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While early intervention in psychosis (EIP) programs have been increasingly implemented across the globe, many initiatives from Africa, Asia and Latin America are not widely known. The aims of the current review are (a) to describe population-based and small-scale, single-site EIP programs in Africa, Asia and Latin America, (b) to examine the variability between programs located in low-and-middle income (LMIC) and high-income countries in similar regions and (c) to outline some of the challenges and provide recommendations to overcome existing obstacles.
Methods
EIP programs in Africa, Asia and Latin America were identified through experts from the different target regions. We performed a systematic search in Medline, Embase, APA PsycInfo, Web of Science and Scopus up to February 6, 2024.
Results
Most EIP programs in these continents are small-scale, single-site programs that serve a limited section of the population. Population-based programs with widespread coverage and programs integrated into primary health care are rare. In Africa, EIP programs are virtually absent. Mainland China is one of the only LMICs that has begun to take steps toward developing a population-based EIP program. High-income Asian countries (e.g. Hong Kong and Singapore) have well-developed, comprehensive programs for individuals with early psychosis, while others with similar economies (e.g. South Korea and Japan) do not. In Latin America, Chile is the only country in the process of providing population-based EIP care.
Conclusions
Financial resources and integration in mental health care, as well as the availability of epidemiological data on psychosis, impact the implementation of EIP programs. Given the major treatment gap of early psychosis in Africa, Latin America and large parts of Asia, publicly funded, locally-led and accessible community-based EIP care provision is urgently needed.
Epidemiological data offer conflicting views of the natural course of binge-eating disorder (BED), with large retrospective studies suggesting a protracted course and small prospective studies suggesting a briefer duration. We thus examined changes in BED diagnostic status in a prospective, community-based study that was larger and more representative with respect to sex, age of onset, and body mass index (BMI) than prior multi-year prospective studies.
Methods
Probands and relatives with current DSM-IV BED (n = 156) from a family study of BED (‘baseline’) were selected for follow-up at 2.5 and 5 years. Probands were required to have BMI > 25 (women) or >27 (men). Diagnostic interviews and questionnaires were administered at all timepoints.
Results
Of participants with follow-up data (n = 137), 78.1% were female, and 11.7% and 88.3% reported identifying as Black and White, respectively. At baseline, their mean age was 47.2 years, and mean BMI was 36.1. At 2.5 (and 5) years, 61.3% (45.7%), 23.4% (32.6%), and 15.3% (21.7%) of assessed participants exhibited full, sub-threshold, and no BED, respectively. No participants displayed anorexia or bulimia nervosa at follow-up timepoints. Median time to remission (i.e. no BED) exceeded 60 months, and median time to relapse (i.e. sub-threshold or full BED) after remission was 30 months. Two classes of machine learning methods did not consistently outperform random guessing at predicting time to remission from baseline demographic and clinical variables.
Conclusions
Among community-based adults with higher BMI, BED improves with time, but full remission often takes many years, and relapse is common.
Diagenetic kaolin minerals are very common in the Permo-Triassic succession from the SE Iberian Range, Spain. The morphology and crystal structure of kaolin minerals has been examined in four size fractions (<1 µm, <2 µm, <6.3 µm and <20 µm) of sandstone samples by means of scanning electron microscopy, X-ray diffraction, infrared spectroscopy, differential thermal analysis and thermogravimetry. Experimental data reveal that dickite is the dominant kaolin-type mineral in the entire range of size fractions, whereas small amounts of kaolinite coexists with dickite in all size fractions. Dickite appears typically as booklets of pseudo-hexagonal plates with blocky habit. The increase in size fraction is concomitant with the increase in the amount of dickite and the progressive improvement of its structural order. The extensive dickitization is attributed to the high paleogeothermal gradient recorded in the studied area and the increase in H+, presumably resulting from the flux of organic acids derived from the underlying Carboniferous rocks and/or the late Permian succession. These conditions are more likely to be associated with the late Cretaceous post-rift thermal stage of the eastern Iberian Basin. Lately, during the maximum burial depth, the fine crystalline kaolin minerals were slightly illitized. Given the very small feldspar content in the studied sequence, the results reflect the important contribution of mica alteration to the early diagenetic formation of kaolinite as well as the late conversion to dickite.
