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Abilify (Aripiprazole) - Summary



Increased Mortality in Elderly Patients with Dementia-Related Psychosis

Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks) in these patients revealed a risk of death in the drug-treated patients of between 1.6 to 1.7 times that seen 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. ABILIFY (aripiprazole) is not approved for the treatment of patients with dementia-related psychosis.



ABILIFY® (aripiprazole) is a psychotropic drug that is available as tablets for oral administration.

ABILIFY (aripiprazole) is indicated for the treatment of schizophrenia. The efficacy of ABILIFY in the treatment of schizophrenia was established in short-term (4- and 6-week) controlled trials of schizophrenic inpatients (see CLINICAL PHARMACOLOGY: Clinical Studies).

The efficacy of ABILIFY in maintaining stability in patients with schizophrenia who had been symptomatically stable on antipsychotic medications for periods of 3 months or longer, were discontinued from those other medications, and were then administered ABILIFY 15 mg/day and observed for relapse during a period of up 26 weeks was demonstrated in a placebo-controlled trial (see CLINICAL PHARMACOLOGY: Clinical Studies). 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 AND ADMINISTRATION).
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Media Articles Related to Abilify (Aripiprazole)

Help for schizophrenia patients and their caregivers
Source: Caregivers / Homecare News From Medical News Today [2014.11.14]
University of Miami researchers are developing a novel, culturally informed, family therapy for schizophreniaResearchers at the University of Miami (UM) have developed a family-focused...

New real-world data highlight health and financial impact of caring for an adult with schizophrenia
Source: Caregivers / Homecare News From Medical News Today [2014.11.12]
Data presented at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Annual European Congress, Amsterdam, The Netherlands, reveal that caregivers of adults with...

Robot may explain some symptoms in schizophrenia and other neurological conditions
Source: Epilepsy News From Medical News Today [2014.11.10]
People don't really tend to see ghosts or guardian angels as much as "feel" them, and now researchers reporting in the Cell Press journal Current Biology think they know where that "feeling of a...

A fifth of schizophrenia cases 'may be attributable to T. gondii infection'
Source: Schizophrenia News From Medical News Today [2014.11.02]
A researcher from the University of Pennsylvania calculates that Toxoplasma gondii - a parasite that causes toxoplasmosis - may be involved in more than 20% of schizophrenia cases.

EEG test to help understand and treat schizophrenia
Source: Schizophrenia News From Medical News Today [2014.11.01]
Researchers at University of California, San Diego School of Medicine have validated an EEG test to study and treat schizophrenia.

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Published Studies Related to Abilify (Aripiprazole)

Aripiprazole plus divalproex for recently manic or mixed patients with bipolar I disorder: a 6-month, randomized, placebo-controlled, double-blind maintenance trial. [2011.12.02]
OBJECTIVES: The goal of this study was to investigate the safety and efficacy in preventing relapse of a mood episode in recently manic or mixed episode patients with bipolar I disorder stabilized with aripiprazole and divalproex combination... CONCLUSIONS: In this study, relapse of mood episode occurred fewer and later for aripiprazole with divalproex treatment than divalproex monotherapy, but the differences were not statistically significant. Copyright (c) 2011 John Wiley & Sons, Ltd. Copyright (c) 2011 John Wiley & Sons, Ltd.

Aripiprazole treatment for patients with schizophrenia: from acute treatment to maintenance treatment. [2011.11]
The most current treatment guidelines for schizophrenia recommend more than 1 year of maintenance therapy after the first psychotic episode, and more than 5 years of maintenance therapy after multiple psychotic episodes. Approximately two-thirds of such patients are known to relapse within 1 year and almost 90% of such patients may recur within 2 years...

Adjunctive low-dose aripiprazole with standard-dose sertraline in treating fresh major depressive disorder: a randomized, double-blind, controlled study. [2011.10]
OBJECTIVES: Second-generation (atypical) antipsychotics have been accepted as an adjunctive medication in patients with treatment-resistant depression. This clinical trial evaluated the efficacy and safety of low-dose aripiprazole combined with regular-dose sertraline for acute major depressive episode in non-treatment-resistant depression outpatients... CONCLUSIONS: The primitive data showed that adjunctive low-dose aripiprazole could augment the efficacy of regular-dose sertraline in fresh major depressive disorder. A large-scale study is needed to confirm this finding.

Efficacy of dose increase among nonresponders to low-dose aripiprazole augmentation in patients with inadequate response to antidepressant treatment: a randomized, double-blind, placebo-controlled, efficacy trial. [2011.09.20]
CONCLUSIONS: Augmentation with aripiprazole 5 mg/d may provide only a modest additional benefit in patients who do not benefit from lower doses. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00683852. (c) Copyright 2011 Physicians Postgraduate Press, Inc.

Rationale and baseline characteristics of PREVENT: a second-generation intervention trial in subjects at-risk (prodromal) of developing first-episode psychosis evaluating cognitive behavior therapy, aripiprazole, and placebo for the prevention of psychosis. [2011.09]
Antipsychotics, cognitive behavioral therapy (CBT), and omega-3-fatty acids have been found superior to control conditions as regards prevention of psychosis in people at-risk of first-episode psychosis. However, no large-scale trial evaluating the differential efficacy of CBT and antipsychotics has been performed yet.

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Clinical Trials Related to Abilify (Aripiprazole)

The Combination of Aripiprazole and Antidepressants in Psychotic Major Depression [Active, not recruiting]
The purpose of the study is to assess the safety and effectiveness of the combination of aripiprazole (Abilify) and selective serotonin reuptake inhibitors (SSRIs) in subjects with psychotic major depression.

Cognitive Improvement With Aripiprazole (Abilify) in Patients With Schizophrenia (SFBRI) [Terminated]
This is the sister study to the BMS "Cognitive Improvement with Aripiprazole (Abilify)" study (LSUHSC #H04-022). Evaluation of cognitive ability in patients with schizophrenia or schizoaffective disorder both before and after a switch from risperidone, olanzapine, or risperidone Consta injections to aripiprazole may reveal some of the cognitive changes that correlate with the improved response, better side effect profile, and effects on other components of the negative symptom array. Further, examination of brain functional activity using functional magnetic resonance imaging (fMRI) during an episodic memory task, as well as behavioral performance and associated electroencephalographic (EEG) data of working memory and intermediate term verbal memory collected with the Sustained Attention and Memory Brain Function Test (SAM-BFT), may also provide data showing the neural correlates of these changes in cognition.

Aripiprazole (Abilify´┐Ż) as an Adjunctive Treatment for Inadequate Response in Major Depressive Disorder [Recruiting]
The investigators hypothesized that combined pharmacotherapy using adjunctive aripiprazole of standard antidepressants would be associated with improved depression response in Major depressive disorder, especially in Quality of life.

The investigators compare the mean changes in the quality of life between before add-on and 8 weeks treatment of aripiprazole and between before add-on and 6 weeks treatment of 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.

Aripiprazole in Late Life Bipolar Disorder [Completed]
The purpose of this research study is to analyze the effectiveness and tolerability of a new medication, aripiprazole (Abilify), in individuals age 50 years and older who have bipolar disorder (manic-depressive illness).

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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: 2014-11-14

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