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

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

Schizophrenia

Aripiprazole Lauroxil

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

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.

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).

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).

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.

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.

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

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Not accepting

Trial Timing

What is this trial about?

What are the participation requirements?

Locations

Location

Status