A 52-week, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of an Intramuscular Depot Formulation of Aripiprazole (OPC-14597) as Maintenance Treatment in Patients with SchizophreniaASPIRE US” (Aripiprazole Intramuscular Depot Program in Schizophrenia) - ASPIRE US
- Conditions
- SchizophreniaMedDRA version: 9.1Level: LLTClassification code 10039626Term: Schizophrenia
- Registration Number
- EUCTR2008-002675-27-SK
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1500
Screening
1. Subjects who are able to provide written informed consent and/or consent obtained from a legally acceptable representative (as required by IRB/IEC), prior to the initiation of any protocol-required procedures.
2. Male and female subjects 18 to 60 years of age, inclusive, at time of informed consent.
3. Subjects with a current diagnosis of schizophrenia as defined by DSM-IV-TR criteria and a history of the illness for at least 3 years prior to screening.*
4. Subjects who, in the investigator’s judgment, require chronic treatment with antipsychotic medication(s).
5. Subjects who showed previous response to antipsychotic treatment (other than clozapine) in the past year, according to the investigator’s opinion.
6. Subjects who are current treatment with oral or depot antipsychotics other than clozapine (a recent lapse in antipsychotic treatment [defined as >3 consecutive days without medication] will be considered as current treatment for the purpose of determining eligibility for this trial) and who, in the investigator’s judgment, require chronic treatment with an antipsychotic medication and would benefit from treatment with aripiprazole IM depot.
7. Subjects with a history of relapse and/or exacerbation of symptoms when they are not receiving antipsychotic treatment.
8. Inpatient or outpatient status prior to entry into Phase 3 (single-blind IM depo stabilization).
9. Subjects able to understand the nature of the study and follow protocol requirements, including the prescribed dosage regimens, tablet ingestion, IM depot injection, discontinuation of prohibited concomitant medications, who can read and understand the written word in order to complete patient-reported outcomes measures, and who can be reliably rated on assessment scales.
Inclusion Criteria Assessed Prior to Entry into Phase 1
10. Adequate washout of prohibited concomitant medications, including 3 days prior to entry into Phase 1 for mood stabilizers and antidepressants (14 days for fluoxetine or Symbyax).
11. Subject is receiving no more than one benzodiazepine beyond screening.*
12. Inpatient or outpatient status.
13. Subject is receiving antipsychotic(s) other than aripiprazole or clozapine and must be cross-titrated to aripiprazole monotherapy (study drug) over 4 to 6 weeks using an initial dose of 5 mg to achieve a recommended target aripiprazole monotherapy starting dose in Phase 2 of 10 or 15 mg.*
Inclusion Criteria Assessed Prior to Entry into Phase 2
14. Adequate washout of prohibited concomitant medications.*
15. Subject is receiving oral aripiprazole as monotherapy (generic aripiprazole must be cross-titrated in Phase 1) for treatment of schizophrenia at a starting dose of 10 or 15 mg daily.*
16. Inpatient/outpatient status.
Inclusion Criteria Assessed Prior to Entry into Phase 3
17. Subject is receiving oral aripiprazole as monotherapy (generic aripiprazole must be cross-titrated in Phase 1) for treatment of schizophrenia at a dose ranging from 10 to 30 mg daily.
18. Outpatient status.
19. Subject’s condition is stable as evidenced by meeting ALL of the following criteria for 4 consecutive weeks (2 consecutive bi-weekly visits), including the last visit prior to entering Phase 3:
a) Outpatient status
b) PANSS Total Score =<80
c) Lack of specific psychotic symptoms as measured by a score of =<4 on the following PANSS items:
• Conceptual disorganization
• Suspiciousness
• Hallucinatory behavior
Sex and Reproductive Status
1. Sexually active males not practicing double-barrier birth control or who will not remain abstinent during the study and for 180 days following the last dose of study medication, or sexually active females of childbearing potential not practicing double-barrier birth control or who will not remain abstinent during the study and for 150 days following the last dose of study medication. If employing birth control, 2 precautions to be used*
2. Females who are breast-feeding and/or who have a positive serum pregnancy test result prior to receiving study drug.
Target Disease
3. Subjects with a current DSM-IV-TR diagnosis other than schizophrenia*
4. Subjects experiencing acute depressive symptoms within the past 30 days, according to the investigator’s opinion, that requires treatment with an antidepressant.
5. Subjects with schizophrenia that are considered resistant/refractory to antipsychotic treatment by history.
6. Subjects with a history of failure to clozapine treatment or response to clozapine treatment only.
Medical History and Concurrent Disease
7. Subjects with a significant risk of violent behavior or a significant risk of committing suicide based on history or investigator’s judgment.
8. Subjects who currently meet DSM-IV-TR criteria for substance dependence*
9. Subjects with known hypothyroidism or hyperthyroidism (unless condition has been stabilized with medications for at least the past 90 days).
10. Subjects having a history or evidence of a medical condition that would expose them to an undue risk of a significant adverse event or interfere with assessments of safety or efficacy during the course of the trial*
11. Subjects with epilepsy or a history of seizures, except for a single childhood febrile seizure, post traumatic, alcohol withdrawal, etc.
Physical and Laboratory Test Findings
12. Subjects with two positive drug screens for cocaine prior to Phase 2*
13. The following laboratory test, vital sign, and ECG results are exclusionary:
a) Platelets =<75,000/mm3
b) Hemoglobin =<9 g/dL
c) Neutrophils, absolute =<1000/mm3
d) AST > 3x upper limit of normal
e) ALT > 3x upper limit of normal
f) Creatinine >=2 mg/dL
g) Diastolic blood pressure > 105 mmHg
h) QTc > 475 msec*
Allergies and Adverse Drug Reactions
14. Subjects who are known to be allergic, intolerant, or unresponsive to prior treatment with aripiprazole or other quinolinones.
15. Subjects with a history of hypersensitivity to antipsychotic agents.
16. Subjects who are known to be allergic, intolerant, hypersensitive, or refractory to antipsychotic agents.
17. Subjects with a history of neuroleptic malignant syndrome or clinically significant tardive dyskinesia at screening.
Prohibited Therapies and/or Medications
18. Subjects likely to require prohibited concomitant therapy during the trial.
19. Subjects receiving CYP2D6 or CYP3A4 inhibitors or CYP3A4 inducers at screening or anticipated use of such agents during the trial*
20. Subjects who received any investigational agent in a clinical trial within 30 days prior to screening or who were randomized into a clinical trial with aripiprazole IM depot at any time*
Other Exclusion Criteria
21. Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (eg, infectious disease) illness must not be enrolled into this trial.
22. Subjects who have been hospitalized, including hospitalization
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method