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PubMed2005

Aripiprazole: pharmacology, efficacy, safety and tolerability.

Aripiprazole is a recently released antipsychotic medication which differs from other atypical antipsychotic agents by its partial agonist activity at postsynaptic D2 receptors. It is administered orally and is distinguished by a long elimination phase half-life relative to other antipsychotic medications. Randomized studies have demonstrated the efficacy of aripiprazole relative to placebo in the treatment of acute relapse of schizophrenia and schizoaffective disorder, maintenance treatment of schizophrenia, and treatment of acute bipolar mania. Aripiprazole is generally well tolerated relative to other antipsychotic medications, although commonly reported side effects include worsening extrapyramidal symptoms and motoric activation similar to akathisia. Further studies and postmarketing data will be helpful in providing additional information about the comparative safety, efficacy and tolerability of aripiprazole.

Animals↗
PubMed2006

Role of aripiprazole in treating mood disorders.

Atypical antipsychotics have been used to treat patients with schizophrenia for many years, but now there is increasing evidence of their utility in the treatment of mood disorders. In the past few years, several atypical agents have received regulatory approval for use in mania. The evidence shows that atypical antipsychotics are effective in the treatment of manic symptoms, either alone or in combination with traditional mood stabilizers, such as lithium and divalproex. Although emerging data indicate that atypical antipsychotics will be a promising addition to those therapies that are currently available for managing patients during the maintenance phase of bipolar illness, their potential in the long-term management of bipolar disorder remains to be fully explored. Aripiprazole is a recently released antipsychotic medication that differs from other atypical antipsychotic agents by its mode of action as a dopamine D2 partial agonist. It is administered orally and has a long half-life. Randomized studies have demonstrated the efficacy of aripiprazole compared with placebo in the treatment of acute relapse of schizophrenia and schizoaffective disorder, maintenance treatment of schizophrenia, treatment of acute mania, and prevention of manic relapse in patients who responded to the drug during a manic episode. Further studies are ongoing in bipolar and unipolar depression. Aripiprazole is generally well tolerated compared with other antipsychotic medications, although commonly reported side effects include extrapyramidal symptoms and motoric activation similar to akathisia. Further studies and postmarketing data will be helpful in providing additional information regarding the comparative safety, efficacy and tolerability of aripiprazole in the treatment of affective disorders.

Administration, Oral↗
PubMed2004

Aripiprazole, a novel atypical antipsychotic drug.

Before the 1990s, treatment of psychoses centered on conventional agents whose tolerability was limited by extrapyramidal side effects (EPS). The past decade has seen the emergence of a newer generation of antipsychotic agents, first with clozapine and followed shortly by risperidone, olanzapine, quetiapine, and ziprasidone. These agents have been touted as providing better negative symptom efficacy, less impaired cognition, and lower risk of extrapyramidal syndromes. However, evolving evidence suggests that several drugs in this class may be associated with significant weight gain and lipid abnormalities. Aripiprazole, a new atypical antipsychotic drug, displayed efficacy similar to that of haloperidol and risperidone and superior to that of placebo in numerous clinical trials. Aripiprazole does not cause significant prolactin elevation and is associated with a low rate of clinically significant weight gain compared with other atypical antipsychotics. Patients receiving aripiprazole experienced EPS at a rate similar to that seen with placebo. Aripiprazole provides a new treatment option with limited adverse effects for patients in need of antipsychotic therapy.

Antipsychotic Agents↗
PubMed2004

Excessive somnolence from aripiprazole in a child.

A 9-year-old girl was hospitalized with prolonged somnolence that began 3.5 hours after a single 15-mg dose of aripiprazole. After extensive workup, physical examinations were unremarkable, and all laboratory test results were within normal limits. The patient's extreme somnolence was attributed to aripiprazole, a new atypical antipsychotic prescribed for oppositional defiant disorder. In clinical trials, somnolence has been reported with a frequency of approximately 11%. However, the somnolence experienced by this child was severe, requiring 24-hour hospitalization for observation. Although a recent dose-finding study in 22 pediatric patients (> or = 6 yrs old) described weight-based dosages that were safe and well tolerated, dosing of aripiprazole in children has not been well established. Further studies are needed to identify optimal dosing of aripiprazole in pediatric patients.

Antipsychotic Agents↗
PubMed2006

Aripiprazole augmentation of clozapine in treatment-resistant schizophrenia: a clinical observation.

