Intramuscular long-acting paliperidone palmitate in acute patients with schizophrenia unsuccessfully treated with oral antipsychotics.

AbstractIn this prospective multicentre, open-label, 6-month study (Paliperidone Palmitate Flexible Dosing in Schizophrenia [PALMFlexS]), tolerability, safety and treatment response with paliperidone palmitate (PP) were explored in patients with acute symptoms of schizophrenia following switching from previously unsuccessful treatment with oral antipsychotics. This pragmatic study was conducted in a large, more representative sample of the general schizophrenia population compared to randomized controlled pivotal trials, to specifically mimic real-world clinical situations. After initiation on Day 1 and Day 8, patients received PP once monthly at flexible doses (50–150mgeq.) intramuscularly. The primary efficacy outcome was defined as the percentage of patients achieving ≥30% improvement in PANSS total score from baseline (BL) to last-observation-carried-forward (LOCF) endpoint (EP). Safety and tolerability assessments included Extrapyramidal Symptom Rating Scale (ESRS) total score and treatment-emergent adverse events (TEAEs). Overall, 212 patients received PP at least once after switching from oral antipsychotics, primarily due to lack of efficacy (45.8%). Significant improvements from BL in mean (SD) PANSS total score were observed from Day 8 onwards (BL to LOCF EP: −31.0 [29.0]; p<0.0001). At endpoint, two-thirds (66.7%) and 43.5% of patients achieved a ≥30% and ≥50% improvement in mean PANSS total score, respectively. PP was associated with significant improvements across secondary measures of symptom severity, subjective well-being, medication satisfaction, illness-related disorders of activity and participation, and patient functioning (p<0.0001; BL to LOCF EP). PP was generally well tolerated, with significant reductions in ESRS total score (p<0.0001) and mainly mild-to-moderate TEAEs. TEAEs reported in ≥5% of patients were injection-site pain (13.7%), insomnia (10.8%), psychotic disorder (10.4%), headache and anxiety (both 6.1%). The PALMFlexS study findings provide valuable pragmatic clinical data on PP treatment in patients with acute schizophrenia previously unsuccessfully treated with oral antipsychotics

A Prospective Flexible-Dose Study of Paliperidone Palmitate in Nonacute But Symptomatic Patients With Schizophrenia Previously Unsuccessfully Treated With Oral Antipsychotic Agents

AbstractPurposeThe goal of this study was to explore the tolerability, safety, and treatment response of flexible doses of once-monthly paliperidone palmitate (PP) in the subset of nonacute but symptomatic adult patients with schizophrenia previously unsuccessfully treated with oral antipsychotic agents in the PALMFlexS (Paliperidone Palmitate Flexible Dosing in Schizophrenia) study.MethodsThis was an interventional, single-arm, international, multicenter, unblinded, 6-month study performed in patients with schizophrenia. Patients were categorized according to reasons for switching. In patients switching because of lack of efficacy or for other reasons, primary efficacy outcomes were the proportion achieving treatment response (defined as ≥20% improvement in Positive and Negative Syndrome Scale [PANSS] total score from baseline to last-observation-carried-forward end point) and maintained efficacy (defined as noninferiority in the change in PANSS total score at end point versus baseline [Schuirmann's test]), respectively.FindingsA total of 593 patients (intention-to-treat population) were enrolled: 63.1% were male; their mean (SD) age was 38.4 (11.8) years; and 78.6% had paranoid schizophrenia. The main reasons for transition to PP were patient's wish (n = 259 [43.7%]), lack of efficacy (n = 144 [24.3%]), lack of compliance (n = 138 [23.3%]), and lack of tolerability (n = 52 [8.8%]) with the previous oral antipsychotic medication. The recommended PP initiation regimen (150 milligram equivalents [mg eq] day 1 and 100 mg eq day 8) was administered in 93.9% of patients. Mean PANSS total score decreased from 71.5 (14.6) at baseline to 59.7 (18.1) at end point (mean change, –11.7 [15.9]; 95% CI, –13.0 to –10.5; P < 0.0001). Sixty-four percent of patients showed an improvement of ≥20% in PANSS total score, and the percentage of patients rated mildly ill or less in Clinical Global Impression–Severity increased from 31.8% to 63.2%. Mean personal and social performance total score (SD) increased (ie, improved) significantly for all patients from baseline to end point (58.1 [13.4] to 66.1 [15.7]; P < 0.0001).ImplicationsThe PALMFlexS study is a pragmatic interventional study compared with randomized controlled trials, conducted in a large, more representative sample of patients with schizophrenia, and designed specifically to mimic real-world clinical situations. The findings support the results from randomized controlled studies. They also demonstrate that a clinically relevant treatment response is possible in patients who are considered to be clinically stable by their physician, supporting the use of flexibly dosed PP in such patients. Clinical trials.gov number: NCT01281527

