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Background <p>Nonadherence is a major cause of relapse in patients with schizophrenia, schizoaffective disorder, or bipolar disorder who have achieved remission. However, it is also a significant challenge during manic episodes. Risperidone in-situ microimplant (ISM) releases the drug early and in a sustained manner once a month, eliminating the need for daily administration, which can be difficult during a manic episode. In this study, we described symptom trajectories and tolerability of a brief oral risperidone lead-in followed off-label initiation of risperidone ISM within multimodal inpatient care in nonadherent inpatients with schizoaffective disorder experiencing a manic episode with psychotic symptoms.</p> Methods <p>This retrospective, observational, single-centre study included 50 consecutive adults admitted after discontinuation/marked non-adherence and with prior response to risperidone who received ≥ 6 days of oral risperidone to confirm tolerability, then risperidone ISM (75 or 100&#xa0;mg) and were followed for 6 weeks. Mania severity was assessed with the Young Mania Rating Scale (YMRS).</p> Results <p>Fifty patients were included; most received concomitant mood stabilisers and benzodiazepines. Median YMRS decreased from 32 at admission (Tx) to 26 at the first injection (T0, after the oral lead-in), 8 by day 8, and remained low at day 28 (5) and day 42 (6). Activation/behavioural items improved earlier, whereas psychotic thought content improved more gradually, predominantly between days 8 and 28. Side-effect burden at weeks 4 and 6 was minimal, and no discontinuations due to adverse events occurred.</p> Conclusions <p>In this exploratory uncontrolled cohort, an oral risperidone lead-in plus monthly risperidone ISM within multimodal inpatient care was associated with with rapid and sustained improvement in symptom trajectories and favourable short-term tolerability. Findings reflect multimodal inpatient care and cannot be attributed to ISM alone. Prospective, controlled studies are warranted.</p>

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Risperidone long-acting in-situ microimplant following a brief oral risperidone lead-in in the acute inpatient management of manic episodes with psychotic symptoms in non-adherent patients with schizoaffective disorder: a retrospective, uncontrolled real-world study

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  • 发表日期：

    2026年5月28日

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  • Giovanni Barillà,
  • Andrea Fagiolini,
  • Debora Bussolotti,
  • Cristina Venco,
  • Alessandro Cuomo

摘要

Background

Nonadherence is a major cause of relapse in patients with schizophrenia, schizoaffective disorder, or bipolar disorder who have achieved remission. However, it is also a significant challenge during manic episodes. Risperidone in-situ microimplant (ISM) releases the drug early and in a sustained manner once a month, eliminating the need for daily administration, which can be difficult during a manic episode. In this study, we described symptom trajectories and tolerability of a brief oral risperidone lead-in followed off-label initiation of risperidone ISM within multimodal inpatient care in nonadherent inpatients with schizoaffective disorder experiencing a manic episode with psychotic symptoms.

Methods

This retrospective, observational, single-centre study included 50 consecutive adults admitted after discontinuation/marked non-adherence and with prior response to risperidone who received ≥ 6 days of oral risperidone to confirm tolerability, then risperidone ISM (75 or 100 mg) and were followed for 6 weeks. Mania severity was assessed with the Young Mania Rating Scale (YMRS).

Results

Fifty patients were included; most received concomitant mood stabilisers and benzodiazepines. Median YMRS decreased from 32 at admission (Tx) to 26 at the first injection (T0, after the oral lead-in), 8 by day 8, and remained low at day 28 (5) and day 42 (6). Activation/behavioural items improved earlier, whereas psychotic thought content improved more gradually, predominantly between days 8 and 28. Side-effect burden at weeks 4 and 6 was minimal, and no discontinuations due to adverse events occurred.

Conclusions

In this exploratory uncontrolled cohort, an oral risperidone lead-in plus monthly risperidone ISM within multimodal inpatient care was associated with with rapid and sustained improvement in symptom trajectories and favourable short-term tolerability. Findings reflect multimodal inpatient care and cannot be attributed to ISM alone. Prospective, controlled studies are warranted.