This analysis of the Paliperidone Palmitate Research in Demonstrating Effectiveness (PRIDE) study (NCT01157351) compared outcomes after administration of once-monthly paliperidone palmitate (PP) vs conventional oral antipsychotics (COAs) or atypical oral antipsychotics (AOAs).

PRIDE was a 15-month study of 444 individuals with schizophrenia and a history of incarceration. They were randomly assigned to PP or to 1 of 7 commonly prescribed OAs. Primary endpoint was time to first treatment failure (TF). Event-free probabilities were estimated using the Kaplan–Meier method; treatment group differences (PP vs COAs, PP vs AOAs, and PP vs oral paliperidone/risperidone) were assessed using a log-rank test. Hazard ratios (HRs) and 95% confidence intervals (CIs) were estimated using Cox proportional hazards regression models. No adjustment was made for multiplicity.

Compared with PP, risk for first TF was 34% higher with COAs (HR: 1.34; 95% CI: 0.80–2.25), 41% higher with AOAs (HR: 1.41; 95% CI: 1.06–1.88), and 39% higher with paliperidone/risperidone (HR: 1.39; 95% CI: 0.97–1.99). Incidences of extrapyramidal symptom–related adverse events (AEs) were 45.7%, 13.7%, and 10.6% in the COA, AOA, and oral paliperidone/risperidone groups vs 23.9% in the PP group. Incidences of prolactin-related AEs were 5.7%, 3.8%, and 3.5% vs 23.5%, and incidences of ≥7% weight increase were 11.4%, 14.9%, and 16.0% vs 32.4%.

Results suggest a lower risk of TF but a higher rate of some AEs after treatment with PP vs COAs, AOAs, and paliperidone/risperidone. Deselection of specific OAs and low patient-compliance rates with OAs likely biased the safety results.

To evaluate the safety and effectiveness of lurasidone in the long-term treatment of patients with schizophrenia.

Patients who completed a 6-week, double-blind (DB), placebo-controlled trial continued in a 22-month, open-label (OL) study during which they received once-daily, flexible-doses of lurasidone, 40–120 mg. Change in the Positive and Negative Syndrome Scale (PANSS) was analyzed using both observed case (OC) and last observation carried forward (LOCF) analyses.

Of the 251 patients who entered the OL extension, 51.4% completed 6 months, 36.7% completed 12 months, and 26.7% completed 22 months of OL treatment. Treatment with lurasidone was associated with a mean change from DB baseline, in weight of +0.4 kg at Month 12 (n=99), and +0.8 kg at Month 24 (n=67; OC analyses). Median change from DB baseline to Month 12 and Month 24, respectively, was -1.0 and -9.0 mg/dL for total cholesterol; 0.0 and -1.0 mg/dL for LDL; +1.0 and -11.0 mg/dL for triglycerides; and 0.0 and +0.1/% for HbA1c (OC analyses). The mean PANSS total score was 96.5 at DB baseline and 69.5 at OL baseline. The mean change from DB baseline in the PANSS total score at Month 24 was -43.6 (OC) and -28.4 (LOCF). Thirty-seven patients (14.7%) discontinued due to an adverse event (AE) during OL treatment. Three AEs occurred in ≥10% of patients: schizophrenia (12.4%), akathisia (10.8%), and somnolence (10.8%); and 19.2% reported at least one movement disorder–related AE. Discontinuations due to AEs occurred in 14.8% of patients.

In this 22-month, open-label extension study, treatment with lurasidone was associated with minimal effects on weight, glucose, lipids, and prolactin. Patients demonstrated sustained improvement in the PANSS total score for up to 24 months of lurasidone treatment.

To identify and explore concepts important to patients with cognitive symptoms of major depressive disorder (MDD) and adapt an existing patient-reported outcome (PRO) measure to assess these symptoms.

Four focus groups were conducted with MDD patients (n = 33) to elicit relevant concepts and determine whether one of several PRO scales could be used to assess cognitive symptoms of depression. Following selection and minor modification of the Perceived Deficits Questionnaire (PDQ), cognitive debriefing interviews were conducted with additional patients (n = 17) to further refine and adapt this measure for use in MDD. Minor revisions based on patient input yielded the PDQ for Depression (PDQ-D).

