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STAR*D: Results and Implications for Clinicians, Researchers, and Policy Makers Bradley N. Gaynes, M.D., M.P.H. Associate Professor of Psychiatry University

Mar 27, 2015

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STAR*D: Results and Implications for Clinicians, Researchers, and Policy Makers Bradley N. Gaynes, M.D., M.P.H. Associate Professor of Psychiatry University of North Carolina School of Medicine Chapel Hill, North Carolina AcademyHealth Annual Research Meeting 2007 Slide 2 What is STAR*D? Sequenced Treatment Alternatives to Relieve Depression Sequenced Treatment Alternatives to Relieve Depression www.star-d.org www.star-d.org Slide 3 Overall Aim of STAR*D Define preferred treatments for treatment-resistant depression Define preferred treatments for treatment-resistant depression Slide 4 4 Overview - I Duration: 7 years (October 1999 - September 2006) Duration: 7 years (October 1999 - September 2006) Funding: National Institute of Mental Health Funding: National Institute of Mental Health National Coordinating Center, UT Southwestern Medical Center, Dallas National Coordinating Center, UT Southwestern Medical Center, Dallas Data Coordinating Center, Pittsburgh Data Coordinating Center, Pittsburgh Slide 5 Overview - II 14 Regional Centers 14 Regional Centers 41 Clinical Sites 41 Clinical Sites 18 Primary Care Settings (PC) 18 Primary Care Settings (PC) 23 Psychiatric Care Settings (Specialty Care, or SC) 23 Psychiatric Care Settings (Specialty Care, or SC) Slide 6 Obtain Consent CIT Follow-Up Level 2 Satisfactory response Satisfactory response Unsatisfactory response* Unsatisfactory response* *Response = >50% improvement in QIDS-SR from baseline Level 1 Slide 7 Level 2 RandomizeRandomize Switch Options Augmentation Options SER BUP-SR VEN-XR CT CIT + BUP-SR CIT + BUS CIT + CT Slide 8 Level 2A RandomizeRandomize Switch Options BUP-SR VEN-XR Slide 9 Level 3 RandomizeRandomize Switch Options Augmentation Options MRT NTP L-2 Tx + Li L-2 Tx + THY Slide 10 Level 4 RandomizeRandomize Switch Options TCP VEN-XR + MRT Slide 11 Participants Major depressive disorder Major depressive disorder Nonpsychotic Nonpsychotic Representative primary and specialty care practices (nonacademic/non efficacy venues) Representative primary and specialty care practices (nonacademic/non efficacy venues) Self-declared patients Self-declared patients Slide 12 Inclusion Criteria Clinician deems antidepressant medication indicated. Clinician deems antidepressant medication indicated. 18-75 years of age. 18-75 years of age. Baseline HRSD 17 14. Baseline HRSD 17 14. Most concurrent Axis I, II, III disorders allowed. Most concurrent Axis I, II, III disorders allowed. Suicidal patients allowed Suicidal patients allowed Slide 13 Clinical Procedures Open treatment with randomization Open treatment with randomization Symptoms/side effects measured at each clinical visit (measurement- based care, or MBC) Symptoms/side effects measured at each clinical visit (measurement- based care, or MBC) Clinicians guided by algorithms/ supervision Clinicians guided by algorithms/ supervision Slide 14 Research Innovations Real world patient participants from nonacademic/nonefficacy research venues Real world patient participants from nonacademic/nonefficacy research venues Non-research clinicians Non-research clinicians Identical criteria and concurrent enrollment from PC and SC sites Identical criteria and concurrent enrollment from PC and SC sites Broadly selective inclusion criteria Broadly selective inclusion criteria Patient preference built into study design Patient preference built into study design Slide 15 STAR*D Hybrid Design - I Efficacy*Effectiveness STAR D Patients Symptomatic Volunteers Self-declaredSelf-declared Masked Treatment YesNoNo Masked Raters YesYesYes Baseline Severity HRSD 17 >20 Variable HRSD 17 >14 Diagnostic Method Structured Interview ClinicalClinical Concurrent Axis I and Axis III Allowed MinimalMostMost *To establish efficacy versus placebo. Allowed to enter if MDD requires medication. Slide 16 STAR*D Hybrid Design - II Efficacy*Effectiveness STAR D Treatment Methods ProtocolClinician Protocol + Clinician Symptomatic Outcomes YesSometimesYes Functional Outcomes NoYesYes Cost/Utilization Outcomes NoYesYes Psychotherapy Allowed NoYesSometimes Placebo Allowed YesNoNo Suicidal Patients Allowed NoYesYes *To establish efficacy versus placebo. Allowed if not depression-targeted, empirically tested