Daytime sleepiness associated with lurasidone and quetiapine XR: results from a randomized double-blind, placebo-controlled trial in patients with schizophrenia The Comparative Effects of Risperidone Long-Acting Injection and Paliperidone Palmitate on Social Functioning in Schizophrenia: A 6-Month, Open-Label, Randomized Controlled Pilot Trial Computerized cognitive remediation training for schizophrenia: An open label, multi-site, multinational methodology study Proof-of-concept randomized controlled trial of pregnenolone in schizophrenia Multimedia consent for research in people with schizophrenia and normal subjects: a randomized controlled trial. Compensatory cognitive training for psychosis: effects in a randomized controlled trial. The efficacy of supported employment for middle-aged and older people with schizophrenia
Objective The aim of this analysis was to compare the effects of 2 atypical antipsychotic agents , lurasidone ( 80 mg/d or 160 mg/d ) and quetiapine XR ( 600 mg/d ) , on daytime alertness , and to evaluate the effects of daytime sleepiness on treatment outcomes in patients with an acute exacerbation of schizophrenia . Methods Patients who met Diagnostic and Statistical Manual of Mental Disorders , 4th edition , text revision ( DSM-IV-TR ) criteria for schizophrenia were r and omized to 6 weeks of double-blind treatment with fixed doses of lurasidone 80 mg/d ( n = 125 ) , lurasidone 160 mg/d ( n = 121 ) , quetiapine XR 600 mg/d ( n = 119 ) , or placebo ( n = 121 ) , all dosed once daily in the evening , with food . Daytime sleepiness was assessed using the Epworth Sleepiness Scale ( ESS ) . Results Daytime sleepiness improved in the lurasidone and placebo-treated groups but worsened in the quetiapine XR treatment group when compared to placebo ( p = 0.001 ) and to either dose of lurasidone ( both p < 0.01 ) . Sedation associated with quetiapine XR treatment mediated an improvement in agitation [ assessed by the Positive and Negative Syndrome Scale — Excitement ( PANSS-EC ) subscale ] and a worsening in functional capacity [ assessed by the University of California – San Diego ( UCSD ) Performance-Based Skills Assessment —Brief Version ( UPSA-B ) total score ] ; these mediating relationships were not observed for the lurasidone or placebo treatment groups . Conclusion In this 6-week double-blind study , treatment with lurasidone 80 mg or 160 mg , administered once daily in the evening , was associated with a reduction in daytime sleepiness similar in magnitude to placebo , while quetiapine XR 600 mg/d was associated with a significant increase in daytime sleepiness , compared to both lurasidone dose groups and placebo . Daytime sleepiness was associated with improvement in agitation and worsening in functional capacity for quetiapine XR , but not lurasidone or placebo-treated patients Purpose : The aim of this study was to compare the effects of risperidone long-acting injection ( RLAI ) and paliperidone palmitate ( PP ) on non-acute-phase social functioning in patients with schizophrenia . Patients and Methods : In this 6-month pilot , open-label , r and omized controlled study , 30 patients with schizophrenia who had been treated with RLAI were r and omly allocated to the RLAI continuation group or switched to the PP group . Patients were evaluated at baseline and 6 months with the Social Functioning Scale ( SFS ) as the primary outcome variable and University of California San Diego Performance-Based Skills Assessment Brief ( UPSA-B ) , Social Emotional Cognition Task ( SECT ) , Positive and Negative Syndrome Scale ( PANSS ) , and Drug-Induced Extrapyramidal Symptoms Scale ( DIEPSS ) scores as secondary outcomes . Results : At baseline , the two groups did not significantly differ in demographic or clinical features . The two groups did not differ in total score changes for the UPSA-B , the SECT , the PANSS , and the DIEPSS . However , the total scores and the two subscales of the SFS , i.e. independence-competence and independence-performance , were more improved in the PP group compared to the RLAI group ( total scores , p = 0.038 ; competence , p = 0.001 , and performance , p = 0.007 , respectively ) . Conclusion : These results suggest that PP may improve the total social functioning , independent life competence , and performance as compared to the RLAI group . However , these results are preliminary and need independent replication in larger sample s before any definitive statement can be made A recent single-site study ( Fisher et al. , 2009 . Am J Psychiatry . 