Phase 4
Completed N=51
A Study of Aripiprazole Lauroxil (Also Known as ARISTADA TM) in Subjects With Schizophrenia
Source: ClinicalTrials.gov NCT02634320 ↗Enrolled (actual)
51
Serious AEs
9.8%
Results posted
Nov 2018
Primary outcomePrimary: Change From Baseline to Last Treatment Visit in Clinical Global Impressions-Severity (CGI-S) Scores — -0.2 units on a scale — p=0.078
◆ Published Evidence
Not yet cited
0citations
Functioning and Cognition in Patients with Schizophrenia After Initiating Treatment with Aripiprazole Lauroxil: Secondary Outcomes and Post Hoc Analysis.
Summary
This study will evaluate the safety and tolerability of aripiprazole lauroxil (also known as ARISTADA, ALKS 9070).
Linked Publications
-
Functioning and Cognition in Patients with Schizophrenia After Initiating Treatment with Aripiprazole Lauroxil: Secondary Outcomes and Post Hoc Analysis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Last Treatment Visit in Clinical Global Impressions-Severity (CGI-S) Scores |
-0.2 | 0.078 |
| SECONDARY Change From Baseline to Last Treatment Visit in Brief Psychiatric Rating Scale (BPRS) Scores |
-2.7 | — |
| SECONDARY Number of Participants With Adverse Events |
21 | — |
| SECONDARY Daily and Social Functioning Will be Measured Using the Heinrichs-Carpenter Quality of Life Scale (QLS) |
0.4 | — |
| SECONDARY Characterization of Healthcare Burden Will be Measured Using the Treatment Services Review, Version 6-Modified for Mental Health (mTSR-6) |
3; 17; 6; 2 | — |
| SECONDARY Characterization of Family Burden Will be Measured Using the Burden Assessment Scale (BAS) |
-3.2 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02634320) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.