—SSSSSSSeeaaeee
`
`
`DIAGNOSTIC AND STATISTICAL
`MANUAL OF
`MENTAL DISORDERS
`
`FOURTH EDITION
`
`TEXT REVISION
`
`DSM-IV-TR™
`
`
`
`Published by the
`American Psychiatric Association
`Washington, DC
`
`
`
`1 of 146
`
`Alkermes, Ex. 1022
`
`1 of 146
`
`Alkermes, Ex. 1022
`
`

`

`
`
`
`
`
`
`os
`
`
`
`
`
`
`aeeaees
`
`
`a
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Copyright © 2000 American Psychiatric Association
`DSM, DSM-IV, and DSM-IV-TR are trademarks of the American Psychiatric Association. Use
`of these terms is prohibited without permission of the American Psychiatric Association.
`ALL RIGHTS RESERVED.Unless authorized in writing by the APA, no partof this book may
`be reproduced or used in a mannerinconsistent with the APA's copyright. This prohibition ap-
`plies to unauthorized uses or reproductions in any form, including electronic applications.
`Correspondence regarding copyright permissions should be directed to the DSM Permissions,
`Office of Publishing Operations, American Psychiatric Association, 1400 K Street, N.W., Wash-
`ington, DC 20005.
`
`Manufactured in the United States of America on acid-free paper.
`American Psychiatric Association
`1400 K Street, N.W., Washington, DC 20005
`WwWww.psych.org
`
`The correctcitation for this book is American Psychiatric Association: Diagnostic and Statistical
`Manual of Mental Disorders, Fourth Edition, Text Revision. Washington, DC, American Psychi-
`atric Association, 2000.
`
`Library of Congress Cataloging-in-Publication Data
`Diagnostic andstatistical manual of mental disorders ; DSM-IV.—4th ed., text revision.
`Pp.
`; cm.
`Prepared by the Task Force on DSM-IV and other committees and work groupsof the Amer-
`ican Psychiatric Association.
`Includes index.
`ISBN 0-89042-024-6 (casebound : alk. paper)—ISBN 0-89042-025-4 (pbk. : alk. Paper)
`1. Mentalillness—Classification—Handbooks, manuals, etc. 2. Mental illness—Diagnosis—
`Handbooks, manuals,etc. I. Tite: DSM-IV. I, American Psychiatric Association. IN, American
`Psychiatric Association. Task Force on DSM-IV.
`[DNLM:1, Mental Disorders—classification. 2. Mental Disorders—diagnosis.
`WM 15 D536 2000]
`RC455.2.C4 D536 2000
`616,89'075—dc21
`
`00-024852
`
`
`
`British Library Cataloguing in Publication Data
`A CIP recordis available from the British Library.
`
`Text Design—Anne Barnes
`Manufacturing—R. R. Donnelley & Sons Company
`
`
`
`
`2 of 146
`
`Alkermes, Ex. 1022
`
`2 of 146
`
`Alkermes, Ex. 1022
`
`

`

`
`
`TASK FORCE ON DSM-IV
`
`ALLEN FRANCES, M.D.
`Chairperson
`HAROLD ALAN PINCUS, M.D.
`Vice-Chairperson
`MICHAEL B, First, M.D.
`Editor, Text and Criteria
`
`Nancy Coover Andreasen, M.D., Ph.D,
`David H. Barlow, Ph.D.
`Magda Campbell, M.D.
`Dennis P. Cantwell, M.D.
`Ellen Frank, Ph.D.
`Judith H. Gold, M.D.
`John Gunderson, M.D.
`Robert E. Hales, M.D.
`Kenneth S. Kendler, M.D,
`
`David J. Kupfer, M.D.
`Michael R. Liebowitz, M.D.
`Juan Enrique Mezzich, M.D., Ph.D.
`Peter E. Nathan,Ph.D.
`Roger Peele, M.D.
`Darrel A. Regier, M.D., M.P.H.
`A. John Rush, M.D.
`
`Chester W. Schmidt, M.D.
`Marc Alan Schuckit, M.D.
`David Shaffer, M.D.
`Robert L. Spitzer, M.D.
`Special Adviser
`Gary J. Tucker, M.D.
`B. Timothy Walsh, M.D.
`Thomas A. Widiger, Ph.D.
`Research Coordinator
`
`Janet B. W. Williams, D.5.W.
`John C. Urbaitis, M.D.
`Assembly Liaison
`James J. Hudziak, M.D.
`Resident Fellow (1990-1993)
`Junius Gonzales, M.D.
`Resident Fellow (1988-1990)
`
`Ruth Ross, M.A.
`Science Editor
`Nancy E. Vettorello, M.U.P.
`Administrative Coordinator
`Wendy Wakefield Davis, Ed.M.
`Editorial Coordinator
`Cindy D. Jones
`Administrative Assistant
`Nancy Sydnor-Greenberg, M.A.
`Administrative Consultant
`Myriam Kline, M.S.
`Focused Field-Trial Coordinator
`James W, Thompson, M.D., M.P.H.
`Videotape Field-Trial Coordinator
`
`
`
`
`LifeAME,ANTAaaMia
`
`
`—_——_—
`
`The DSM-IV Text Revision Work Groupsare listed on pp. xv—xvii.
`
`3 of 146
`
`Alkermes, Ex. 1022
`
`3 of 146
`
`Alkermes, Ex. 1022
`
`

