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Abilify (Aripiprazole) - Summary



Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (eg, heart failure, sudden death) or infectious (eg, pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. ABILIFY (aripiprazole) is not approved for the treatment of patients with dementia-related psychosis. [see WARNINGS AND PRECAUTIONS ]

Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of adjunctive ABILIFY or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. ABILIFY is not approved for use in pediatric patients with depression. [see WARNINGS AND PRECAUTIONS ]



Aripiprazole is a psychotropic drug that is available as ABILIFY (aripiprazole) Tablets, ABILIFY DISCMELT (aripiprazole) Orally Disintegrating Tablets, ABILIFY (aripiprazole) Oral Solution, and ABILIFY (aripiprazole) Injection, a solution for intramuscular injection. Aripiprazole is 7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydrocarbostyril.


ABILIFY is indicated for the treatment of schizophrenia. The efficacy of ABILIFY was established in four 4-6 week trials in adults and one 6-week trial in adolescents (13 to 17 years). Maintenance efficacy was demonstrated in one trial in adults and can be extrapolated to adolescents. [see CLINICAL STUDIES ]

Bipolar I Disorder

Acute Treatment of Manic and Mixed Episodes

ABILIFY is indicated for the acute treatment of manic and mixed episodes associated with bipolar I disorder, both as monotherapy and as an adjunct to lithium or valproate. Efficacy as monotherapy was established in four 3-week monotherapy trials in adults and one 4-week monotherapy trial in pediatric patients (10 to 17 years). Efficacy as adjunctive therapy was established in one 6-week adjunctive trial in adults. [see CLINICAL STUDIES ]

Maintenance Treatment of Bipolar I Disorder

ABILIFY is indicated for the maintenance treatment of bipolar I disorder, both as monotherapy and as an adjunct to either lithium or valproate. Maintenance efficacy was demonstrated in one monotherapy maintenance trial and in one adjunctive maintenance trial in adults. [see CLINICAL STUDIES ]

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 two 6-week trials in adults with MDD who had an inadequate response to antidepressant therapy during the current episode. [see CLINICAL STUDIES ]

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 pediatric 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 CLINICAL STUDIES ]

Agitation Associated with Schizophrenia or Bipolar Mania

ABILIFY Injection is indicated for the acute treatment of agitation associated with schizophrenia or bipolar disorder, manic or mixed. “Psychomotor agitation” is defined in DSM-IV as “excessive motor activity associated with a feeling of inner tension.” Patients experiencing agitation often manifest behaviors that interfere with their diagnosis and care (eg, threatening behaviors, escalating or urgently distressing behavior, or self-exhausting behavior), leading clinicians to the use of intramuscular antipsychotic medications to achieve immediate control of the agitation. Efficacy was established in three short-term (24-hour) trials in adults. [see CLINICAL STUDIES ]

Special Considerations in Treating Pediatric Schizophrenia, Bipolar I Disorder, and Irritability Associated with Autistic Disorder

Psychiatric disorders in children and adolescents are often serious mental disorders with variable symptom profiles that are not always congruent with adult diagnostic criteria. It is recommended that psychotropic medication therapy for pediatric patients only be initiated after a thorough diagnostic evaluation has been conducted and careful consideration given to the risks associated with medication treatment. Medication treatment for pediatric patients with schizophrenia, bipolar I disorder, and irritability associated with autistic disorder is indicated as part of a total treatment program that often includes psychological, educational, and social interventions.

See all Abilify indications & dosage >>


Media Articles Related to Abilify (Aripiprazole)

FDA approves first generic Abilify to treat mental illnesses
Source: Bipolar News From Medical News Today [2015.04.30]
The U.S. Food and Drug Administration has approved the first generic versions of Abilify (aripiprazole).

Cognitive Therapy May Reduce Insomnia in Patients With Schizophrenia
Source: Medscape Medical News Headlines [2015.10.02]
Cognitive behavioral therapy (CBT) may reduce insomnia in patients with persistent delusions or hallucinations, a new study suggests.
Reuters Health Information

ERs Often 'Safety Net' Care for People With Schizophrenia: CDC
Source: MedicineNet Schizophrenia Specialty [2015.09.24]
Title: ERs Often 'Safety Net' Care for People With Schizophrenia: CDC
Category: Health News
Created: 9/23/2015 12:00:00 AM
Last Editorial Review: 9/24/2015 12:00:00 AM

Repairing the brain - Two genes unlock potential for treatment of schizophrenia
Source: Schizophrenia News From Medical News Today [2015.09.21]
Research led by scientists from Duke-NUS Graduate Medical School Singapore (Duke-NUS) has linked the abnormal behaviour of two genes (BDNF and DTNBP1) to the underlying cause of schizophrenia.

