Archive for the ‘Guidelines’ category

Toward the New World Order

March 11th, 2013

If the federal health reform initiative proceeds apace, before long almost all Americans will have health insurance. But there are nowhere near enough physicians to care for all of us—especially as the population ages.

Many approaches make sense to enhance the quality and efficiency of our care system—including algorithms, more effective use of extenders, electronic decision support, and patient education. Another feature to come is more selective use of specialists—including psychiatrists.

When care is paid for by a third party, we cannot afford to have many patients cared for primarily by a specialist. The model to come will have specialists create algorithms and protocols for primary care providers (PCPs). Specialists will be available for brief electronic or phone consultations and, less commonly, for one-on-one direct consultation with patients. A psychiatrist will see a patient and refer the patient back to a PCP, with backup as needed. Sometimes we may see the patient for a few visits to ensure stability.

There will always be a small cadre of chronically ill patients who require ongoing care from specialists—brittle diabetics, unstable cardiac patients, and in psychiatry, people who suffer from schizophrenia or bipolar disorder, for example. People who pay out of pocket can call their own tune. But for most Americans, care will have to be more rationalized. I regularly point out to medical students and residents that this will soon change the way we practice and the lives we lead.

-Alan J. Gelenberg, M.D.
Editor, Biological Therapies in Psychiatry
Shively/Tan Professor and Chair, Psychiatry, Penn State University
Editor-in-Chief, Journal of Clinical Psychiatry

What’s MDD?

March 1st, 2013

I chaired the APA workgroup that authored the third edition of the treatment guideline for major depressive disorder (MDD), published at the end of 2010. MDD is a typical DSM-3 (and beyond) diagnostic category—a behavioral syndrome, which doubtlessly encompasses many biologically distinct diseases. (Hence the varied responses of patients to our ministrations.) But even while we eagerly await the dawning of the era of personalized, genomically informed medicine in psychiatry, we can still assess each depressed patient with a careful differential diagnosis—considering substance abuse, medical and neurologic diseases, and personality disorders, among other possibilities.

This came to mind when a resident presented a case to me. The chief complaints were lack of energy and interest—certainly key components of MDD, but easily reflecting a host of other diagnoses. When I saw the middle-aged man, he had mask-like facies, bradykinetic features, and a resting tremor. On examination he displayed muscular rigidity. We referred the patient to a neurologist, who confirmed a diagnosis of Parkinson disease. The patient’s psychiatric complaints responded favorable to the antiparkinson regimen, as did his motor signs. We will soon taper his SSRI. It didn’t take long, and it sure helped this man.

-Alan J. Gelenberg, M.D.
Editor, Biological Therapies in Psychiatry
Shively/Tan Professor and Chair, Psychiatry, Penn State University
Editor-in-Chief, Journal of Clinical Psychiatry

NCDEU 2012

June 13th, 2012

I just attended the annual NCDEU meeting—this year in Phoenix, AZ. NCDEU stands for New Clinical Drug Evaluation Unit (formerly ECDEU, Early Clinical Drug Evaluation Unit) These are now meaningless acronyms, but it was originally a symposium of clinical psychopharmacology researchers funded by NIMH. NIMH has recently relinquished “ownership” of the meeting to the American Society of Clinical Psychopharmacology, but it, along with its sister institutes NIDA and NIAAA as well as the FDA, retains a partnership stake and roll [?a role] in the program.

No one was certain how this meeting, which many of us are devoted to, would survive the transition from NIMH’s leadership. But this year’s program, with ASCP in the lead, was a sparkling success: in attendance, participation, enthusiasm and—most of all—groundbreaking science.

Meetings evolve. ECDEU/NCDEU began as a methods-focused conclave in the early days of biological psychiatry. Over the decades, it evolved to incorporate understanding of brain function, psychosocial interventions, and combined treatments. NCDEU became a unique assembly of industry, government, and university scientists, regulators, teachers, and clinicians. The papers, posters, and panels contained cutting-edge information, but much of the spark came in the informal conversations, from which flowed new research ideas and collaborations.

This year’s agenda included news on innovative treatments and new data on old techniques and agents. A bold new diagnostic methodology, the NIMH Research Domain Criteria (RDoC) is shifting the focus from DSM categories to dimensions and traits, in the hope of mapping disorders to biological underpinnings and the human genome. Whether—and when—this will bear fruit in furthering understanding of brain disorders and creating new and personalized treatments remains to be seen. It could take years or even decades to unfold.

-Alan J. Gelenberg, M.D.
Editor, Biological Therapies in Psychiatry
Shively/Tan Professor and Chair, Psychiatry, Penn State University
Editor-in-Chief, Journal of Clinical Psychiatry


Overall, the information imparted at NCDEU 2012 was invigorating, and the energy in the meeting has never been higher. With the disclosure that I sit on ASCP’s board and have an abiding passion for its mission and NCDEU’s future, I encourage my faculty members and BTP readers to think about ASCP membership and attending NCDEU. BTP (and the Journal of Clinical Psychiatry) are partners with ASCP, which is a dynamic and growing organization. Coming away from this year’s meeting, I am very optimistic about psychiatry’s future.

