Effects of Depth of Needle Insertion with Risperidone Long-Acting Injectable in Persons with Schizophrenia: A Randomized Double-Blind Study

In some cases, if the insertion depth is shallower than expected, intramuscular (IM) injection of risperidone long-acting injectable (RLAI) may not penetrate the muscle fascia. However, if needle insertion depth is deeper than anticipated, needle penetration may cause damage to nerves, arteries and veins. Few clinical studies were done to evaluate the depth of needle length insertion reaching the intended gluteal muscle. The aim of this study was to evaluate the suitable depth of injecting RLAI. Twenty-six patients with schizophrenia were treated with RLAI, and randomly divided into two groups: 50 mm needle inserted group (Group-D, deep insertion, n = 13) and 20 mm needle insertion group (Group-S, shallow insertion, n = 13). For Group-S, the needle length was marked with a spacer at exactly 20 mm. Injections were performed by the psychiatrist or nurse, alternating between the two gluteal sites by double-cross method every two weeks. Clinical psychotic symptoms and injection site reactions were recorded throughout the study period. Experienced psychologists who were blinded from the needle-length experimental variable evaluated patients’ psychotic symptoms using the Positive and Negative Syndrome Scale (PANSS) every two weeks. The plasma 9-hydroxyrisperidone (9-OH-RIS) concentrations were measured every two weeks;comparison data were determined on the 8th week and the 14th week. No significant difference was observed in 9-OH-RIS concentrations, psychotic symptoms, injection site skin reactions of subjects in both groups. However, in Group-D, injection site adverse reactions were confirmed in two subjects (15%). In Group-S, injection site reactions were confirmed in six subjects (46%). Although effective 9-OH-RIS concentrations were obtained with the insertion using both depth, it was concluded that the 50 mm insertion length was more suitable for dorsogluteal IM injections in adult patients with schizophrenia as demonstrated by the incidence of local adverse skin reactions.

The Effect of a Psycho-Educational Program on Psychiatric Symptoms, Drug Attitude and Treatment Satisfaction of Patients with Schizophrenia

The purpose of this study was to determine the effect of a Comprehensive Psycho-Educational Approach and Scheme Set (COMPASS) for patients with schizophrenia who were treated with risperidone long-acting injectable (RLAI), on their psychiatric symptoms, drug attitudes, and treatment satisfaction levels. Participants were sixty-five patients at thirteen hospitals in Japan who met ICD-10 F2 criteria for schizophrenia or schizo-affective disorder and were treated with RLAI. A correlational study design was used to measure the effect of the COMPASS on the psychiatric symptoms, drug attitudes, and treatment satisfaction levels of patients treated with RLAI. Using the following evaluation indicators: The Subjective Satisfaction to Treatment Scale (SSTS), Brief Psychiatric Rating Scale (BPRS), Global Assessment of Functioning (GAF), Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS), and Drug Attitude Inventory-10 (DAI-10), measurements were taken at the beginning of the program (baseline), at the end of the program, and six months after (endpoint). Data analysis included descriptive statistics, Mann-Whitney U test or Wilcoxon signed-rank test, and Spearman’s rank correlation coefficient. Significant differences were observed in BPRS total (p < 0.001), sub-scales of BPRS positive (p < 0.001), BPRS negative (p < 0.01), BPRS affective (p < 0.01), and GAF (p < 0.001). However, there was no significant change in subscale of BPRS manic, DAI-10, DIEPSS, or SSTS but significant positive correlations were found between SSTS and DAI-10 and GAF at baseline;a negative correlation was found between SSTS and BPRS. The findings of the study suggested the benefit of using the COMPASS in conjunction with RLAI to decrease patients’ psychiatric symptomatology and improve treatment satisfaction. In addition, patient satisfaction was found to be an important factor to be considered by the psychiatrist.