Vraylar Approved for Schizophrenia, Bipolar Disorder
Source: MedicineNet Bipolar Disorder Specialty [2015.09.21]
Title: Vraylar Approved for Schizophrenia, Bipolar Disorder
Category: Health News
Created: 9/18/2015 12:00:00 AM
Last Editorial Review: 9/21/2015 12:00:00 AM

more news >>

Published Studies Related to Abilify (Aripiprazole)

Efficacy and safety of aripiprazole in Chinese Han schizophrenia subjects: a randomized, double-blind, active parallel-controlled, multicenter clinical trial. [2014]
CONCLUSION: The study demonstrated that aripiprazole, as well as risperidone, had

A head-to-head comparison of aripiprazole and risperidone for safety and treating autistic disorders, a randomized double blind clinical trial. [2014]
Aripiprazole and risperidone are the only FDA approved medications for treating irritability in autistic disorder, however there are no head-to-head data comparing these agents. This is the first prospective randomized clinical trial comparing the safety and efficacy of these two medications in patients with autism spectrum disorders...

Systematic review of clinical trials of aripiprazole for treating attention deficit hyperactivity disorder. [2013]
This systematic review assesses the effectiveness and safety of aripiprazole for treating attention deficit hyperactivity disorder (ADHD). The databases of PubMed/MEDLINE and Google Scholar were searched...

A multicenter, randomized, double-blind, placebo-controlled study of aripiprazole in children and adolescents with Tourette's disorder. [2013]
CONCLUSIONS: In comparison with placebo, aripiprazole was efficacious, generally

Early antipsychotic response to aripiprazole in adolescents with schizophrenia: predictive value for clinical outcomes. [2013]
CONCLUSIONS: Like adults with chronic schizophrenia, adolescents with early-phase

more studies >>

Clinical Trials Related to Abilify (Aripiprazole)

Aripiprazole and Topiramate on Free-Choice Alcohol Use [Recruiting]
The current study investigates the effects of two potential alcohol treatment medications on drinking in a laboratory setting. Aripiprazole (APZ), effects dopamine and serotonin receptors with fewer limiting side effects seen with other atypical antipsychotics. Topiramate (TPMT), an antiepileptic, affects glutamate and GABA-A receptors and shows promise in reducing heavy drinking. Few studies have used two medications with such a diverse combination of actions to examine a potential synergistic effect on reducing alcohol consumption. The primary aims are to: 1. determine if APZ and TPMT are each more effective than placebo, and the combination of APZ and TPMT is more effective than either drug alone or placebo, in reducing alcohol use in non-treatment seeking alcohol dependent subjects in a laboratory based alcohol self-administration experiment (ASAE) 2. examine a hypothesized dose-response for three doses of APZ (0, 7. 5 mg/d and 15 mg/d) along with three doses of TPMT (0, 100mg/d and 200mg/d) 3. examine the putative mechanisms of action of APZ, TPMT alone and together on craving, subjective stimulation, candidate gene influences and other behavioral effects associated with alcohol consumption 4. establish the safety of giving APZ and TPMT together. Non-treatment seeking, alcohol dependent Participants (N=216) will be recruited from the community and randomly assigned to one of the 9 cells. Subjects drinking and safety is monitored over a 5-week titration to their target dose, leading to an in-laboratory alcohol self administration session, during which clinical and behavioral effects are assessed during access to alcohol. A 1 month follow-up assesses adverse events and drinking.

Intramuscular Depot Formulation of Aripiprazole as Maintenance Treatment in Patients With Schizophrenia [Completed]
The purpose of the this trial is to evaluate the efficacy, safety, and tolerability of an intramuscular (IM) depot formulation of aripiprazole as maintenance treatment in patients with schizophrenia The trial is designed into three treatment phases. Phase 1 is designed to allow for a subject to be converted from the current anti-psychotic treatment to oral non-generic aripiprazole monotherapy (oral conversion phase from 4 to 6 weeks). During Phase 2 the subject will be stabilized on oral non-generic aripiprazole monotherapy. Once the subject is stabilized in Phase 2 (oral stabilization phase from minimum 8 weeks to maximum 28 weeks), they are eligible to be randomized into the double-blind IM depot maintenance phase, Phase 3. During Phase 3, the subject will be assessed for exacerbation of psychotic symptoms and impending relapse for up to 38 weeks.

