A 1-year double-blind study of 2 doses of long-acting risperidone in stable patients with schizophrenia or schizoaffective disorder
ABSTRACT This study examined the effects of 2 doses of long-acting risperidone injection in patients with schizophrenia or schizoaffective disorder.
This 52-week, prospective, randomized, double-blind, multicenter, international study included clinically stable outpatients with schizophrenia or schizoaffective disorder (DSM-IV criteria). Settings included physicians' offices and clinics. Patients received a fixed dose of long-acting risperidone (25 or 50 mg) every 2 weeks. Primary outcome was time to relapse, defined as either re-hospitalization or other exacerbation criteria. Other assessments included the Positive and Negative Syndrome Scale, Clinical Global Impressions-Severity of Illness scale, and functional and quality-of-life measures. Safety was assessed via treatment-emergent adverse events, laboratory tests, and movement disorder rating scales. Data were collected from December 2002 to September 2004.
A total of 324 patients were randomized to 25 mg (N = 163) or 50 mg (N = 161) of long-acting risperidone. Time to relapse was comparable (p = .131) for both groups. Projected median time to relapse was 161.8 weeks (95% CI = 103.0 to 254.2) with 25 mg and 259.0 weeks (95% CI = 153.6 to 436.8) with 50 mg. One-year incidences of relapse were 21.6% (N = 35) and 14.9% (N = 24), respectively (p = .059). Psychiatric hospitalization was the reason for relapse for 16 (10%) in the 25-mg group and 10 (6%) in the 50-mg group. Patients experienced statistically significant but modest improvements at endpoint in most measures (i.e., psychotic symptoms, functioning, movement disorder severity) with both doses, with no significant between-group differences.
In this 1-year study, long-acting risperidone was associated with low relapse and rehospitalization rates, indicating that doses of 25 to 50 mg are appropriate for long-term treatment in schizophrenia.
- SourceAvailable from: Maju Koola
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- "For example, a 12-week, doubleblind , placebo-controlled randomized study of 400 patients with schizophrenia receiving either 25-, 50-or 75 mg biweekly intramuscular injections of placebo or long-acting risperidone found significant improvement on the positive and negative syndrome scale (PANSS) scores for long-acting risperidone relative to placebo (Kane et al., 2003). In another randomized, double-blind 52-week study with risperidone long-acting injectable 25 mg or 50 mg every 2 weeks (N=324), risperidone long-acting injectable 50 mg had a lower rate of relapse and also significant improvements in psychosocial functioning (Simpson et al., 2006). "
ABSTRACT: OBJECTIVE: Treatment of schizophrenia in patients with comorbid substance use (alcohol/illicit drug use, abuse or dependence) presents challenges for public health systems. Substance use in people with schizophrenia is up to four times greater than the general population and is associated with medication nonadherence and poor outcomes. Therefore, continuous antipsychotic treatment in this population may pose more of a challenge than for those with schizophrenia alone. Many clinical trials and treatment recommendations in schizophrenia do not take into consideration substance use as people with comorbid substance use have typically been excluded from most antipsychotic trials. Nonetheless, antipsychotic treatment appears to be as efficacious in this population, although treatment discontinuation remains high. The objective of this review was to highlight the importance and utility of considering long-acting injectable antipsychotics for patients with schizophrenia and comorbid substance use. METHODS: We did a literature search using PubMed with key words schizophrenia and substance use/abuse/dependence, nonadherence, antipsychotics, long acting injectables, relapse, and psychosocial interventions. We limited our search to human studies published in English and 4,971 articles were identified. We focused on clinical trials, case reports, case series, reviews and meta-analyses resulting in 125 articles from 1975-2011. RESULTS: Our review suggests the potential role of long-acting injectables for people with comorbid substance use and schizophrenia in leading to improvements in psychopathology, relapse prevention, fewer rehospitalizations, and better outcomes. CONCLUSIONS: While more research is needed, long-acting antipsychotics should be considered an important option in the management of people with schizophrenia and comorbid substance use.Journal of Dual Diagnosis 01/2012; 8(1):50-61. DOI:10.1080/15504263.2012.647345 · 0.80 Impact Factor
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- "The advantages of antipsychotic depot treatment in the relapse prevention of schizophrenia have been demonstrated for first generation antipsychotics (FGA) in several studies done since their development in the 1960s, showing both diminished rates and reduced durations of rehospitalization (Davis et al., 1994). Current clinical trials (Simpson et al., 2006; Medori et al., 2008; Chue et al., 2005) corroborate these findings and the advantages prove robust even when the outcome of FGA depot treatment is compared to oral second generation antipsychotics (SGA) in naturalistic studies (Tiihonen et al., 2006). With the introduction of oral SGAs, however, prescription rates of depot formulations decreased, probably because psychiatrists wanted their patients to benefit from the potential advantages of SGAs (Patel and David, 2005). "