166 ( 7 ) 805 - 11 ) showed that repeated training with the Brain Fitness Program ( BFP )  improved performance on a battery of neuropsychological tasks . If replicated these data suggest an important non-pharmacological method for ameliorating cognitive impairment in schizophrenia . Our study evaluated the BFP training effects in an open-label , multi-site , multinational clinical trial . Fifty-five stable adult patients with schizophrenia on regular antipsychotic medication completed ≥ 32 BFP training sessions over 8 - 10 weeks . Training effects on cognitive performance and functional capacity outcome measures were measured using CogState ® schizophrenia battery , UCSD Performance based Skills Assessment ( UPSA-2 ) and Cognitive Assessment Interview ( CAI )  . BFP training showed a large and significant treatment effect on a training exercise task ( auditory processing speed ) , however this effect did not generalize to improved performance on independent CogState ® assessment . There were no significant effects on UPSA-2 or CAI scores . Our study demonstrated the feasibility of implementing BFP training in a multi-site study . However , BFP training did not show significant treatment effects on cognitive performance or functional capacity outcome measures despite showing large and significant effects on a training exercise Rationale Pre clinical and clinical data suggest that pregnenolone may be a promising therapeutic in schizophrenia .  Pregnenolone is neuroprotective and enhances learning and memory , myelination , and microtubule polymerization . Treatment with pregnenolone elevates allopregnanolone ( a neurosteroid that enhances GABAA receptor responses ) and pregnenolone sulfate ( a positive NMDA receptor modulator ) . Pregnenolone could thus potentially mitigate GABA dysregulation and /or NMDA receptor hypofunction in schizophrenia via metabolism to other neurosteroids . Objective The objective of this study is to conduct a r and omized controlled trial of adjunctive pregnenolone in schizophrenia . Methods Following a placebo lead-in , 120 participants were r and omized to pregnenolone or placebo for 8 weeks ( Institute for Mental Health , Singapore ) . Primary endpoints were changes in MATRICS Consensus Cognitive Battery ( MCCB ) composite scores ( cognitive symptoms ) , UCSD Performance-based Skills Assessment —Brief ( UPSA-B ) composite scores ( functional capacity ) , and Scale for Assessment of Negative Symptoms ( SANS ) total scores ( negative symptoms ) . A modified intent-to-treat analysis approach was utilized . Results No significant changes compared to placebo were demonstrated in composite MCCB scores . In contrast , participants r and omized to pregnenolone ( n = 56 ) demonstrated greater improvements in functional capacity ( UPSA-B composite changes ) compared to placebo ( n = 55 ) , p = 0.03 . Pregnenolone was also superior to placebo in the communication subscale of the UPSA-B ( p < 0.001 ) . Serum pregnenolone changes post-treatment were correlated with UPSA-B composite score changes in females ( rs = 0.497 , p < 0.042 , n = 17 ) but not in males . Mean total SANS scores were very low at baseline and did not improve further post-treatment . Pregnenolone was well-tolerated . Conclusions Pregnenolone improved functional capacity in participants with schizophrenia , but did not improve cognitive symptoms over an 8-week treatment period . Neurosteroid changes correlated with functional improvements in female participants . Neurosteroid interventions may exhibit promise as new therapeutic leads for schizophrenia Limitations of printed , text-based , consent forms have long been documented and may be particularly problematic for persons at risk for impaired decision-making capacity , such as those with schizophrenia . We conducted a r and omized controlled comparison of the effectiveness of a multimedia vs routine consent procedure ( augmented with a 10-minute control video presentation ) as a means of enhancing comprehension among 128 middle-aged and older persons with schizophrenia and 60 healthy comparison subjects . The primary outcome measure was manifest decisional capacity ( underst and ing , appreciation , reasoning , and expression of choice ) for participation in a ( hypothetical ) clinical drug trial , as measured with the MacArthur Competence Assessment Tool for Clinical Research ( MacCAT-CR ) and the University of California San Diego ( UCSD ) Brief Assessment for Capacity to Consent ( UBACC ) . The MacCAT-CR and UBACC were administered by research assistants kept blind to consent condition . Additional assessment s included st and ardized measures of psychopathology and cognitive functioning . Relative to patients in the routine consent condition , schizophrenia patients receiving multimedia consent had significantly better scores on the