`

`
` Use of the Manual
`
`7 ‘
`
`on
`
`Coding and Reporting Procedures
`
`-
`
`
`
`F
`
`
`
`Diagnostic Codes
`Theofficial coding system in usein the UnitedStates as of Publication of this manual
`is the International Classification of Diseases, Ninth Revision, Clinical Modification
`(ICD-9-CM). Most DSM-IV disorders have a numerical ICD-9-CM code that appears
`=. several times: 1) preceding the nameofthe disorderin the Classification (pp. 13-26),
`a 2) at the beginningof the text section for each disorder, and 3) accompanyingthe cri-
`teria set for each disorder. For some diagnoses (e.g., Mental Retardation, Substance-
`
`; Induced Mood Disorder), the appropriate code depends onfurther specification and
`
`is listed after the text and criteria set for the disorder. The namesof some disorders
`are followedbyalternative terms enclosed in parentheses, which, in most cases, Were
`
`“the DSM-III-R namesforthe disorders,
`__. The useof diagnostic codesis fundamental to medical record keeping. Diagnostic
`
`<0 ing facilitates data collection and retrieval and compilation ofstatistical informa-
`ton. Codes also areoften required to report diagnostic datato interested third parties,
`©
`
`iticluding governmentalagencies, private insurers, and the World Health Organiza-
`
`tion. For example, in the United States, the use of these codes has been mandated by
`he Health Care Financing Administration for purposes ofreimbursement under the
`Medicare system.
`,. Subtypes (someof which are coded in thefifth digit) and specifiers are provided
`- for increased specificity. Subtypes define mutually exclusive and jointly exhaustive
`Phenomenological subgroupings within a diagnosis and are indicated bythe instruc-
`‘Hon “specify type”in thecriteria set. For example, Delusional Disorderis subtyped
`|based on the content of the delusions, with seven subtypes provided: Erotomanic
`=Type, Grandiose Type, Jealous Type, Persecutory Type, Somatic Type, Mixed Type,
`and Unspecified Type. In contrast, specifiers are notintended to be mutuallyexclusive
`-0rjointly exhaustive and are indicated by theinstruction “specify” or “specify if” in
`=»
`thecriteria set (e.g., forSocial Phobia, the instructionnotes “Specifyif: Generalized”).
`: Specifiers Provide an opportunity to define a more homogeneous subgrouping of
`individuals with the disorder whosharecertain features (e.g., Major Depressive Dis-
`= Order, With Melancholic Features). Althougha fifth digit is sometimes assigned to
`Sode a Subtypeorspecifier (e.g., 294.11 Dementia of the Alzheimer’s Type, With Late
`“set, With Behavioral Disturbance)or severity (296.21 Major Depressive Disorder,
`~ Single Episode, Mild), the majority of subtypes and specifiers included in DSM-IV
`ee becoded within theICD-9-CMsystem and areindicated onlyby includingthe
`type orspecifierafterthename ofthe disorder(e.g., Social Phobia, Generalized),
`
`
`
`j
`
`j
`
`|
`
`|
`
`Seaeae
`
`4 of 146
`
`Alkermes, Ex. 1022
`
`4 of 146
`
`Alkermes, Ex. 1022
`
`