therapy. Slide 17 Level 1 Findings Slide 18 Patients from real world settings are quite chronically ill Mean (SD) HRSD 17 (ROA) 21.8 (5.2) No. of MDEs 6.0 (11.4) Length of current MDE (months) 24.6 (51.7) Length of illness (years) 15.5 (13.2) No. No. with either chronic or recurrent MDE 85% Depressed 2 years 25% No. with concurrent medical conditions 67% Slide 19 Depressed patients in PC and SC settings are surprisingly similar No difference in No difference in depressive severity depressive severity distribution of depressive severity distribution of depressive severity specific depressive symptom presentation specific depressive symptom presentation likelihood of presenting with a comorbid psychiatric illness likelihood of presenting with a comorbid psychiatric illness Main difference: SC patients more likely to have made prior suicide attempt, but common in both (20% vs. 14%, p Conclusions One-quarter of patients have been depressed for >2 years and 2/3 have concurrent GMCs One-quarter of patients have been depressed for >2 years and 2/3 have concurrent GMCs About 1/3 will remit About 1/3 will remit Response occurs in 1/3 AFTER 6 weeks Response occurs in 1/3 AFTER 6 weeks MBC is feasible and works, with equivalent outcomes in PC or SC settings MBC is feasible and works, with equivalent outcomes in PC or SC settings Studies of remission require longer study periods than 8 weeks Studies of remission require longer study periods than 8 weeks Slide 23 Level 2 Medication Switch Slide 24 Conclusions: Level 2 Switch Either switching to the same class of antidepressant (SSRI to SSRI) or to a different class (SSRI to non-SSRI) did not matter Either switching to the same class of antidepressant (SSRI to SSRI) or to a different class (SSRI to non-SSRI) did not matter Substantial differences in pharmacology did not translate into substantial clinical differences in efficacy Substantial differences in pharmacology did not translate into substantial clinical differences in efficacy Slide 25 Level 2 Medication Augmentation Slide 26 Conclusions: Level 2 Augmentation There was no substantial differences in the likelihood of either of the two augmentation medications to produce remission There was no substantial differences in the likelihood of either of the two augmentation medications to produce remission Slide 27 Patients had clear preferences about accepting augmentation vs. switching, and, accordingly, the groups differed at entry into level 2 Patients had clear preferences about accepting augmentation vs. switching, and, accordingly, the groups differed at entry into level 2 Consequently, whether switching vs. augmenting is preferred after one treatment failure could not be addressed Consequently, whether switching vs. augmenting is preferred after one treatment failure could not be addressed Slide 28 QIDS-SR 16 Remission Rates * Theoretical Slide 29 Conclusions Cumulative remission rate is over 50% with first 2 steps Cumulative remission rate is over 50% with first 2 steps Patient preference plays a big role in strategy selection Patient preference plays a big role in strategy selection Pharmacological distinctions do not translate into large clinical differences Pharmacological distinctions do not translate into large clinical differences Slide 30 Level 2 Cognitive Therapy Findings Slide 31 Conclusions CT is an acceptable switch option in the second step CT is an acceptable switch option in the second step CT is an acceptable augmentation option in the second step CT is an acceptable augmentation option in the second step Whether CT responders/remitters fare better in follow-up is in analysis Whether CT responders/remitters fare better in follow-up is in analysis CT was not as popular as expected CT was not as popular as expected Slide 32 Remission Rates by Levels a a By QIDS-SR 16 STAR*D Participant Flow (CONSORT Chart) Screened (4,790) Not offered Consent or Refused to Consent (613) Ineligible (136) Consented (4,177) Efficacy Sample (635) Nonefficacy Sample (2,220) Could Not Be Classified (21) Failed to Return (234) Eligible (4,041) HRSD 17 >14 (3,110) Eligible for Analysis (2,876) HRSD 17 < 14 a (607) Or Missing (324) a Some of these subjects were eligible for entry into Level 2. Wisniewski et al, The Lancet, in preparation Slide 35 Clinical Features a a Descriptive statistics presented as meansd and n (%N). Sums do not always equal N due to missing values. Percentages based on available data; b p

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