UBACC and on the MacCAT-CR underst and ing and expression of choice subscales and were significantly more likely to be categorized as being capable to consent than those in the routine consent condition ( as categorized with several previously established criteria ) . Among the healthy subjects , there were few significant effects of consent condition . These findings suggest that multimedia consent procedures may be a valuable consent aid that should be considered for use when enrolling participants at risk for impaired decisional capacity , particularly for complex and /or high-risk research protocol OBJECTIVE Treatments for the cognitive impairments of schizophrenia are urgently needed . We developed and tested a 12-week , group-based , manualized , compensatory cognitive training intervention targeting prospect i ve memory , attention , learning/memory , and executive functioning . The intervention focused on compensatory strategies , such as calendar use , self-talk , note taking , and a 6-step problem-solving method , and did not require computers . METHOD In a r and omized controlled trial , 69 out patients with DSM-IV primary psychotic disorders were assigned to receive st and ard pharmacotherapy alone or compensatory cognitive training + st and ard pharmacotherapy for 12 weeks . Assessment s of neuropsychological performance and functional capacity ( primary outcomes ) and psychiatric symptom severity , quality of life , social skills performance , cognitive insight , and self-reported everyday functioning ( secondary outcomes ) were administered at baseline , posttreatment , and 3-month follow-up . Data were collected between September 2003 and August 2009 . RESULTS Hierarchical linear modeling analyses demonstrated significant compensatory cognitive training-associated effects on attention at follow-up ( P = .049 ) , verbal memory at posttreatment and follow-up ( P values ≤ .039 ) , and functional capacity ( University of California , San Diego Performance-based Skills Assessment ) at follow-up ( P = .004 ) . The compensatory cognitive training group also differentially improved in negative symptom severity at posttreatment and follow-up ( P values ≤ .025 ) and subjective quality of life at follow-up ( P = .002 ) . CONCLUSIONS Compensatory cognitive training , a low-tech , brief intervention , has the potential to improve not only cognitive performance but also functional skills , negative symptoms , and self-rated quality of life in people with psychosis . TRIAL REGISTRATION Clinical Trials.gov identifier : NCT01521026 OBJECTIVE Supported employment is the evidence -based treatment of choice for assisting individuals with severe mental illness to achieve competitive employment , but few supported employment programs specifically target older clients with psychiatric illness . The purpose of this study was to evaluate the efficacy of supported employment for middle-aged or older people with schizophrenia . METHOD Participants included 58 out patients with schizophrenia or schizoaffective disorder aged 45 or older who were recruited from a community mental health clinic . Participants were r and omly assigned to receive Individual Placement and Support ( IPS ; the manualized version of supported employment ) or conventional vocational rehabilitation ( CVR ) for one year , and completed assessment s at baseline , six months , and twelve months . RESULTS IPS was superior to CVR on nearly all work outcome measures , including attainment of competitive employment , weeks worked , and wages earned . Fifty-seven percent of IPS participants worked competitively , compared with 29 % of CVR participants ; 70 % of IPS participants obtained any paid work , compared with 36 % of CVR participants . Within the IPS group , better baseline functional capacity ( as measured by the UCSD Performance Based Skills Assessment ) and more recent employment were modestly associated with better work outcomes . CONCLUSIONS Middle-aged and older adults with schizophrenia are good c and i date s for supported employment services
Conclusion The SLOF was the most often used functional measure and had the strongest observed correlation with the UPSA .
Although knowledge gaps remain , evidence from this review indicates that there is a quantitative relationship between functional capacity and real-world outcomes in individuals with schizophrenia
Objective To perform a systematic review of the published literature to evaluate how functional capacity , as measured by the University of California at San Diego ( UCSD ) Performance-based Skills Assessment ( UPSA ) , relates to other functional measures and real-world outcomes among individuals with schizophrenia .