`

`
`
`Use of the Manual
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`|
`
`Severity and Course Specifiers
`A DSM-IV diagnosis is usually applied to the individual’s current presentation andis
`nottypically used to denote previous diagnoses from which the individual] has recov-
`ered. The following specifiers indicating severity and course maybelisted after the
`diagnosis: Mild, Moderate, Severe, In Partial Remission,In Full Remission, and Prior
`History,
`The specifiers Mild, Moderate, and Severe should be used only whenthefull cri-
`teria for the disorderare currently met. In deciding whetherthe presentation should
`be described as mild, moderate, or severe,the clinician should take into accountthe
`numberand intensity of the signs and symptoms of the disorder and any resulting
`impairment in occupational or social functioning. For the majority of disorders, the
`following guidelines may beused:
`Mild.
`Few,if any, symptomsin excess of those required to make the diagno-
`sis are present, and symptomsresult in no more than minor impairmentin so-
`cial or occupational functioning,
`Moderate. Symptoms or functional impairment between “mild” and “se-
`vere” are present.
`Severe. Many symptomsin excess of those required to make the diagnosis,
`or several symptomsthat are particularly severe, are present, or the symptoms
`result in marked impairmentin social or occupational functioning.
`In Partial Remission.
`Thefull criteria for the disorder were previously met,
`but currently only someof the symptomsorsigns of the disorder remain.
`In Full Remission. There are no longer any symptoms or signs of the dis-
`order, butitis still clinically relevant to note the disorder—for example,in an
`individual with previous episodesof Bipolar Disorder who has been symptom
`free on lithium for the past 3 years, After a period of timein full remission, the
`clinician may judge the individual to be recovered and, therefore, would no
`longer code the disorder as a current diagnosis. The differentiation of In Full
`
`Remission from recovered requires consideration of many factors, including
`the characteristic course of the disorder, the length oftimesincethe last period
`
`of disturbance, the total duration of the disturbance, and the need for contin-
`
`
`ued evaluation or prophylactic treatment.
`
`Prior History. For some purposes, it may be useful to note a history of the
`
`
`criteria having been metfor a disorder even whenthe individual is considered
`to be recovered from it. Such past diagnoses of mental disorder would bein-
`
`
`dicated by using the specifier Prior History (e.g., Separation Anxiety Disorder,
`
`
`Prior History, for an individual with a history of Separation Anxiety Disorder
`whohas no current disorder or who currently meetscriteria for Panic Dis-
`order).
`
` Specific criteria for defining Mild, Moderate, and Severe have been provided for
`the following: Mental Retardation, Conduct Disorder, Manic Episode, and Major
`
`
`
`Depressive Episode. Specific criteria for defining In Partial Remission and In Full
`Remission have been provided for the following: Manic Episode, Major Depressive
`
`
`Episode, and Substance Dependence.
`
`
`
`
`
`
`
`5 of 146
`
`Alkermes, Ex. 1022
`
`5 of 146
`
`Alkermes, Ex. 1022
`
`