BACKGROUND: Therapeutic options for patients with treatment-resistant schizophrenia are limited, and combination treatment with atypical antipsychotic drugs is an often used strategy. We tested the hypothesis that the combination of aripiprazole and clozapine would lead to an improvement in this patient group. METHODS: Eleven patients with treatment-resistant schizophrenia participated in this clinical trial and received a combination of aripiprazole and clozapine. Patients had to have remained on a stable dose of clozapine for at least 6 months in order to ensure a reasonable opportunity to respond to clozapine monotherapy. Clinical status was evaluated at baseline and at 3 months' follow-up using the Brief Psychiatric Rating Scale (BPRS). RESULTS: All patients completed 3 months' combination treatment. There was a significant reduction in the mean BPRS score in seven patients (63.6%) over the 3 months of combination treatment. Augmentation with aripiprazole in clozapine-treated patients did not result in a corresponding increase in adverse effects. Use of the combination allowed a significant reduction in the daily dose of clozapine. CONCLUSIONS: Combined application of clozapine and aripiprazole is in accordance with a neurobiological rationale and appears to be safe and well tolerated without increased risk of adverse effects.

Adult↗
PubMed2005

The use of aripiprazole in obsessive-compulsive disorder: preliminary observations in 8 patients.

OBJECTIVE: To assess the effectiveness of aripiprazole, an atypical antipsychotic with dopamine- and serotonin-stabilizing properties, as monotherapy in treating obsessive-compulsive disorder (OCD). METHOD: Adult subjects meeting DSM-IV criteria for OCD who were not currently receiving pharmacotherapy for the disorder were entered into an 8-week open-label trial of treatment with aripiprazole (10-30 mg/day). Efficacy assessments included the Yale-Brown Obsessive Compulsive Scale (YBOCS) and the Clinical Global Impressions-Improvement scale. Safety assessments included evaluation of vital signs, weight, and treatment-emergent side effects. Data were collected from June 2003 to August 2004. RESULTS: Eight subjects were enrolled, 7 of whom took at least 1 dose of study medication. Using the last observation carried forward, the mean total YBOCS score decreased from 23.9 at baseline to 17.6 at the final visit (p = .06). More pronounced improvement was observed in compulsive symptoms (p < .05) compared with obsessive symptoms (p = .09). Three subjects (43%) responded to treatment, showing a 30% or greater reduction in YBOCS total score. Two subjects discontinued treatment within 1 week due to side effects (akathisia, nausea). While no changes were noted in vital signs, a mean weight gain of 1.8 kg was observed. CONCLUSION: Although from a small, open-label study, these results suggest that aripiprazole holds promise for treating OCD. Larger, controlled studies of aripiprazole as monotherapy and as augmentation in partial responders to selective serotonin reuptake inhibitors are needed.

Adult↗
PubMed2005

Aripiprazole augmentation of selective serotonin reuptake inhibitors for treatment-resistant major depressive disorder.

BACKGROUND: Due to their favorable side effect profile, atypical antipsychotic agents offer important therapeutic advantages in mood disorders. Aripiprazole, an atypical antipsychotic agent with partial dopaminergic and serotonin 1A receptor agonist activity, may be particularly useful when used in conjunction with standard antidepressants in treatment-resistant depression. The purpose of this study was to test this hypothesis in depressed outpatients who have not experienced significant clinical improvement following an adequate trial of a selective serotonin reuptake inhibitor (SSRI). METHOD: 12 patients (mean +/- SD age = 46.6 +/- 11.3 years, 66.7% female) with major depressive disorder (MDD) diagnosed by use of the Structured Clinical Interview for DSM-IV-Axis I Disorders, who had failed to experience a clinical response following an adequate trial of an SSRI, were treated with open-label aripiprazole in addition to their SSRI for 8 weeks. Clinical response was defined as a 50% or greater decrease in depressive symptoms during the course of the trial (baseline-endpoint) as measured by the 17-item Hamilton Rating Scale for Depression total score. Data were collected from August 2003 to July 2004. RESULTS: 9/12 (75.0%) patients completed the trial. Using a completer analysis, 5/9 (55.6%) patients were classified as responders. An intent-to-treat (ITT) analysis resulted in 7 responders (58.3%). The overall proportion of remitters was 3/9 (33.3%) using a completer analysis and 5/12 (41.7%) using the ITT analysis. Aripiprazole administration appeared safe, with no severe adverse events observed in any of the study participants. CONCLUSIONS: These results suggest a possible augmentation role for aripiprazole when used in conjunction with SSRIs in SSRI-resistant MDD.

