A Study of Aripiprazole Lauroxil (Also Known as ARISTADA TM) in Subjects With Schizophrenia

Study Overview
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Brief Summary
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This study will evaluate the safety and tolerability of aripiprazole lauroxil (also known as ARISTADA, ALKS 9070).

Official Title
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Safety and Tolerability of Initiating Aripiprazole Lauroxil in Subjects With Schizophrenia Who Are Inadequately Treated With Paliperidone Palmitate or Risperidone Long Acting Injection

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: Aripiprazole Lauroxil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Has demonstrated tolerability to test doses of oral aripiprazole during screening; OR has a history of tolerated use of aripiprazole Has a diagnosis of schizophrenia Is clinically stable Has received at least 3 doses of risperidone long acting injection (Risperdal Consta) or paliperidone palmitate (Invega Sustenna) prior to screening. Has no antipsychotic medication regimen change for 4 weeks prior to Day 1 Agreed to abide by the contraceptive requirements o the protocol Resides in a stable living situation Additional criteria may apply Exclusion Criteria: Is currently pregnant or breastfeeding, or is planning to become pregnant during the study Has received Invega Trinza, aripiprazole lauroxil, or IM depot aripiprazole within 6 months of screening Has participated in a clinical trial involving any investigational product within the past 3 months, or is currently participating in a clinical trial involving an investigational product Has a positive urine drug test for illicit use of amphetamines, barbiturates, cocaine, methadone, opiates, phencyclidine at screening Additional criteria may apply

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Aripiprazole Lauroxil<br>Intramuscular (IM) injection | Drug: Aripiprazole Lauroxil<br>* Monthly IM injection<br>* Other names: ARISTADA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline to Last Treatment Visit in Clinical Global Impressions-Severity (CGI-S) Scores | The CGI-S is a 7-point scale that requires the clinician to assess how mentally ill the patient is in a specific point in time. Results indicate participants evaluated at one of the following categories: 1: normal, not at all ill; 2: borderline mentally ill; 3: mildly ill; 4: moderately ill; 5: markedly ill; 6: severely ill; and 7: among the most extremely ill patients. Results indicate a change in CGI-S score from baseline to last visit in the treatment period based on the observed data. | Up to 7 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline to Last Treatment Visit in Brief Psychiatric Rating Scale (BPRS) Scores | The BPRS is an instrument for evaluating change in psychopathology in patients with schizophrenia. It consists of 18 items in which clinicians rate patient symptoms on a 7-point scale (1=not present, 7=extremely severe). Scores range from 18 to 126, with higher scores indicative of more severe psychopathology). | Up to 7 months | 
| Number of Participants With Adverse Events |  | Up to 7 months | 
| Daily and Social Functioning Will be Measured Using the Heinrichs-Carpenter Quality of Life Scale (QLS) | The QLS is a clinician-rated scale that is used to assess health-related quality of life and functioning in patients with schizoprehnia during the preceding 4 weeks. The QLS consists of 21 items in 4 major domains (Intrapsychic Foundations, Interpersonal Relations, Instrumental Role, and Common Objects and Activities). Following a semi-structured interview, each item is rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). | Up to 7 months | 
| Characterization of Healthcare Burden Will be Measured Using the Treatment Services Review, Version 6-Modified for Mental Health (mTSR-6) | Responses to 4 mTSR-6 questions have been provided. Results include the number of participants who responded positively to the category during the entire post-baseline treatment period. | Up to 7 months | 
| Characterization of Family Burden Will be Measured Using the Burden Assessment Scale (BAS) | The BAS is a 19-item scale completed by the caregiver that focuses on specific subjective and objective consequences of families caring for individuals with severe mental disorders. Respondents are required to indicate whether they have experienced each of the types of burden - 'Not at all', 'A little', 'Some' or A lot' - in the previous four weeks. These are scored 1, 2, 3 and 4, respectively. The total score ranges between 19 and 76. A higher score indicates more perceived burden. Subjects required a reliable informant (caregiver) in order to participate in the study. These caregivers did not receive study treatment, and they are not represented elsewhere in the results data. The data provided indicates the change from baseline to the last treatment visit. | Up to 7 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alkermes, ARISTADA, Aripiprazole Lauroxil, Schizophrenia