`

`Use of the Manual
`
`nt presentation and is
`‘individual has recov-
`nay be listed after the
`| Remission, and Prior
`
`nly when the full cri-
`e presentation should
`take into account the
`der and any resulting
`arity of disorders, the
`
`d to makethe diagno-
`nor impairmentin so-
`
`reen “mild” and “se-
`
`> makethe diagnosis,
`sent, or the symptoms
`incioning.
`were previously met,
`disorder remain.
`is or signs ofthe dis-
`r—for example, in an
`ho has been symptom
`‘in full remission, the
`. therefore, would no
`ferentiation of In Full
`ny factors, including
`e sincethe last period
`1 the need for contin-
`
`note a history of the
`lividual is considered
`lisorder would be in-
`on Anxiety Disorder,
`ion Anxiety Disorder
`riteria for Panic Dis-
`
`ve been provided for
`Episode, and Major
`2>mission and In Full
`le, Major Depressive
`
`Use of the Manual
`
`Recurrence
`
`3
`
`Not infrequently in clinical practice, individuals after a period of time in which the
`full criteria for the disorder are no longer met(i.e., in partial or full remission or re-
`covery) may develop symptoms that suggest a recurrenceoftheir original disorder
`put that do not yet meetthefull threshold for that disorder as specified in the criteria
`set, It is a matter of clinical judgment as to how bestto indicate the presence ofthese
`symptoms. The following optionsare available;
`
`« If the symptomsare judged to be a new episode of a recurrent condition,the dis-
`order may be diagnosed as current (or provisional) even before the full criteria
`have been met(¢.g., after meeting criteria for a Major Depressive Episode for only
`10 days instead of the 14 days usually required).
`« If the symptomsare judged tobeclinically significant but it is not clear whether
`they constitute a recurrence of the original disorder, the appropriate Not Other-
`wise Specified category may be given.
`* Ifitisjudged that the symptomsare notclinically significant, no additional current
`or provisional diagnosisis given, but “Prior History” may be noted (see p.2).
`
`Principal Diagnosis/Reason for Visit
`
`When more than one diagnosis for an individualis given in an inpatientsetting, the
`principal diagnosis is the condition established after studyto be chiefly responsible for
`oceasioning the admission ofthe individual. When morethan one diagnosis is given
`for an individual in an outpatient setting, the reason for visit is the condition that is
`chiefly responsible for the ambulatory care medical services received duringthevisit.
`In mostcases, the principal diagnosis or the reason forvisit is also the main focus of
`attention or treatment. It is often difficult (and somewhat arbitrary) to determine
`which diagnosis is the principal diagnosis or the reason forvisit, especially in situa-
`tions of “dual diagnosis” (a substance-related diagnosis like Amphetamine Depen-
`dence accompanied by a non-substance-related diagnosis like Schizophrenia). For
`example, it may be unclear which diagnosis should be considered “principal” for an
`individual hospitalized with both Schizophrenia and AmphetamineIntoxication, be-
`cause each condition may have contributed equally to the need for admission and
`treatment,
`Multiple diagnoses can be reported in a multiaxial fashion (see p. 35) or in a non-
`axial fashion (see p. 37). When the principal diagnosis is an Axis I disorder,this is in-
`dicated by listing it first. The remaining disorders are listed in order of focus of
`attention and treatment, When a person has both an Axis I and an Axis II diagnosis,
`the principal diagnosis or the reasonforvisit will be assumedto be on Axis L unless
`the Axis II diagnosis is followed by the qualifying phrase “(Principal Diagnosis)” or
`“(ReasonforVisit).”
`
`Provisional Diagnosis
`The Specifier provisional can be used whenthereis a strong presumption thatthefull
`“titeria will ultimately be metfor a disorder, but not enough informationis available
`
`
`
`6 of 146
`
`Alkermes, Ex. 1022
`
`6 of 146
`
`Alkermes, Ex. 1022
`
`

`

`4
`
`Use of the Manual
`
`to makea firm diagnosis. Theclinician can indicate the diagnostic uncertainty by re-
`cording “(Provisional)” following the diagnosis. For example,the individual appears
`to have a Major Depressive Disorder, butis unable to give an adequatehistory to es-
`tablish thatthe full criteria are met. Anotheruse of the term provisionalis for thosesit-
`uations in which differential diagnosis depends exclusively on the durationofillness.
`For example, a diagnosis of Schizophreniform Disorder requires a duration ofless
`than 6 months and can only be given provisionally if assigned before remission has
`occurred.
`
`Use of Not Otherwise Specified Categories
`Becauseofthe diversity ofclinical presentations,it is impossible for the diagnostic no-
`menclature to cover every possible situation. For this reason, each diagnostic class has
`at least one Not Otherwise Specified (NOS) category and someclasses have several
`NOScategories. There are four situations in which an NOSdiagnosis may be appro-
`priate:
`
`agnostic uncertainty:
`
`* The presentation conforms to the general guidelines for a mental disorder in the
`diagnostic class, but the symptomatic picture does not meetthe criteria for any of
`the specific disorders. This would occureither when the symptoms are below the
`diagnostic threshold for one of the specific disorders or whenthere is an atypical
`or mixed presentation.
`* The presentation conformsto a symptom pattern that has not been includedin the
`DSM-IV Classification but that causesclinically significant distress or impairment.
`Research criteria for some of these symptom patterns have beenincludedin Appen-
`dix B ("Criteria Sets and Axes Provided for Further Study”), in which case a page
`reference to the suggested research criteria set in AppendixBis provided.
`* There is uncertainty aboutetiology (i.e., whether the disorder is due to a general
`medical condition, is substance induced,oris primary).
`* There is insufficient opportunity for complete data collection (e.g., in emergency
`situations)or inconsistent or contradictory information,but thereis enoughinfor-
`mation to placeit within a particular diagnostic class(e.g., the clinician determines
`that the individual has psychotic symptoms but does not have enough information
`to diagnosea specific Psychotic Disorder).
`
`WaysofIndicating Diagnostic Uncertainty
`The followingtable indicates the various ways in whichaclinician mayindicate di-
`
`7 of 146
`
`Alkermes, Ex. 1022
`
`7 of 146
`
`Alkermes, Ex. 1022
`
`