Ambulatory Care↗
PubMed2006

Elevated lipase and diabetic ketoacidosis associated with aripiprazole.

CONTEXT: Atypical antipsychotic agents are associated with diabetes mellitus and pancreatitis. Aripiprazole, a new antipsychotic, has never been implicated to cause either diabetes mellitus or pancreatitis. We present a patient who developed diabetes mellitus after being started on aripiprazole. CASE REPORT: A 33 year-old male with schizophrenia presented with fatigue, dyspepsia and epigastric pain. Patient was found to have hyperglycemia, diabetic ketoacidosis, and hyperlipasemia. Imaging studies of the pancreas were normal. Patient was started on aripiprazole treatment 18 months prior to this episode and had experienced progressive weight gain since then. Work up for other causes of pancreatitis was negative. CONCLUSIONS: Diabetes mellitus in this patient was probably a complication of aripiprazole due to progressive weight gain. In the absence of radiologic evidence of pancreatitis, hyperlipasemia was probably secondary to diabetic ketoacidosis. Possible causes of hyperlipasemia and its significance in diabetic ketoacidosis are discussed.

Adult↗
PubMed2006

[Clinical observations with aripiprazole in schizophrenia].

The atypical antipsychotic aripiprazole was administered once a day by peroral dose--10-15 mg--in 103 schizophrenics; they were hospitalized or in day-hospital or outpatient department. During the simple blind clinical trial it was compared by 70 schizophrenics administered by haloperidol treatment (9-15 mg/day dose). The aripiprazole had good therapeutic effect at the positive and negative symptoms of acute schizophrenia, and at the other antipsychotic non-responder patients, and had no serious side-effects. The hypothesis, that of aripiprazol had good effect on the mesolimbic dopamine system as dopamine antagonist, causes improvement on positive symptoms; also good effect on the mesocortical dopamine system as partial agonist, causes improvement on negative symptoms of schizophrenia. The patients had good compliance with aripiprazol.

Administration, Oral↗
PubMed1998

Spontaneous brain magnetic activity in schizophrenia patients treated with aripiprazole.

This magnetoencaphalographic (MEG) study was conducted as part of a multicenter clinical trial to study the efficacy of aripiprazole. Participants included 5 DSM-IV schizophrenia subjects and 10 age-matched normal controls. The schizophrenia subjects underwent a second MEG recording after 8 weeks of open-label treatment with aripiprazole. Overall, control subjects showed no abnormal spontaneous magnetic brain activity. At washout, 3 patients showed increased delta and theta activity along with paraxosymal bitemporal slow waves. In 2 of these patients, the slow waves were generated in the superior temporal plane, as determined by dipole modeling. In the third patient, the slow waves appeared to have been generated at multiple regions throughout the temporal and inferior parietal lobes. As a group, schizophrenia patients, when compared with normal controls, demonstrated significant decreases in alpha peak frequency and power. Following treatment, aripiprazole had a significant normalizing effect on delta and theta activity. Patients on aripiprazole continued to demonstrate significant abnormalities in alpha frequency and power.

Adult↗
PubMed2005

Aripiprazole for the treatment of Tourette's disorder.

OBJECTIVE: Tourette's disorder is a neuropsychiatric syndrome that manifests with motor and vocal tics, including coprolalia. This article presents a report of successful treatment of these tics with aripiprazole in 2 consecutive patients with Tourette's disorder. METHOD: After an informed consent was obtained from the subjects, approval for this retrospective case series was sought from the Institutional Review Board. A detailed history was obtained and physical and mental state examination was performed for each patient. Tic severity was assessed using the Yale Global Tic Severity Scale. Aripiprazole was started at a low dose (5 mg/day) and titrated. The severity of tics was monitored during follow-up. RESULTS: The 2 individuals presented in these case reports tolerated aripiprazole well and showed a clinically significant decrease in tic frequency and severity. CONCLUSIONS: Aripiprazole, a newer atypical antipsychotic with a unique pharmacodynamic profile, appears to be efficacious in treatment of tics in Tourette's disorder, thus impressing upon the need for placebo-controlled trials in the management of this neuropsychiatric syndrome.

Journal Article↗
PubMed2007

Aripiprazole augmentation for treatment of patients with inadequate antidepressants response.

