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)
Aripiprazole (ABILIFY®) Approved For The Treatment Of Moderate To Severe Manic Episodes In Bipolar I Disorder In Adolescents Source: Bipolar News From Medical News Today [2013.02.08] Otsuka Pharmaceutical Co., Ltd. announced today that the European Medicines Agency (EMA) has approved a label extension for aripiprazole for the treatment up to 12 weeks of moderate to severe manic episodes in Bipolar I Disorder in adolescents aged 13 and older...
Schizophrenia 'Guideline of Guidelines' Released Source: Medscape Psychiatry & Mental Health Headlines [2013.05.16] New "meta-guidelines" combining recommendations from several expert organizations on the management and treatment of schizophrenia have been released. Medscape Medical News
Model Cell System Offers Insights Into Epilepsy, Schizophrenia, Other Neuropsych Disorders Source: Autism News From Medical News Today [2013.05.06] Medical researchers have manipulated human stem cells into producing types of brain cells known to play important roles in neurodevelopmental disorders such as epilepsy, schizophrenia and autism...
Neurons In The Nose Could Be The Key To Early, Fast, And Accurate Diagnosis Of Schizophrenia Source: Schizophrenia News From Medical News Today [2013.05.01] A debilitating mental illness, schizophrenia can be difficult to diagnose. Because physiological evidence confirming the disease can only be gathered from the brain during an autopsy, mental health professionals have had to rely on a battery of psychological evaluations to diagnose their patients. Now, Dr. Noam Shomron and Prof...
Schizophrenia May Be Diagnosed By Testing Nerve Cells From The Nose Source: Schizophrenia News From Medical News Today [2013.05.01] Collecting neurons from the nose could be a fast way to test for schizophrenia, a debilitating mental illness that is often difficult to diagnose. This was the finding of a new study led by researchers from Tel Aviv University (TAU) in Israel...
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.
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�) 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).
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 >>
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PATIENT REVIEWS / RATINGS / COMMENTSBased 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 | | | Rating |
| 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 |
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| | 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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| | Abilify review by 50 year old male patient | | | Rating |
| 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. |
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Page last updated: 2013-05-16
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