A 52-week, Multicenter, Open-label Study to Evaluate the Effectiveness of Aripiprazole Intramuscular Depot as Maintenance Treatment in Patients with SchizophreniaASPIRE OPEN-LABEL (Aripiprazole Intramuscular Depot Progam in Schizophrenia) - ASPIRE OPEN-LABE
- Conditions
- SchizophreniaMedDRA version: 9.1Level: LLTClassification code 10039626Term: Schizophrenia
- Registration Number
- EUCTR2008-002699-83-AT
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 800
Direct Entry Into Study 248 After Studies 246/247
Entry into Phase 2
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
- are Male/female 18-65 years of age, inclusive, at the time of informed consent
- have completed 246/247 or who were withdrawn from the double-blind phase of either study for any reason (*) and did not receive any antipsychotic treatment(s) other than aripiprazole monotherapy after participation in 246/247 *
- in the investigator’s judgment, require chronic treatment with an antipsychotic medication and would benefit from extended treatment with an IM depot formulation
- have =<30 days between the completion/discontinuation date from 246/247 and the enrollment date into 248 *
- have had adequate washout of prohibited concomitant medications *
- have inpatient or outpatient status
- are able to understand the nature of the study and follow protocol requirements, including: prescribed dosage regimens/tablet ingestion/IM depot injection/restrictions on concomitant medications/can read and understand the written word in order to complete patient-reported outcomes measures/can be reliably rated on assessment scales
Entry into Phase 3
Subjects who:
- have outpatient status
- meet ALL of the following criteria on at least one occasion after receiving at least four weeks of treatment with oral aripiprazole at a dose of 10 to 30 mg: Outpatient status; PANSS Total Score =< 80; Lack of specific psychotic symptoms as measured by a score of =<4 on the following PANSS items: Conceptual disorganization/ Suspiciousness/Hallucinatory behavior/Unusual thought content; CGI-S =<4 (moderately ill); CGI-SS =<2 (mildly suicidal) on Part 1 and =<5 (minimally worsened) on Part 2
Entry After Last Visit of 246/247 and Additional Subjects
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
- are male/female 18-65 years of age, inclusive, at time of informed consent
- are currently diagnosised with schizophrenia as defined by DSM-IV-TR criteria and a history of the illness for at least three years prior to screening*
- in the investigator’s judgment, require chronic treatment with antipsychotic medication and would benefit from extended treatment with an IM depot formulation
- showed previous response to antipsychotic treatment (other than clozapine) in the past year, according to the investigator’s opinion
- are currently being treated with oral or depot antipsychotics other than clozapine (*) and who, in the investigator’s judgment, require chronic treatment with an antipsychotic medication and would benefit from treatment with aripiprazole IM depot
- have inpatient or outpatient status prior to entry into Phase 3*
- are able to understand the nature of the study and follow protocol requirements, including: prescribed dosage regimens/tablet ingestion/IM depot injection/restrictions on concomitant medications/can read and understand the written word in order to complete patient-reported outcomes measures/can be reliably rated on assessment scales
Entry into Phase 1:
Subjects who:
- have had adequate washout of prohibited concomitant medications*
- is receiving no more than one benzodiazepine beyond screening*
- has inpatient
Direct Entry After Studies 246/247
Entry into Phase 2
Subjects who:
- are sexually active males/females of childbearing potential, not practicing double-barrier birth control, or who will not remain abstinent during the study and for 180 days (for males) and 150 days (for females) following the last dose of study medication. If employing birth control, two of the precautions (*listed int he protocol) must be used
- are females who have a positive serum pregnancy test prior to receiving study drug
- are receiving any antipsychotic(s) other than oral aripiprazole monotherapy (study drug) after completion/withdrawal from 246/247*
- are currently receiving or likely to require prohibited concomitant therapy during the trial*
- are currently receiving CYP2D6 or CYP3A4 inhibitors or CYP3A4 inducers or anticipated use of such agents during the trial*
- have had electroconvulsive therapy since concluding participation in 246/247
Entry into Phase 3
Subjects who:
- receive at least four consecutive weeks of treatment with oral aripiprazole monotherapy int he range of 10-30mg daily and do not achieve stability criteria on at least one occasion between Week 4 and Week 16 of Phase 2
Entry After Last Visit of 246/247 + Additional Subjects
Subjects:
- who are sexually active males/females of child-bearing potential who are not practicing double-barrier birth control or who will not remain abstinent during the study and for 180 days (for males) and 150 days (for females) following the last dose of study medication. If employing birth control, two of the precautions (*listed in protocol) must be used
- who are females who are breast-feeding and/or who have a positive serum pregnancy test result prior to receiving study drug
- with a current DSM-IV-TR diagnosis other than schizophrenia*
- experiencing acute depressive symptoms within the past 30 days, according to the investigator’s opinion, that requires treatment with an antidepressant
- with schizophrenia that are considered resistant/refractory to antipsychotic treatment by history
- with a history of failure to clozapine treatment or response to clozapine treatment only
- with a significant risk of violent behavior or a significant risk of committing suicide based on history or investigator’s judgment
- who currently meet DSM-IV-TR criteria for substance dependence; including alcohol and benzodiazepines, but excluding caffeine and nicotine
- with known hypothyroidism or hyperthyroidism (unless condition has been stabilized with medications for at least the past 90 days)
- who have a history or evidence of a medical condition that would expose them to an undue risk of a significant AE or interfere with assessments of safety or efficacy during the course of the trial*
- with epilepsy or a history of seizures, except for a single childhood febrile seizure, post traumatic, alcohol withdrawal, etc
- with two positive drug screens for cocaine prior to Phase 2*
- with the following laboratory test, vital sign, and ECG results are exclusionary: platelets =< 75,000/mm3; hemoglobin =<9 g/dL; neutrophils, absolute =<1000/mm3; AST > 3x upper limit of normal; ALT > 3x upper limit of normal; Creatinine >= 2 mg/dL; Diastolic blood pressure > 105 mmHg--QTc > 475 msec *
- who are known to be allergic, intolerant, or unresponsive to prior treatment with aripiprazole or other quinolinones
- with a history of hypersensitivity to antipsychotic agents
- who are known to be allergic, intolerant, hypersensitive, or re
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