Patient perspectives on use of long-acting antipsychotics in bipolar disorder: focus on risperidone injection

Figures & data

Table 1 Studies of risperidone long-acting injection in the treatment of bipolar disorder

Study	Design	Patients	Treatment	Time	Results
					Efficacy	Tolerance/satisfaction
Switch from oral antipsychotic to RLAI
RLAI Monotherapy
Han et al^Citation36	Open-label observational study	10 bipolar I patients in a stable remission state	Switch from oral SGA: risperidone 1 mg/day (n = 6), olanzapine 10 mg/day (n = 3), amisulpride 100 mg/day (n = 1) to RLAI (25–37.5 mg)	One year	No relapses reported. No significant difference in the YMRS, HAM-D, and BPRS scores Significant improvement in CGI-S score	No serious adverse events reported Significant improvement in ESRS No change to the mean body weight High level of satisfaction (10-point VAS)
Quiroz et al^Citation37	Double-blind randomized trial versus placebo	559 bipolar I patients. After open-label period, 303 patients were randomized in placebo group (n = 149), and RLAI group (n = 154)	Open-label period: oral risperidone (3 weeks), then RLAI (26 weeks) Double-blind randomized period: RLAI (12.5– 50 mg/2 weeks) versus placebo	2 years	Significant improvement in time to recurrence of mood episode Significantly longer time for elevated mood recurrences, but no difference for depressive episodes Significant improvement in YMRS, MADRS, and CGI-S scores	More frequent weight increase No significant difference in incidence of depression
RLAI + mood stabilizers
Savas et al^Citation38	Retrospective chart review	12 bipolar I patients on manic or hypomanic episode	Unspecified mood stabilizer + RLAI (25–50 mg/2 weeks)	6 months before and 6 months after the switch	No relapses reported Significant improvement in BRMAS and CGI-S scores No significant difference in 24-item HAM-D scores	No serious adverse events reported No extrapyramidal symptoms reported
Benabarre et al^Citation39	Open-label trial	14 bipolar I patients + 8 schizoaffective disorder patients, with poor treatment adherence and frequent relapses	Mood stabilizer: valproate, n = 9; lithium carbonate, n = 8; carbamazepine, n = 3; none, n = 1; + RLAI (25 or 37.5 mg/2 weeks)	40 weeks	Significant improvement in YMRS and CGI-S scores No significant difference in HAM-D scores	No significant weight increase No significant change in UKU scores
Vieta et al^Citation40	Open-label trial	29 manic or mixed inpatients, with poor treatment adherence	Mood stabilizer, FGAs, SSRIs + RLAI (25 to 50 mg/2 weeks)	2 years	Significant decrease of hospitalization mean number per patient Significant decrease of the number of elevated mood episodes but not for the number of depressive episodes Significant increase in relapse time Significant decrease in mean time of hospitalizations for mood episodes Significant improvement in CGI-S scores number of hetero-aggressive episodes, but no significant difference in suicide attempts	Extrapyramidal symptoms: n = 5 Weight gain: n = 5 Depression: n = 1 Prolactin increase: n = 3
Yatham et al^Citation41	Randomized active-comparator versus oral SGA	49 clinically stable bipolar I or II patients	RLAI (25– 50 mg/2 weeks) + mood stabilizer, antidepressant	6 months	No significant difference in CGI-S, YMRS, MADRS, or HAM-A scores	No significant difference in adverse events incidence, vital signs, laboratory tests, weight gain, and BARS, SAS, and AIMS scores No significant difference in patient satisfaction (VAS), and in quality of life (EuroQol Q05D questionnaire)
Addition of RLAI to mood stabilizers
Malempati et al^Citation42	Open-label trial	8 bipolar I patients and 2 bipolar II patients, with a predominantly depressive course of illness	RLAI (25–50 mg/2 weeks) + mood stabilizer for 8 patients (divalproex, lithium carbonate, carbamazepine), SGA for 3 (olanzapine, quetiapine) and antidepressant for 2 patients	2 years	No hospitalization required. Decrease in average number of medications per patient Significant improvement in YMRS scores One depressive relapse and 4 elevated mood relapses	Limited weight gain. No extrapyramidal symptoms indexed for 7 patients, and extrapyramidal symptoms reduction in 3 patients
Macfadden et al^Citation43	Double-blind randomized trial versus placebo	240 bipolar I patients with a high relapse rate. After stabilization period with RLAI, 124 patients were randomized: 59 in a placebo group, and 65 who continued RLAI	RLAI (25–50 mg/2 weeks) + treatment as usual (antidepressant, anxiolytic, mood stabilizer)	68 weeks	Significant improvement in time to and number of relapses Significant improvement in YMRS and MADRS scores	Weight gain and extrapyramidal symptoms were significantly increased in the RLAI group. No significant difference in suicidal ideation and for prolactin-related adverse events

Abbreviations: YMRS, Young Mania Rating Scale; HAM, Hamilton Depressive Scale; BPRS, Brief Psychiatric Rating Scale; MADRS, Montgomery Asberg Rating Scale; CGI-S, Clinical Global Improvement Scale; BRMAS, Bec-Raelsen Mania Rating Scale; ESRS, Extrapyramidal Rating Scale, BARS; Barnes Akathisia Scale; SAS, Simpson Angus Scale; AIMS, Abnormal Involuntary Movements Scale; VAS, visual analog scale; RLAI, risperidone long-acting injection; FGA, first-generation antipsychotics; UKU, Udvalg for Kliniske Undersøgelser.

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