Review
Copyright ©The Author(s) 2022.
World J Psychiatry. Dec 19, 2022; 12(12): 1335-1355
Published online Dec 19, 2022. doi: 10.5498/wjp.v12.i12.1335
Table 1 Benchmarks for the revisions of the new classifications[9-13]
Principles and priorities
ICD-11-CDDR
DSM-51
Guiding principles
Public health imperativeThe guidelines should be useful in alleviating the global mental health burden, especially the burden in the low-and middle-income countriesThe manual is meant to be used as a tool for collecting and communicating accurate public health statistics on mental disorders
Clinical imperativeClinical and public health utility were accorded the greatest priority followed by scientific validityClinical utility was accorded the highest priority followed by the scientific evidence
Stakeholders The guidelines are meant for use in all countries, for all professionals, and for all service usersThe manual is meant for all professionals and service users
Multiple usesThe guidelines are meant for clinical, research, teaching, and training purposes, and for collecting dataThe manual is meant for clinical, research, teaching, and training purposes, and for collecting data
SettingsThe guidelines are meant for all settings including specialist and primary-care settings, with special emphasis on primary-care settings in low-and middle-income countriesThe manual should be applicable to all settings including specialist, primary-care, community, and forensic settings
Cross-cultural applicabilityThe revision should be relevant and acceptable to clinicians from all culturesCultural aspects relevant to the diagnosis was a key consideration
Priorities
Global applicabilityGlobal and universal applicability: The guidelines should be relevant for all countries, all stakeholders, and in all settingsProfessionals from 39 countries were involved in developing the scientific basis of the diagnostic criteria
Clinical utilityClinical and public-health utility was accorded the highest priority during the process of revisionThe manual is primarily intended for clinical use and should be feasible for clinical practice
Scientific validityThe scientific basis should be based on best available evidence. Compromises for the sake of utility should be avoidedThe revision was guided by a thorough review of the best scientific evidence
HarmonizationEfforts to harmonize the ICD-11 revision with the DSM-5 involved enhancing similarities and minimizing arbitrary differences between the two systemsThe APA collaborated with the WHO to develop a common and globally applicable research base for the DSM-5 and the ICD-11 disorders
Table 2 Comparison of diagnostic criteria for manic and hypomanic episodes

ICD-11-CDDR
DSM-5
Manic episode
Gate/entry level criteriaBoth extreme and persistent mood changes (euphoria, irritability, expansiveness, mood lability) and abnormally increased activity or subjective experience of increased energyBoth abnormal and persistent mood changes (elevated, expansive, or irritable) and abnormal and persistent increase in goal-directed activity or energy1
Accessory criteriaSignificant changes in several of the following seven areas: talkativeness/pressured speech, flight of ideas/racing thoughts, increased self-esteem/grandiosity, decreased need for sleep, distractibility, impulsive/reckless behaviour, increased sexual or social drive/increased goal directed activitySignificant and noticeable changes in three of the seven accessory symptoms; four if mood is only irritable; accessory criteria almost identical to the ICD-11 definition
Persistence and durationSymptoms present most of the day, nearly every day for a minimum of one week unless shortened by treatmentSymptoms present most of the day, nearly every day for a minimum of one week unless shortened by hospitalization
Functional impairmentSignificant impairment in all the areas of functioning; the patient may require intensive treatment/hospitalization to prevent self-harm or violence; the episode may be accompanied by psychotic symptomsSignificant impairment in all the areas of functioning; the patient may require hospitalization to prevent self-harm or violence; the episode may be accompanied by psychotic symptoms
ExclusionsMania secondary to medical conditions or substance use; mixed episodes excludedMania secondary to medical conditions or substance use; manic episodes with mixed features allowed
Effects of antidepressant treatmentThe episode should be considered a manic one if all the criteria are met even after the effects of treatment have diminishedThe episode should be considered a manic one if all the criteria are met even after the effects of treatment have diminished
Grading of severitySeverity not gradedSeverity graded as mild, moderate, or severe based on the number of symptoms, their intensity, and functional impairment
Psychotic symptomsNo distinction between mood-congruent and incongruent symptomsMood-congruent and incongruent symptoms distinguished
Hypomanic episode
Gate/entry criteriaBoth persistent mood changes (elevation, irritability, mood lability) and abnormally increased activity or subjective experience of increased energy that are significantly different from the usual mood state; changes are apparent to others and do not include changes that are appropriate to the circumstances2Both abnormal and persistent mood changes (elevated, expansive, or irritable) and abnormal and persistent increase in activity or energy; changes in mood differ significantly from the usual state and are apparent to others
