Patients With Early-Phase Schizophrenia Will Accept Treatment With Sustained-Release Medication (Long-Acting Injectable Antipsychotics): Results From the Recruitment Phase of the PRELAPSE Trial

Objective: To document the acceptability of treatment with long-acting injectable (LAI) antipsychotic medication to early-phase schizophrenia patients as demonstrated by enrollment in a cluster-randomized LAI clinical trial.

Methods: Eligible patients aged 18-35 years with a DSM-5 diagnosis of schizophrenia and less than 5 years of lifetime antipsychotic use were recruited between December 2014 and December 2016. Training for LAI antipsychotic site staff included education regarding the role of nonadherence in relapse/hospitalization and the rationale for LAI antipsychotic use with early-psychosis patients, training in shared decision-making and communication strategies, review of frequently asked questions about LAI antipsychotics, and role-playing to develop skills and solutions to overcoming LAI antipsychotic logistical barriers. Study prescribers also received training on prescribing guidelines.

Results: At the 19 US outpatient clinics randomized to provide LAI antipsychotic treatment, 576 potential participants were identified who met inclusion criteria based on a screening interview. Of these, 83 (14.4%) declined participation because they would not consider LAI antipsychotic treatment and 165 (28.6%) declined for other reasons, resulting in 328 providing written study consent. The first post-consent visit included detailed evaluations to confirm inclusion/exclusion criteria. Thirty-nine participants who consented did not complete this evaluation and 55 were found to not meet criteria, resulting in a final sample of 234 participants. Two hundred thirteen (91.0%) accepted at least one LAI antipsychotic injection during their first 3 months of study participation.

Conclusions: Large numbers of early-phase patients with schizophrenia were willing to participate in an LAI antipsychotic trial and by inference in non-study LAI antipsychotic treatment. LAI antipsychotic-focused staff training has the potential to substantially enhance the use of LAI antipsychotics.

Trial Registration: ClinicalTrials.gov identifier: NCT02360319