Grief and Depression

March 16th, 2012

If you read the popular press, you are aware of the controversy about dropping the bereavement exclusion from the diagnosis of Major Depressive Disorder in DSM-V. The Lancet published an editorial in their February 18th issue decrying what they called the classification of grief as a mental illness. The same issue carried a moving Perspective by Dr. Arthur Kleinman, who described the recent death of his wife, his own bereavement, and his warning against “medicalizing” grief.

Freud struggled with the separation of grief and depression. His elegant monograph Mourning and Melancholia bears re-reading today.

The thought of turning natural grief into an illness and treating it with drugs is anathema to me. Grieving truly is a normal, personal, intimate process. It requires friends and loved ones and, as Freud describes, it is a gradual, healing path of saying good-bye and moving forward with the rest of one’s life.

But sometimes loss triggers the pathological mood state of depression. I have seen patients whose normal grief went off track and ground to a halt when the pall of depression descended on them. When they were treated with antidepressants or psychotherapy, they were able to resume the healing process, move forward in grieving, and find their place again in the world.

I am no expert in nosology. But as a clinical psychiatrist, I do hope the framers of the next DSM will find a path between the extremes—neither medicalizing a normal process, nor making it impossible for a grieving person who then develops depression to legitimately receive proper treatment.

-Alan J. Gelenberg, M.D.
Biological Therapies in Psychiatry
Shively/Tan Professor and Chair, Psychiatry, Penn State University
Journal of Clinical Psychiatry


Do You Believe In Magic?

March 18th, 2011

Psychiatrists often treat patients who have magical thinking. But I’ve also observed magical thinking in psychiatrists and other physicians.

I recently spoke at a conference about treating depression. I presented data from several large recent studies (STAR*D, REVAMP, PREVENT), all of which refuted hypotheses about how to tailor depression treatment to individual cases. I spoke of what Gary Sachs calls a “menu of reasonable options.” I endorsed algorithm- and measurement-based care, recommending TMAP as a reasonable and easily accessed algorithm. I cited numerous articles I’ve reviewed in the pages of BTP.

When it was time for questions, someone asked if I could please provide guidance on how to choose the right antidepressant for a given patient. For example, the questioner went on, could the agitated/retarded dimension be used to select the optimal drug? I could give an answer, I responded, but it would be free of science or evidence—since there is none. There have been many theories on this, going back to the 1950s—using behavioral symptoms, urinary metabolites, and more. But they’ve all come a cropper.

I’ve heard speakers endorse hypotheses as if they were facts. Some “experts” were well compensated by companies, who hoped their products would gain competitive market advantage from doctors believing groundless theories. Other speakers promoting magical solutions to unanswered questions appeared simply to relish the celebrity status pseudoscience provided.

I do not like to be ignorant. I yearn for the day when personalized medicine will be a reality in all specialties, psychiatry included. But for our patients, it is better to be candid, to acknowledge the boundaries of medical knowledge. Today the best treatment for a patient is the one the patient will adhere to. And the best doctor is the one who knows what he or she does not know.

- Alan J. Gelenberg, M.D.
Biological Therapies in Psychiatry
Professor and Chair, Psychiatry, Penn State University
Journal of Clinical Psychiatry

Unintended Consequences

March 1st, 2011
I read in the New York Times recently about the NIH establishing a National Center forAdvancing Translational Sciences, whose purpose is to foster the development of newmedicines. The raison d’etre of the new center is that the pharmaceutical industry is slowingdown the entry of new molecules into therapeutics. The cost of bringing a new drug to marketnow stands north of $1 billion. One of the areas of greatest concern is psychiatric therapeutics.

There are many valid explanations for this worrisome slowdown in drug development:changing business models, shifting subject populations in clinical trials, an evolving regulatoryenvironment, worldwide concerns about escalating healthcare costs, etc.

But a recent development that troubles me is the growing rift between talented experts inbiomedical research and the development process.

In the last few years, there have been legitimate and shocking stories about conflicts of interestamong some researchers and academics. As a result of This has led to intense media focus andscrutiny in the U.S. Senate., As a result, the NIH, the FDA, journals, professional societies, anduniversities rapidly constructed elaborate and often cumbersome mechanisms to avoid theslightest hint of taint. It’s now very difficult for the most knowledgeable experts to advise theNIH, the FDA, or the pharmaceutical industry, or to work on treatment guidelines and the like.Because of restrictions on research, paperwork, and fear of embarrassment if they consult withindustry, many experts stay home and focus on their science. And so we get less of the healthydynamic—the flow of knowledge and perspective—that enhances new-product development.

