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

`
`Copyright (9 2000 American Psychiatric Association
`
`DSM, DSM-IV. and DSM—IV—TR are trademarks of the American Psychiatric Association. Use
`ofthcse terms is prohibited without perrnission of the American Psychiatric Association.
`
`ALL RIGHTS RESERVED. Unless authorized in writing by the APA, no part of this book may
`be reproduced or used in a manner inconsistent with the APA’s copyright. Tl1.is prohibition ap-
`plies to unauthorized uses or reproductions in any form, ind riding electronic applications.
`Correspondence regarding copyright permissions Should be directed to the DSM Permissions,
`Office of Publishing Operations, American Psychiatric Association, 1400 K Street, l\J.W., Wash-
`ington, DC 20005.
`
`Manufactured in the United States of America on acid-rree paper.
`American Psychiatric Association
`1-100 K Street. NW., Washington, DC 20005
`www.psych.org
`
`The correctcitai-ion for this book is American Psychiatric Association: Diagnostic mm‘ Statistical
`Mmiuni of Mental Disorders, Fourth Edition, Text Revision. Wash.i.ngton, DC, American Psychi-
`atric Association, 2000.
`
`Library of Congress Cataloging—in-Publication Data
`Diagnostic and statistical manual of mental disorders : DSM-l'V.-—-4th ed., text revision.
`p.
`; cm.
`
`Prepared by the Task Force on DSM—lV and other corm:rLitlees and work groups of the Amer-
`ican Psyelijatric Association.
`Includes index.
`
`ISBN 0-890-12-02-1-6 (casebound : aI_k. pa per)—[Sl3N 0—S9042—025—4 (pbk. : alk. paper)
`1. Mental il]ness——Classification—l-Ianclhooks, manuals. etc. 2. Mental il1ness——Diagnosis—
`Handbooks, manuals, etc. I. Title: DEM-IV. El. American Psychiatric Association. III. American
`Psychiatric Association. Task Force on DSM-IV.
`
`[DNLM: 1. Mental Disorders-—ctas5ification. 2. Mental Disorders—diagnosis.
`WM 15 D536 2000]
`RC-’i55.2.C4 D536 2000
`ol6.89'075—dc21
`
`British Library Cataloguing in Publication Data
`A CIP record is available from the British Library.
`Text Desi gn—Anne Barnes
`Manufactui-ing—R. R. Donnelley 5: Sons Company
`
`2 of 146
`
`Alkermes, Ex. 1022
`
`

`
`TASK FORCE ON DSM-IV
`
`ALLEN FRANCES, MI).
`Chairperson
`HAROLD ALAN Pmcus, MD.
`Vz'ce—C}mirperson
`MICHAEL B. FIRST, NLD.
`Editor, Text and Criteria
`
`Nancy Coover Andrea-sen, M.D., Ph.D.
`David H. Barlow, Ph.D.
`
`Chester W. Schmidt, MD.
`Marc Alan Schuckit, MD.
`
`Magda Campbell, MD.
`Dennis P. Cantwell, MD.
`Ellen Frank, PhD.
`Judith H. Gold, MD.
`John Gundersonl M_D_
`Robert E_ Haiea M‘[-_;_
`Kenneth S Kendler M D
`David I‘ Kupfer MID
`Michael R Liebowitz M D
`
`Iuan Enrique Mezzich, M.D., Ph.D.
`Peter 13- Nathanr P1"-13‘
`
`Roger Peele, MD.
`
`Darrel A. Regier. M.D., M.F'.H.
`A. Icahn Rush, M.D.
`
`David Shaffer, MD.
`Robert L. Spitzer, MD.
`Special Adviser
`Gary 3- Tucker» M-131
`B. Timothy Walsh, MD.
`Thomas A. Widiger, P}1.D.
`Research Coordinator
`Ianel B. W. Williams. D.S.W.
`1°“ C‘ U’b“jfi5’ MD‘
`Assembly Liaison
`Limes II Hudziak’ MD‘
`Resident Feuow (1990-1993)
`
`Iurlius Gonzales, M.D.