The National Institutes of Health’s (NIH) K99/R00 Pathway to Independence Award offers promising postdoctoral researchers and clinician-scientists an opportunity to receive research support at both the mentored and the independent levels with the goal of facilitating a timely transition to a tenure-track faculty position. This transitional program has been generally successful, with most K99/R00 awardees successfully securing R01-equivalent funding by the end of the R00 period. However, often highly promising proposals fail because of poor grantsmanship. This overview provides guidance from the perspective of long-standing members of the National Heart, Lung, and Blood Institute’s Mentored Transition to Independence study section for the purpose of helping mentors and trainees regarding how best to assemble competitive K99/R00 applications.
Amyotrophic lateral sclerosis (ALS), the most common disease within motor neuron diseases (MND), and frontotemporal dementia (FTD) belong to a broad spectrum of neurodegenerative diseases that are sometimes clinically overlapping.
Objectives
The aim of the description of this case report is to sensitize professionals to this type of presentation and encourage the investigation of signs and symptoms of motor decline in patients with suspected FTD.
Methods
Research in the patient’s clinical process. Framing the clinical case in the current literature, searching the terms “frontotemporal dementia” and “amyotrophic lateral sclerosis” in the Pubmed database.
Results
A 71-year-old patient, followed in psychiatry for several years for Dysthymic Disorder. At the end of 2020, he presented cognitive and behavioral changes, with rapid progression, with a marked loss of functionality, compatible with dementia. In 2021, it was noticed a motor decline, which progressively worsened. In this sense, an electromyographic study of the limbs was performed with an abnormal result, compatible with a diagnosis of Motor Neuron Disease.
Conclusions
A significant overlap of these two disorders has been observed clinically. Thus, the presentation of a patient with dementia, specifically suspected of having FTD, should ring the bell to the presence of signs and symptoms of motor impairment.
Several studies have been carried out in order to understand the relationship between these entities, and the discussion remains whether their presentation together constitutes or not a form of phenotypic presentation of ALS.
We present the case of a 49-year-old woman who was diagnosed with multiple sclerosis at the age of 19 and suffers from an affective disorder that has been evolving for years. This condition, for which she has been followed by psychiatry and psychology for more than ten years, consists of alternating periods of hypomania lasting weeks and phases in which frank depressive symptomatology predominates, with no phases of euthymia in between and with a predominance of severe deterioration of her functionality at both poles.
Objectives
(1) We will review the term cyclothymia and explore the concept of “cyclothymic temperament” advocated by some authors, in order to be able to understand the dimension of the present case and reformulate its approach.
(2) The relationship between multiple sclerosis and bipolar spectrum disorders will be covered, reviewing the current knowledge in this regard and relating it to the patient’s symptomatology.
Methods
A review of the patient’s clinical history will be carried out, taking into account her life history, the complementary tests performed as well as the multiple therapeutic approaches tried over the last few years.
Likewise, a bibliographic review of the available scientific literature will be carried out in relation to the diagnosis of cyclothymia or bipolar disorder type II, the controversial term “cyclothymic temperament”, and the relationship that these diagnoses have with the diagnosis of Multiple Sclerosis.
Results
(1) Our patient could fit into what many authors define as a cyclothymic temperament, fulfilling, in certain episodes, the criteria that the manuals propose for bipolar disorder type II.
(2) 2.1 The prevalence of bipolar affective disorder in MS is approximately twice as high as in the general population (rates of 0.3-2.4%). 2.2 Patients with MS have higher scores in cyclothymic and hyperthymic temperament than the control group. 2.3 Certain drugs generally used in BD also seem to have a beneficial effect on MS.
