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CLINICAL OUTCOMES IN MEASUREMENT-BASED TREATMENT (COMET): A TRIAL OF DEPRESSION MONITORING AND FEEDBACK TO PRIMARY CARE PHYSICIANS

Authors


  • Conflict of interest: Dr. Yeung and Dr. Baer have no financial relationships that pose a conflict of interest. Dr. Jing, Dr. Hebden, and Dr. Kalsekar are employees of Bristol-Myers Squibb and Dr. McQuade is an employee of Otsuka Pharmaceutical Co., Ltd. Dr. Brenneman, Dr. Siebenaler, and Mr. Kurlander are employees of OptumInsight (formerly Innovus), an independent research organization contracted by Bristol-Myers Squibb to conduct the study. Dr. Chang and Dr. Fava have relationships with companies with an interest in depression treatment, although no specific products are discussed in the manuscript. Dr. Chang has received lifetime research support from Alkermes, AstraZeneca, Euthymics, CeNeRx, Forest, GlaxoSmithKline, Johnson & Johnson, and Pfizer and has received travel reimbursement from Bristol-Myers Squibb. Dr. Fava has received research support from or served as a consultant to or on the board of numerous companies, including Abbott Laboratories; Affectis Pharmaceuticals AG; Alkermes, Inc.; Amarin Pharma, Inc.; Aspect Medical Systems; AstraZeneca; Auspex Pharmaceuticals; Bayer AG; Best Practice Project Management, Inc.; BioMarin Pharmaceuticals, Inc.; Biovail Corporation; BrainCells, Inc.; Bristol-Myers Squibb; CeneRx; Cephalon, Inc.; Clinical Trials Solutions; CNS Response, Inc.; Compellis Pharmaceuticals; Covance; Cypress Pharmaceutical, Inc.; DiagnoSearch Life Sciences (P) Ltd.; Dinippon Sumitomo Pharma Co., Inc.; Dov Pharmaceuticals, Inc.; Edgemont Pharmaceuticals, Inc.; Eisai, Inc.; Eli Lilly and Company; EnVivo; ePharmaSolutions; EPIX Pharmaceuticals, Inc.; Euthymics Bioscience, Inc.; Fabre-Kramer Pharmaceuticals, Inc.; Forest Pharmaceuticals, Inc.; Ganeden; GenOmind, LLC; GlaxoSmithKline; Grunenthal GmbH; i3 Innovus/Ingenix; Janssen Pharmaceutica; Jazz Pharmaceuticals, Inc.; Johnson & Johnson; Knoll Pharmaceuticals Corp.; Labopharm, Inc.; Lorex Pharmaceuticals; Lundbeck, Inc.; Lundbeck/Takeda; MedAvante, Inc.; Merck & Co., Inc.; MSI Methylation Sciences, Inc.; Naurex, Inc.; NCCAM; Neuronetics, Inc.; NextWave Pharmaceuticals; NIDA; NIH; NIMH; Novartis; Nutrition 21; Orexigen Therapeutics, Inc.; Organon Pharmaceuticals; Otsuka Pharmaceuticals; PamLab, LLC; Pfizer, Inc.; PharmaStar; PsychoGenics; Psylin; Roche; Sanofi-Aventis; Scherring-Plough; and Transcept.

  • Contract grant sponsor: Bristol-Myers Squibb; Contract grant sponsor: Otsuka Pharmaceutical Co., Ltd.

Correspondence to: Albert S. Yeung, DCRP, Massachusetts General Hospital, 1 Bowdoin Square, 6th Fl, Boston, MA 02114. E-mail: ayeung@partners.org

Abstract

Background

Despite the availability of effective treatments for depression, many patients under the care of primary care physicians do not achieve remission. Clinical Outcomes in Measurement-based Treatment (COMET) was designed to assess whether communicating patient-reported depression symptom severity to primary care physicians affects patient outcomes at 6 months.

Methods

Nine hundred fifteen patients (intervention: n = 503; control: n = 412) diagnosed with major depressive disorder were enrolled in a prospective trial in which physician practice sites were assigned to either the intervention or control study arm. Only patients who were prescribed an antidepressant by their physician were eligible, but medication type was independent of the study protocol. Intervention-arm physicians received monthly updates on their patients’ depression severity, which was determined with the nine-item Patient Health Questionnaire (PHQ-9) administered during telephone interviews. Remission was defined as a PHQ-9 score <5 at 6 months; response was defined as a score reduction ≥50%.

Results

Among patients with baseline PHQ-9 score ≥5, 45.0% achieved remission (46.7% intervention versus 42.8% control) and 63.9% responded (67.0% intervention versus 59.7% control) at 6 months. After adjusting for baseline demographic and clinical variables, odds of remission (odds ratio [OR], 1.59 [95% CI, 1.07–2.37]) or response (OR, 2.02 [95% CI, 1.36–3.02]) were significantly greater for the intervention group than for control patients.

Conclusions

This study demonstrated that regular patient symptom monitoring with feedback to physicians improved outcomes of depression treatment in the primary care setting. Determining reasons for the high observed nonremission rates requires further investigation.

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