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12-WEEK SHORT-TERM STUDY
Study design
12-week, randomized, double-blind, placebo-controlled study evaluated acutely relapsed* adult patients with schizophrenia were randomized to either ABILIFY MAINTENA (n=168) or intramuscular placebo (n=172). After initial injection, patients received 14 days of oral aripiprazole or oral placebo based on treatment arm. Safety was assessed throughout the duration of the study.1
*Baseline characteristics: PANSS Total Score ≥80 and a PANSS score >4 on each of 4 specific psychotic symptoms (conceptual disorganization, hallucinatory behavior, suspiciousness/persecution, and unusual thought content). Patients were required to remain as inpatients for at least the first 2 weeks of treatment, after which hospitalization status was determined on the basis of the investigator’s judgment of the patient’s clinical status. Those discharged were followed with clinic visits and phone calls.1
PANSS=Positive and Negative Syndrome Scale.
Study design
A 12-week, randomized, double-blind, placebo-controlled study in which acutely relapsed adult patients with schizophrenia were randomized to either ABILIFY MAINTENA (n=168) or intramuscular placebo (n=172). After initial injection, patients received 14 days of oral aripiprazole or oral placebo based on treatment arm.1
- Primary endpoint was mean change in PANSS Total Score from baseline to Week 101
- Safety was assessed throughout the duration of the study1
12-week study evaluated mean change in PANSS Total Score in acutely relapsed adult patients with schizophrenia1†
†Baseline characteristics: PANSS Total Score >80 and PANSS score >4 on each of 4 specific psychotic symptoms (conceptual disorganization, hallucinatory behavior, suspiciousness/persecution, and unusual thought content). Patients were required to remain as inpatients for at least the first 2 weeks of treatment, after which hospitalization status was determined on the basis of the investigator’s judgment of the patient’s clinical status. Those discharged were followed with clinic visits and phone calls.1
Screening phase
Patients without prior exposure received oral aripiprazole to establish tolerability1
- Patients had a mean PANSS Total Score of 103 (range 82 to 144) and a CGI-S score of 5.2 (markedly ill) at baseline
93.5% of patients were treated with an antipsychotic other than aripiprazole or no antipsychotic prior to study entry.2
Patients were receiving a range of medications prior to study enrollment2‡ | |
---|---|
Risperidone | 21.5% |
Quetiapine | 15.3% |
Olanzapine | 8.2% |
Aripiprazole | 6.5% |
Another antipsychotic | 22% |
No antipsychotic | 26.5% |
‡Percentages provided were patient-reported estimations. All patients underwent a 7-day washout period at trial entry.
CGI-S=Clinical Global Impression-Severity.
Statistically significant improvement in PANSS Total Score vs placebo as early as Week 1 and through Week 121
Primary endpoint: Mean change in PANSS Total Score from baseline to Week 101
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Review the schizophrenia brochure
See clinical data on ABILIFY MAINTENA for appropriate adult patients with schizophrenia.
Important Warning and Precaution Regarding Cerebrovascular Adverse Events, Including Stroke
Increased incidence of cerebrovascular adverse events (e.g., stroke, transient ischemic attack), including fatalities, have been reported in clinical trials of elderly patients with dementia-related psychosis treated with oral aripiprazole.
