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

Phase 4CompletedNCT02634320

Alkermes, Inc.51 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Schizophrenia

Interventions

Aripiprazole LauroxilDRUG

Monthly IM injection

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (18)

Alkermes Investigational Site

Little Rock, Arkansas, United States

Alkermes Investigational Site

Rogers, Arkansas, United States

Outcomes

Primary Outcomes

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.

Time frame: Up to 7 months

Secondary Outcomes

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).

Time frame: Up to 7 months

Number of Participants With Adverse Events

Time frame: 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).

Time frame: Up to 7 months

Characterization of Healthcare Burden Will be Measured Using the Treatment Services Review, Version 6-Modified for Mental Health (mTSR-6)

Data from ClinicalTrials.gov

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