This interview took place on April 16, 2007, and was conducted by Norman Sussman, MD.

 

This interview is also available as an audio PsychCastTM at http://psychcast.mblcommunications.com.

Disclosure: Dr. Regier oversees all federal- and industry-sponsored research and research training grants at the American Psychiatric Institute for Research and Education but receives no external salary funding or honoraria from any government or industry sources.

 

Dr. Regier is executive director of the American Psychiatric Institute for Research and Education and director of the Division of Research at the American Psychiatric Association. During his 25 years at the National Institute of Mental Health, Dr. Regier was involved with the World Health Organization in international programs on the classification of mental disorders. He currently serves as vice chair of the task force to develop the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition.

What is the expected publication date for the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V)?

Our current target date is May 2012. We are hoping to have all the work groups fully functioning by Fall 2007. Then we still need to review all of the literature that we have been pulling together over the last 8 years and conduct field trials prior to publication.

 

How would you best describe the DSM system?

The best description of it is a dictionary of mental disorder diagnoses that describes the characteristics of each mental disorder diagnosis. It also serves as a textbook of abnormal psychology or of psychiatric diagnosis. It lists “associated features” of these disorders that describes something about the distribution in the population or epidemiology of the illness as well as what we know about the course of illness; correlates of age, gender, and cultural variations; risk factors; and potential etiology and pathophysiology of the disorders.

 

Will the DSM-V have a different kind of classification system than the categorical approach in the current edition of the manual?

One of the most important advances in the field since the publication of the DSM-IV1 has been the emergence of greater attention to what has been referred to as measurement-based care, particularly brought out in the recent Sequenced Treatment Alternatives to Relieve Depression (STAR*D) clinical trial, which emphasized the need to be able to measure both the thresholds for disorders on some kind of continuous scale as well as be able to look at the response to treatment on such a scale.

For years, researchers have known that to conduct clinical trials, it is necessary to have dimensional measures of severity and to establish adequate thresholds. Instruments such as the Quick Inventory for Depression Scale are being used more often, such as in the STAR*D study. In routine primary care settings, there has been an increasing reliance on instruments like the nine-item Patient Health Questionnaire to assess what is a severe illness and what is an adequate treatment response.

Throughout the full range of mental disorders, measures like these have been used in research studies. Researchers are now very interested in looking at dimensional measures for assessing thresholds for disorders and providing some guidance for clinicians to be able to look at a way of monitoring treatment response.

 

The degree of comorbidity among psychiatric disorders is so great that a diagnosis of several disorders is often the rule rather than the exception. How will the DSM-V address this fact?

A series of conferences supported by the National Institutes of Health (NIH), including the National Institute of Mental Health (NIMH), the National Institute on Drug Abuse, and the National Institute on Alcohol Abuse and Alcoholism, that have been ongoing since 2003, have been systematically looking at major disorder areas. We have intentionally focused on spectra of disorders that cut across traditional boundaries. We have examined psychosis spectra and obsessive-compulsive syndrome spectra that cut across multiple disorders. Also under review is the relationship between generalized anxiety disorder and major depression, where the genetic risk for such disorders seems to be shared and where there is perhaps a different environmental exposure that results in expression of either anxiety or a mood syndrome. We have also examined what we have called stress-induced and fear circuitry disorders to look at some common, perhaps pathophysiologic mechanisms that tie together certain disorders that go across existing spectra.

We are very interested and focused on trying to understand how endophenotypes or phenomenological subtypes might drift across multiple disorder boundaries, so that we can perhaps have another way of characterizing an individual patient other than simply saying they meet criteria for two or more disorders.

 

Will the DSM-V offer any means of diagnosing based on treatment response?

There are no pathognomonic treatment responses in psychiatry, although at one point there was some thinking that the major separation between schizophrenia and manic-depressive illness was that one responded to phenothiazines and the other responded to lithium. We now have the atypical antipsychotics which have indications for both the psychoses and for mood stabilization. Thus, treatment response has not been a diagnostic-specific issue, certainly with the treatments available at this time. If such a specific treatment actually emerged, something equivalent to colchicine for the treatment of gout, that might be of great interest. However, we do not have anything like that, that really is almost diagnostic once the treatment is applied.

 

Is there any liaison process taking place with the authors of the International Classification of Diseases (ICD) to create more consistency between the ICD and DSM?

One of the major accomplishments of the DSM-IV and the ICD-X2 was to achieve almost 90% congruence between the two reference manuals. This was the result of a conscious effort that was initiated by Gerald L. Klerman, MD, just before he left as the administrator of the Alcohol, Drug Abuse, and Mental Health Administration in 1980. He launched a decade-long series of consultations that I chaired when I was at the NIMH in the 1980s and early 1990s to link the DSM process with the World Health Organization (WHO) ICD process. The result was that the ICD completely changed the orientation of their nomenclature, added explicit diagnostic criteria for the first time, and adopted virtually the same names for illnesses that were used in the DSM-IV. That was a tremendous advance.

