Learning disorders are diagnosed when the individual's achievement on individually administered, standardized tests in reading, mathematics, or written expression is substantially below that expected for the age, schooling and level of intelligence.⁶

DSM-IV diagnostic criteria for 313.81 Oppositional Defiant Disorder:

A. A pattern of negativistic, hostile, and defiant behavior lasting at least 6 months, during which four (or more) of the following are present⁶:

• (1) often loses temper
• (2) often argues with adults
• (3) often actively defies or refuses to comply with adults’ requests or rules
• (4) often deliberately annoys people
• (5) often blames others for his or her mistakes or misbehavior
• (6) is often touchy or easily annoyed by others
• (7) is often angry and resentful
• (8) is often spiteful or vindictive

NOTE: Consider a criterion only if the behavior occurs more frequently than is typically observed in individuals of comparable age and developmental level.

B. The disturbance in behavior causes clinically significant impairment in social, academic, or occupational functioning.

C. The behaviors do not occur exclusively during the course of a Psychotic or Mood Disorder.

Criteria for the diagnosis of Oppositional Defiant Disorder are provided to help healthcare professionals characterize conditions frequently comorbid with ADHD. CONCERTA^® is indicated only for the treatment of attention deficit hyperactivity disorder.

DSM-IV diagnostic criteria for 312.81, 312.82 Conduct Disorder⁶:

The DSM-IV categorizes Conduct Disorder behaviors into four main groupings: (A) Aggressive conduct that causes or threatens physical harm to other people or animals, (B) Non-aggressive conduct that causes property loss or damage, (C) Deceitfulness or theft, and (D) Serious violations of rules. Conduct Disorder consists of a repetitive and persistent pattern of behaviors in which the basic rights of others or major age-appropriate norms or rules of society are violated. Typically there would have been three or more of the following behaviors in the past 12 months, with at least one in the past 6 months.

Criteria for the diagnosis of Conduct Disorder are provided to help healthcare professionals characterize conditions frequently comorbid with ADHD. CONCERTA^® is indicated only for the treatment of attention deficit hyperactivity disorder.

DSM-IV diagnostic criteria for 307.23, Tourette's Disorder⁶:

A. Both multiple motor and one or more vocal tics have been present at some time during the illness, although not necessarily concurrently. (A tic is a sudden, rapid, recurrent, nonrhythmic, stereotyped motor movement or vocalization.)

B. The tics occur many times a day (usually in bouts) nearly every day or intermittently throughout a period of more than 1 year, and during this period there was never a tic-free period of more than 3 consecutive months.

C. The onset is before age 18 years.

D. The disturbance is not due to the direct physiological effects of a substance (eg, stimulants) or a general medical condition (eg, Huntington’s disease or postviral encephalitis).

Criteria for the diagnosis of Tourette's Syndrome are provided to help healthcare professionals characterize conditions frequently comorbid with ADHD. CONCERTA^® is indicated only for the treatment of attention deficit hyperactivity disorder. CONCERTA^® is contraindicated in patients with Tourette's Syndrome, tics, or family history of Tourette's Syndrome.

DSM-IV criteria for Bipolar Disorders 296.0 — 296.89⁶

There are six separate criteria sets for Bipolar I Disorder: Single Manic Episode, Most Recent Episode Hypomanic, Most Recent Episode Manic, Most Recent Episode Mixed, Most Recent Episode Depressed, and Most Recent Episode Unspecified. Bipolar I Disorder, Single Manic Episode, is used to describe individuals who are having a first episode of mania. The remaining criteria sets are used to specify the nature of the current (or most recent) episode in individuals who have had a recurrent mood episode.

Bipolar I Disorder is a clinical course that is characterized by the occurrence of 1 or more Manic Episodes or Mixed Episodes. Bipolar II Disorder is a clinical course that is characterized by the occurrence of one or more Major Depressive Episodes accompanied by at least one Hypomanic Episode.

Diagnostic Criteria for Manic Episode⁶

A. A distinct period of abnormally and persistently elevated, expansive, or irritable mood, lasting at least 1 week (or when hospitalization is necessary).

B. During the period of mood disturbance, three (or more) of the following symptoms have persisted (four if the mood is only irritable) and have been present to a significant degree:

• (1) inflated self-esteem or grandiosity
• (2) decreased need for sleep (eg, feels rested after only 3 hours of sleep)
• (3) more talkative than usual or pressure to keep talking
• (4) flight of ideas or subjective experience that thoughts are racing
• (5) distractibility (eg, attention too easily drawn to unimportant or irrelevant external stimuli)
• (6) increase in goal-directed activity (either socially, at work or school, or sexually) or psychomotor agitation
• (7) excessive involvement in pleasurable activities that have a high potential for painful consequences (eg, engaging in unrestrained buying sprees, sexual indiscretions, or foolish business investments)

C. The symptoms do not meet criteria for a Mixed Episode.

D. The mood disturbance is sufficiently severe to cause marked impairment in occupational functioning or in usual social activities or relationships with others, or to necessitate hospitalization to prevent harm to self or others, or there are psychotic features.