Accessory criteriaSignificant changes in several of the seven accessory symptoms that are identical to the definition of mania; these changes are apparent to othersSignificant and noticeable changes in three of the seven accessory symptoms, four if mood is only irritable; accessory criteria are the same as those for mania and almost identical to the ICD-11 definition
Persistence and durationSymptoms present most of the day, nearly every day for at least several daysSymptoms present most of the day, nearly every day for a minimum of four consecutive days
Functional impairment, hospitalization, and psychotic symptomsSocio-occupational functioning is not markedly impaired; the patient does not require intensive treatment or hospitalization to prevent self-harm or violence; the episode is not accompanied by psychotic symptomsClear change in socio-occupational functioning from the usual state apparent to others, but functioning is not markedly impaired; the patient does not require hospitalization to prevent self-harm or violence; the episode is not accompanied by psychotic symptoms
ExclusionsHypomania secondary to medical conditions or substance use; mixed episodes are excludedHypomania secondary to substance use3; hypomanic episodes with mixed features allowed
Effects of antidepressant treatmentThe episode should be considered a hypomanic one if all the criteria are met even after effects of treatment have diminishedThe episode should be considered a hypomanic one if all the criteria are met even after effects of treatment have diminished; however, full syndromal manifestation of hypomania is necessary
Table 3 Prevalence of bipolar disorder according to the International Classification of Diseases, 11th version and the Diagnostic and Statistical Manual of Mental Disorder, 5th edition criteria
Ref.
Criteria sets
Patients
Bipolar types
Type of prevalence
Results regarding the prevalence of BD
No change in the prevalence of bipolar disorder
Fassassi et al[55], 2014DSM-5Community-basedBP-I, BP-II, Other BD112-mo and lifetimePrevalence similar to earlier studies of BD
Calvó-Perxas et al[56], 2015DSM-5Community-basedBP-I, BP-II, Other BDLifetimePrevalence was within the range of previous reports of BD
Blanco et al[57], 2017DSM-5Community-basedBP-ILifetimePrevalence was within the range of previous reports of BD
Gordon-Smith et al[58], 2017 DSM-IV and DSM-5Community-based and outpatientsBP-I, BP-IILifetimeUp to 94% of the patients with DSM-IV BD also met the DSM-5 criteria
Decrease in the prevalence of bipolar disorder
Angst et al[53], 20132DSM-5Analysis based on a previous community study (BRIDGE)BDLifetimeAbout 22% reduction in prevalence
Machado-Vieira et al[38], 2017DSM-IV and DSM-5OutpatientsManiaand hypomaniaPoint prevalenceThe prevalence of mania and hypomania according to the DSM-5 criteria was reduced by about 50%
Fredskild et al[59], 2019DSM-IV TR and DSM-5OutpatientsManiaand hypomaniaPoint prevalenceA reduction of 35% in the prevalence of mania and hypomania with the DSM-5 criteria was noted
Faurholt-Jepsen et al[60], 2020DSM-5Patients taking part in trialsMania and hypomaniaSmartphone-based activity assessments over 6-9 moThe prevalence of hypomania according to the DSM-5 criteria was substantially less (0.12%) than patients not meeting these criteria (24%)
Fredskild et al[61], 2021DSM-IVand DSM-5OutpatientsMania and hypomaniaAssessments at baseline and at 3-year follow-upThe prevalence of mania and hypomania according to the DSM-5 criteria was reduced by 62% at baseline and by 50% on follow-up
Increase in the prevalence of type II bipolar disorder
Angst et al[53], 20133DSM-5Analysis based on a previous community study (BRIDGE)BP-IILifetimePrevalence of BP-II disorder will be twice as much with the DSM-5 than earlier
Angst et al[31], 20204ICD-10, DSM-5, and ICD-11Analysis based on an earlier community study (Zurich cohort study)Mania (BP-I) and hypomania (BP-II)LifetimePrevalence of hypomania (BP-II) will be doubled with the ICD-11 criteria compared to the ICD-10 and the DSM-5 criteria; no change in the prevalence of mania (BP-I) is likely
Table 4 Changes to the diagnostic guidelines for bipolar depression in the International Classification of Diseases, 11th version

ICD-11-CDDR
DSM-5
ICD-10
Core symptomsOne of the following: Depressed mood or diminished interest or pleasureOne of the following: Depressed mood or loss of interest or pleasureTwo of the following: Depressedmood, loss of interest and enjoyment, and reduced energy leading to increased fatiguability, diminished activity, and marked tiredness
Reported or observed changesReported or observed changes
Change from usual functioningChange from usual functioning
Accessory symptomsEight symptoms including the new symptoms of hopelessness, fatigue, and agitation/retardationSeven symptoms: Hopelessness is not included, but fatigue and psychomotor changes are includedSeven symptoms: Bleak and pessimistic views of future instead of hopelessness, no psychomotor changes or fatigue that are part of the core symptoms
Other symptoms (unchanged) are inattentiveness, changes in sleep and appetite, low self-worth or guilt, and suicidal ideationOther symptoms are the same as in the ICD-11Other symptoms are the same as in the ICD-11