52-WEEK MAINTENANCE STUDY
The placebo-controlled, 52-week maintenance study evaluated the time to relapse for adult patients with schizophrenia3
Study design
A multiphase study that included open-label stabilization on oral aripiprazole, single-blind stabilization on ABILIFY MAINTENA (along with oral aripiprazole for the first 14 days), and a 52-week, randomized, double-blind, placebo-controlled study in which adult patients with schizophrenia were randomized to either ABILIFY MAINTENA (n=269) or intramuscular placebo (n=134).3
- The study enrolled patients with schizophrenia diagnosed ≥3 years and a history of symptom exacerbation or relapse when not receiving antipsychotic treatment3II
- In the open-label phase 1 (4-6 weeks): Patients were converted to oral aripiprazole (n=633)
- In the open-label phase 2 (4-12 weeks): Patients were stabilized on oral aripiprazole 10 mg to 30 mg once daily (n=710)
- In the single-blind phase 3 (12-36 weeks): Patients continued on oral aripiprazole 10 mg to 20 mg for the first 14 days following the initial ABILIFY MAINTENA 400 mg dose (n=576)
- In the double-blind, placebo-controlled, randomized phase 4 (up to 52 weeks): Patients were randomized at baseline to either ABILIFY MAINTENA (n=269) or placebo (n=134)
Primary endpoint: Time from randomization to relapse3
Relapse was defined as one or more of the following3:
- Clinical worsening
- CGI-Improvement score ≥5 and an increase on any of 4 specific PANSS¶ items to a score ≥4: with an absolute increase of ≥2 on that specific item since randomization or with an absolute increase of ≥4 on the combined score of these items since randomization
- Psychiatric hospitalization
- Due to worsening of psychotic symptoms
- Risk of suicide
- CGI-SS score of 4 (severely suicidal) or 5 (attempted suicide) on part 1 or CGI-SS score of 6 (much worse) or 7 (very much worse) on part 2
- Violent behavior
- Clinically significant self-injury, injury to another person, or property damage
IIDSM-IV-TR criteria.
¶PANSS items were conceptual disorganization, hallucinatory behavior, suspiciousness, or unusual thought content.3
CGI=Clinical Global Impression; CGI-SS=Clinical Global Impression of Severity of Suicidality.
ABILIFY MAINTENA significantly delayed time to relapse# vs placebo (HR=0.199 [95% CI, 0.1-0.3], P<0.0001)3,4**
Primary endpoint: Time from randomization to relapse3
#Relapse was defined as one or more of the following: clinical worsening, psychiatric hospitalization, risk of suicide, or violent behavior.3
**This figure is based on a total of 80 relapse events.3
CI=confidence interval; HR=hazard ratio.
The hazard ratio was used to calculate the reduction in risk of relapse for patients on ABILIFY MAINTENA vs placebo.
Key secondary endpoint:
Percent of patients meeting relapse criteria3††
The percent of patients who relapsed was 4x higher on placebo than ABILIFY MAINTENA (HR=5.03 [95% CI, 3.15-8.02]).
††Relapse was defined as one or more of the following: clinical worsening, psychiatric hospitalization, risk of suicide, or violent behavior.3
Important Warning and Precaution Regarding Neuroleptic Malignant Syndrome (NMS)
NMS is a potentially fatal symptom complex reported in association with administration of antipsychotic drugs including ABILIFY MAINTENA. Clinical signs of NMS are hyperpyrexia, muscle rigidity, altered mental status and evidence of autonomic instability. Additional signs may include elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure. Manage NMS with immediate discontinuation of ABILIFY MAINTENA, intensive symptomatic treatment, and monitoring.
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Considering ABILIFY MAINTENA for your patients?
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Review the clinical safety profile
ABILIFY MAINTENA has been evaluated for safety in 2128 adult patients with schizophrenia and 804 adult patients with bipolar I disorder.
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View pharmacokinetics
See the pharmacokinetic data for ABILIFY MAINTENA in adult patients with schizophrenia.
Please see FULL PRESCRIBING INFORMATION, including BOXED WARNING.
References: 1. Kane JM, Peters-Strickland T, Baker RA, et al. Aripiprazole once-monthly in the acute treatment of schizophrenia: findings from a 12-week, randomized, double-blind, placebo-controlled study. J Clin Psychiatry. 2014;75(11):1254-1260. 2. Data on file. ABIMAI-122. 3. Kane JM, Sanchez R, Perry PP, et al. Aripiprazole intramuscular depot as maintenance treatment in patients with schizophrenia: a 52-week, multicenter, randomized, double-blind, placebo-controlled study. J Clin Psychiatry. 2012;73(5):617-624. 4. Data on file. ABIMAI-027.