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

Phase 4

Completed

• Conditions: Schizophrenia
• Interventions: Drug: Aripiprazole Lauroxil

• Registration Number: NCT02634320
• Lead Sponsor: Alkermes, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12
• Study First Submitted: 2015-12-16
• Study First Submitted QC: 2015-12-16
• Study First Posted: 2015-12-18
• Primary Completion: 2017-07-11
• Study Completion: 2017-07-11
• Results First Submitted: 2018-07-11
• Results First Submitted QC: 2018-10-09
• Status Verified: 2018-11
• Results First Posted: 2018-11-08
• Last Update Submitted: 2018-11-09
• Last Update Posted: 2018-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Aripiprazole Lauroxil	Aripiprazole Lauroxil	Intramuscular (IM) injection

Primary Outcome Measures

Name	Time	Method
Change From Baseline to Last Treatment Visit in Clinical Global Impressions-Severity (CGI-S) Scores	Up to 7 months	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.

Secondary Outcome Measures

Name	Time	Method
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)	Up to 7 months	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).
Change From Baseline to Last Treatment Visit in Brief Psychiatric Rating Scale (BPRS) Scores	Up to 7 months	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).
Characterization of Healthcare Burden Will be Measured Using the Treatment Services Review, Version 6-Modified for Mental Health (mTSR-6)	Up to 7 months	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.
Characterization of Family Burden Will be Measured Using the Burden Assessment Scale (BAS)	Up to 7 months	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.

Trial Locations

Locations (1)

Alkermes Investigational Site; 🇺🇸 DeSoto, Texas, United States