrochloride therapy, cognitive behavior therapy (CBT), and their combination in adolescents with major depressive disorder. Objective: To report effectiveness outcomes across 36 weeks of randomized treatment. Design and Setting: Randomized, controlled trial conducted in 13 academic and community sites in the United States. Cognitive behavior and combination therapies were not masked, whereas administration of placebo and fluoxetine was double-blind through 12 weeks, after which treatments were unblinded. Patients assigned to placebo were treated openly after week 12, and the placebo group is not included in these analyses by design. Participants: Three hundred twenty-seven patients aged 12 to 17 years with a primary DSM-IV diagnosis of major depressive disorder. Interventions: All treatments were administered per protocol. Main Outcome Measures: The primary dependent measures rated blind to treatment status by an independent evaluator were the Children's Depression Rating Scale-Revised total score and the response rate, defined as a Clinical Global Impressions-Improvement score ofmuchor very much improved. Results: Intention-to-treat analyses on the Children's Depression Rating Scale-Revised identified a significant time X treatment interaction (P<.001). Rates of response were 73% for combination therapy, 62% for fluoxetine therapy, and 48% for CBT at week 12; 85% for combination therapy, 69% for fluoxetine therapy, and 65% for CBT at week 18; and 86% for combination therapy, 81% for fluoxetine therapy, and 81% for CBT at week 36. Suicidal ideation decreased with treatment, but less so with fluoxetine therapy than with combination therapy or CBT. Suicidal events were more common in patients receiving fluoxetine therapy (14.7%) than combination therapy (8.4%) or CBT (6.3%). Conclusions: In adolescents with moderate to severe depression, treatment with fluoxetine alone or in combination with CBT accelerates the response. Adding CBT to medication enhances the safety of medication. Taking benefits and harms into account, combined treatment appears superior to either monotherapy as a treatment for major depression in adolescents. Trial Registration: clinicaltrials.gov Identifier: NCT00006286.

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