`
`Resident Fellow (1933-1990)
`
`Ruth Ross, M.A.
`Science Editor
`
`Nancy E. Vettorello, M.U.P.
`Admin istroffve Coordinafor
`
`Wendy Wakefield Davis, Ecl.M.
`Editorial‘ Coordinator
`
`Cmdy D. Iones
`Administrative Assisram‘
`
`Nancy Sydnor-Greenberg, MA.
`AdmI'nistrot1'vc Consulfartt
`
`Myriam Kline, M.S.
`Focused FieId—Tr:'oJ Coordina tor
`
`jarnes W. Thompson, MD., MPH.
`Videotape F:'.eId~Trfal Coordimztor
`
`‘'-—I:—:
`
`The DEM-W Text Revision Work Groups are listed on pp. xv——>cvii.
`
`3 of 146
`
`Alkermes, Ex. 1022
`
`

`
`Use of the Manual
`
`4
`
`..
`
`Coding and Reporting Procedures
`
`pjagnostic Codes
`
`. The gfificial coding system in use in the United States as ofpublication of this manual
`is the lnteniational Classrficatiart of Diseases, Ninth Revision, Clinical Modification
`aCD.9.CM)_ Most DSM-IV disorders have a numerical ICD-9-CM code that appears
`_ several times: 1) preceding the name of the disorder in the Classification (pp. 13-26},
`-
`*
`' 2} at the beginning of the text section for each disorder, and 3) accompanying the cri-
`'1 _.
`_
`teria set for each disorder. For some diagnoses (e.g., Mental Retardation, Substance-
`_- induced Mood Disorder), the appropriate code depends on further specification and
`
`'
`
`'
`
`libn. Codes also are often required to report diagnostic data to interested third parties,
`including governmental agencies, private insurers, and the World Health Organiza-
`'f;lJ(_iIl'l. For example, in the United States, the use of these codes has been mand
`_e Health Care Financing Admi
`,—l\=/iedicare system.
`
`e mutually exclusive
`3 and U1'|5peC'LFJ'ed T
`_. ’§1f1_'jointly exhaustive and are indicated by the instruction "specify” or ”specify if" in
`‘ Elie criteria set (e.g., for Social Phobia, the instruction notes "Specify if: Generalized").
`$PE'Cifie1's provide an opportunity to define a more homogeneous subgrouping of
`_r
`Il'ldividuals with the disorder who share certain features (e.g., Major Depressive Dis-—
`
`'.l
`
`'
`
`ystern and are indicated only by including the
`fier after the name of the disorder {e.g., Social Phobia, Generalized).
`1
`
`4 of 146
`
`Alkermes, Ex. 1022
`
`

`
`Use of the Manual
`
`Severity and Course Specifiers
`
`A DSM-IV diagnosis is usually applied to the individuals current presentation and is
`not typically used to denote previous diagnoses from which the individual has recov~
`ered. The following specifiers indicating severity and course may be listed after the
`diagnosis: Mild, Moderate, Severe, in Partiai Remission, In Full Remission, and Prior
`History.
`The specifiers Mild, Moderate, and Severe should be used only when the full cri-
`teria for the disorder are currently met. In deciding whether the presentation should
`be described as mild, moderate, or severe, the clinician should take into account the
`number and 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 be used:
`
`Mild. Few, if any, symptoms in excess of those required to make the diag'no~
`sis are present, and symptoms result in no more than minor impairment in so-
`cial or occupational functioning.
`Moderate. Symptoms or functional impairment between "mild" and "se-
`vere" are present.
`Severe. Many symptoms in excess of those required to make the diagnosis,
`or several symptoms that are particularly severe, are present, or the symptoms
`result i.n marked impairment i.n social or occupational functioning.
`In Partial Remission. The full criteria for the disorder were previously met,
`but currently only some of the symptoms or signs of the disorder remain.