Image:
Image 2:
Conclusions
The reformulation of the concept of cyclothymia would allow us to recognize in our patient a basic temperament of long evolution that would be the substrate on which different factors have subsequently influenced, such as antidepressant drugs or multiple sclerosis. In addition, it is necessary to know the association between BD and MS, in order to be able to offer an adequate treatment, contemplating some pharmacological options such as Lithium or some Atypical Antipsychotics, given the beneficial effect both for the affective disorder and for the neurological process.
The term “blue justice” was coined in 2018 during the 3rd World Small-Scale Fisheries Congress. Since then, academic engagement with the concept has grown rapidly. This article reviews 5 years of blue justice scholarship and synthesizes some of the key perspectives, developments, and gaps. We then connect this literature to wider relevant debates by reviewing two key areas of research – first on blue injustices and second on grassroots resistance to these injustices. Much of the early scholarship on blue justice focused on injustices experienced by small-scale fishers in the context of the blue economy. In contrast, more recent writing and the empirical cases reviewed here suggest that intersecting forms of oppression render certain coastal individuals and groups vulnerable to blue injustices. These developments signal an expansion of the blue justice literature to a broader set of affected groups and underlying causes of injustice. Our review also suggests that while grassroots resistance efforts led by coastal communities have successfully stopped unfair exposure to environmental harms, preserved their livelihoods and ways of life, defended their culture and customary rights, renegotiated power distributions, and proposed alternative futures, these efforts have been underemphasized in the blue justice scholarship, and from marine and coastal literature more broadly. We conclude with some suggestions for understanding and supporting blue justice now and into the future.
Sepsis is a complex clinical syndrome triggered by an inflammatory host response to an infection. It is usually complicated to detect and diagnose, and has severe consequences in human and veterinary health, especially when treatment is not started early. Therefore, efforts to detect sepsis accurately are needed. In addition, its proper diagnosis could reduce the misuse of antibiotics, which is essential fighting against antimicrobial resistance. This case is a particular issue in farm animals, as antibiotics have been traditionally given massively, but now they are becoming increasingly restricted. When sepsis is suspected in animals, the most frequently used biomarkers are acute phase proteins such as C-reactive protein, serum amyloid A and haptoglobin, but their concentrations can increase in other inflammatory conditions. In human patients, the most promising biomarkers to detect sepsis are currently procalcitonin and presepsin, and there is a wide range of other biomarkers under study. However, there is little information on the application of these biomarkers in veterinary species. This review aims to describe the general concepts of sepsis and the current knowledge about the biomarkers of sepsis in pigs, horses, and cattle and to discuss possible advances in the field.
No established risk prediction tool exists in United Kingdom and Irish Paediatric Cardiology practice for patients undergoing cardiac catheterisation. The Catheterisation RISk score for Paediatrics is used primarily in North American practice to assess risk prior to cardiac catheterisation. Validating the utility and transferability of such a tool in practice provides the opportunity to employ an already established risk assessment tool in everyday practice.
Aims:
To ascertain whether the Catheterisation RISk score for Paediatrics assessment tool can accurately predict complications within United Kingdom and Irish congenital catheterisation practice.
Methods:
Clinical and procedural data including National Institute for Cardiovascular Outcomes Research derived outcome data from 1500 patients across five large congenital cardiology centres in the United Kingdom and Ireland were retrospectively collected. Catheterisation RISk score for Paediatrics were then calculated for each case and compared with the observed procedural outcomes. Chi-square analysis was used to determine the relationship between observed and predicted events.
Results:
Ninety-eight (6.6%) patients in this study experienced a significant complication as qualified by National Institute for Cardiovascular Outcomes Research classification. 4% experienced a moderate complication, 2.3% experienced a major complication and 0.3% experienced a catastrophic complication resulting in death. Calculated Catheterisation RISk score for Paediatrics scores correlated well with all observed adverse events for paediatric patients across all CRISP categories. The association was also transferable to adult congenital heart disease patients in lower Catheterisation RISk score for Paediatrics categories (CRISP 1–3).