`

`
`
`
`~ yse of the Manual
`
`-. Term
`Other Conditions That May
`ee
`OTE
`v codes(for
`_. Bea Focus of Clinical Attention)
`Be
`Br
`
`Use of the Manual
`
`2 uncertainty by re-
`individual appears
`quate history to es-
`ional is for those sit-
`‘durationof illness.
`3 a duration of less
`2fore remission has
`
`
`
`Si
`
`Examples of clinical situations
`Insufficient information to know whether or
`tb
`el
`not a presenting problemis attributable to a
`mentaldisorder, e.g., Academic Problem;
`Adult Antisocia! Behavior
`
`799.3
`
`Diagnosis or Condition Deferred on Information inadequate to make any diag-
`Axis |
`nostic judgment about an Axis | diagnosis or
`condition
`
`egories
`
`799.9 Diagnosis Deferred on Axis Il
`
`information inadequate to make any diag-
`nostic judgment about an Axis I diagnosis
`
`g 300.9 Unspecified Mental Disorder
`:
`(nonpsychotic)
`
`
`
`ir the diagnostic no-
`Enough information available to rule out a
`diagnostic class has
`Psychotic Disorder, but furtherspecification
`‘lasses have several
`is not possible
`iosis may be appro-
`298.9 Psychotic Disorder Not Otherwise|Enough information available to determine
`E
`Specified
`the presence of a Psychotic Disorder, but fur-
`ther specification is not possible
`otal disorder in the
`[Class of disorder] Not Otherwise Specified Enough information available to indicate
`ie criteria for any of
`
`itoms are below the
`@g., Depressive Disorder Not Otherwise—_—the class of disorder that is present, but fur-
`Specified
`ther specificationis not possible, either be-
`there is an atypical
`cause there is not sufficient information to
`make a more specific diagnosis or because
`the clinical features of the disorder do not
`meet the criteria for any of the specific cate-
`gories in that class
`
`_ Criteria Used to Exclude Other Diagnoses and
`’
`to Suggest Differential Diagnoses
`Mostofthecriteria sets presented in this manualinclude exclusioncriteria that are
`Necessary to establish boundaries between disorders andtoclarify differential diag-
`Noses. The severaldifferent wordingsof exclusioncriteria in thecriteria sets through-
`out DSM-IV reflectthe different types of possible relationships among disorders:
`
`7 “Criteria have never been met for...” This exclusion criterion is used to define
`alifetime hierarchy betweendisorders. For example, a diagnosis of Major Depres-
`sive Disorder can no longer be given once a Manic Episode has occurred and must
`be changed to a diagnosis of Bipolar I Disorder.
`
`RSSateTL
`aeq
`
`
`8 of 146
`
`Alkermes, Ex. 1022
`
`
`
`
`
`if
`
`i
`ae
`ati
`[Specific diagnosis] (Provisional)
`e.g., Schizophreniform Disorder
`‘ (Provisional)
`:
`
`Enoughinformation available to make a
`“working” diagnosis, but the clinician wishes
`to indicate a significant degree of diagnostic
`uncertainty
`
`Frequently Used Criteria
`
`een includedin the
`ress or impairment.
`included in Appen-
`1 which case a page
`s provided.
`is due to a general
`
`(e.g., in emergency
`ere is enoughinfor-
`‘linician determines
`mnough information
`
`tainty
`
`an may indicate di-
`
`8 of 146
`
`Alkermes, Ex. 1022
`
`

