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Cognitive Therapy Versus Medication in Augmentation and Switch Strategies as Second-Step Treatments: A STAR*D Report

Objectives: The authors compared the effectiveness of cognitive therapy and pharmacotherapy as second-step strategies for outpatients with major depressive disorder who had received inadequate benefit from an initial trial of citalopram. Cognitive therapy was compared with medication augmentation and switch strategies. Method: An equipoise-stratified randomization strategy was used to assign participants to either augmentation of citalopram with cognitive therapy (N = 65) or medication (N = 117; either sustained-release bupropion [N = 56] or buspirone [N = 61]) or switch to cognitive therapy (N = 36) or another antidepressant (N = 86; sertraline [N = 27], sustained-release bupropion [N = 28], or extended-release venlafaxine [N = 31]). Treatment outcomes and the frequency of adverse events were compared. Results: Less than one-third of participants consented to randomization strata that permitted comparison of cognitive therapy and pharmacotherapy. Among participants who were assigned to second-step treatment, those who received cognitive therapy (either alone or in combination with citalopram) had similar response and remission rates to those assigned to medication strategies. For those who continued on citalopram, medication augmentation resulted in significantly more rapid remission than augmentation with cognitive therapy. Among those who discontinued citalopram, there were no significant differences in outcome, although those who switched to a different antidepressant reported significantly more side effects than those who received cognitive therapy alone. Conclusions: After an unsatisfactory response to citalopram, patients who consented to random assignment to either cognitive therapy or alternative pharmacologic strategies had generally comparable outcomes. Pharmacologic augmentation was more rapidly effective than cognitive therapy augmentation of citalopram, whereas switching to cognitive therapy was better tolerated than switching to a different antidepressant.

(Reprinted with permission from the American Journal of Psychiatry 2007; 164:739–752)

Dr. Thase has served in an advisory or consulting capacity to, or received speakers honoraria from AstraZeneca, Bristol-Myers Squibb, Cephalon, Ceberonics, Eli Lilly, GlaxoSmithKline, Janssen Pharmaceutica, MedAvante, Neuronetics, Novartis, Organon, Sanofi-Aventis, Sepracor, Shire US, and Wyeth Pharmaceuticals and has equity holdings in MedAvante. Dr. Friedman has received research support from, served in an advisory or consulting capacity to, or received speakers honoraria from Abbott Laboratories, AstraZeneca, Bristol-Myers Squibb, Cephalon, Eli Lilly, Forest Specialty Sales, GlaxoSmithKline, Roerig Division of Pfizer, Sanofi-Aventis, and Wyeth-Ayerst Laboratories, and he owns shares of Cephalon stock. Dr. Biggs has received honoraria for consultations to Bristol-Myers Squibb, Eli Lilly, GlaxoSmithKline, Merck, and Pfizer. Dr. Wisniewski has provided consultation to Bristol-Myers Squibb, Cyberonics, and ImaRx Therapeutics and has received research support from NIMH. Dr. Trivedi has received research support from, served in an adisory or consulting capacity to, or received speakers honoraria from Abbott Laboratories, Akzo (Organon Pharmaceuticals), Bayer, Bristol-Myers Squibb, Cephalon, Corcept Therapeutics, Cyberonics, Forest Pharmaceuticals, GlaxoSmithKline, Janssen Pharmaceutica Products LP, Johnson & Johnson PRD, Eli Lilly, Meade Johnson, Merck, NIMH, National Alliance for Research in Schizophrenia and Depression, Novartis, Parke-Davis Pharmaceuticals, Pfizer, Pharmacia & Upjohn, Predix Pharmaceuticals, Sepracor, Solvay Pharmaceuticals, and Wyeth-Ayerst Laboratories. Dr. Fava has received research support from, served in an advisory or consulting capacity to, or received speakers honoraria from Abbott Laboratories, Alkermes, Aspect Medical Systems, AstraZeneca, Bayer AG, Biovail Pharmaceuticals, BrainCells, Boehringer-Ingelheim, Bristol-Myers Squibb, Cephalon, Compellis, Cypress Pharmaceuticals, Dov Pharmaceuticals, Eli Lilly, EPIX Pharmaceuticals, Fabre-Kramer Pharmaceuticals, Forest Pharmaceuticals, GlaxoSmithKline, Grunenthal GmbH, Janssen Pharmaceutica, Jazz Pharmaceuticals, J & J Pharmaceuticals, Knoll Pharmaceutical Company, Lichtwer Pharma GmbH, Lorex Pharmaceuticals, Lundbeck, MedAvante, Neuronetics, Novartis, Nutrition 21, Organon, PamLab, Pfizer, PharmaStar, Phamavite, Roche, Sanofi-Synthelabo, Sepracor, Solvay Pharmaceuticals, Somaxon, Somerset Pharmaceuticals, and Wyeth-Ayerst Laboratories. He has equity holdings with Compellis and MedAvante. Dr. Nierenberg has received research support from, served in an advisory or consulting capacity to or received speakers honoraria from BrainCells, Bristol-Myers Squibb, Cederroth, Cyberonics, Eli Lilly, Forest Pharmaceuticals, Genaissance, GlaxoSmithKline, Innapharma, Janssen Pharmaceutica, Lichtwer Pharma, National Alliance for Research in Schizophrenia and Depression, NIH, Novartis, Pfizer, Sepracor, Shire, Somerset, Stanley Foundation, and Wyeth-Ayerst Laboratories. Dr. McGrath has received research support from or served in an advisory or consulting capacity to GlaxoSmithKline, NIMH, National Institute on Alcohol Abuse and Alcoholism, New York State Department of Mental Hygiene, Research Foundation for Mental Hygiene (New York State), GlaxoSmithKline, Eli Lilly, Organon, Lipha Pharmaceuticals, and Somerset Pharmaceuticals. Dr. Warden owns shares of Pfizer stock and has owned shares of Bristol-Myers Squibb stock. Dr. Rush has received research support from, served in an advisory or consulting capacity to, or received speakers honoraria from Advanced Neuromodulation Systems, AstraZeneca, Best Practice Project Management, Bristol-Myers Squibb, Cyberonics, Forest Pharmaceuticals, Gerson Lehman Group, GlaxoSmithKline, Jazz Pharmaceuticals, Eli Lilly, Merck, NIMH, Neuronetics, Ono Pharmaceutical, Organon USA, PamLab, Personality Disorder Research Corp., Pfizer, Robert Wood Johnson Foundation, Stanley Foundation, Urban institute, and Wyeth-Ayerst Laboratories. He has received royalties from Guilford Press and Health Technology Systems, and he owns shares of Pfizer stock. Drs. Niederehe and Holton and Mr. Luther report no competing interests.

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