ABSTRACT: The prescription rate of antipsychotic depots for patients suffering from schizophrenia is currently low. Among these patients the assumable acceptance rate of depot as treatment of choice is markedly higher, but psychiatrists do report that patients frequently reject the offer of depot treatment. In a first step to highlight this contradiction we aimed at identifying attributes of patients that indicate their qualification for depot treatment in the eyes of the psychiatrists. We surveyed 201 psychiatrists about their evaluation of patients' attributes potentially influencing their qualification for depot treatment. Multidimensional and cluster analyses were applied to detect associated attributes. A second sample of further 248 psychiatrists was asked about their proposal of depot treatment to patients depending on the number of relapses in the past. Two clusters of attributes were identified characterizing patients' qualification for depot treatment. In cluster I episodes of non-compliance and relapses in the past were considered as favoring the qualification. cluster II included a high level of insight, openness to drug treatment and profound knowledge about the disease representing attributes that increase patients' qualification. Patients were significantly more likely to be offered depot treatment after their fourth reexacerbation compared to their first relapse. Attributes comprised in cluster I highly qualify a patient for depot treatment which is in line with the current prescription stereotype. This conservative notion of depot use is supplemented by an alternative cluster II patient profile. Patients fitting this cluster also potentially qualify for depot treatment according to the surveyed psychiatrists and should be offered depot in clinical routine considering the advantages of this form of administration.Progress in Neuro-Psychopharmacology and Biological Psychiatry 11/2008; 32(8):1987-93. DOI:10.1016/j.pnpbp.2008.09.025 · 4.03 Impact Factor
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ABSTRACT: Schizophrenia remains a severe disorder that is associated with a poor outcome in a large subgroup of patients. Major efforts should be made to improve treatment for all patients who have this debilitating disease. Second-generation antipsychotics were a major step forward in this respect; however, important unmet needs remain, such as a better solution for frequent noncompliance problems. Depot formulations are known to have advantages in this respect. However, for a long time, only depot formulations of conventional antipsychotics were available, with their high risk of extrapyramidal adverse effects. Therefore, there has been only very restricted use of depot antipsychotics, which mainly focused on patients with chronic disease who were difficult to treat and had a high risk of noncompliance. The situation may change with the advent of a depot formulation of an atypical antipsychotic. The first depot formulation of an atypical antipsychotic to be introduced to the market is long-acting injectable risperidone. On the basis of the pharmacokinetic properties of the depot formulation, a 2-week interval between administrations is recommended. The antipsychotic efficacy of long-acting risperidone was demonstrated in two 12-week, double-blind, randomised, phase III studies, one versus placebo and the other versus oral risperidone. These two studies, together with one open-label, long-term study over 12 months, belong to the core group of trials that were relevant for the licensing of long-acting risperidone. A relapse-prevention, control group study comparing the long-acting formulation versus oral risperidone was not performed because of the known principal methodological problems of such a comparison. Instead, as much clinical data as possible was collected from observational studies that investigated questions relevant for clinical practice, such as efficacy, safety and tolerability in different subgroups, and transition from pre-treatment with different kinds of antipsychotics to long-acting risperidone. On the basis of these data, it can be stated that the efficacy of the long-term formulation of risperidone is proven, and that the safety and tolerability are more or less comparable to those of oral risperidone. The local tolerability at the injection site is good. Because it is well known that noncompliance is a frequent feature of the treatment of schizophrenia, and considering the advantages of atypical antipsychotics, consideration of whether long-acting atypical antipsychotics should have a broader indication than is the case with the depot formulations of the classical antipsychotics is warranted.Drugs 02/2007; 67(11):1541-66. DOI:10.2165/00003495-200767110-00003 · 4.13 Impact Factor