`

`6
`
`SSP cma eb
`
`Use of the Manual
`
` See tee ee ee aero Ee Peasy ee a ea Seer ale Ae ee ee Red eee
`
`*
`
`* “Criteria are not met for...” This exclusion criterion is used to establish a hier-
`archy betweendisorders (or subtypes) defined cross-sectionally. For example, the
`specifier With Melancholic Features takes precedence over With Atypical Features
`for describing the current Major Depressive Episode.
`“does not occur exclusively during the course of... This exclusion criterion
`prevents a disorder from being diagnosed when its symptom presentation occurs
`only during the course of another disorder. For example, dementia is not diag-
`nosed separately if it occurs only during delirium; Conversion Disorder is not
`diagnosed separatelyif it occurs only during Somatization Disorder; Bulimia Ner-
`vosais not diagnosed separately if it occurs only during episodes of Anorexia Ner-
`vosa, This exclusion criterion is typically used in situations in which the symptoms
`of one disorderare associated features or a subsetof the symptomsof the preempt-
`ing disorder. Theclinician should consider periods ofpartial remission as part of
`the “course of another disorder.” It should be noted that the excluded diagnosis
`can be given at times whenit occurs independently (e.g., when the excluding dis-
`orderis in full remission).
`* “notdueto the direct physiological effects of a substance(e.g., a drug of abuse,
`a medication) or a general medical condition.” This exclusioncriterion is used
`to indicate that a substance-induced and general medical etiology must be consid-
`ered and ruled outbefore the disorder can be diagnosed (e.g., Major Depressive
`Disorder can be diagnosed only after etiologies based on substance use and a gen-
`eral medical condition have been ruled out),
`* “not better accounted for by...” This exclusion criterion is used to indicate that
`the disorders mentionedin the criterion mustbe considered in the differential di-
`agnosis of the presenting psychopathology andthat, in boundary cases, clinical
`judgmentwill be necessary to determine which disorder provides the most appro-
`priate diagnosis. In such cases, the “Differential Diagnosis” section of the text for
`the disorders should be consulted for guidance.
`The general convention in DSM-IVis to allow multiple diagnoses to be assigned
`for those presentationsthat meetcriteria for more than one DSM-IV disorder. There
`are three situations in which the above-mentioned exclusioncriteria help to establish
`a diagnostic hierarchy (and thus prevent multiple diagnoses) or to highlight differen-
`tial diagnostic considerations (and thus discourage multiple diagnoses):
`* When a Mental Disorder Due to a General Medical Condition or a Substance-
`Induced Disorderis responsible for the symptoms,it preempts the diagnosis of the
`corresponding primary disorder with the same symptoms(e.g., Cocaine-Induced
`MoodDisorder preempts Major Depressive Disorder). In such cases, an exclusion
`criterion containing the phrase “not dueto the direct physiological effects of...”
`is includedin the criteria set for the primary disorder.
`* When a more pervasive disorder (e.g., Schizophrenia) has among its defining
`symptoms (or associated symptoms)whatare the defining symptomsofaless per-
`vasive disorder (e.g,, Dysthymic Disorder), one of the following three exclusion
`criteria appears in the criteria set for the less pervasive disorder, indicating that
`only the more pervasive disorder is diagnosed: “Criteria have never been met
`for...,” “Criteria are not met for. .
`.,” “does not occur exclusively during the
`course of ,. .”
`
`
`AAsAEnHARTNASAUBERBERS8SPSETHReSTUHR onie
`
`9 of 146
`
`Alkermes, Ex. 1022
`
`9 of 146
`
`Alkermes, Ex. 1022
`
`