This study evaluated whether or not augmentation with aripiprzazole is beneficial and tolerable to patients with an inadequate response to antidepressants (ADs). Thirteen patients with nonpsychotic major depression, who had failed to respond to an adequate trial of at least one AD, were prescribed aripiprazole (dose, 5-30 mg) for 8 weeks. The dose of their preexisting ADs was not changed. The treatment response was defined as the mean changes in the scores of the Hamilton Depression Rating Scale (HAM-D) from the baseline to the end of treatment. Eleven (84.6%) patients returned for at least one follow-up visit, and 7 (53.8%) patients completed the study. The HAM-D and Clinical Global Impression-Severity (CGI-S) scores decreased significantly from the baseline to the end of treatment by 53.8% and 56.0%, respectively (Z = -2.937, P =.003; Z = -2.961, P =.003). Seven (63.6%) patients showed a > or = 50% reduction in the HAM-D score at the end of treatment. Three (27.3%) patients met the remission criteria at the end of treatment. There were no serious side effects. Despite the high dropout rate in this open study, aripiprazole appears to be reasonably effective and tolerated as an augmentation strategy in conjunction with conventional ADs treatment in patients with an inadequate AD response. These results highlight the potential benefits of aripiprazole for these patients. However, adequately powered, randomized, controlled trials are needed to confirm these results.

Adult↗
PubMed2005

Clozapine, ziprasidone and aripiprazole but not haloperidol protect against kainic acid-induced lesion of the striatum in mice, in vivo: role of 5-HT1A receptor activation.

Excessive activation of non-NMDA receptors, AMPA and kainate, contributes to neuronal degeneration in acute and progressive pathologies, possibly including schizophrenia. Because 5-HT(1A) receptor agonists have neuroprotective properties (e.g., against NMDA-induced neurotoxicity), we compared the effects of the antipsychotics, clozapine, ziprasidone and aripiprazole, that are partial agonists at 5-HT(1A) receptor, with those of haloperidol, which is devoid of 5-HT(1A) agonist properties, on kainic acid (KA)-induced striatal lesion volumes, in C57Bl/6N mice. The involvement of 5-HT(1A) receptors was determined by antagonist studies with WAY100635, and data were compared with those obtained using the potent and high efficacy 5-HT(1A) receptor agonist, F13714. Intra-striatal KA lesioning and measurement of lesion volumes using cresyl violet staining were carried out at 48 h after surgery. F13714, antipsychotics or vehicle were administered ip twice, 30 min before and 3 1/2 h after KA injection. WAY100635 (0.63 mg/kg) or vehicle were given sc 30 min before each drug injection. Clozapine (2 x 10 mg/kg), ziprasidone (2 x 20 mg/kg) and aripiprazole (2 x 10 mg/kg) decreased lesion volume by 61%, 59% and 73%, respectively. WAY100635 antagonized the effect of ziprasidone and of aripiprazole but only slightly attenuated that of clozapine. In contrast, haloperidol (2 x 0.16 mg/kg) did not affect KA-induced lesion volume. F13714 dose-dependently decreased lesion volume. The 61% decrease of lesion volume obtained with F13714 (2 x 0.63 mg/kg) was antagonized by WAY100635. WAY100635 alone did not affect lesion volume. These results show that 5-HT(1A) receptor activation protects against KA-induced striatal lesions and indicate that some atypical antipsychotic agents with 5-HT(1A) agonist properties may protect against excitotoxic injury, in vivo.

Aminopyridines↗
PubMed2005

Overdose of aripiprazole, a new type of antipsychotic.

Aripiprazole is the first member of a new class of antipsychotic medications. Unlike other antipsychotics, it acts as a partial agonist at dopamine D(2) and 5-HT(1A) receptors, thereby mitigating most of the adverse reactions such as extrapyramidal side effects and hyperprolactinemia. Additionally, most research to date has suggested a low incidence of QTc prolongation and orthostatic hypotension at therapeutic doses. Experience in the setting of intentional overdose, however, is limited. We present a case of a 27-year-old woman who intentionally ingested 330 mg of aripiprazole in a suicide attempt. Clinical effects were limited to mild sedation. Serum levels performed by the drug's manufacturer confirmed a total level (parent drug and active metabolite) of 716 ng/mL, nearly six times the upper limit of accepted therapeutic levels. This suggests that aripiprazole's therapeutic index is quite high and reinforces the drug's known safety profile.

Adult↗
PubMed2006

Pisa syndrome during aripiprazole treatment: a case report.