Comparative Bioavailability Study of Aripiprazole 10 mg Oral Soluble Film vs Abilify 10 mg Tablet in Healthy Volunteers [Not yet recruiting]

Efficacy of Aripiprazole Versus Placebo in the Reduction of Aggressive and Aberrant Behavior in Autistic Children [Completed]
Hypothesis: (1) Aripiprazole treatment will be superior to placebo in reducing aggression and irritability in autistic individuals as shown by reductions in the Aberrant Behavior Checklist-irritability subscale. (2) Aripiprazole treatment will be superior to placebo in the acute treatment of global autism severity. The purpose of this study is to examine the possible benefit of the medication Aripiprazole in autistic individuals.

Efficacy & Safety Study of Once-weekly Oral Aripiprazole in Children and Adolescents With Tourette's Disorder [Completed]
The goal of the current trial is to determine efficacy and safety of Once-weekly aripiprazole in reducing Total Tic Severity in children and adolescents with Tourette's Disorder.

more trials >>

Reports of Suspected Abilify (Aripiprazole) Side Effects

Weight Increased (234)Tardive Dyskinesia (173)Tremor (133)Dyskinesia (113)Akathisia (96)Drug Ineffective (83)Insomnia (81)Pregnancy (80)Psychotic Disorder (75)Suicidal Ideation (72)more >>


Based on a total of 8 ratings/reviews, Abilify has an overall score of 5.38. The effectiveness score is 7.25 and the side effect score is 7. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.

Abilify review by 43 year old female patient

Overall rating:  
Effectiveness:   Highly Effective
Side effects:   No Side Effects
Treatment Info
Condition / reason:   depression/anxiety
Dosage & duration:   2 mg taken daily for the period of 3 months
Other conditions:   anxiety
Other drugs taken:   Lexapro
Reported Results
Benefits:   Within 1 week of taking the cocktail of Abilify and Lexapro, a extremely unorganized person....became organized. I am now able to remember appointment times, keep up with my daily responsibilities...it has been a lifesaver
Side effects:   no side effects have been noticed
Comments:   I take one pill of each 1st thing in the am.....I am feeling better than ever


Abilify review by 26 year old female patient

Overall rating:  
Effectiveness:   Marginally Effective
Side effects:   Severe Side Effects
Treatment Info
Condition / reason:   bipolar disorder
Dosage & duration:   15mg taken daily for the period of 12 weeks
Other conditions:   none
Other drugs taken:   Cymbalta, 90mg/daily
Reported Results
Benefits:   I didn't notice any benefit at all. Supposedly, it was to help keep my mood balanced. More than anything, I was focused on the very apparent and prevalent side effects.
Side effects:   A very uncomfortable inner restlessness was the worst side effect. I felt like I had to constantly get up and move around, but it didn't even help. I couldn't sit still, had major problems sleeping at night, AND started gaining weight.
Comments:   I was prescribed Abilify (15mg/daily) to assist in moderating my mood. In the three months I took it, I did not notice any significant improvement in mood stability, and DID notice majorly debilitating side effects. I finally convinced my doctor to wean me off of it, and I guarantee I will never go back!


Abilify review by 50 year old male patient

Overall rating:  
Effectiveness:   Ineffective
Side effects:   Severe Side Effects
Treatment Info
Condition / reason:   bipolar
Dosage & duration:   2mg to start taken once daily for the period of 2 days
Other conditions:   anxiety
Other drugs taken:   klonopin
Reported Results
Benefits:   None due to the short time taking drug.
Side effects:   Headache first morning at 4AM that was relieved with Excedrin. Migraine headache with vomiting that lasted 14 hours. Couldn't go to work that day and stopped taking it.
Comments:   Not much to tell. I was just starting treatment with Klonopin and Abilify with the goal of stopping Klonopin in 30 days and then seeing how Abilify was working.

See all Abilify reviews / ratings >>

Page last updated: 2015-10-02

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