Phase 4 N=489 Randomized Single-blind Health Services Research

Comparison of a Long-acting Injectable Antipsychotic vs Clinician's Choice Early in Treatment to Break the Cycle of Relapse in Early Phase Schizophrenics

Schizophrenia

Bottom Line

View on ClinicalTrials.gov: NCT02360319 ↗

Enrolled (actual)

489

Serious AEs

35.2%

Results posted

Nov 2020

Primary outcome: Primary: Time to First Hospitalization — 530.6; 613.7 days

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Any FDA approved antipsychotic agent (Drug); aripiprazole long acting injectable formulation (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Vanguard Research Group
Primary completion: Mar 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Time to First Hospitalization	530.6; 613.7	—
SECONDARY Total Number of Psychiatric Hospitalizations Per Treatment Arm	208; 133	—
SECONDARY Brief Psychotic Rating Scale (BPRS) Total Score	35.59; 35.45; 30.7; 31.31; 30.73; 30.87	—
SECONDARY Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Sum of Scores	182.4; 177.7; 189.2; 178.2; 194.1; 180.8	—
SECONDARY Quality of Life (QLS) Total Score	63.60; 58.40; 68.45; 65.02; 62.21; 70.05	—

Summary

The goal of this project is to show that the best possible option for preventing relapses in patients suffering from first episode (<1 year of anti-psychotic medication) or early phase (< 5 years of lifetime exposure to anti-psychotic medication) schizophrenia is by enhancing medication adherence. The study is designed to answer the question of whether the use of long-acting injectable (LAI) antipsychotics early in the course of treatment can break the cycle of frequent relapse that affects so many patients with early phase schizophrenia. The participating research sites (not individual patients) will be randomly assigned to either medication prescribed by their treating physician (with no restrictions) or to a regimen that involves a monthly long acting injectable antipsychotic. The sites will be assigned on a one to one basis to either of the arms taking into account types of patient population and geographical area. Patients enrolled in the study will participate in regular assessments either over the phone or in person and be followed for a period of 2 years. The primary outcome measure is time to first hospitalization.

Eligibility Criteria

Inclusion Criteria

Are able to provide written informed consent Have a confirmed diagnosis of schizophrenia as defined by Diagnostic and Statistical Manual (DSM) 5 criteria using the SCID (Structured Clinical Interview for DSM disorders) Are between the ages of 18 and 35, inclusive Have the following history with antipsychotic medications

First episode subjects: < 1 year of lifetime exposure to antipsychotic medication and only one episode of psychosis
EP subjects: between 1 year and 5 years of lifetime exposure to antipsychotic medication or subjects with < 1 year of lifetime antipsychotic medication and more than one episode of psychosis.

For LAI subjects: Must be willing to accept an injectable form of treatment

Exclusion Criteria

Have a current primary DSM-5 diagnosis other than schizophrenia, including schizophreniform disorder, schizoaffective disorder, major depressive disorder, bipolar disorder, delirium, dementia, and amnestic or other cognitive disorders.

For LAI sites only - have a known allergy or intolerance to aripiprazole, or a past negative response to aripiprazole that is not explained by nonadherence Be pregnant or lactating Have any unstable medical condition that, in the opinion of the investigator, would be detrimental to the subject or would confound the results of the study Subjects in the MRI subset only- presence of any metal implants, pacemakers, irremovable prosthetic devices, or other devices or situations that may preclude imaging

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02360319). 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.