Persistence and durationSymptoms occur most of the day, nearly every day during a minimum period of two weeksSymptoms occur most of the day, nearly every day during a minimum period of two weeksMinimum duration of two weeks usually required but shorter periods suffice if symptoms are unusually severe and of rapid onset
Diagnostic thresholdFive out of ten symptomsFive out of nine symptomsFour out of ten symptoms
Functional impairmentPart of the diagnostic criteriaPart of the diagnostic criteriaUsed to rate severity
ExclusionsDepression secondary to medical conditions or substance use and mixed episodes; mixed episodes excludedDepression secondary to medical conditions or substance use; diagnosis of depressive episodes with mixed features possibleNo clear exclusions
Bereavement exclusionOperationalized definition presentOnly an explanatory note that advises the use of clinical judgement in such instancesNot mentioned as a part of the diagnostic guidelines
Severity ratingsMild, moderate and severe depressive episodes based on symptom-severity and functional impairment; no requirement for a minimum number of symptomsGrading similar to the ICD-11; no requirement for a minimum number of symptomsGrading similar to the ICD-11, but a minimum number of symptoms required for grading different levels of severity; clinical judgement also advised
Psychotic symptomsModerate depression with psychotic symptoms is a new categoryMood congruent and incongruent symptoms distinguishedMood congruent and incongruent symptoms distinguished
Description of melancholiaDescriptions similar to the ICD-10, but no requirement for a minimum number of symptomsDescription more elaborate; a minimum of four symptoms requiredDescriptions similar to the ICD-11; a minimum of four symptoms required
Additional specifiersWith prominent anxiety, panic attacks, chronicity, seasonal pattern, puerperal onsetSimilar to the ICD-11; additionally mixed features, atypical features, and catatoniaNo other specifiers
Table 5 Controversies about type two bipolar disorder
Controversy
For retaining BP-II disorder
Against retaining BP-II disorder
The definition of hypomaniaCurrent definitions of BP-II disorder in the ICD-11 and the DSM-5 represent an optimal balance between sensitivity and specificity; they will prevent the over-diagnosis and harmful effects of inappropriate treatment of a false positive diagnosis[30,38,42,43]Current criteria are too restrictive and under-diagnose hypomania and BP-II disorder. The minimum duration required is not evidence-based and should be shorter[32,113,114,120,121]
Prevalence of BP-II disorderThe prevalence of BP-II disorder is as high as BP-I disorder, or even higher than the BP-I subtype[98,108-110]Data on prevalence are mixed. Prevalence is also influenced by factors such as broader definitions, improved recognition, and increased awareness[111,114]
Course of BP-II disorderCompared to BP-I disorder, BP-II disorder has a more chronic course, greater syndromal and subsyndromal depressive symptoms, and higher episode frequency[98,107-109,112]The seemingly adverse course of BP-II disorder could be a function of confounding factors such as symptom-severity, comorbidity, and the effects of treatment[32,70,99,114]
Diagnostic stability of BP-II disorderThe diagnosis of BP-II disorder remains the same for several years. Only 5%-15% of the patients with BP-II disorder develop BP-I disorder[6,98,105,109]The boundaries between BP-II and BP-I disorder, between BP-II disorder and cyclothymia, and between BP-II disorder and personality disorders are unclear[70,99,113,115]
The prevalence of psychotic symptomsPatients with BP-I disorder are more likely than those with BP-II disorder to have psychotic symptoms[66,111,115]Psychosis is also associated with hypomania, especially in longitudinal community studies[68,69,113]
Suicidal behaviourSuicide rates are higher in BP-II disorder than BP-I disorder[107-109,120,121]The higher suicide rates in BP-II disorder could be a function of comorbid personality disorders and comorbid substance use[98]
Family-geneticsBP-II disorder runs in families. Genetic studies help distinguish BP-II disorder from BP-I disorder[98,110,116,118,121]Genetic studies show that BP-II and BP-I disorders lie on a continuum of genetic risk without any distinction between the two subtypes[106,112,114,120]
NeuroimagingSome studies suggestquantitative or qualitative differences between the two subtypes[116,123]There are no differences in neuroimaging between the two subtypes[98,111,112,114,120]
NeurocognitionPatients with BP-II disorder are less impaired on neuropsychological tests than those with BP-I disorder[98]There is a great degree of overlap in the neurocognitive performance between the two subtypes[114,116]
Treatment responseThe treatment requirements of patients with BP-II disorder are different[115,118,119]There is no difference in treatment response between the two subtypes[98,108,111,114,120]
Table 6 Changes to the diagnostic guidelines in the International Classification of Diseases, 11th version for cyclothymic disorder

ICD-11-CDDR
DSM-5
ICD-10