`In Full Remission. There are no longer any symptoms or signs of the dis-
`order, but it is still clinically relevant to note the disorder—~for example, in an
`individual with previous episodes of Bipolar Disorder who has been symptom
`free on lithium for the past 3 years. After a period of time in full remission, the
`clinician may judge the individual to be recovered and, dierefore, would no
`longer code the disorder as a cunent diagnosis. The differentiation of In Full
`Remission from recovered requires consideration of many factors, including
`the characteristic course of the disorder, the length of time since the last period
`of disturbance, the total duration of the disturbance, and the need for contin-
`ued evaluation or prophylactic trea trnen t.
`Prior History. For some purposes, it may be useful to note a history of the
`criteria having been met for a disorder even when the individual is considered
`to be recovered from it. Such past diagnoses of mental disorder would be in-
`dicated by using the specifier Prior History (e.g., Separation Anxiety Disorder,
`Prior History, for an individual with a history of Separation Anxiety Disorder
`who has no current disorder or who currently meets criteria 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
`
`

`
`Use of the Manual
`
`int presentation and is
`~ individual has recov-
`
`nay be listed after the
`. Remission, and Prior
`
`mly when the full cri-
`e presentation should
`take into account the
`
`:ler and any resulting
`Jrity of disorders, the
`
`d to make the diagno-
`nor irnpairrnent in so-
`
`'een “mild” and "se-
`
`3 make the diagnosis,
`sent, or the symptoms
`Lnctioning.
`were previously met,
`disorder rernain.
`
`IS or signs of the dis-
`1‘-—for example, in an
`10 has been symptom
`.-in full remission, the
`. therefore, would no
`fereniiation of In Full
`
`ny factors, including
`e since the 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-
`
`JE been provided for
`Episode, and Major
`arnission and In Full
`
`ie, Major Depressive
`
`Use of the Manual
`
`RBCUITEFICE
`
`Not jnfgequently 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-
`Cove;-y) may develop symptoms that suggest a recurrence of their original disorder
`but that do not yet meet the full threshold for that disorder as specified in the criteria
`Set, It is a matter of clinical judgment as to how best to indicate the presence of these
`5y-mptotns. The following options are available:
`
`a If the symptoms are judged to be a new episode of a recurrent condition, the dis-
`order may be diagnosed as current (or provisional) even before the hill criteria
`have been met [e.g., after meeting criteria for a Major Depressive Episode for only
`1!] days instead of the 14 days usually required).
`[f the symptoms are judged to be clinically significant but it is not clear whether
`may constitute a recurrence of the original disorder, the appropriate Not Other-
`wise Specified category may be given.
`If it is judged that the symptoms are not clinically significant, no additional current
`or provisional diagnosis is given, but ”Prior History" may be noted (see p. 2).
`
`Principal Diagnosismeason for Visit
`
`When more than one diagnosis for an individual is given in an inpatient setting, the
`principal diagnosis is the condition established after study to be chiefly responsible for
`occasioning the admission of the individual. When more than one diagnosis is given
`for an individual in an on tpatient setting, the reason for visit is the condition that is
`chiefly responsible for the ambulatory care medical services received during the visit.
`in most cases, the principal diagnosis or the reason for visit 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 for visit, especially in situa-
`lions of "dual diagnosis" (61 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 "pi-incipal” for an
`individual hospitalized with both Schizophrenia and Amphetamine Intoxication, be-
`cause each condition may have contributed equally to the need for admission and
`treahnent.
`
`Multiple diagnoses can be reported in a mu] tiaxial 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 [I diagnosis,
`the principal diagnosis or the reason for visit will be assumed to be on Axis I unless
`the Axis II diagnosis is followed by the qualifying phrase "(Principal Diagnosis)" or
`"(Reason for Visit)."
`
`Provisional Diagnosis
`
`The specifier provisional can be used when there is a strong presumption that the full
`Criteria will ultimately be met for a disorder, but not enough information is available
`
`6 of 146
`
`Alkermes, Ex. 1022
`
`

`
`4
`
`Use of the Manual
`
`to make a firm diagnosis. The clinician can indicate the diagnostic uncertainty by re-
`cording "(ProvisionaI)“ following the diagnosis. For example, the individual appears
`to have a Major Depressive Disorder, but is unable to give an adequate history to es-
`tablish that the full criteria are met. Another use of the term provisional is for those sit-
`uations in which differential diagnosis depends exclusively on the duration of illness.
