WARNING
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.
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ABILIFY SUMMARY
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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NEWS HIGHLIGHTSMedia Articles Related to Abilify (Aripiprazole)
Schizophrenia
Source: MedicineNet Alcohol Abuse and Alcoholism Specialty [2009.10.30]
Title: Schizophrenia
Category: Diseases and Conditions
Created: 12/31/1997
Last Editorial Review: 10/30/2009
Forest Laboratories, Inc. And Gedeon Richter Announce Positive Results From A Phase IIb Study Of Cariprazine For The Treatment Of Schizophrenia
Source: Schizophrenia News From Medical News Today [2009.10.29]
Forest Laboratories, Inc. (NYSE: FRX) and Gedeon Richter Plc announced positive top-line results from a Phase IIb clinical trial of the novel, investigational antipsychotic agent cariprazine for the treatment of acute exacerbation of schizophrenia.
New "Schizophrenia Gene" Prompts Researchers To Test Potential Drug Target
Source: Autism News From Medical News Today [2009.10.27]
Johns Hopkins scientists report having used a commercially available drug to successfully "rescue" animal brain cells that they had intentionally damaged by manipulating a newly discovered gene that links susceptibility genes for schizophrenia and autism. The rescue, described as "surprisingly complete" by the researchers, was accomplished with rapamycin, a drug known to act on a protein called mTOR whose role involves the production of other proteins.
Onset Of Schizophrenia Triggered By Faulty 'Wiring' In The Brain
Source: Schizophrenia News From Medical News Today [2009.10.27]
A new study by researchers at the Institute of Psychiatry (IoP), King's College London has discovered abnormalities in the white matter of the brain that seem to be critical for the timing of schizophrenia. The study, led by Professor Phillip McGuire and Dr Sophia Frangou, has been published in this month's edition of the British Journal of Psychiatry. The white matter of the brain consists of nerve fibres that connect parts of the brain and help regulate behaviour.
Rare Mutation Linked To Autism Now Also Linked To Schizophrenia Risk
Source: Autism News From Medical News Today [2009.10.26]
An international team of researchers led by geneticist Jonathan Sebat, Ph.D., of Cold Spring Harbor Laboratory (CSHL), has identified a mutation on human chromosome 16 that substantially increases risk for schizophrenia. The mutation in question is what scientists call a copy number variant (CNV). CNVs are areas of the genome where the number of copies of genes differs between individuals. The CNV is located in a region referred to by scientists as 16p11.2.
Published Studies Related to Abilify (Aripiprazole)
Aripiprazole in major depression and mania: meta-analyses of randomized placebo-controlled trials. [2009.09]
OBJECTIVE: We performed meta-analyses to obtain pooled estimates from controlled clinical trials on the efficacy of aripiprazole in major depression disorder and manic phase of bipolar disorder... CONCLUSION: We found evidence suggesting that aripiprazole is effective in both depressive and manic patients, but has relevant side effects. Further research is needed to identify its benefits for comorbid patients and its long-term effect.
Focus on Aripiprazole: A Review of its use in Child and Adolescent Psychiatry. [2009.08]
CONCLUSION: Aripiprazole may represent an important alternative for some children and adolescents who have experienced poor efficacy or significant metabolic adverse effects with their current antipsychotic treatment regimen.
Immediate versus gradual suspension of previous treatments during switch to aripiprazole: results of a randomized, open label study. [2009.08]
The aim of the present work was to investigate possible differences in terms of efficacy and tolerability between different switching options to aripiprazole. 77 subjects were randomly assigned to (1) administration of aripiprazole (10 mg) with simultaneous discontinuation of current antipsychotic; (2) administration of aripiprazole (10 mg) and tapering off current antipsychotic over 4 weeks with half dose after the first 2 weeks; (3) administration of aripiprazole (10 mg) and tapering off current antipsychotic over 6 weeks with half dose after the first 2 weeks.
A 12-week, naturalistic switch study of the efficacy and tolerability of aripiprazole in stable outpatients with schizophrenia or schizoaffective disorder. [2009.07]
The objectives of this 12-week multicenter open-label switching study were to evaluate the overall clinical efficacy, safety, and tolerability of aripiprazole in stable patients with schizophrenia or schizoaffective disorder, and to assess, in a naturalistic setting, whether such patients experience symptom worsening when switched from D2 receptor antagonists to aripiprazole (a D2 receptor partial agonist)...
UK cost-consequence analysis of aripiprazole in schizophrenia: diabetes and coronary heart disease risk projections (STAR study). [2009.06]
Patients with schizophrenia experience elevated rates of morbidity and mortality, largely due to an increased incidence of cardiovascular disease and diabetes. There is increasing concern that some atypical antipsychotic therapies are associated with adverse metabolic symptoms, such as weight gain, dyslipidaemia and glucose dysregulation...
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 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).
Cognitive Improvement With Aripiprazole (Abilify) in Patients With Schizophrenia (BMS) [Terminated]
Evaluation of cognitive ability in patients with schizophrenia or schizoaffective disorder
both before and after a switch from risperidone 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 a verbal
learning task, as well as behavioral performance and associated electroencephalographic (EEG)
data of episodic memory, 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.
Evaluation of Effectiveness of Risperdal® Consta® Compared to Abilify® Over a Two-Year Period in Patients With Schizophrenia [Active, not recruiting]
The purpose of this study is to compare the effectiveness of two antipsychotic medications,
Risperdal® Consta® versus Abilify®, over a 2-year treatment period in the long-term
maintenance of patients with schizophrenia.
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 1 ratings/reviews, Abilify has an overall score of 3. The effectiveness score is 4 and the side effect score is 4. The scores are on ten point scale: 10 - best, 1 - worst.
| | Abilify review by 26 year old female patient | | | Rating |
| 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! |
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Page last updated: 2009-10-30
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