Focus group participants reported a variety of cognitive symptoms that were classified into 7 general categories: lack of focus and clear thought, memory problems, difficulty with lexical access, difficulty with divided attention, difficulty with decision making, difficulty thinking quickly, and difficulty learning new things. Limitations in work productivity were the most commonly reported impacts of cognitive symptoms. While suggesting a few modifications, focus group participants reacted positively to the PDQ based on the breadth, specificity, and relevance of the items. Cognitive debriefing participants indicated that the modified PDQ items were generally easy to understand and relevant to their experiences with MDD.

Because cognitive symptoms are burdensome to patients with MDD, their assessment is important to optimize treatment outcomes. The PDQ-D has the potential to supplement existing assessment methods, providing unique information important for both comprehensive evaluation of individuals with MDD and evaluation of new treatments.

To meta-analytically summarize lamotrigine’s effectiveness and safety in unipolar and bipolar depression.

We conducted systematic PubMed and SCOPUS reviews (last search =10/01/2015) of randomized controlled trials comparing lamotrigine to placebo or other agents with antidepressant activity in unipolar or bipolar depression. We performed a random-effects meta-analysis of depression ratings, response, remission, and adverse effects calculating standardized mean difference (SMD) and risk ratio (RR) ±95% confidence intervals (CIs).

Eighteen studies (n=2152, duration=9.83 weeks) in patients with unipolar depression (studies=4, n=187; monotherapy vs lithium=1, augmentation of antidepressants vs placebo=3) or bipolar depression (studies=14, n=1965; monotherapy vs placebo=5, monotherapy vs lithium or olanzapine+fluoxetine=2, augmentation of antidepressants vs placebo=1, augmentation of mood stabilizers vs placebo=3, augmentation of mood stabilizers vs trancylpromine, citalopram, or inositol=3) were meta-analyzed. Lamotrigine’s efficacy for depressive symptoms did not differ significantly in monotherapy vs augmentation studies (vs. placebo: p=0.98, I2=0%; vs active agents: p=0.48, I2=0%) or in unipolar vs bipolar patients (vs placebo: p=0.60, I2=0%), allowing pooling of each placebo-controlled and active-controlled trials. Lamotrigine outperformed placebo regarding depressive symptoms (studies=11, n=713 vs n=696; SMD=–0.15, 95% CI=–0.27, –0.02, p=0.02, heterogeneity: p=0.24) and response (after removing one extreme outlier; RR=1.42, 95% CI=1.13–1.78; p=0.003, heterogeneity: p=0.08). Conversely, lamotrigine did not differ regarding efficacy on depressive symptoms, response, or remission from lithium, olanzapine+fluoxetine, citalopram, or inositol (studies=6, n=306 vs n=318, p-values=0.85–0.92). Adverse effects and all-cause/specific-cause discontinuation were similar across all comparisons.

Lamotrigine was superior to placebo in improving unipolar and bipolar depressive symptoms, without causing more frequent adverse effects/discontinuations. Lamotrigine did not differ from lithium, olanzapine+fluoxetine, citalopram, or inositol.

There is a close functional and neuroanatomical relationship between olfactory ability and emotional processing. The present study seeks to explore the association between olfactory ability and social cognition, especially facial emotion perception, in euthymic bipolar patients.

Thirty-nine euthymic outpatients meeting DSM-IV-TR criteria for bipolar disorder and 40 healthy volunteers matched on socio-demographic criteria were recruited. Both groups were assessed at one time point with the University of Pennsylvania Smell Identification Test (UPSIT), the Emotion Recognition Test, and The Faux Pas Recognition Test, as well as measures of general cognition and functioning.

The bipolar patients showed a significant impairment in olfactory identification (UPSIT) and social cognition measures compared to healthy controls. Analyses revealed significant relationships between olfactory identification and facial emotion recognition, theory of mind, general cognition, and a trend-level relationship with functioning. Controlling for age and cigarettes smoked, relationships remained significant between olfactory function and facial emotion recognition.

There is a deficit of olfactory identification in euthymic patients with bipolar disorder that is correlated with a deficit in both verbal and non-verbal measures of social cognition.

Apathy has been reported as a possible adverse effect of deep brain stimulation of the subthalamic nucleus (STN-DBS). We investigated the prevalence and severity of apathy in 22 patients with Parkinson’s disease (PD) who underwent STN-DBS, as well as the effects of apathy on quality of life (QOL).