The satisfaction levels of the patients admitted to a university hospital

Objectives: The aim of this study was to determine various aspects of satisfaction levels and related socio-demographical variables of both inpatients and outpatients admitted to a university hospital.Material and Method: Two different questionnaires were prepared to evaluate the satisfaction levels of both inpa-tients and outpatients. Face to face interview was conducted with a total of 820 patients; 379 (%46.2) inpatients and 441 (%53.8) outpatients, to fill out the prepared questionnaires.Results: Among the inpatients 79.5% reported that they were generally satisfied at the level of or above their expec-tations, whereas it was the case for 76.2% of outpatients in the study. When the satisfaction levels of the inpatients and outpatients were compared; inpatients were more satisfied with the care provided by their doctors, the radiology services and patient security than the outpatients. In terms of general hospital hygiene outpatients reported a greater satisfaction than the inpatients. Among inpatients, the patients with advanced age were found to be more satisfied in terms of meal quality and hygiene of the clinic than the younger patients. Literate patients reported higher degrees of satisfaction of general hygiene and intent to re-prefer the hospital than high school graduates. Almost half of the pa-tients in the study (48%) were from lower socioeconomical status and in some dimensions they reported less satis-faction than the patients from higher socioeconomical status.Conclusion: Low socioeconomical status is associated with decreased patient satisfaction. Although general satis-faction levels of inpatients and outpatients are similar, the care provided by doctors, the radiology services, patient security and general hospital hygiene may show some differences between these two groups

Obsessif kompulsif bozukluk hastalarında artmış plazma nesfatin -1 düzeyi

Objective: To determine and compare the plasma nesfatin-1 (a satiety peptide) levels of patients with obsessive compulsive disorder (OCD) and healthy control subjects. Method: Plasma nesfatin-1 levels of 31 patients with OCD (18 females, 13 males) and 28 healthy control subjects (16 females and 12 males) similar to the study group in terms of weight, age, and gender were measured in this study. Severity of obsessions and compulsions both in OCD patients and control subjects were determined by using Yale-Brown Obsessive Compulsive Scale (Y-BOCS). ELISA method was used to measure plasma nesfatin-1 levels. Results: Median plasma nesfatin-1 levels in patients with OCD and healthy control subjects were 4.61 ng/ml (min-max: 1.28-8.11) and 2.0 ng/ml (min-max: 0.11-4.98) respectively. The observed difference in plasma nesfatin-1 levels between two groups was statistically significant (p&lt;0.001). No statistically significant correlation was observed between Y-BOCS scores and plasma nesfatin-1 levels either in the study group (r=0.205, p=0.27) or in the control group (r=0.335, p=0.071). Conclusion: Increased plasma nesfatin-1 levels observed in patients with OCD suggest a potential role to nesfatin-1 in anxiety states besides its previosly known anorexigenic effects.Amaç: Bu yazıda, obsesif kompulsif bozukluk (OKB) tanısı olan hastalarda ve sağlıklı kontrollerde plazma nesfatin-1 (bir tokluk peptidi) düzeylerinin tespit edilmesi ve karşılaş- tırılması amaçlanmıştır. Yöntem: OKB tanısı olan 31 hastanın (18 kadın, 13 erkek) ve ağırlık, yaş ve cinsiyet açısından benzer nitelikte 28 sağlıklı bireyin (16 kadın, 12 erkek) plazma nesfatin-1 düzeyi ölçülmüş- tür. OKB hasta grubunda ve kontrol grubunda obsesyon ve kompulsiyonların şiddeti Yale-Brown Obsesyon Kompulsiyon Ölçeği (Y-BOKÖ) kullanılarak elde edilmiştir. Plazma nesfatin-1 düzeyi ölçümü için ELİSA yöntemi kullanılmıştır. Bulgular: OKB tanısı olan hastalarda ve kontrol grubunda ortanca plazma nesfatin-1 düzeylerinin sırasıyla 4.61 ng/ ml (min-max: 1.28-8.11) ve 2.0 ng/ml (min-max: 0.11- 4.98) olduğu bulunmuştur. Gruplar arasında plazma nesfa- tin-1 düzeyi açısından gözlemlenen fark istatistiksel olarak anlamlı düzeydedir (p<0.001). Hem hasta grubunda hem de kontrol grubunda Y-BOCS skorları ve plazma nesfatin-1 düzeyleri arasında anlamlı bir korelasyon saptanmamıştır (sırasıyla r=0.205, p=0.27 ve r=0.335, p=0.071). Sonuç: OKB tanısı olan hastalarda gözlenen plazma nes- fatin-1 düzeyi yüksekliği, bu peptidin önceden bilinen anoreksijenik etkilerinin yanı sıra anksiyete durumlarında da potansiyel bir rolünün olabileceğini düşündürmektedir