Pisa syndrome (or pleurothotonus), consisting of a tonic flexion of the trunk, has been recently reported also in association with atypical antipsychotics. We describe the first case of Pisa syndrome during aripiprazole treatment in an elderly (77-year-old) woman, admitted to hospital for behavioural and psychological symptoms of dementia. The ongoing treatment with quetiapine was rapidly tapered and stopped, and a switch to aripiprazole (15 mg/die) was attempted the subsequent day. Six days later, an acute tonic flexion of trunk and head towards the right was observed. Aripiprazole was discontinued and the Pisa syndrome completely disappeared within 3 days, without any adjunctive treatment.

Aged↗
PubMed2006

Aripiprazole augmentation in the management of residual symptoms in clozapine-treated outpatients with chronic schizophrenia: An open-label pilot study.

OBJECTIVE: The aim of this study was to investigate whether augmentation of clozapine with aripiprazole improves clinically significant residual symptoms in stabilized outpatients with chronic schizophrenia. METHODS: Twenty seven stabilized outpatients meeting criteria for chronic schizophrenia, who had residual symptoms despite clozapine treatment, were assigned to receive oral aripiprazole (15 mg/day) for a period of 16 weeks. Patients remained on clozapine (100-900 mg/day) for at least 12 months, prior to study initiation. Symptoms assessments were made with the Positive and Negative Symptom Scale (PANSS), the Montgomery-Asberg Depression Rating Scale (MADRS), and the Mini-Mental State Examination (MMSE), at baseline and at weeks 4, 8, 12, and 16. The Quality of Life Scale (QLS) was administered at baseline and at week 16. RESULTS: There was a statistically significant improvement in the mean scores for PANSS (p<0.05), PANSS negative (p<0.001), MADRS (p<0.05), MMSE (p<0.01), and QLS (p<0.05), but not for PANSS positive (p>0.05). Extrapyramidal side effects (as assessed by the Simpson-Angus Scale and the Abnormal Involuntary Movement Scale) did not vary significantly at any point of the study. No statistically significant change was observed in prolactin levels and body weight. Results were similar for the intention-to-treat (n=27) and completer (n=23) groups. CONCLUSIONS: Aripiprazole augmentation in a group of chronic schizophrenic outpatients treated with clozapine led to a substantial improvement in clinically significant residual symptoms, such as negative-depressive symptoms, cognitive impairment and quality of life, without worsening the side effect burden.

Adolescent↗
PubMed1998

Differential effects on D2 dopamine receptor and prolactin gene expression by haloperidol and aripiprazole in the rat pituitary.

[3H]Spiperone-binding assay to D2 receptors and quantitative ribonuclease protection assay for both isoforms (D2L and D2S receptor) of the D2 receptor mRNA and the prolactin mRNA were performed on pituitaries from the control rat and from the rat injected orally daily with either haloperidol (2 mg/kg) or aripiprazole (24 mg/kg) for 21 days. Haloperidol treatment increased the [3H]spiperone-binding by 28%, the levels of D2L and D2S receptor mRNA by 41% and 38%, respectively, and the level of prolactin mRNA by 26%. In contrast, the treatment with aripiprazole, a newly developed atypical antipsychotic with reduced side effects, decreased the [3H]spiperone-binding by 24% and the levels of D2L and D2S receptor mRNA by 23% and 23%, respectively, and did not have any effect on the level of prolactin mRNA. The same treatment with sulpiride (100 mg/kg) increased the levels of D2L and D2S receptor mRNA by 59% and 62%, respectively, but treatment with clozapine (25 mg/kg) did not cause any effect. Neither treatment changed the ratio of the level of D2S receptor mRNA to the level of D2L receptor mRNA in the pituitary. These findings indicate that D2 receptor densities in the pituitary are influenced differentially by the treatment with these antipsychotics, which could be induced at least partly by the changes in the levels of mRNA without any effects on the splicing mechanisms and thus affect the plasticity of the prolactin mRNA expression. The inhibitory effects of chronic aripiprazole treatment on D2 receptors in the pituitary might underlie this drug's clinical property of reduced hyperprolactinemia side effect.

Administration, Oral↗
PubMed2006

Aripiprazole-related tardive dyskinesia.

The low prevalence of extrapyramidal symptoms associated with atypical antipsychotics has led to their widespread use during the past decade. Aripiprazole, the newest medication in this class, has been associated with extrapyramidal symptoms (eg, akathisia) and with improvement of tardive dyskinesia (TD), but to date it has not been associated with the development of TD. We report a case of TD associated with the use of aripiprazole 15 mg/day for 18 months for refractory depression. Symptoms of TD resolved within several weeks of discontinuation of aripiprazole.

Antipsychotic Agents↗