`For example, a diagnosis of Schizophreniforrn Disorder requires a duration of less
`than 6 months and can only be given provisionally if assigned before remission has
`occurred.
`
`Use of Not Otherwise Specified Categories
`
`Because of the 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 some classes have several
`NOS categories. There are four situations in which an NOS diagnosis may be appro-
`priate:
`
`- The presentation conforms to the general guidelines for a mental disorder in the
`diagnostic class, but the symptomatic picture does not meet the criteria for any of
`the specific disorders. This would occur either when the symptoms are below the
`diagnostic threshold for one of the specific disorders or when there is an atypical
`or mixed presentation.
`0 The presentation conforms to a symptom pattern that has not been included in the
`DSM-IV Classification but that causes clinically significant distress or irnpairment.
`Research criteria for some of these symptom patterns have been included in Appen-
`dix B ("Criteria Sets and Axes Provided for Further Study"), in which case a page
`reference to the suggested research criteria set in Appendix B is provided.
`There is uncertainty about etiology (i.e., whether the disorder is due to a general
`medical condition, is substance induced, or is primary).
`There is insuificient opportunity for complete data collection (e.g., in emergency
`situations) or inconsistent or contradictory information, but there is enough infor-
`mation to place it within a particular diagnostic class [e.g., the clinician detennihes
`t.hat the individual has psychotic symptoms but does not have enough information
`to diagnose a specific Psychotic Disorder).
`
`Ways of Indicating Diagnostic Uncertainty
`
`The following table indicates the various ways in which a clinician may indicate di-
`agnostic uncertainty:
`
`7 of 146
`
`Alkermes, Ex. 1022
`
`

`
`use of the Manual
`
`2 uncertainty by re.
`individual appears
`qua te history to es-
`Eomii is for those sit-
`‘duration ofillness.
`s a duration of less
`afore remission has
`
`egories
`
`-r the diagnostic no-
`diagnostic class has
`ilasses have several
`
`l0SlS may be appro-
`
`ntal disorder in the
`
`re criteria for any of
`rtorns are below the
`
`there is an atypical
`
`Ieen included in the
`
`ress or impairment.
`included in Appen-
`1 which case a page
`.5 provided.
`is due to a general
`
`(e.g., in emergency
`ere is enough infor-
`:linician determines
`
`enough informa tion
`
`ertainty
`
`an may indicate di-
`
`Use of
`
`9 Manual
`
`-;
`
`'
`
`Examples of clinical situations
`_
`-
`(for other Conditions That May
`Insufficient information to know whether or
`odes
`.
`.
`.
`V C
`not a presenting problem Is attributable to a
`us of Clinical Attention)
`_ Bea F0:
`mental disorder, e.g., Academic Problem:
`Adult Antisocial Behavior
`
`.799 9 Diagnosis or Condition Deferred on Information inadequate to make any diag-
`'
`Axis |
`nostic judgment about an Axis I diagnosis or
`condition
`
`799.9 Diagnosis Deferred on Axis II
`
`in
`
`- 3393 unspecified Mental Disorder
`(nonpsychoticl
`
`Ii 7 253.9 Psychotic Disorder Not otherwise
`Specified
`
`Information inadequate to make any diag-
`nostic judgment about an Axis II diagnosis
`
`Enough information available to rule out a
`Psychotic Disorder. but further specification
`is not possible
`
`Enough information available to determine
`the presence of a Psychotic Disorder. but fur-
`ther specification is not possible
`
`'.'[Ciass of disorder] Not Othenivise Specified Enough information available to indicate
`:é,_ij., Depressive Disorder Not U‘lIl'IEl'Wl5E
`the class of disorder that is present, but fur-
`spiecifigd
`ther specification is not possible, either be-
`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
`
`'.['5ili.|E|:l‘flC diagnosis] (Provisional)
`e.g., Schizophreniforrri Disorder
`. ifflrovisional)
`
`Enough information available to make a
`"working" diagnosis. butthe clinician wishes
`to indicate a significant degree of diagnostic
`uncertainty
`
`Frequently Used Criteria
`
`";C_riteria Used to Exclude Other Diagnoses and
`If! Suggest Differential Diagnoses
`.M°5t Of the criteria sets presented in this manual include exclusion criteria that are
`necessary to establish boundaries between disorders and to clarify differential diag-
`noses. The several different wordings of exclusion criteria in the criteria sets through-
`°'-“ DSM-IV reflect the different types of possible relationships among disorders:
`
`.