Conclusion:
The Catheterisation RISk score for Paediatrics score accurately predicts significant complications in congenital catheterisation practice in the United Kingdom and Ireland. Our data validated the Catheterisation RISk score for Paediatrics assessment tool in five congenital centres using National Institute for Cardiovascular Outcomes Research-derived outcome data.
COVID-19 is a respiratory disease and its main symptoms are fever, dry cough and difficulty breathing. It spread to several countries, which led the World Health Organization to decree, on March 11, 2020, a pandemic state that deeply affected Brazil. Due to the impossibility of leaving the house, the routine of children with autism was changed. Children in Autism Spectrum Disorder (ASD) have a qualitative deficit in social interaction. Clinical and daily observations reinforce several scientific studies that defend the importance of maintaining a routine as stable as possible for people with ASD, without this stability they may become emotionally disorganized, feel discomfort or even irritability.
Objectives
Investigate the impact caused by social distancing on the development of children and adolescents with autism.
Methods
An online questionnaire based on the DIR/Floortime basic map of emotional functional capacity development was distributed in Brazil from April to May, 2020. The results were analyzed using SPSS software.
Results
Results obtained from 122 questionnaires showed that after 30 days of quarantine 20% of children no longer had the characteristic of being able to remain calm and organized for at least 2 minutes; 11% no longer initiates interactions with their parents; 27% demonstrated more protests and anger than before the social distancing; 18% demonstrated more emotions such as anger, fear and intimacy, 28% began to understand their limits and 12% of the children are using greater facial expression during the social distancing.
Conclusions
This study brings results that can help to understand the processes in a child with autism.
Glucagon-like peptide-1 (GLP-1) is an endogenous peptide that stimulates insulin secretion and decreases glucagon secretion. The use of GLP-1 receptor agonists (GLP-1RA) showed efficacy reducing the weight and glucose levels in patients with and without type 2 diabetes. This effect was also associated with a decreased risk of major cardiovascular events.
Objectives
Our aim is to review the role of GLP-1RA in psychiatric patients at cardio-metabolic risk due to antipsychotics treatment.
Methods
We reviewed articles published in PubMed using the keywords: “GLP-1” “glucagon like peptide” “antipsychotics” and “psychiatry”.
Results
The number need to treat (NNT) to achieve clinical meaningful weight loss was 3.8. GLP-1RA treatment was also associated with greater reductions in body mass index, fasting glucose, HbA1c and visceral fat. This effect is true for antipsychotic treatment in general and for those on clozapine and olanzapine in particular. Overall, the GLP-1RA are well tolerated with nausea being the most common related adverse effect. Other variables such as age, sex, psychosis severity, nausea or any adverse drug reaction did not affect the weight loss.
Conclusions
Studies showed a promising role in the management of antipsychotics induced weight gain, particularly in clozapine and olanzapine treated patients. Although these promising results, the route of administration, with a daily or weekly subcutaneous injection, and the GLP-1RA associated financial costs, can be viewed as important factors which can limit the wide use of this type of treatment in psychiatric patients.
Solutions like crowd screening and machine learning can assist systematic reviewers with heavy screening burdens but require training sets containing a mix of eligible and ineligible studies. This study explores using PubMed's Best Match algorithm to create small training sets containing at least five relevant studies.
Methods
Six systematic reviews were examined retrospectively. MEDLINE searches were converted and run in PubMed. The ranking of included studies was studied under both Best Match and Most Recent sort conditions.
Results
Retrieval sizes for the systematic reviews ranged from 151 to 5,406 records and the numbers of relevant records ranged from 8 to 763. The median ranking of relevant records was higher in Best Match for all six reviews, when compared with Most Recent sort. Best Match placed a total of thirty relevant records in the first fifty, at least one for each systematic review. Most Recent sorting placed only ten relevant records in the first fifty. Best Match sorting outperformed Most Recent in all cases and placed five or more relevant records in the first fifty in three of six cases.
