Workshop on Adaptive Treatment Strategies. Janet Levy, Ph.D. Jim McKay, Ph.D. Carl Pieper, Dr.Ph. Madhukar Trivedi, M.D. Purpose. EDUCATIONAL: What are “adaptive treatment strategies” (“dynamic treatment regimes”)?
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Janet Levy, Ph.D.
Jim McKay, Ph.D.
Carl Pieper, Dr.Ph.
Madhukar Trivedi, M.D.
EDUCATIONAL: What are “adaptive treatment strategies” (“dynamic treatment regimes”)?
THOUGHT PROVOKING: How might they be applied within the community of treatment providers within our network?
Introductions: Janet Levy
Experimental Designs: Carl Pieper
Adaptive Treatment Strategies in:
The Addictions: Jim McKay
Mental Health: Madhukar Trivedi
The CTN: Janet Levy
Closing: Janet Levy
Innovations in the design of clinical trials have been in the service of pharmaceutical companies to facilitate drug development.
The results OFTEN do NOT inform clinical practice,
especially in mental health.
“A less considered aspect of the usual placebo-controlled
non-equivalence design is the disparity between the
decisions that it supports and those that pervade clinical
practice” p. 3250, Dawson and Lavori(2004).
Development of CTN0030, a trial for the treatment of prescription opioid dependence began in 2004.
Team wanted to design a study which would be “practical” (i.e. inform clinical practice).
Idea of re-randomizing those who relapse during “detoxification” surfaced quickly (to support inferences about which treatment is best following relapse).
How to frame the primary hypothesis? Is it about the first phase (detoxification?) OR is it about what to do for those who relapse early?
We struggled, the DSMB struggled!!
Work illustrating how one might design trials to support the development of clinical strategies in addiction and mental health was just beginning to be published in 2004!!
Dawson, R. and Lavori, P.W. (2004) Discuss the need for innovations in trial design to inform clinical practice.
Murphy, S.A. (2005). Presents preliminary sample size formulae to test hypotheses about strategies in a trial using multiple randomizations. Presents actual simple trial designs.
Murphy, S.A. et al, (with McKay, J.R.), (2006 and 2007). Provides further thinking around how to construct adaptive treatment strategies and how to design trials specifically for the development of long terms strategies.
Clinical Trials Network,
National Institute on Drug Abuse
Assistant Research Professor,Dept. of Biometry & Bioinformatics,Duke University Medical Center.
Director and Chief, Computer and Statistics Laboratory, Center for Aging & Human Development, Duke University Medical Center
Senior Fellow, Center for Aging & Human Development,
Professor of Psychology in Psychiatry at the University of Pennsylvania.
Director of the joint Penn--TRI Center on the Continuum of Care in the Addictions.
Co-director of the Center of Excellence in Substance Abuse Treatment and Education (CESATE) at the Philadelphia Veterans Affairs Medical Center."
Professor and director of the Mood Disorders Research Program and Clinic at the University of Texas Southwestern Medical Center in Dallas where he holds the Lydia Bryant Test Professorship in Psychiatric Research.
Director for the depression algorithm for the Texas Medication Algorithm Project (TMAP).
Co-director of the Dallas Coordinating Center of the NIMH funded project “Sequences Treatment and Alternatives to Relieve Depression (Star*D), of which he is co-principal investigator.
1a. In your clinical practice, what clinical signs indicate that
A client is not responding well to treatment?
1b. In your program, what treatment options are available when
the client is not responding to standard care, or the first
treatment he/she is provided?
1c. In your clinical practice, what clinical signs indicate that a
client is responding well to treatment?
1d. In your program, when the patient is doing well, what
treatment options are available besides more of the same
2. Based on your own experience as a clinician, which clinical
decisions about patient care are the most challenging
(for any reason)?
3. Based on your own experience as a clinician, which clinical
decisions are in most need of empirical research
(for any reason)?
4. What do you do when a patient returns to treatment several
times without a prolonged period of success between
5. How long would you continue to apply a particular treatment
to a client before determining whether or not the treatment