Long-term efficacy of risperidone long-acting injectable in bipolar disorder with psychotic features

Abstract

Bipolar disorder (BD) with psychotic features is a difficult-to-treat form of the illness that is associated with a poor prognosis. We hypothesized that treatment with adjunctive risperidone long-acting injectable (RLAI) is well-tolerated and efficacious in treating patients with psychotic BD. Ten patients with BDI or BDII with psychotic features who were refractory to earlier treatments were prescribed adjunctive open-label RLAI 25-62.5 mg q twice weekly. The patients were followed prospectively for 3 years. The severity of mood and psychotic symptoms was measured using clinical rating scales, and information regarding relapses, hospitalizations, extra-pyramidal symptom, weight gain, and other side effects was also gathered. Young Mania Rating Scale scores, Montgomery Asberg Depression Rating Scale scores, psychosis rating scale scores, and the numbers of mood episodes and hospitalizations were reduced during 3 years of RLAI therapy compared with an equivalent pretreatment period. Only three patients experienced relapses with psychotic symptoms. Functional outcomes were also improved, with substantial numbers of previously disabled patients able to return to gainful employment and independent living. RLAI was associated with minimal extra-pyramidal symptom, modest weight gain, and few other side effects. Adjunctive RLAI can be considered as a treatment option in patients with psychotic BD.

Long‐acting injectable antipsychotics as maintenance treatments for bipolar disorder—A critical review of the evidence

“…One study examining 10 patients with bipolar I or II disorder over 2 years on risperidone LAI was notable in finding a reduction in depressive episodes 36. Specifically, in psychotic, refractory bipolar disorder (n = 10), clinical outcomes were better on risperidone LAI over 3 years compared with the previous periods of treatment 33. Savas et al,32 Han et al,37 and Vieta et al38 all recruited patients only in a manic or mixed episode, and all showed a reduction in manic relapse on LAI risperidone.…”

“…A particular issue in the selection of patients is that non‐adherent patients are less likely to consent to participate in an RCT and often meet exclusion criteria for clinical trials, and it is in these non‐adherent patients that the greatest benefits may be expected. Four of the open‐label studies specifically included non‐adherent patients,32-35 but there are no studies specifically in non‐consenting patients, and the registry studies make no mention of whether patients “volunteered” into being administered an LAI. In this case, different methodologies may be more useful, for example, the mirror image study of Wu et al41 and the examination of outcomes from a large Finnish data base,42 or using more broad‐based “outcome” studies of clinical cohorts.…”

“…Four of the open-label studies specifically included non-adherent patients, [32][33][34][35] but there are no studies specifically in non-consenting patients, and the registry studies make no mention of whether patients "volunteered" into being administered an LAI. In this case, different methodologies may be more useful, for example, the mirror image study of Wu et al 41 While there are clear benefits (lower risk of relapse) from treating patients using risperidone or aripiprazole LAIs, either as monotherapy or an adjunctive treatment, there are also significant side effects that need to be considered.…”

“…36 Specifically, in psychotic, refractory bipolar disorder (n = 10), clinical outcomes were better on risperidone LAI over 3 years compared with the previous periods of treatment. 33 Savas et al, 32 Han et al, 37 and Vieta et al 38 with risperidone LAI, the FGAs were associated with a higher rate of hospitalisation for any mood episode and specifically for major depressive episode, but there was no difference in discontinuation rate. In a retrospective analysis of health care data from 18,018 patients who had been hospitalised with bipolar disorder in Finland, 42 the use of risperidone LAI, perphenazine LAI, lithium, and gabapentin (which did not survive in sensitivity analysis) were associated with a reduced risk of re-hospitalisation.…”

“…These have mainly involved small numbers of patients. Four small (n = 12-16) open-label studies specifically recruited non-adherent patients [32][33][34][35] and examined the effect of treatment with risperidone LAI. In each (including one which was a retrospective file review), there was a reduction in the severity of symptoms and the rate of relapse.…”