Discussion
Using a predetermined set size such as fifty may not provide enough true positives for an effective systematic review training set. However, screening PubMed records ranked by Best Match and continuing until the desired number of true positives are identified is efficient and effective.
Conclusions
The Best Match sort in PubMed improves the ranking and increases the proportion of relevant records in the first fifty records relative to sorting by recency.
Recent studies have suggested that functional impairment in bipolar disorder may be strongly associated with residual depressive symptoms. However, there is a notable disparity between functional recovery and symptomatic recovery. This study was carried out to investigate clinical factors as potential predictors on functional impairment in a well defined euthymic bipolar sample.
Methods:
Seventy-one patients were recruited from the Bipolar Disorder Program at the Clinic Hospital of Barcelona. A Structured Clinical Interview for DSM-IV-TR, HAM-D and YMRS were used to diagnostic assessment and euthymia criteria. The Functioning Assessment Short Test (FAST) was employed to assess functional impairment. The FAST is a reliable and valid, interview-administered scale, rapid and easy to apply (3-6 min). It consists of 24 items which allow to assess six specific areas of functioning such as autonomy, occupational functioning, cognitive functioning, financial issues, interpersonal relationships, and leisure time.
Results:
The sample comprised 36 (51%) men, aged 48±13.56 years. Several clinical variables were associated with poor functioning on a linear regression model, such as age, depressive symptoms, number of previous mixed episodes and number of previous hospitalizations. This model explained 44% of the variance (F=12.54, df=58, p< 0.001).
Discussion:
In this study, specific clinical and socio-demographic characteristics were identified as predictors of functional impairment in remitted bipolar patients. Poor functioning was identified in patients with older age and more severe illness course.
Antidepressants are recommended to be withdrawn during a manic episode. This analysis explored the characteristics of patients receiving antidepressants during an acute manic episode in the context of a large, observational study.
Method:
EMBLEM (European Mania in Bipolar Longitudinal Evaluation of Medication) is a 2-year prospective observational study of acute mania/mixed mania. Of 2416 patients, 345 (14%) were taking an antidepressant (AD) and 2071 (86%) were not (NAD) during acute mania. Demographic and clinical variables were collected at baseline and at outpatient visits up to 2 years. Illness severity was measured using Clinical Global Impressions–Bipolar Disorder (CGI-BP), 5-item Hamilton Depression Rating Scale (HAM-D-5), and Young Mania Rating Scale (YMRS). Logistic regression analysis was used to identify variables associated with AD use.
Results:
AD use varied across countries (p<0.05), more use with mixed episodes (p<0.001), rapid cyclers (p=0.02), more previous depressive episodes (p<0.001) and higher HAM-D-5 severity at baseline (p<0.001) but less use with higher education (p=0.029), YMRS (p=0.022), CGI-BP overall (p=0.006) severity and inpatients at baseline (p<0.001). There were no differences in alcohol abuse or suicide attempts. Depression recurrence rates were significantly higher with AD (p<0.001).
Conclusions:
The EMBLEM study suggests that patients with mania receiving antidepressants are more likely to be outpatients with mixed mania or rapid cycling, and have a higher risk of depressive recurrence during follow-up. Clinicians seem to maintain antidepressants in manic patients to address depressive features during mania and prevent further depressive episodes.
To explore functioning in adult patients with recently diagnosed (< 5 years) and more chronic (> 5 years) schizophrenia treated with flexible doses of paliperidone ER.
Methods
International prospective open-label 6-month study. Endpoints were the Positive and Negative Syndrome Scale (PANSS), patient functioning (Personal and Social Performance Scale; PSP) and treatment-emergent adverse events (TEAEs).