Pendulums swing. I worry about the unintended consequences of how far this one has swung.This challenge for our society is vaguely analogous to the need to strike a balance between civilliberties and public safety. How can our regulatory systems reasonably leverage the power ofacademic knowledge and expertise while, at the same time, safeguarding all of us against therogue scientist who would put personal gain above the welfare of fellow citizens?

- Alan J. Gelenberg, M.D.
Biological Therapies in Psychiatry
Professor and Chair, Psychiatry, Penn State University
Journal of Clinical Psychiatry

Press Reactions to the MDD Treatment Guideline

October 6th, 2010

The 3rd APA Treatment Guideline for Major Depressive Disorder is about to be published. Press releases went out late last week. I’m the only person who participated in the writing of all three iterations, and I chaired the work group that wrote the most recent one.

We began in 2006. I was then in Tucson and have since migrated to Madison, WI, and then to Central Pennsylvania and Penn State. It’s been a long four years. First came the scholarship, sifting through myriad papers, studies, and data. Many, many calls and emails. Then came over a thousand comments from colleagues in practice, scientists, and medical directors of companies that made depression treatments. All had to be responded to in multiple drafts and what felt like endless rewriting. Finally, the complex APA hierarchy had to read, discuss, consider, and vote. We’re finally done.

I was surprised  by some of the press reaction. ECT was a small part of a very long document, which details a growing panoply of options for treating depressed people: from diet and exercise through therapy and medication and on to various ways to stimulate the brain electrically or magnetically. But ECT, with its echoes of “Cuckoo’s Nest,” evokes emotion and, I suppose, captures readers’ attention.

A blogger for a major news weekly turned the Guideline into a battle between psychiatrists and psychologists. I learned that we hate each other. (Really?)

When Marty Keller and others looked at depression treatment in the early 1980s, they learned that only 20% to 25% of depressed people get minimally adequate treatment. NIMH and various advocacy groups launched campaigns to educate doctors and the public. Managed care was graded by accrediting agencies on how well they diagnosed and treated depression. Now, 30 years later, the percentage of depressed people who receive minimally adequate treatment remains more or less the same.

But what titillates the press is that “shock treatment” remains among our treatments. And that sometimes psychiatrists and psychologists disagree or have guild arguments. To me that’s sad. We need better press agents for improving mental health access and care.


September 20th, 2010

Most psychiatrists are aware of the turmoil swirling around the next iteration of the venerable DSM: DSM-V. The process and many proposed changes are under scrutiny and sometimes attack. I have two lower-key concerns, which apply to DSM-IV and probably will be relevant to the next generation.

The shift from DSM-II to DSM-III gave us the current multi-axial format, based largely on the systematic descriptive approach used  at Washington University in St. Louis. DSM-III brought superior reliability: independent assessors were more likely to agree on a diagnosis.

But many senior clinicians have lamented the “checklist interview” this approach has fostered. We observe residents rush from question to question, dutifully recording the spoken answer, without taking in the nuance, tone of voice, facial expression, and body posture of the person sitting opposite. The follow-up question that a patient may be begging to have asked goes unaddressed. Surely, we need to collect and record data. But we can do so without losing the art of good interviewing. Psychiatrists still need to “listen with the third ear.”

And if reliability with DSM-III and IV are so high, how do we account for patients with long strings of incompatible diagnoses? Sit at the door on any psychiatric unit, and those conflicting diagnoses in patients’ histories are the rule, not the exception. In my experience, they reflect the sloppy use of the DSM rules. Sure, you and I are likely to agree on a diagnosis in most axes—provided that we both play by the same rules.  Like it or not, the DSM is our dictionary, the common language that allows communications. And like any language, it requires precise use per agreed-upon definitions. When we do less, any “signal” gets lost in the “noise.”

MDD Guidelines

June 15th, 2010

Whew. This wasn’t easy. But it was necessary. And I hope useful for years to come.

A work group of the American Psychiatric Association just finished a 4-year gargantuan effort to revise and update the Major Depressive Disorder Treatment Guideline. And the APA has now formally approved the document.

I chaired the work group, made up of esteemed scholars, scientists and clinicians who gave generously of their time and talents.  Together we considered how much had changed since the second version of the guideline came out in 2000.

  • New medications have been studied in short- and long-term trials.
  • Drugs have been approved as adjuncts.
  • New forms of psychotherapy have been created and studied.
  • Nutritional supplements and exercise have been proposed and studied.
  • New stimulation interventions are available.

The work group looked carefully at each, and debated the pros and cons on their scientific merits. Some of the new treatments met the test for recommendation by this work group, and subsequently by the APA.

While there are many effective treatments, both new and old, as a whole, available options leave much to be desired.  Even after repeated treatments with a variety of medications and methodology, as many as one third of patients will remain symptomatic. There remains a tremendous need.

Given our current limitations, however, I am confident the new guidelines will help clinicians choose among a wide variety of approved treatments, from diet and exercise to brain stimulation. And our work must continue.