`

`Use of the Manual
`
`use of the Manual
`
`7
`
`ied to establish a hier-
`ally. For example, the
`vith Atypical Features
`
`iis exclusion criterion
`
`n presentation occurs
`dementia is not diag-
`rsion Disorder is not
`hisorder; Bulimia Ner-
`ades of Anorexia Ner-
`i which the symptoms
`2toms of the preempt-
`il remission as part of
`ie excluded diagnosis
`ven the excludingdis-
`
`‘e.g., a drug of abuse,
`ision criterion is used
`ology must be consid-
`.2., Major Depressive
`‘stance use and a gen-
`
`3 used to indicate that
`in the differential di-
`andary cases,clinical
`vides the most appro-
`section of the text for
`
`moses to be assigned
`M-IV disorder. There
`teria help to establish
`to highlight differen-
`ignoses):
`
`tion or a Substance-
`:s the diagnosisof the
`.g., Cocaine-Induced
`‘h cases, an exclusion
`logical effects of...”
`
`among its defining
`mptomsofa less per-
`ving three exclusion
`der, indicating that
`ave never been met
`clusively during the
`
`» Whenthereare particularly difficult differential diagnostic boundaries, the phrase
`“not better accounted for by...” is included to indicate that clinical judgment is
`necessary to determine which diagnosis is most appropriate. For example, Panic
`Disorder With Agoraphobia includes the criterion “not better accounted for by
`Social Phobia” and Social Phobia includes the criterion “not better accounted for
`by Panic Disorder With Agoraphobia”in recognition of the fact thatthis is a par-
`ticularly difficult boundary to draw.
`In some cases, both diagnoses might be
`appropriate.
`
`criteria for Substance-Induced Disorders
`
`It is often difficult to determine whether presenting symptomatology is substance in-
`duced, that is, the direct physiological consequence of Substance Intoxication or
`Withdrawal, medication use, or toxin exposure. In an effort to provide someassis-
`tance in making this determination, the twocriteria listed below have been added to
`each of the Substance-Induced Disorders. These criteria are intended to provide gen-
`eral guidelines, but at the same time allow forclinical judgment in determining
`whetheror not the presenting symptoms are best accounted for by the direct physio-
`logical effects of the substance. For further discussion ofthis issue, see p. 209.
`
`ne.
`
`B. There is evidence from the history, physical examination, or laboratory
`findings ofeither (1) or (2):
`
`(1)
`
`the symptoms developed during, or within a month of, Substance
`Intoxication or Withdrawal
`(2) medication use is etiologically related to the disturbance
`
`C. The disturbance is not better accounted for by a disorderthat is not sub-
`stance induced. Evidence that the symptoms are better accounted for by a
`disorder that is not substance induced might include the following: the
`symptoms precede the onset of the substance use (or medication use); the
`symptoms persistfor a substantial period oftime(e.g., about a month)after
`the cessation of acute withdrawal orsevere intoxication, or are substantial-
`ly in excess of what would be expected giventhe type, duration, or amount
`of the substance used;or there is other evidence that suggests the existence
`of an independent non-substance-induced disorder(e.g., a history of recur-
`rent non-substance-related episodes).
`
`Criteria for a Mental Disorder Due to a
`General Medical Condition
`
`Thecriterion listed below is necessary to establish the etiological requirement for
`each of the Mental Disorders Due to a General Medical Condition (e.g., Mood Disor-
`der Due to Hypothyroidism). For further discussion ofthis issue, see p. 181.
`There is evidence from the history, physical examination,or laboratory find-
`ings that the disturbanceis the direct physiological consequence of a general
`medical condition.
`
`
`
`10 of 146
`
`Alkermes, Ex. 1022
`
`10 of 146
`
`Alkermes, Ex. 1022
`
`