There still are perhaps as many as 10% of diagnoses where there are slight differences in the two systems. For example, with schizophrenia there is a requirement for 6 months of a prodrome in the DSM and only a 1-month prodrome in the ICD. There are also some differences in the eligibility criteria for posttraumatic stress disorder. There are numerous diagnoses scattered across the diagnostic spectrum that result in actual differences in prevalence rates when these criteria are applied in epidemiologic studies.

As part of our extensive collaboration with the WHO, we have established a harmonization group that will monitor and attempt to correct any discordancies between the ICD-11 chapter on “Mental and Behavioural Disorders” and the DSM-V. We will be working with Benedetto Saraceno, MD, the director of the Mental Health and Substance Abuse Division at the WHO. Steven E. Hyman, MD, the former NIMH director and now the provost at Harvard, is serving as the chair of an international advisory group to the WHO and as a member of the DSM-V task force. Hence, we have some bridges that are intentionally set up to make sure that we can keep a very strong international component to the development of both the review of the scientific literature and then some of the judgments on what is the most appropriate revision to take place for the DSM-V and the ICD-XI.

 

Is there a separate group trying to develop a user-friendly version of the DSM for nonpsychiatrists?

Not as of yet. It is still undecided how that will work for the DSM-V. With the DSM-IV, both a primary care and pediatric version were developed with the assistance of the American Psychiatric Association (APA) Division of Research. The WHO actually developed three versions of the ICD, which included a research version, a clinician version with less explicit diagnostic requirements, and a primary care version that had a very simple listing of diagnostic criteria. The latter is a very thin notebook with diagnostic criteria on one side of the page and on the facing page some simple treatment guidelines for a patient with that disorder. The WHO version proved to be much more user-friendly than anything that the APA had pulled together for primary care physicians (PCPs).

We are very heartened in making sure that we start with the best research basis we have for understanding the nature and boundaries of disorders that are helpful for clinicians and researchers to move the field forward. We are also very concerned that these diagnostic tools are clinically useful and helpful at the front-line levels of a given healthcare system. In many countries in the world, these diagnostic criteria are used even at nonphysician levels.

 

Do psychiatrists treat certain disorders more frequently than PCPs?

There is a selection process that takes place, usually visible when there are combined epidemiologic and services research studies where one can identify what the division of responsibility tends to be in the care for patients with different types of disorders. In the United States, a higher percentage of people with the more severe disorders such as schizophrenia, bipolar disorder, and severe obsessive-compuslive disorder end up in specialty sector settings. When it comes to depression, anxiety disorders, and substance use disorders, the balance switches to a much heavier treatment rate in primary healthcare settings.

 

Will the DSM-V continue to have diagnoses in organization of five levels?

That item is up for consideration. There has been much concern about the impact of having an Axis II that separates personality disorders in particular from the other clinical disorders and mental health sections—which is different than in ICD, where those are all combined. Mental retardation is also in Axis II. There has been much interest in reevaluating the value of the current axial structure. For example, there have been calls to replace personality disorders with something like personality dimensions on an Axis II that might be combined with temperament for young children as a way of looking at potential modifiers for a range of disorders. Certainly, no decisions have been made on that score.

Also of concern is how disorders might be expressed differently depending on cultural settings. Amazing differences in prevalence rates have emerged in international epidemiologic studies using the DSM, ICD, and common instruments. The concern is that there may be differences in the way people characterize their symptoms and express their disorders. One assumes that there are methodologic differences rather than true differences in these rates, until one has really carefully examined the possibility of adequate cultural adaptation of the wording and the criteria for the instruments used in those settings.

As mentioned previously, better measures of severity and impairment are critical for disability assessment and treatment response determinations. One value of the Axis V, the global assessment of functioning, is that it currently is the only dimensional measure that we have that is consistently applied in the DSM-IV. We will be looking at all of those issues very carefully as we go through the developmental process for the DSM-V.

 

Are there any policies on conflict of interest for the people involved in the development of the DSM-V?

The field has changed since the publication of the DSM-IV. The APA board of trustees has required a disclosure policy for DSM-V participants, both in the task force and in the work groups, that has been far more extensive than anything that we have experienced in the past. Each of the nominees are vetted by the board of trustees to look at potential conflicts of interest and the level of interest that a given scientist or expert might have in the field. We have decided not to add some of these people to the task force when there seems to be a level of involvement that is beyond what would permit an objective review. This is an ongoing issue. There will be a requirement for reporting and updates on any involvement every year through the 5-year life of the task force and work groups. It is something we are certainly very cognizant of.

We are also making a very clear distinction between individuals who are receiving research grant support from industry and those who are serving on speaker’s bureaus or as direct consultants to a given industry. Certainly in the US, there is approximately $60 billion worth of research that is funded by the industry in comparison with approximately $30 billion that comes from the NIH. It would be unwise for experts in academic settings not to participate in advancing knowledge with approximately two-thirds of the research support that is available in our biomedical research area. We are very cognizant of the difference between research that is conducted under that auspice versus that which is conducted by researchers who have other relationships within the industry.