Results
Of 713 recently diagnosed patients, most were male (60.9%), mean age was 33.6 ± 11.2 years and mean time since diagnosis was 2.3 ± 1.7 years. Chronic patients (n = 1003) were predominantly male (59.2%) with a mean age of 43.8 ± 11.4 and mean time since diagnosis of 15.6 ± 9.2 years. Mean mode doses of paliperidone ER were similar between recently diagnosed and chronic patients (7.0 ± 2.9 mg/day and 7.2 ± 2.9 mg/day). At endpoint PANSS total scores were improved by 13.7 and 12.9 points, respectively, in recently diagnosed and chronic patients. The rate of patients with mild or less functional impairment increased from 17.7% to 39.8% in recently diagnosed and from 14.4% to 32.9% in chronic patients. Major functional improvements were observed for socially useful activities and personal and social relationships. TEAEs reported in >5% of recently diagnosed or chronic patients were insomnia (10.7% and 8.1%), anxiety (8.6% and 6.0%) and somnolence (5.8% and 3.4%), respectively.
Conclusion
These data suggest that both recently diagnosed and chronic patients previously unsuccessfully treated with other oral antipsychotics may benefit from paliperidone ER, with a tendency for recently diagnosed patients showing some higher treatment response in psychotic symptoms and patient functioning, particularly in socially useful activities and personal and social relationships.
To explore tolerability and treatment response in adult patients with recently diagnosed (≤5 years) and chronic (>5 years) schizophrenia treated with flexible doses of paliperidone ER.
Methods
International prospective open-label 6-month study. Endpoints were the Positive and Negative Syndrome Scale (PANSS), patient functioning and treatment-emergent adverse events (TEAEs).
Results
Of 713 recently diagnosed patients, most were male (60.9%), mean age was 33.6 ± 11.2 years and mean time since diagnosis was 2.3 ± 1.7 years. Chronic patients (n = 1003) were predominantly male (59.2%) with a mean age of 43.8 ± 11.4 and mean time since diagnosis of 15.6 ± 9.2 years. 70.4% and 71.7% of patients completed the study, respectively. Mean mode doses of paliperidone ER were similar between recently diagnosed and chronic patients (7.0 ± 2.9 mg/day and 7.2 ± 2.9 mg/day). 63.1% of recently diagnosed and 60.8% of chronic patients switching due to lack of efficacy with their previous antipsychotic had a ≥20% improvement in PANSS total score at endpoint, and improvement with other switching reasons was consistently numerically higher in recently diagnosed patients. The rate of patients with mild or no functional impairment increased from 17.7% to 39.8% in recently diagnosed and from 14.4% to 32.9% in chronic patients. TEAEs reported in ≥5% were insomnia (10.7% and 8.1%), anxiety (8.6% and 6.0%) and somnolence (5.8% and 3.4%), respectively.
Conclusion
These data suggest that both recently diagnosed and chronic patients previously unsuccessfully treated with other oral antipsychotics may benefit from paliperidone ER, with a tendency for recently diagnosed patients showing some higher treatment response in psychotic symptoms and patient functioning.
Antipsychotic treatment is known to be associated with secondary sexual dysfunction (SD). Recognition and treatment of this adverse effect has received growing attention. Until now, all antipsychotic agents were thought to potentially cause SD mediated by increased prolactin. Our aim was to observe whether aripiprazole modifies SD in patients with schizophrenia after 3 months of treatment.
Material and Methods:
Multicenter, observational, open-label, prospective, three-month study with single group of aripiprazole treated patients. Sexual activity was assessed using CGI-S and CGI-I for SD; SALSEX scale, validated for Spanish, 3 times after initiating study drug. Patient's clinical status was evaluated by CGI-S and CGI-I for psychotic disorders, and by BPRS Scale.
Result: 42 patients (70% men), 38 completed the study. Incidence of SD at 3 months was null for all patients studied. As period of treatment advanced, the Salsex score decreased, showing a mean overall reduction of –5 points (SD 3.6). Largest reduction was observed in subgroup of patients with SD in baseline visit, who exhibited a mean reduction of –6 points (SD 3.1).
Men with SD in baseline evaluation showed more marked improvement than women at 40 days of treatment (p=0.0447). However, recovery was similar for both groups at 90 days of treatment.