`
`4
`
`' "Criteria have never been met for. . ." This exclusion criterion is used to define
`“P56-time hierarchy between disorders. 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.
`
`8 of 146
`
`Alkermes, Ex. 1022
`
`

`
`Use of the Manual
`
`- "Criteria are not met for . . ." This exclusion criterion is used to establish a hier-
`archy between disorders (or subtypes] defined cross-sectiunally. For example, the
`specifier With Melancholic Features takes precedence over With Atypical Features
`for describing the current Major Depressive Episode.
`. ." This exclusion criterion
`"does not occur exclusively during the course of .
`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 separately if it occurs only dtu-‘mg Sornatization Disorder; Bulimia Ner-
`vosa is 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 disorder are associated features or a subset of the symptoms of the preempt-
`ing disorder. The clinician should consider periods of partial remission as part of
`the ”course of another disorder." It should be noted that the excluded diagnosis
`can be given at times when it occurs independently (e.g., when the excluding dis-
`order is in full remission).
`"not due to the direct physiological effects of a substance (e.g., a drug of abuse,
`a medication) or a general medical condition.” This exclusion criterion is used
`to indicate that a substance-induced and general medical etiology must be consid-
`ered and ruled out before 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 mentioned in the criterion must be considered in the differential di-
`agnosis of the presenting psychopathology and that, in boundary cases, clinical
`judgment will be necessary to determine which disorder provides the most appro-
`priate diagnosis. In such cases, the ”Di.fferential Diagnosis" section of the text for
`the disorders should be consulted for guidance.
`
`The general convention in DSM-IV is to allow multiple diagnoses to be assigned
`for those presentations that meet criteria for more than one DSM-IV disorder. There
`are three situations in which the above-mentioned exclusion criteria help to establish
`a diagnostic hierarchy {and thus prevent multiple diagnoses) or to highlight differen-
`tial diagnostic considera tions {and thus discourage multiple diagnoses):
`
`- When a Mental Disorder Due to a General Medical Condition or a Substance-
`lnd uced Disorder is responsible for the symptoms, it preempts the diagnosis of the
`corresponding primary disorder with the same symptoms (eg, Cocaine—lnduced
`Mood Disorder preempts Major Depressive Disorder). In sudw cases, an exclusion
`criterion containing the phrase "not due to the direct physiological effects of .
`. ."
`is included in the criteria set for the primary disorder.
`When a more pervasive disorder (e.g., Schizophrenia) has among its defining
`symptoms {or associated symptoms) what are the defining symptoms ofa less per-
`vasive disorder (e.g., Dysthymic Disorder), one of the following three exclusion
`criteria appears in the criteria set for die 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. .
`
`aerssrsrrereaaaaar,-‘f _
`
`-'= *-
`
`9 of 146
`
`Alkermes, Ex. 1022
`
`

`
`Use of the Manual
`
`use of the Manual
`
`7
`
`ted to establish a hier-
`
`ally. For example, the
`with Atypical Features
`
`iis exclusion criterion
`
`11 presentation occurs
`dementia is not diag-
`rsion Disorder is not
`Disorder; Bulimia Ner-
`Jdes of Anorexia Ner-
`
`l which the symptoms
`atoms of the preempt-
`ll remission as part of
`:5‘ excluded diagnosis
`ten the excluding dis-
`
`'.e-g., a drug of abuse,
`lSlDl'l criterion is used
`
`ilogy must be consid-
`.g., Maior Depressive
`-stance use and a gen-
`
`; used to indicate that
`in the differential di-
`
`indary cases, clinical
`rides the most appro-
`section of the text for
`
`moses to be assigned
`M-IV disorder. There
`
`teria help to establish
`to highlight differen-
`lg1'IOSE5)I
`
`tion or a Substance-
`
`T5 the diagnosis of the
`-.g., Cocaine-Induced
`‘h cases, an exclusion
`logical effects of .