Core featuresChronic mood instability of more than two years consisting of several hypomanic and depressive periods (irritability in children and adolescents)Several hypomanic or depressive symptoms for more than two yearsA persistent instability of mood, involving numerous periods of mild depression and mildelation (No duration mentioned)
Hypomanic symptoms may meet the criteria for hypomanic episodesSymptoms do not meet the criteria for hypomanic or major depressive episodesNone of these symptoms meet criteria for mania/BD or depressive episode/recurrent depressive disorder
Symptom-free periodsSymptom-free periods are no longer than two months during the course of the disorderHypomanic and depressive symptoms are present at least half of the time during the course of the disorderMood state may be normal and stable for months (No minimum duration for symptom-free periods specified)
Symptom-free periods are no longer than two months during this period
Children and adolescentsDuration of one year is appropriateDuration of one year sufficientNo mention of duration in children and adolescents
Manic mixed, and depressive episodesCriteria for manic and mixed episodes are never met. Depressive episodes cannot be diagnosed during the first two years of cyclothymia. After that, they can be diagnosed if criteria are metCriteria for manic, hypomanic, or major depressive episodes are never met during the first 2 years. If the person subsequently experiences major depression, mania, or hypomania, the diagnosis is changed to major depressive disorder, BP-I disorder, or other specified or unspecified bipolar and related disordersCriteria for manic, mixed, and depressive episodes are never met
Criteria for BP-I or BP-II disorder are never metCriteria for BD or recurrent depressive disorder are never met
ExclusionsCyclothymia secondary to medical conditions or substance useCyclothymia secondary to medical conditions or substance useNo exclusions
Functional impairmentSymptoms result in significant distress and/or functional impairmentSymptoms result in significant distress and/or functional impairmentSymptoms are so mild that patients often do not seek treatment
Progression to BDMentionedMentionedMentioned
Inclusion of additional personality featuresNot included-unlike personality disorders, cyclothymia does not include persistent self and interpersonal dysfunctionIncluded-the person may be temperamental, moody, unpredictable, inconsistent, or unreliableIncluded-in some instances, mood changes are less prominent than cyclical disturbances of activity, self-confidence, and social behaviour
Table 7 Considerations guiding the notion of clinical utility in the International Classification of Diseases, 11th version
Concept
Application to the ICD-11 CDDR
Working definitionClinical utility of the classification and its categories includes the ability to facilitate communication among clinicians, having characteristics that help clinical practice (diagnostically accurate, easy to use, and feasible), and containing guidance for appropriate treatment choices[141,142]
Why clinical utility?Validity is not a pragmatic goal; enhanced diagnostic reliability has not led to increased validity[143,144]. Current classifications have several shortcomings and are not useful in real-world settings[11,37,142]
Levels of utilityClinical utility has two levels including the architectural or organizational level and the category level[24,141], utility should focus on both the levels and emphasize coverage, description of attributes, and ease of use[145]
Application to healthcare settingsThe need for utility is the greatest during clinical encounters in routine practice settings. The classification must provide information of value to the clinician in these situations[9-11,13,146]
Public health utilityConsideration must be given to the features of the classification that enhance global applicability and reduce global mental health burden[9,147]
Contextual aspectsUtility is context-specific; it depends on the purpose for which a classification is used, clinical, research, or for public health[9,10,146]
Utility and scientific validityClinical utility has to go hand-in hand with the scientific evidence. Moreover, compromising the scientific basis of the classification to meet the needs of clinical utility has to be avoided as far as possible. There is considerable overlap between clinical utility and predictive validity and sometimes it is difficult to distinguish between them[105,145,147]
Greater emphasis on clinical utility in the ICD-111Clinical utility as the ultimate organizing principle is not a new notion, but the ICD-11 has paid the greatest systematic attention to this aspect[10,147,148]
Improving clinical utility in the ICD-11Clinical utility has been the guiding principle at all the stages, from the evidence review, to content formation, and to the field trials. The standardized template or content-form was structured to enhance clinical utility. Working Groups were asked to consider the clinical utility of the changes suggested. The protype-based approach contributed to enhanced clinical utility. Cross-cultural usefulness was addressed. The ICD-11 field-trial studies used methodology specifically designed to examine clinical utility in naturalistic settings. The results of these studies have been used to improve the revision further[9-13]
Table 8 The International Classification of Diseases, 11th version field trials on reliability and clinical utility of bipolar disorder1
Ref.
