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Abilify (Aripiprazole) - Summary

 



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.

 

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 HIGHLIGHTS

Media Articles Related to Abilify (Aripiprazole)

Immune System Activated In Schizophrenia
Source: Immune System / Vaccines News From Medical News Today [2009.11.19]
Researchers at the Swedish medical university Karolinska Institutet have discovered that patients with recent-onset schizophrenia have higher levels of inflammatory substances in their brains. Their findings offer hope of being able to treat schizophrenia with drugs that affect the immune system. The causes of schizophrenia are largely unknown, and this hinders the development of effective treatments.

Major Schizophrenia Study Finds Striking Similarities Across 37 Countries In Six Regions
Source: Mental Health News From Medical News Today [2009.11.16]
An international study of more than 17,000 people with schizophrenia has found striking similarities in symptoms, medication, employment and sexual problems, despite the fact that it covered a diverse range of patients and healthcare systems in 37 different countries.

World's Leading Experts In Schizophrenia To Meet At 26th Annual Pittsburgh Schizophrenia Conference Nov. 13
Source: Schizophrenia News From Medical News Today [2009.11.08]
Internationally renowned experts in schizophrenia and other psychotic disorders, researchers and clinicians, patients and their families and friends will gather in Pittsburgh to discuss the latest in research and clinical advances at the 26th Annual Pittsburgh Schizophrenia Conference to be held Friday, Nov. 13, at the Sheraton Station Square, Pittsburgh.

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.

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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...

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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 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 / COMMENTS

Based 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: 2009-11-19

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