E. The symptoms are not due to the direct physiological effects of a substance (eg, a drug of abuse, a medication, or other treatment) or a general medical condition (eg, hyperthyroidism).

NOTE: Manic-like episodes that are clearly caused by somatic antidepressant treatment (eg, medication, electroconvulsive therapy, light therapy) should not count toward a diagnosis of Bipolar I Disorder.

Diagnostic Criteria for a Mixed Episode⁶

A. The criteria are met both for a Manic Episode and for a Major Depressive Episode (except for duration) nearly every day during at least a 1-week period.

B. The mood disturbance is sufficiently severe to cause marked impairment in occupational functioning or in usual social activities or relationships with others, or to necessitate hospitalization to prevent harm to self or others, or there are psychotic features.

C. The symptoms are not due to the direct physiological effects of a substance (eg, a drug of abuse, a medication, or other treatment) or a general medical condition (eg, hyperthyroidism).

NOTE: Mixed-like episodes that are clearly caused by somatic antidepressant treatment (eg, medication, electroconvulsive therapy, light therapy) should not count toward a diagnosis of Bipolar I Disorder.

Diagnostic Criteria for Major Depressive Episodes⁶

A. Five (or more) of the following symptoms have been present during the same 2-week period and represent a change from previous functioning; at least one of the symptoms is either (1) depressed mood or (2) loss of interest or pleasure.

NOTE: Do not include symptoms that are clearly due to a general medical condition, or mood-incongruent delusions or hallucinations.

• (1) depressed mood most of the day, nearly every day, as indicated by either subjective report (eg, feels sad or empty) or observation made by others (eg, appears tearful)NOTE: In children and adolescents, can be irritable mood.
• (2) markedly diminished interest or pleasure in all, or almost all, activities most of the day, nearly every day (as indicated by either subjective account or observation made by others)
• (3) significant weight loss when not dieting or weight gain (eg, a change of more than 5% of body weight in a month), or decrease or increase in appetite nearly every dayNOTE: In children, consider failure to make expected weight gains.
• (4) insomnia or hypersomnia nearly every day
• (5) psychomotor agitation or retardation nearly every day (observable by others, not merely subjective feelings of restlessness or being slowed down)
• (6) fatigue or loss of energy nearly every day
• (7) feelings of worthlessness or excessive inappropriate guilt (which may be delusional) nearly every day (not merely self-reproach or guilt about being sick)
• (8) diminished ability to think or concentrate, or indecisiveness, nearly every day (either by subjective account or as observed by others)
• (9) recurrent thoughts of death (not just fear of dying), recurrent suicidal ideation without a specific plan, or a suicide attempt or a specific plan for committing suicide

B. The symptoms do not meet criteria for a Mixed Episode.

C. The symptoms cause clinically significant distress or impairment in social, occupational, or other important areas of functioning.

D. The symptoms are not due to the direct physiological effects of a substance (eg, a drug of abuse, a medication) or a general medical condition (eg, hypothyroidism).

E. The symptoms are not better accounted for by Bereavement, eg, after the loss of a loved one, the symptoms persist for longer than 2 months or are characterized by marked functional impairment, morbid preoccupation with worthlessness, suicidal ideation, psychotic symptoms, or psychomotor retardation.

Diagnostic Criteria for Hypomanic Episode⁶

A. A distinct period of persistently elevated, expansive, or irritable mood, lasting throughout at least 4 days, that is clearly different from the usual nondepressed mood.

B. During the period of mood disturbance, 3 (or more) of the following symptoms have persisted (4 if the mood is only irritable) and have been present to a significant degree:

• (1) inflated self-esteem or grandiosity
• (2) decreased need for sleep (eg, feels rested after only 3 hours of sleep)
• (3) more talkative than usual or pressure to keep talking
• (4) flight of ideas or subjective experience that thoughts are racing
• (5) distractibility (eg, attention too easily drawn to unimportant or irrelevant external stimuli)
• (6) increase in goal-directed activity (either socially, at work or school, or sexually) or psychomotor agitation
• (7) excessive involvement in pleasurable activities that have a high potential for painful consequences (eg, the person engages in unrestrained buying sprees, sexual indiscretions, or foolish business investments)

C. The episode is associated with an unequivocal change in functioning that is uncharacteristic of the person when not symptomatic.

D. The disturbance in mood and the change in functioning are observable by others.

E. The episode is not severe enough to cause marked impairment in social or occupational functioning, or to necessitate hospitalization, and there are no psychotic features.

F. The symptoms are not due to the direct physiological effects of a substance (eg, a drug of abuse, a medication, or other treatment) or a general medical condition (eg, hyperthyroidism).