 

What else would you deem important for people to know about the development process of the DSM-V?

The process is really one of the most intensive scientific review efforts that we have in our field. We started in 1999 with a program that was initiated by Dr. Hyman, then director of the NIMH; David Kupfer, MD, who was the chair of our Committee on Psychiatric Diagnosis and Assessment; and Steven M. Mirin, MD, who was then the medical director of the APA. They were concerned about criticisms of the DSM-IV and initiated a review process that within 2 years developed a series of papers focusing on the research agenda for the DSM-V. The series was published by the American Press Institute.3

That initial research agenda volume underscored the importance of age and gender considerations in psychiatric diagnosis, and prompted us to subsequently commission an extensive set of white papers on those topics, which the APA will publish this year.4 The new volume will contain a section on gender edited by Katharine Phillips, MD, of Brown University. Also, our interest in a developmental perspective on the onset and course of mental disorders will be evident in two sections. Irene Chatoor, MD, of the National Children’s Medical Center in Washington, DC, and Daniel Pine, MD, with the NIMH Intramural Research Program, edited the section on mental disorders in infancy and early childhood. Finally, Dilip Jeste, MD, at the University of California in San Diego, assumed responsibility for a series of articles on geriatric mental health. We would like to see each of these special population concerns receive due attention in the DSM-V; toward that end, we have established task force-level study groups to be sure that diagnosis-specific work groups address these concerns in a systematic manner.

As I noted earlier, we at the American Psychiatric Institute for Research and Education, in collaboration with colleagues from the WHO and the NIH, also have convened 12 conferences focused on individual diagnostic topics. This conference series began in 2004 and will wrap up later this year. This is an international effort. Each conference has co-chairs, one from the US and one from another country; also, half of the conferences have met in venues outside the US. A listing of the complete conference schedule and summary reports of conferences held to date are available on the Internet.5 We also are in the process of publishing full reports of the conferences both in the peer-reviewed literature and in monographs that will be available from the APA’s in-house American Psychiatric Press, Inc.6-13 The APA Website will continue to update the status of future reports as they are published.

This intensive literature review will constitute the source books for the DSM-V Task Force and Work Groups to review before decisions are made about what the research base can support in terms of revisions of our existing criteria. The output of this effort is going to be a diagnostic manual that is flexible and that can accomodate new research information as it is replicated and validated.

For the DSM-V, we also are exploring the potential for electronic publishing, which will afford the opportunity to make revisions over time, and not wait for publication of a new edition every 15–20 years. Readers should be aware of this process and our plans as we launch the upcoming revision of the DSM. PP

 

References

1. Diagnostic and Statistical Manual of Mental Disorders. 4th ed. Washington, DC: American Psychiatric Association; 1994.
2. International Classification of Diseases. 10th rev. Albany, NY: World Health Organization; 1993.
3. Kupfer DA, First MB, Regier DA, eds. A Research Agenda for DSM-V. Washington, DC: American Psychiatric Association; 2002.
4. Narrow WE, First MB, Sirovatka PJ, Regier DA, eds. Age and Gender Considerations in Psychiatric Diagnosis: A Research Agenda for DSM-V. Arlington, VA: American Psychiatric Association. In press.
5. DSM-V Prelude Project: Research and Outreach. Available at: www.dsm5.org. Accessed May 31, 2007.
6. Widiger TA, Simonsen E. A research agenda for the development of a dimensional classification of personality disorders. Part I. J Personal Disord. 2005;19(2):103-201.
7. Widiger TA, Simonsen E. A research agenda for the development of a dimensional classification of personality disorders. Part II. J Personal Disord. 2005;19(3):211-338.
8.  Widiger TA, Simonsen E, Sirovatka PJ, Regier DA, eds. Dimensional Models of Personality Disorders: Refining the Research Agenda for DSM-V. Arlington, VA: American Psychiatric Association; 2006.
9. Saunders JB, Schuckit MA. Diagnostic issues in substance use disorders: refining the research agenda. Addiction. 2006;101(Suppl 1):1-173.
10. Saunders JB, Schuckit MA, Sirovatka PJ, Regier DA, eds. Diagnostic Issues in Substance Use Disorders: Refining the Research Agenda for DSM-V. Arlington, VA: American Psychiatric Association; 2007.
11.  Sunderland T. Diagnostic criteria for dementia: research goals for DSM-V. J Geriatr Psychiatry Neurol. 2006;19(3):123-191.
12. Sunderland T, Jeste DV, Baiyewu O, Sirovatka PJ, Regier DA, eds. Diagnostic Issues in Dementia: Advancing the Research Agenda for DSM-V. Arlington, VA: American Psychiatric Association; 2007.
13. Kraemer HC, Shrout PE, Rubio-Stipec M. Developing the diagnostic and statistical manual V: what will “statistical” mean in DSM-V? Soc Psychiatry Psychiatr Epidemiol. 2007;42(4):259-267.