`. ."
`
`among its defining
`mptoms of a less per-
`ving three exclusion
`-rder, indicating that
`ave never been met
`
`clusively during the
`
`. When there are particularly difficult clifterential diagnostic boundaries, the phrase
`“not better accounted for b y .
`. ." 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 recogution of the fact that this is a par-
`ticularly difficult boundary to draw.
`tn some cases, both diagnoses might be
`appropriate.
`
`criteria for Su bstance-Ind uced Disorders
`
`it is often difficult to determine whether presenting symptomatolog-y is substance in-
`duced, lhat is, the direct physiological consequence of Substance [ntoxication or
`Withdrawal, medication use, or toxin exposure. In an effort to provide some assis-
`tance in making this determination, the two criteria 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 for clinical judgment in determining
`whether or not the presenting symptoms are best accounted for by the direct physio-
`logical effects of the substance. For further discussion of this issue, see p. 209.
`
`B. There is evidence from the history, physical examination, or laboratory
`findings of either {1} or (2):
`
`(1)
`
`the symptoms developed during, or witl-tin a month of, Substance
`Intoxication or Withdrawal
`
`(2) medication use is etiologically related to the disturbance
`
`The disturbance is not better accounted for by a disorder that 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 persist for a substantial period of time (e. g., about a month) after
`the cessation of acute withdrawal or severe intoxication, or are substantial-
`
`ly in excess of what would be expected given the type, duration, or amount
`of the substance used; or there is other evidence that suggests the existence
`of an independent non-substancednduced disorder {e.g., a history of recur-
`rent non-substance-related episodes).
`
`Criteria for a Mental Disorder Due to a
`
`General Medical Condition
`
`The criterion 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 of this issue, see p. 181.
`
`There is evidence from the history, physical examination, or laboratory find-
`ings that the dishirbance is the direct physiological consequence of a general
`medical condition.
`
`10 of 146
`
`Alkermes, Ex. 1022
`
`

`
`Use of the Manual
`
`Criteria for Clinical Significance
`
`The definition of mcntrrl rlisordei'i.I1 the introduction to DSM-IV requires that there be
`clinically significant impairment or distress. To highlight the importance of consider-
`ing this issue, the criteria sets for most disorders include a clinical significance crite-
`rion (usually worded ". .
`. causes clinically significant distress or impairment in social.
`occupational, or other important areas of functioning"). This criterion helps establish
`the threshold for the diagnosis of a disorder in those situations in which the syInp~
`tomatic presentation by itself (particularly in its milder forms) is not inherently
`pathological and may be encountered in individuals for whorn a diagnosis of ” mental
`disorder” would be inappropriate. Assessing whether this criterion is met, especially
`in terms of role function, is an inherently difficult clinical iudgment. Reliance on in-
`formation from family members and other third parties (in addition to the individual)
`regarding the individual’s performance is often necessary.
`
`Types of Information in the DSM-IV Text
`
`The text of DSM-IV systematically describes each disorder under the 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." W'hen no
`infonriation is available for a section, that section is not included. in some instances,
`
`when many of the specific disorders in a group of disorders share common features,
`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:
`
`0 Associated descriptive _features and Plttftlftil disorders. This section includes clinical
`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 diagnostic criteria but were insufficiently sensitive or
`specific to be included in 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 of the
`disorder in question (e,g., Alcohol-induced Persisting Dementia is a consequence
`
`11 of 146
`
`Alkermes, Ex. 1022
`
`

`
`Use of the Manual
`
`use of the Manual
`
`9
`
`equires that there be
`ortance of consider-
`
`il significance crite-
`npairrnent in social,
`trion helps establish
`in which the symp-
`;]
`is not inherently
`liagnosis of "mental
`an is met, especially
`ent. Reliance on in-
`
`in to the individual)
`
`V Text
`
`the following head-
`nrding Procedures";
`I Gender Features";
`
`agnosis." When no
`_ In some instances,
`3 common fea titres,
`IUP.
