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.