Aripiprazole
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Aripiprazole is a prescription drug used for the treatment of schizophrenia, bipolar disorder and depression. It was approved in November 2002 for use in schizophrenia and gained approval later for its other indications.
Aripiprazole belongs to a sub-family of psychiatric drugs called atypical antipsychotics or second generation antipsychotics. These drugs are also sometimes called neuroleptics. Other members of this family include clozapine (Clozaril), risperidone (Risperdal), olanzapine (Zyprexa), quetiapine (Seroquel), ziprasidone (Geodon), and amisulpriride.
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Other Names
Aripiprazole is co-marketed as Abilify by Bristol-Myers Squibb and Otsuka Pharmaceuticals.
Uses
Aripiprazole is specifically indicated for:
- Acute and maintenance treatment of schizophrenia in adults and in adolescents 13-17 years of age
- Acute and maintenance treatment of manic and mixed episodes associated with bipolar disorder with or without psychotic features in adults and adolescents 10-17 years of age
- Combination therapy with lithium or valproate for the acute treatment of manic and mixed episodes associated with bipolar disorder with or without psychotic features in adults and in adolescents 10-17 years of age.
- Combination therapy with antidepressants for the acute treatment of major depressive disorder in adults.
The injection form of Aripiprazole is indicated for the acute treatment of agitation associated with schizophrenia or bipolar disorder (manic or mixed) in adults.
How Aripiprazole is Taken
Aripiprazole is available in tablets containing 2, 5, 10, 15, 20, or 30 mg of active ingredient; as orally-disintegrating tablets containing 10 or 15 mg active ingredient; and as a 1 mg/mL solution.
Schizophrenia
The recommended starting and target dose for adults is 10 mg/day or 15 mg/day administered on a once-a-day schedule.
The recommended target dose in adolescents is 10 mg/day.
Bipolar Disorder
The recommended starting and target dose is 15 mg by itself or as a combination therapy with lithium or valproate given once a day.
Combination Treatment for Major Depressive Disorder
The recommended starting dose as a combination treatment for patients already taking an antidepressant is 2 mg/day to 5 mg/day.
Agitation Associated with Schizophrenia or Bipolar Mania (Intramuscular Injection)
The recommended dose for the treatment of agitation is 9.75 mg.
How Aripiprazole Works
The mechanism of action of aripiprazole is unknown.
However, it has been proposed that the efficacy of aripiprazole is mediated through a combination of partial increasing uptake of dopamine D2 and serotonin 5-HT1A at their receptors, and decreasing uptake of serotonin 5-HT2A at its receptors.
How the Body Affects Aripiprazole
Aripiprazole is well absorbed, with peak circulating levels occurring within 3 hours to 5 hours after dosing.
The liver enzymes CYP3A4 and CYP2D6 enzymes are responsible for the metabolism of aripiprazole.
Approximately 25% and 55% of the original dose is excreted in the urine and feces, respectively.
Side Effects
The most commonly observed side effects in adults(occurring in ≥ 10% of treated adults) are:
- Nausea
- Vomiting
- Constipation
- Headache
- Dizziness
- Akathisia (inner restlessness)
- Anxiety
- Insomnia
- Restlessness
The most commonly observed side effects in children (occurring in ≥ 10% of treated children) are:
- Sleepiness
- Extrapyramidal disorder (abnormal movements of the body, head, or tongue)
- Headache
- Nausea
Risks and Precautions
Antipsychotics like Aripiprazole may cause an increase in suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment. Patients and their family members are advised to pay close attention to changes in mood, feelings, thoughts and behaviors. There exists as yet no compelling explanation for a drug-induced mechanism that triggers suicidal thinking or behavior, although akathisia, a drug-induced disorder of abnormal movements (restlessness and pacing) and intense anxiety linked to all antipsychotics and to a lesser extent to SSRI antidepressants, has been proposed as a likely mechanism.
Drug Interactions
The liver enzymes CYP3A4 and CYP2D6 are responsible for aripiprazole metabolism.
Therefore, medicines that affect CYP3A4 (like ketoconazole) or CYP2D6 (like quinidine,fluoxetine,or paroxetine) could affect circulating levels of aripiprazole.
Effectiveness
In approaching the issue of effectiveness of atypical antipsychotics, the source of funding of studies should be kept in mind because in head-to-head comparisons of various atypical antipsychotics, the study sponsor's drug came out ahead more than 9 times out of 10.[1]
The effectiveness of most atypical antipsychotics has been shown to be the same as that of the older, "typical" drugs that they replaced. Intensive drug industry marketing of atypical antipsychotics since the early 1990s persuaded most physicians to view them as more effective and safer than the older antipsychotics, and they replaced older drugs as first-line treatments in psychosis. However, the landmark CATIE study funded by the National Institute of Mental Health, showed otherwise. The study recruited nearly 1,500 individuals diagnosed with schizophrenia and randomly assigned them to receive one of five different drugs (four atypicals: olanzapine [Zyprexa], risperidone [Risperdal], quetiapine [Seroquel], ziprasidone [Geodon]; and one older drug rarely prescribed today, perphenazine [Trilafon]). After 18 months, between 62% and 84% of patients had quit their treatment, owing to "intolerable side effects or lack of efficacy or other reasons." [2] Similar findings have been reported in several other studies without industry funding since 2005.
In a 52-week trial in patients with acute relapse of schizophrenia, the percentage of responders maintaining a therapeutic response at the end of the study was 77% of aripiprazole patients versus 73% of haloperidol (another antipsychotic) patients.[3]
Another study demonstrated that aripiprazole delayed the time to relapse in adults with bipolar disorder who had a recent manic or mixed episode and were then stabilized with aripiprazole for at least six weeks.[4]
Another study showed that treatment with Aripiprazole resulted in significant improvement in depressive symptoms in patients with major depressive disorder.[5]
Another study demonstrated that intramuscular injection (IM) Abilify is a well-tolerated alternative to IM haloperidol for the treatment of agitation in patients with schizophrenia.[6]
References
- ↑ Heres S, Davis J, Maino K, Jetzinger E, Kissling W, Leucht S. Why olanzapine beats risperidone, risperidone beats quatiapine, and quetiapine beats olanzapine: an exploratory analysis of head-to-head comparison studies of second-generation antipsychotics. American Journal of Psychiatry 2006(2); 163: 185-194. [1]
- ↑ Lieberman JA, Stroup TS, McEvoy JP, Rosenheck RA, Perkins DO, Keefe RSE et al. Effectiveness of antipsychotic drugs in patients with schizophrenia. New England Journal of Medicine 2005;353(12): 1209-23. [2]
- ↑ Swainston Harrison T, Perry CM. Aripiprazole: a review of its use in schizophrenia and schizoaffective disorder. Drugs. 2004;64(15):1715-36. Abstract
- ↑ ABILIFY(R) (aripiprazole) Demonstrated Efficacy As Long-Term Maintenance Therapy In Adults With Bipolar I Disorder, Medical News Today, 8 Dec 2006
- ↑ Efficacy And Safety Of Aripiprazole As Adjunctive Therapy In Major Depressive Disorder Medical News Today, 28 May 2007
- ↑ Tran-Johnson TK, Sack DA, Marcus RN, Auby P, McQuade RD, Oren DA. Efficacy and safety of intramuscular aripiprazole in patients with acute agitation: a randomized, double-blind, placebo-controlled trial. J Clin Psychiatry. 2007 Jan;68(1):111-9. Abstract
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