Abilify Indications/Uses

Schizophrenia: ABILIFY is indicated for the treatment of schizophrenia. The efficacy of ABILIFY in the treatment of schizophrenia was established in four short-term (4- and 6-week) controlled trials in adults and one 6-week trial in paediatrics (13 to 17 years). Maintenance efficacy was demonstrated in one trial in adults and can be extrapolated to paediatrics [see Pharmacology: Pharmacodynamics: CLINICAL STUDIES: Schizophrenia under Actions]. The physician who elects to use ABILIFY for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient [see DOSAGE & ADMINISTRATION].
Bipolar I Disorder: ABILIFY is indicated for the treatment of acute manic and mixed episodes associated with Bipolar I Disorder and for maintaining stability or preventing recurrence, as monotherapy in adults and in adolescents aged 13 years and older, and as an adjunct to lithium or valproate in adults.
The efficacy of ABILIFY as monotherapy was established in four 3-week monotherapy trials in adults and one 4-week monotherapy trial in paediatric patients. Efficacy as adjunctive therapy was established in one 6-week adjunctive trial in adults [see Pharmacology: Pharmacodynamics: CLINICAL STUDIES: Bipolar Disorder under Actions].
Maintenance efficacy was demonstrated in one monotherapy maintenance trial and in one adjunctive maintenance trial in adults [see Pharmacology: Pharmacodynamics: CLINICAL STUDIES: Bipolar Disorder under Actions]. Physicians who elect to use ABILIFY for extended periods, should periodically re-evaluate the long-term usefulness of the drug for the individual patient [see DOSAGE & ADMINISTRATION].
Adjunctive Treatment of Major Depressive Disorder: ABILIFY is indicated for use as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD).
Efficacy was established in three 6-week trials in adults with MDD who had an inadequate response to antidepressant therapy during the current episode [see Pharmacology: Pharmacodynamics: CLINICAL STUDIES: Adjunctive Treatment of Major Depressive Disorder under Actions].
Irritability Associated with Autistic Disorder: ABILIFY is indicated for the treatment of irritability associated with autistic disorder. Efficacy was established in two 8-week trials in paediatric patients (aged 6 to 17 years) with irritability associated with autistic disorder (including symptoms of aggression towards others, deliberate self-injuriousness, temper tantrums, and quickly changing moods) [see Pharmacology: Pharmacodynamics: CLINICAL STUDIES: Irritability Associated with Autistic Disorder under Actions].
The efficacy of ABILIFY for the maintenance treatment of irritability associated with autistic disorder was not established.
Tourette's Disorder: ABILIFY is indicated for the treatment of Tourette's disorder. Efficacy was established in one 8-week (aged 7 to 17 years) and one 10-week (aged 6 to 18 years) placebo-controlled trial in paediatric patients with Tourette's disorder [see Pharmacology: Pharmacodynamics: CLINICAL STUDIES: Tourette's Disorder under Actions].