`
`and often provides
`
`id brief discussions
`
`-orting the name of
`D-9-CM diagnostic
`3 subtypes and/or
`
`divided into three
`
`n includes clinical
`“lEl.l.' are not consid-
`tures were consid-
`
`ciently sensitive or
`is section are other
`
`is specified
`zed. It
`onsequencesofthe
`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 on three types of
`laboratory findings that may be associated with the disorder: 1) those associated
`laboratory findings that are considered to be "diagnostic" of the disorder—for ex-
`ampje, polysornnographic findings in certain sleep disorders; 2} those associated
`laboratory findings that are not considered to be diagnostic of the disorder but that
`have been noted to be abnormal in groups of individuals with the disorder relative
`to control subjects—for example, ventricle size on computed tomography as 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 N ervosa.
`Associated physical exttnrinntion findings and general medical conditions. This section
`includes information aboutsymptorns elicited by history, or findings noted during
`physical examination, that may be of diagnostic significance but that are not essen-
`tial to the diag‘nosis——for example, dental erosion in Bulimia Nervosa. Also includ-
`ed are those disorders that are coded outside the ”Mental and Behavioural
`Disorders” chapter of ICE.) that are associated with the disorder bei.r1 g discussed.
`A5 is done for associated mental disorders, the type of association {i.e., precedes,
`co-occurs with, is a consequence of) is specified if lcnown—for example, that cir-
`rhosis is a consequence of Alcohol Dependence.
`
`Specific Culture, Age, and Gender Features. This section provides guidance for
`the clinician concerning variations in the presentation of the disorder that may be at-
`tributable to the individuals Cultural setting, developmental stage {e.g., infancy,
`childhood, adolescence, adulthood, late life), or gender. This section also includes in-
`formation on differential prevalence rates related to culture, age, and gender {e.g., sex
`ratio).
`
`Prevalence. This section provides available data on point and lifetime prevalence,
`incidence, and lifetime risk. These data are provided for different settings {e.g., com-
`munity, primary care, outpatient mental health clinics, and inpatient psychiatric Set-
`tings) when this information is known.
`
`Course. This section describes the typical lifetime patterns of presentation and evo-
`lution of the disorder. It contains information on typicai age at onset and mode ofonset
`(E'.g., abrupt or insidious) of the disorder; episodic versus contimions course; single epi-
`sode versus recurrent; dnrntiori, characterizing the typical length of the illness and its
`Episodes; and progression, describing the general trend of the disorder over time (e.g.,
`stable, worsening, improving).
`
`Familial Pattern. This section describes data on the frequency of the disorder
`among first-degree biological relatives of those with the disorder compared with the
`frequency in the general population. It also indicates other disorders that tend to
`Occur more frequently in family members of those with the disorder. lrtforrnation
`regarding the heritable nature of the disorder {e.g., data from twin studies, known
`genetic transmission patterns) is also included in this section.
`
`12 of 146
`
`Alkermes, Ex. 1022
`
`

`
`“)
`
`Use of the Manual
`
`Differential Diagnosis. This section discusses how to differentiate this disorder
`from other disorders that have some similar presenting characteristics.
`
`DSM-IV Organizational Plan
`
`The DSM—IV disorders are grouped into 16 major diagnostic classes (e.g., Substance-
`Related Disorders, Mood Disorders, Anxiety Disorders) and one additional section,
`"Other Conditions That May Be a Focus of Clinical Attention."
`The first section is devoted to ‘Disorders Usually First Diagnosed in Infancy,
`Childhood, or Adolescence.” This division of the Classificat