Manuscript type
Results
Formative field trials
Surveys of mental health professionals: Opinions and utilization patterns
Reed et al[22], 2011Internet-based surveyThe ICD-10 category of BD had considerable clinical utility and was commonly used. The category of single depressive disorder was commonly used and should be retained. Functional impairment should be a diagnostic criterion for mood disorders
Evans et al[151], 2013Internet-based survey of psychologistsThe ICD-10 category of BD was not as commonly used. BD was rated to have low clinical utility, especially regarding its ease of use
Avasthi et al[152], 2014Internet-based surveyThe ICD-10 category of BD was commonly used and was easy to diagnose (high ease of use)
Robles et al[153], 2014Internet-based surveyThe ICD-10 category of BD was considered a problematic diagnosis by about 4% of the participants because of its non-specificity. Only about 1% of the participants felt that BP-II disorder should be included in the current version
Maruta et al[154], 2013Internet-based surveyA majority (69%) of the participants felt that BD should be included in a separate category of mood disorders
Studies on the clinicians’ organizational map for classifications
Roberts et al[23], 2012Internet-based surveyClinicians’ concepts were in keeping with the current evidence and similar across all groups and countries. BP-I, BP-II, and cyclothymic disorders were considered to be adult rather than developmental onset disorders. Clinicians’ views about the organizational structure corresponded more to the ICD-11 classification than the ICD-10 or the DSM-5
Reed et al[24], 2013Clinic-based FTC studyClinicians’ concepts were in keeping with the current evidence and similar across all groups and countries. Mood disorders including BP-I, BP-II, cyclothymic, depressive, and dysthymic disorders were grouped together by clinicians. This group was also among the most cohesively organized groups. The results supported the ICD-11 organization of the mood disorders group
Evaluative field trials
Studies of clinical vignettes
Gaebel et al[155], 2020Internet-based based field studyDiagnostic accuracy of the ICD-11 BP-II disorder category was significantly higher than a modified ICD-10 BP-II category. However, regarding disorders already existing in the ICD-10, e.g., BD, there were no differences between the ICD-11 and the ICD-10. There were no significant differences in overall clinical utility of BD between the ICD-11 and the ICD-10
Kogan et al[156], 2021Internet-based based field studyGreater diagnostic accuracy was found for the ICD-10 categories of BP-I disorder and a modified category of BP-II disorder on initial analysis. However, there were no significant differences on re-analysis. There were no significant differences between the ICD-11 and the ICD-10 categories of cyclothymic disorder. Clinical utility was somewhat lower for the ICD-11 category of BP-I disorder. Ratings of severity of depression were better with the ICD-10
Clinic-based FTC studies
Reed et al[142], 2018ICD-11 diagnoses-reliability and utilityThe clinical utility of BP-I disorder was higher than schizophrenia, schizoaffective disorder, and depressive disorders on all three parameters including diagnostic accuracy, ease of use, and clarity. Agreement between the raters was also the highest for BP-I disorder (k = 0.85)2,3
Reed et al[157], 2018ICD-11 diagnoses-reliabilityAgreement between the raters was one of the highest for BP-I disorder (k = 0.84). It was relatively low though adequate for BP-II disorder (k = 0.62)3,4
Hackmann et al[158], 2019Qualitative study on patient perceptions of BP-I disorderThe patients commented on several additional features that were missing from the description of BP-I disorder in the ICD-11 CDR. They preferred native language and idioms. A lay language version of the diagnostic descriptions was preferred
Medina-Mora et al[159], 2019ICD-11 diagnoses-reliability and utilityInter-rater reliability of the mood disorders category was high (percentage agreement-87%). This was higher than schizophrenia and most of the other disorders. Clinical utility was also high
Onofa et al[160], 2019ICD-11 diagnoses-reliability and utilityInter-rater reliability of BP-I disorder (k = 0.83) was high. Ratings of diagnostic accuracy and ease of use were also high, but the descriptions were felt to be less useful in selecting treatment