Conclusions:
In schizophrenia, SD secondary studies to antipsychotics are important in establishing effectiveness of these agents in chronic treatment. After 3 months of aripiprazole treatment, no SD was observed in patients. Patients who presented SD at study initiation improved over course of 3 months treatment with aripiprazole.
To explore tolerability and treatment response in adult patients with recently diagnosed (<5 years) and chronic (>5 years) schizophrenia treated with flexible doses of paliperidone ER.
Methods
International prospective open-label 6-month study. Endpoints were the Positive and Negative Syndrome Scale (PANSS), patient functioning and treatment-emergent adverse events (TEAEs).
Results
Of 713 recently diagnosed patients, most were male (60.9%), mean age was 33.6 ± 11.2 years and mean time since diagnosis was 2.3 ± 1.7 years. Chronic patients (n = 1003) were predominantly male (59.2%) with a mean age of 43.8 ± 11.4 and mean time since diagnosis of 15.6 ± 9.2 years. 70.4% and 71.7% of patients completed the study, respectively. Mean mode doses of paliperidone ER were similar between recently diagnosed and chronic patients (7.0 ± 2.9 mg/day and 7.2 ± 2.9 mg/day). 63.1% of recently diagnosed and 60.8% of chronic patients switching due to lack of efficacy with their previous antipsychotic had a >20% improvement in PANSS total score at endpoint, and improvement with other switching reasons was consistently numerically higher in recently diagnosed patients. The rate of patients with mild or no functional impairment increased from 17.7% to 39.8% in recently diagnosed and from 14.4% to 32.9% in chronic patients. TEAEs reported in >5% were insomnia (10.7% and 8.1%), anxiety (8.6% and 6.0%) and somnolence (5.8% and 3.4%), respectively.
Conclusion
These data suggest that both recently diagnosed and chronic patients previously unsuccessfully treated with other oral antipsychotics may benefit from paliperidone ER, with a tendency for recently diagnosed patients showing some higher treatment response in psychotic symptoms and patient functioning.
Recent metaanalyses have reported conflicting results on the efficacy of long-acting compared to oral antipsychotics in the prevention of relapse in patients with schizophrenia.
Methods
2-year international randomized active controlled, open-label, rater-blinded study evaluating time to relapse, relapse rates, psychotic symptoms (PANSS) and treatment-emergent adverse events (TEAEs) in recently diagnosed patients with schizophrenia (≥1-5 years) treated with a monotherapy of paliperidone palmitate (PP) compared to investigators’ choice of oral antipsychotics (oAPs), i.e. aripiprazole, olanzapine, quetiapine, paliperidone ER, risperidone or haloperidol.
Results
715 patients (58.4% male, mean age 32.5±10.4 years, 86.2% paranoid schizophrenia, no significant differences in baseline characteristics) entered the 2-year study period (352 PP, 363 oAPs). Time to relapse was significantly longer with PP compared to oAPs (mean±SE: 616±10.9 vs 603±13.1 days, p=0.019). Relapse rates were significantly lower with PP vs oAPs (14.8% vs 20.9%; p=0.032), reflecting a relative risk reduction of 29.2%. Reduction of psychotic symptoms in PANSS was significantly superior with PP at treatment day 8 (p=0.021) and showed a trend in favor of PP at endpoint (p=0.074). TEAEs reported in ≥5% in any group (PP vs oAPs) were weight increase (15.9% vs 17.4%), headache (11.1% vs 8.5%), insomnia (9.7% vs 8.0%), schizophrenia (8.2% vs 9.6%), nasopharyngitis (7.1% vs 5.0%), injection site pain (6.8% vs 0%), anxiety (5.7% vs 4.4%), tremor (5.1% vs 2.2%) and suicidal ideation (4.5% vs 5.5%).
Conclusion
In this randomized active controlled 2-year study PP was significantly delaying time to relapse and reducing relapse rates compared to investigators’ choice of oral APs.