Plazma nesfatin-1 düzeyi panik bozukluğu olan hastalarda hastalık şiddeti ile ilişkili olabilir

Objective: We have compared the plasma levels of the recently discovered peptide hormone nesfatin-1 between patients with panic disorder (PD) and healthy control subjects. Method: The subjects in the patient group were selected from the patients who presented to the psychiatry outpatient clinic of a university hospital and were diagnosed with PD. Healthy subjects similar to the patient group in terms of age, gender, weight, and BMI constituted the control group in this study. The Panic-Agoraphobia Scale (PAS) was applied to all subjects in both groups. Blood samples were collected to measure plasma nesfatin-1 level by using ELISA method. Results: Mean plasma nesfatin-1 level (4.66 &plusmn; 2.39 ng/ml in patient group, 2.13 &plusmn; 1.52 ng/ml in control group) was higher in patients with PD than in the control group (p&lt;0.001). A positive correlation between PAS scores and plasma nesfatin-1 levels was found in the patients with PD. Conclusion: There may be a relationship between disease severity and plasma nesfatin-1 levels in panic disorder patients. Future studies investigating this relationship are needed.Amaç: Panik bozukluk (PB) hastaları ve sağlıklı kontrol grubunda son yıllarda keşfedilmiş peptid bir hormon olan nesfatin-1’in plazma düzeylerini karşılaştırmayı amaçladık. Metod: Hasta grubundaki bireyler bir üniversite hastanesi psikiyatri polikliniğine başvuran ve PB tanısı konulan hastalar arasından seçildi. Yaş, cinsiyet, ağırlık ve Vücut Kitle İndeksi (VKİ) açısından benzer özellikleri olan sağlıklı bireyler ise çalışmanın kontrol grubunu oluşturdu. Her iki gruptaki tüm hastalara Panik Agorafobi Ölçeği (PAÖ) uygulandı. Plazma nesfatin-1 düzeylerini belirlemek için tüm katılımcılardan kan alındı ve analizler ELISA yöntemiyle incelendi. Bulgular: PB hastalarının ortalama plazma nesfatin-1 düzeyi kontrol grubundaki bireylerinkinden daha yüksek bulundu (hasta grubunda 4.66 ± 2.39 ng/ml ve kontrol grubunda 2.13 ± 1.52 ng/ml). Panik bozukluğu olan hastalarda plasma nesfatin-1 düzeyleri ile PAÖ puanları arasında pozitif bir korelasyon olduğu tespit edildi. Sonuç: Panik bozukluğu olan hastalarda anksiyete ve plazma nesfatin-1 düzeyleri arasında bir ilişki olabilir. Bu ilişkiyi araştıracak ileri çalışmalara ihtiyaç vardır

KONVERSİYON BOZUKLUĞUNDA ÇOCUKLUK ÇAĞI YAŞAM OLAYLARI VE AİLESEL İŞLEVLER

ÖZETKonversiyon bozukluğu tespit edilen hastalarda çocukluk çağı yaşam olayları ve ailesel işlevlerdeki değişikliklerin araştırılması amaçlandı. Çalışmaya 25’i erkek, 96’sı kadın 121 konversiyon hastası çalışma grubu olarak; 19’u erkek, 31’i kadın 50 depresyon hastası da kontrol grubu olarak seçildi. Hastalara kısa fiziksel ve seksüel kötüye kullanım anketi, çocukluk çağı yaşam olayları ölçeği ve aile değerlendirme ölçeği uygulandı. Çocukluk çağı yaşam olaylarında duygusal kötüye kullanım (p&lt;0,01), fiziksel kötüye kullanım (p&lt;0,01), cinsel kötüye kullanım (p=0,05) ve toplam puanlarda (p&lt;0,01) aradaki fark istatistiksel olarak konversiyon bozukluğunda kontrol grubundan daha yüksekti. Ailesel işlevler açısından bakıldığında, konversiyon bozukluğunda problem çözme (p&lt;0,01), iletişim (p&lt;0,01), duygusal tepki (p&lt;0,05) ve genel işlevlerde (p&lt;0,05) istatistiksel olarak anlamlı olacak şekilde kontrol grubundan daha fazla idi. Konversiyon bozukluğunda önemli oranda çocukluk çağı duygusal, fiziksel ve cinsel kötüye kullanım öyküsü mevcuttur. Bu da konversiyon hastalarının bilinçteki çatışmaların kaynağı; aile değerlendirme ölçeğindeki değişiklikler ise hastalığın oluşumunda ailesel dinamiklerin ve tedavide ailesel dinamiklere yönelik yaklaşımın önemi hakkında fikir verici olabilir.Anahtar kelimeler: Konversiyon bozukluğu, çocukluk çağı ihmali, cinsel ihmal, fiziksel ihmal, duygusal ihmal, ailesel işlevler