NOTE: Hypomanic-like episodes that are clearly caused by somatic antidepressant treatment (eg, medication, electroconvulsive therapy, light therapy) should not count toward a diagnosis of Bipolar II Disorder.

Criteria for the diagnosis of Bipolar I and II Disorder are provided to help healthcare professionals characterize conditions frequently comorbid with ADHD. CONCERTA^® is indicated only for the treatment of attention deficit hyperactivity disorder. CONCERTA^® should be used with caution in patients with bipolar disorder.

DSM-IV criteria for 300.02 Generalized Anxiety Disorder⁶

A. Excessive anxiety or worry (apprehensive expectation), occurring more days than not for 6 months, about a number of events or activities (such as work or school performance).

B. The person finds it difficult to control the worry.

C. The anxiety and worry are associated with three (or more) of the following six symptoms (with at least some symptoms present for more days than not for the past 6 months). NOTE: Only one item is required in children.

• (1) restlessness or feeling keyed up or on edge
• (2) being easily fatigued
• (3) difficulty concentrating or mind going blank
• (4) irritability
• (5) muscle tension
• (6) sleep disturbance (difficulty falling asleep or staying asleep, or restless, unsatisfying sleep)

D. The focus of the anxiety and worry is not confined to features of an Axis I disorder, eg, the anxiety or worry is not about having a Panic Attack (as in Panic Disorder), being embarrassed in public (as in Social Phobia), being contaminated (as in Obsessive-Compulsive Disorder), being away from home or close relatives (as in Separation Anxiety Disorder), gaining weight (as in Anorexia nervosa), having multiple physical complaints (as in Somatization Disorder), or having a serious illness (as in Hypochondriasis), and the anxiety and worry do not occur exclusively during Posttraumatic Stress Disorder.

E. The anxiety, worry, or physical symptoms cause clinically significant distress or impairment in social, occupational, or other important areas of functioning.

F. The disturbance is not due to the direct physiological effects of a substance (eg, a drug of abuse, a medication) or a general medical condition (eg, hyperthyroidism) and does not occur exclusively during a Mood Disorder, a Psychotic Disorder, or a Pervasive Developmental Disorder.

Criteria for the diagnosis of Generalized Anxiety Disorder are provided to help healthcare professionals characterize conditions frequently comorbid with ADHD. CONCERTA^® is indicated only for the treatment of attention deficit hyperactivity disorder. CONCERTA^® is contraindicated in patients with marked anxiety, tension, or agitation.

DSM-IV criteria for 300.03 Obsessive-Compulsive Disorder⁶

A. Either obsessions or compulsions:

• Obsessions defined by (1), (2), (3), and (4)
• (1) recurrent and persistent thoughts, impulses, or images that are experienced, at some time during the disturbance, as intrusive and inappropriate and that caused marked anxiety or distress
• (2) the thoughts, impulses, or images are not simply excessive worries about real-life problems
• (3) the person attempts to ignore or suppress such thoughts, impulses, or images, or to neutralize them with some other thought or action
• (4) the person recognizes that the obsessional thoughts, impulses, or images are a product of his or her own mind (not imposed from without as in thought insertion)
• Compulsions defined by (1) and (2)
• (1) repetitive behaviors (eg, hand-washing, ordering, checking) or mental acts (eg, praying, counting, repeating words silently) that the person feels driven to perform in response to an obsession, or according to rules that must be applied rigidly
• (2) the behaviors or mental acts are aimed at preventing or reducing distress or preventing some dreaded event or situation; however, these behaviors or mental acts either are not connected in a realistic way with what the are designed to neutralize or prevent, or are clearly excessive

B. At some point during the course of the disorder, the person has recognized that the obsessions or compulsions are unreasonable. NOTE: This does not apply to children.

C. The obsessions or compulsions cause marked distress, are time-consuming (take more than 1 hour a day), or significantly interfere with the person's normal routine, occupational (or academic) functioning, or usual social activities or relationships.

D. If another Axis 1 Disorder is present, the content of the obsessions or compulsions is not restricted to it (eg, preoccupation with food in the presence of an Eating Disorder; hair pulling in the presence of Trichotillomania; concern with appearance in the presence of Body Dysmorphic Disorder; preoccupation with drugs in the presence of a Substance Use Disorder; preoccupation with having a serious illness in the presence of Hypochondriasis; preoccupation with sexual urges or fantasies in the presence of Paraphilia; or guilty ruminations in the presence of Major Depressive Disorder).

E. The disturbance is not due to the direct physiological effects of a substance (eg, a drug of abuse, a medication) or a general medical condition.

Criteria for the diagnosis of Obsessive-Compulsive Disorder are provided to help healthcare professionals characterize conditions frequently comorbid with ADHD. CONCERTA^® is indicated only for the treatment of attention deficit hyperactivity disorder. CONCERTA^® is contraindicated in patients with marked anxiety, tension, or agitation.