Long-Acting Injectable Risperidone for Relapse Prevention and Control of Breakthrough Symptoms After a Recent First Episode of Schizophrenia : A Randomized Clinical Trial

ImportanceLong-acting, injectable, second-generation antipsychotic medication has tremendous potential to bring clinical stability to persons with schizophrenia. However, long-acting medications are rarely used following a first episode of schizophrenia.ObjectiveTo compare the clinical efficacy of the long-acting injectable formulation of risperidone with the oral formulation in the early course of schizophrenia.Design, setting, and participantsA randomized clinical trial performed at a university-based research clinic, between 2005 and 2012. Eighty-six patients with recent onset of schizophrenia were randomized to receive long-acting injectable risperidone or oral risperidone. Half of each group was simultaneously randomized to receive cognitive remediation to improve cognitive functioning or healthy-behaviors training to improve lifestyle habits and well-being. An intent-to-treat analysis was performed between October 4, 2012, and November 12, 2014.InterventionsA 12-month trial comparing the long-acting injectable vs oral risperidone and cognitive remediation vs healthy-behaviors training.Main outcomes and measuresPsychotic relapse and control of breakthrough psychotic symptoms.ResultsOf the 86 patients randomized, 3 refused treatment in the long-acting injectable risperidone group. The psychotic exacerbation and/or relapse rate was lower for the long-acting risperidone group compared with the oral group (5% vs 33%; χ21 = 11.1; P < .001; relative risk reduction, 84.7%). Long-acting injectable risperidone better controlled mean levels of hallucinations and delusions throughout follow-up (β = -0.30; t68 = -2.6, P = .01). The cognitive remediation and healthy-behaviors training groups did not differ significantly regarding psychotic relapse, psychotic symptom control, or hospitalization rates, and there were no significant interactions between the 2 medications and the 2 psychosocial treatments. Discontinuations owing to inadequate clinical response were more common in the oral group than in the long-acting risperidone group (χ21 = 6.1; P = .01). Adherence to oral risperidone did not appear to differ before randomization but was better for the long-acting risperidone group compared with the oral group (t80 = 5.3; P < .001). Medication adherence was associated with prevention of exacerbation and/or relapse (χ21 =11.1; P = .003) and control of breakthrough psychotic symptoms (β = 0.2; t79 = 2.1; P = .04).Conclusions and relevanceThe use of long-acting injectable risperidone after a first episode of schizophrenia has notable advantages for clinical outcomes. The key clinical advantages are apparently owing to the more consistent administration of the long-acting injectable. Such formulations should be offered earlier in the course of illness.Trial registrationclinicaltrials.gov Identifier: NCT00333177

Cognitive remediation can improve negative symptoms and social functioning in first-episode schizophrenia: A randomized controlled trial

BackgroundMeta-analyses have reported that the effects of cognitive remediation might go beyond improvement in cognition to include unexpected benefits for schizophrenia patients such as negative symptom reduction and improvements in functioning. In addition, some evidence indicated that these potentially beneficial effects are also present in the initial course of schizophrenia, but work in this area is still developing.MethodA RCT compared Cognitive Remediation (CR) to Healthy Behaviors Training (HBT) in 80 patients (78% male) with a mean age of 21.9years and mean education of 12.3years who had a first psychotic episode within two years of study entry. Participants were trained using CR programs or received HBT involving 50 sessions over 6months and then booster sessions over the next 6months. The SANS and BPRS were used to assess symptoms. The UCLA Social Attainment Survey assessed social functioning.ResultsUsing GLMM, improvements over 12months were found favoring CR for SANS Expressive Symptoms (p<0.01), which was composed of Affective Flattening (p<0.01) and Alogia (p=0.04), and for SANS Experiential Symptoms, composed of Avolition/Apathy (p=0.04) and Anhedonia/Asociality (p<0.01). CR was associated with improvements in social functioning (p=0.05) as compared to HBT.ConclusionsWe confirmed that the beneficial effects of CR appear to extend beyond cognition to improvements in negative symptoms and social functioning in early course schizophrenia patients. These results suggest that cognitive remediation might have an impact when the reduction of risk factors for chronicity is most critical for promoting recovery

Exercise Predicts a Good Night’s Sleep: Preliminary Findings from a UCLA Study of First-Episode Schizophrenia

Background: Physical exercise can improve sleep quality in the general population. Understanding the negative impact of poor sleep quality on multiple domains of functioning among persons with schizophrenia is a new frontier of exploration. It is also imperative to investigate non-pharmacologic methods to improve sleep quality as these approaches may not carry the side effect burdens associated with medication. Objective: We examined the relationship between regular physical exercise and sleep quality among participants in an intervention consisting of both cognitive training and exercise. Methods: Participants (N = 48) were schizophrenia patients who had a first psychotic episode within two years of study entry. Participants received 4 h/week of internet-based cognitive training and an aerobic exercise program over a 6-month period. Sleep was assessed with the Pittsburgh Sleep Quality Index at baseline and six months later. Results: During the 3 months prior to the 6-month follow-up sleep assessment, participants completed an average of 12.6 group exercise sessions and an average of 12.9 individual at-home exercise sessions. A significant relationship between the number of exercise sessions and global sleep quality was seen at month six, r = −0.44, df = 39, p < 0.01. Group exercise frequency was also associated with improvement in global sleep quality over the six-month intervention, t(34) = −2.84, p = 0.008. Conclusion: We demonstrated that a group of young adults with schizophrenia can be engaged in a regular exercise program, even during the tumultuous early course of the disorder. The number of exercise sessions in which they participated was associated with better sleep quality at six months and pre–postintervention improvement in sleep quality. Key message: Improved sleep quality appears to be a benefit of regular exercise among individuals with serious mental illness

Exercise Predicts a Good Night’s Sleep: Preliminary Findings from a UCLA Study of First-Episode Schizophrenia

Background: Physical exercise can improve sleep quality in the general population. Understanding the negative impact of poor sleep quality on multiple domains of functioning among persons with schizophrenia is a new frontier of exploration. It is also imperative to investigate non-pharmacologic methods to improve sleep quality as these approaches may not carry the side effect burdens associated with medication. Objective: We examined the relationship between regular physical exercise and sleep quality among participants in an intervention consisting of both cognitive training and exercise. Methods: Participants (N = 48) were schizophrenia patients who had a first psychotic episode within two years of study entry. Participants received 4 h/week of internet-based cognitive training and an aerobic exercise program over a 6-month period. Sleep was assessed with the Pittsburgh Sleep Quality Index at baseline and six months later. Results: During the 3 months prior to the 6-month follow-up sleep assessment, participants completed an average of 12.6 group exercise sessions and an average of 12.9 individual at-home exercise sessions. A significant relationship between the number of exercise sessions and global sleep quality was seen at month six, r = −0.44, df = 39, p p = 0.008. Conclusion: We demonstrated that a group of young adults with schizophrenia can be engaged in a regular exercise program, even during the tumultuous early course of the disorder. The number of exercise sessions in which they participated was associated with better sleep quality at six months and pre–postintervention improvement in sleep quality. Key message: Improved sleep quality appears to be a benefit of regular exercise among individuals with serious mental illness