All patients were assessed with the Lille Apathy Rating Scale (LARS), the Apathy Scale (AS), and the Parkinson’s Disease Questionnaire and were compared to a control group of 38 patients on pharmacotherapy alone.

There were no significant differences in the prevalence or severity of apathy between patients who had undergone STN-DBS and those on pharmacotherapy alone. Significant correlations were observed between poorer QOL and degree of apathy, as measured by the LARS (p<0.001) and the AS (p=0.021). PD-related disability also correlated with both apathy ratings (p<0.001 and p=0.017, respectively).

Our findings suggest that STN-DBS is not necessarily associated with apathy in the PD population; however, more severe apathy appears to be associated with a higher level of disability due to PD and worse QOL, but no other clinico-demographic characteristics.

Unemployment can negatively impact quality of life among patients with schizophrenia. Employment status depends on ability, opportunity, education, and cultural influences. A clinician-rated scale of work readiness, independent of current work status, can be a valuable assessment tool. A series of studies were conducted to create and validate a Work Readiness Questionnaire (WoRQ) for clinicians to assess patient ability to engage in socially useful activity, independent of work availability.

Content validity, test–retest and inter-rater reliability, and construct validity were evaluated in three separate studies.

Content validity was supported. Cronbach’s α was 0.91, in the excellent range. Clinicians endorsed WoRQ concepts, including treatment adherence, physical appearance, social competence, and symptom control. The final readiness decision showed good test–retest reliability and moderate inter-rater reliability. Work readiness was associated with higher function and lower levels of negative symptoms. Low positive and high negative predictive values confirmed the concept validity.

The WoRQ has suitable psychometric properties for use in a clinical trial for patients with a broad range of symptom severity. The scale may be applicable to assess therapeutic interventions. It is not intended to assess eligibility for supported work interventions.

The WoRQ is suitable for use in schizophrenia clinical trials to assess patient work functional potential.

Behavioral addictions refer to repeated dysfunctional behaviors that do not involve the ingestion of addictive substances. Studies on the association between behavioral addictions and personality traits have noted in individuals with problematic behaviors a high proclivity toward impulsivity and sensation-seeking and a low predisposition to harm avoidance. The majority of these studies have focused on adults, while far fewer have involved adolescents.

The study population was 109 high school students (age range 15–18 years) in Turin, Italy. Participants completed an assessment that comprised a demographic questionnaire and 3 self-report questionnaires: the Shorter PROMIS Questionnaire (SPQ), the Internet Addiction Test (IAT), and the Multidimensional Questionnaire for Adolescents (QMA).

A gender-related difference in the risk of developing an addictive behavior was observed, with a significantly higher percentage of risk seen for several addiction tendencies among the males. Statistically significant correlations emerged between some personality determinants and certain addictive behaviors.

The study pinpoints epidemiological indicators for the extent of this growing problem among adolescents.

The findings have implications for identifying protection factors and risk factors for addictive behaviors and related psychiatric disorders, and the development of primary prevention strategies derived from such factors.

Not all patients referred for evaluation of multiple sclerosis (MS) meet criteria required for MS or related entities. Identification of markers to exclude demyelinating disease may help detect patients whose presenting symptoms are inconsistent with MS. In this study, we evaluate whether patients who present a self-prepared list of symptoms during an initial visit are less likely to have demyelinating disease and whether this action, which we term the “list sign,” may help exclude demyelinating disease.

Using chart review, 300 consecutive new patients who presented for evaluation to a neurologist at a tertiary MS referral center were identified retrospectively. Patients were defined as having demyelinating disease if diagnosed with MS or a related demyelinating condition.

Of the 233 enrolled subjects, 157 were diagnosed with demyelinating disease and 74 did not meet criteria for demyelinating disease. Fifteen (8.4%) subjects had a positive list sign, of which 1 patient had demyelinating disease. The 15 subjects described a mean of 12.07 symptoms, and 8 of these patients met Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for somatic symptom disorder. The specificity and positive predictive value of the list sign for non-demyelinating disease were 0.99 (95% confidence interval (CI) 0.96–0.99) and 0.93 (95% CI 0.66–0.99), respectively.

A positive list sign may be useful to exclude demyelinating disease and to guide diagnostic evaluations for other conditions. Patients with a positive list sign also have a high incidence of somatic symptom disorder.