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

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

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

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: Aripiprazole Lauroxil

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 27711
      • Alkermes Investigational Site
    • Rogers, Arkansas, United States, 72758
      • Alkermes Investigational Site
  • California
    • Anaheim, California, United States, 92805
      • Alkermes Investigational Site
    • Culver City, California, United States, 90230
      • Alkermes Investigational Site
    • Garden Grove, California, United States, 92845
      • Alkermes Investigational Site
    • National City, California, United States, 91950
      • Alkermes Investigational Site
    • Oceanside, California, United States, 92056
      • Alkermes Investigational Site
    • Orange, California, United States, 92868
      • Alkermes Investigational Site
    • Panorama City, California, United States, 91402
      • Alkermes Investigational Site
  • Georgia
    • Augusta, Georgia, United States, 30901
      • Alkermes Investigational Site
  • Illinois
    • Chicago, Illinois, United States, 60640
      • Alkermes Investigational Site
  • Louisiana
    • Shreveport, Louisiana, United States, 71101
      • Alkermes Investigational Site
  • Missouri
    • Saint Louis, Missouri, United States, 63141
      • Alkermes Investigational Site
  • Ohio
    • Garfield Heights, Ohio, United States, 44125
      • Alkermes Investigational Site
  • Rhode Island
    • Lincoln, Rhode Island, United States, 02865
      • Alkermes Investigational Site
  • Texas
    • Dallas, Texas, United States, 75231
      • Alkermes Investigational Site
    • Dallas, Texas, United States, 75243
      • Alkermes Investigational Site
    • DeSoto, Texas, United States, 75115
      • Alkermes Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Aripiprazole Lauroxil; Intramuscular (IM) injection	Drug: Aripiprazole Lauroxil; Monthly IM injection; Other Names: ARISTADA

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Alkermes, Inc.
• Investigators: Study Director: Sanjeev Pathak, MD, Alkermes, Inc.

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Actual): July 11, 2017
• Study Completion (Actual): July 11, 2017

Study Registration Dates

• First Submitted: December 16, 2015
• First Submitted That Met QC Criteria: December 16, 2015
• First Posted (Estimate): December 18, 2015

Study Record Updates

• Last Update Posted (Actual): December 4, 2018
• Last Update Submitted That Met QC Criteria: November 9, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: Schizophrenia; Alkermes; ARISTADA; Aripiprazole Lauroxil
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Antidepressive Agents; Dopamine Agonists; Dopamine Agents; Serotonin 5-HT1 Receptor Agonists; Serotonin Receptor Agonists; Serotonin 5-HT2 Receptor Antagonists; Serotonin Antagonists; Dopamine D2 Receptor Antagonists; Dopamine Antagonists; Aripiprazole; Aripiprazole lauroxil
• Other Study ID Numbers: ALK9072-A401

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No