Examining the efficacy, safety, and tolerability of an intramuscular formulation
of aripiprazole as maintenance treatment in Bipolar I Disorder
Please consider the ATLAS
Research Studies for
• 18 to 65 years of age, inclusive.
your patients who may benefit from a once-monthly
investigational drug for the management of Bipolar I Disorder.
rolling over into Protocol 31-08-252.
Despite the increased availability of oral treatment options for
• Diagnosed with Bipolar I Disorder.
Bipolar I Disorder, treatment adherence remains a significant problem
with nearly 50 percent of patients being partially adherent or nonadherent.1
As a result, one of the most common causes of relapse is poor treatment
severity to require hospitalization and /
adherence.2 Long-acting intramuscular (IM) formulations of antipsychotics
may have a positive impact on treatment adherence and potentially on
Otsuka Pharmaceutical Development & Commercialization, Inc. is
: All eligible study participants
sponsoring the ATLAS
Research Studies to determine if an IM depot
will receive study-related care and study
formulation of aripiprazole – administered once monthly – may be an
drugs at no cost, and health insurance is
effective option for managing Bipolar I Disorder. The proven efficacy of
oral aripiprazole as maintenance treatment for Bipolar I Disorder, combined with the potential added benefit of adherence with an IM depot formulation,
Please contact the person who provided you with this information sheet.
* Approved rescue medications for Protocol 31-08-252 may not be provided or paid for by Otsuka Pharmaceutical Development and Commercialization, Inc.
Additionally, health insurance requirements may vary on a country-by-country basis in adherence with government regulations.
Aripiprazole (Otsuka Pharmaceutical Company, Ltd [OPC]-
Aripiprazole exhibits high affinity for dopamine D and D ,
14597) is a novel dopamine-serotonin system stabilizer
serotonin 5-HT and 5-HT receptors, moderate affinity for
discovered by OPC. The favorable side-effect profile of oral
dopamine D , serotonin 5-HT and 5-HT , alpha1-adrenergic
aripiprazole, including its low incidence of extrapyramidal
and histamine H1 receptors (Ki values of 44 nM, 15 nM, 39
symptoms (EPS), low risk of prolactin elevation, decreased
nM, 57 nM, and 61 nM, respectively), and moderate affinity
adrenergic and anticholinergic side effects, and minimal
for the serotonin reuptake site (Ki = 98 nM). Aripiprazole has
weight gain, makes it an excellent candidate for a long-
no appreciable affinity for cholinergic muscarinic receptors
acting depot formulation. Aripiprazole IM depot formulation
(IC50 > 1000 nM). Aripiprazole functions as a partial agonist
is also being studied in patients with schizophrenia.
at the dopamine D and the serotonin 5-HT receptors, and
as an antagonist at serotonin 5-HT receptor.
Mechanism of ActionThe mechanism of action of aripiprazole differs from that
of currently marketed typical and atypical antipsychotics.
Aripiprazole IM depot (400 mg/vial) is a sterile, non-pyrogenic,
It has been proposed that aripiprazole’s effectiveness in
single-dose, lyophilized cake, which when reconstituted with
psychiatric disorders, such as schizophrenia and Bipolar
sterile water for injection, forms an injectable suspension.
I Disorder, is mediated through a combination of partial agonism / antagonism at dopamine D and serotonin
5-HT receptors. Aripiprazole has the properties of an
agonist in an animal model of dopaminergic hypoactivity
1. Sajatovic M, Valenstein M, Blow FC, Ganoczy D, Ignacio RV.
and the properties of an antagonist in animal models of
Treatment adherence with antipsychotic medications in Bipolar Disorder. Bipolar Disord. 2006;8:232-41.
dopaminergic hyperactivity. Aripiprazole exhibits high affinity for dopamine D and D , serotonin 5-HT , and
2. Sajatovic M, Davies M, Hrouda DR. Enhancement of treatment
adherence among patients with Bipolar Disorder. Psychiatr
5-HT receptors. It seems likely that the favorable safety
and tolerability profile of aripiprazole is also mediated by
3. Chue P, Emsley R. Long-acting formulations of atypical
its unique profile of interaction with central neuroreceptors.
antipsychotics: Time to reconsider when to introduce depot antipsychotics. CNS Drugs. 2007;21:441-48.
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