`

`Criteria for Clinical Significance
`
`Use of the Manual
`
`Types of Information in the DSM-IV Text
`The text of DSM-IV systematically describes each disorder underthe following head-
`ings: “Diagnostic Features”; “Subtypes and/or Specifiers”; “Recording Procedures”;
`“Associated Features and Disorders”; “Specific Culture, Age, and Gender Features”;
`“Prevalence”; “Course”; “Familial Pattern”; and “Differential Diagnosis.” When no
`information is available for a section, that section is not included. In someinstances,
`when manyof the specific disorders in a group of disorders share commonfeatures,
`this information is included in the general introduction to the group.
`
`Diagnostic Features. This section clarifies the diagnostic criteria and often provides
`illustrative examples.
`
`Subtypes and/or Specifiers. This section provides definitions and brief discussions
`concerning applicable subtypes and/or specifiers.
`
`Recording Procedures. This section provides guidelines for reporting the name of
`the disorder and for selecting and recording the appropriate ICD-9-CM diagnostic
`code. It also includes instructions for applying any appropriate subtypes and/or
`specifiers.
`
`Associated Features and Disorders. This section is usually subdivided into three
`parts:
`
`Thedefinition of mental disorder in the introduction to DSM-IV requires that there be
`clinically significant impairmentor distress. To highlight the importanceof consider-
`ing this issue, the criteria sets for most disorders includea clinical significancecrite-
`rion (usually worded “.. . causesclinically significant distress or impairmentin social,
`occupational, or other importantareas of functioning”). This criterion helps establish
`the threshold for the diagnosis of a disorderin those situations in which the symp-
`tomatic presentation byitself (particularly in its milder forms) is not inherently
`pathological and may be encounteredin individuals for whom a diagnosis of "mental
`disorder” would be inappropriate. Assessing whetherthis criterion is met, especially
`in terms of role function, is an inherently difficult clinical judgment. Reliance on in-
`formation from family members and other third parties (in addition to the individual)
`regarding the individual’s performanceis often necessary.
`
`disorder in question (e.g., Alcohol-Induced Persisting Dementia is a consequence
`
`© Associated descriptive features and mental disorders, This section includesclinical
`features that are frequently associated with the disorder but that are not consid-
`ered essential to making the diagnosis. In some cases, these features were consid-
`ered for inclusion as possible diagnosticcriteria but were insufficiently sensitive or
`specific to be includedin the final criteria set. Also noted in this section are other
`mental disorders associated with the disorder being discussed. It is specified
`(when known)if these disorders precede, co-occur with,or are consequences ofthe
`
`11 of 146
`
`Alkermes, Ex. 1022
`
`11 of 146
`
`Alkermes, Ex. 1022
`
`

`

`Use of the Manual
`
`Use of the Manual
`
`9
`
`‘quiresthat there be
`ortanceof consider-
`al significancecrite-
`npairment in social,
`‘rion helpsestablish
`in which the symp-
`3)
`is not inherently
`liagnosis of “mental
`on is met, especially
`ent. Reliance on in-
`m to the individual)
`
`V Text
`
`the following head-
`ding Procedures”;
`| GenderFeatures”;
`agnosis.” When no
`. In some instances,
`2 commonfeatures,
`‘up.
`
`andoften provides
`
`id brief discussions
`
`vorting the name of
`D-9-CMdiagnostic
`> subtypes and/or
`
`divided into three
`
`n includesclinical
`nat are not consid-
`tures wereconsid-
`ciently sensitive or
`is Section are other
`ied. It
`is specified
`onsequences ofthe
`a is a consequence
`
`of chronic Alcohol Dependence).If available, information on predisposing factors
`and complications is also included in this section.
`Associated laboratory findings. This section provides information onthree typesof
`laboratory findings that may be associated with the disorder: 1) those associated
`laboratory findings that are consideredto be “diagnostic” of the disorder—for ex-
`ample, polysomnographic findings in certain sleep disorders; 2) those associated
`laboratory findingsthatare not considered to be diagnosticofthe disorder but that
`have been noted to be abnormal in groupsofindividuals with the disorder relative
`to control subjects—for example, ventricle size on computed tomographyas a val-
`idator of the construct of Schizophrenia; and 3) those laboratory findings that are
`associated with the complications of a disorder—for example, electrolyte imbal-
`ances in individuals with Anorexia Nervosa.
`« Associated physical examinationfindings and general medical conditions. This section
`includes information about symptoms elicited by history, or findings noted during
`physical examination, that may be ofdiagnostic significance butthat are not essen-
`tial to the diagnosis—for example, dental erosion in Bulimia Nervosa. Also includ-
`ed are those disorders that are coded outside the “Mental and Behavioural
`Disorders” chapter of ICD that are associated with the disorder being discussed.
`As is done for associated mental disorders, the type of association(i.e., precedes,
`co-occurs with, is a consequenceof) is specified if known—for example,that cir-
`thosis is a consequence of Alcohol] Dependence.
`
`Specific Culture, Age, and Gender Features. This section provides guidance for
`the clinician concerning variations in the presentationof the disorder that maybe at-
`tributable to the individual's cultural setting, developmental stage (e.g., infancy,
`childhood, adolescence, adulthood,late life), or gender. This section also includes in-
`formation on differential prevalenceratesrelated to culture, age, and gender(e.g., sex
`ratio).
`
`Prevalence. This section provides available data on point andlifetime prevalence,
`incidence, andlifetime risk. These data are provided for differentsettings (e.g., com-
`munity, primary care, outpatient mental health clinics, and inpatient psychiatric set-
`tings) whenthis informati