Effectiveness of long-term aripiprazole therapy in patients with acutely relapsing or chronic, stable schizophrenia: a 52-week, open-label comparison with olanzapine.

OBJECTIVE: To compare the long-term efficacy and safety of aripiprazole with olanzapine in patients with either acute relapsing or chronic, stable schizophrenia. MATERIALS AND METHODS: A 52-week, open-label extension to a 26-week, multicenter, randomized, double-blind, placebo-controlled trial in patients with chronic schizophrenia. Patients who completed the initial treatment or who met the protocol definition of relapse after > or =2 weeks of double-blind treatment were randomized to aripiprazole (15-30 mg/day, n = 104) or olanzapine (10-20 mg/day, n = 110) for 52 weeks. RESULTS: Sixty-nine percent of patients completed the study. Efficacy improvements were similar between groups at endpoint, mean reductions in Positive and Negative Syndrome Scale (PANSS) Total scores from baseline for patients completing the study (observed cases) were similar in chronic stable patients (aripiprazole, -7.94; olanzapine, -7.36) and in patients with acute relapse (aripiprazole, -31.19; olanzapine, -29.55). Olanzapine-treated patients reported more extrapyramidal symptoms (EPS)-related adverse events (18%) than aripiprazole-treated patients (10%). No significant differences in EPS were seen between treatments at endpoint. Olanzapine was associated with significantly greater weight gain than aripiprazole at all time points (week 52 [LOCF]: +2.54 vs +0.04 kg; p < 0.001). Changes in fasting glucose and lipid levels at endpoint favored aripiprazole over olanzapine, with significant differences observed for total cholesterol, low- and high-density lipoprotein. While differences observed for changes in fasting glucose and triglycerides favored aripiprazole, they were not statistically significant. CONCLUSION: Aripiprazole showed similar efficacy to olanzapine for long-term treatment of acutely psychotic and chronic, stable schizophrenia patients, with a lower liability for weight gain or increased lipid levels.

[SP-selectin and beta-TG as serum markers of platelet activation in menopausal women with depression]. / SP-selektyna i beta-tromboglobulina jako osoczowe markery aktywacji plytek krwi u kobiet z depresja w okresie menopauzy.

UNLABELLED: During activation, blood platelets (PLT) release a number of micromolecular compounds, of which P-selectin and beta-thromboglobulin (beta-TG) are considered the major markers of the activation. The activated platelets and the released micromolecular compounds actively participate in thromboembolic disorders frequently observed in menopause. Low estrogen level in menopausal women is a common cause of depressive disorders. The aim of the study was to compare the state of PLT activation in menopausal women with and without depression. The assessment of PLT activation was based on the concentration of sP-selectin and beta-TG as serum markers of the activation. MATERIAL AND METHODS: Among 65 menopausal women examined, 16 (approx. 25%) had depression. PLT activation was assessed on the basis of sP-selectin and beta-TG levels. The investigation was performed in the low-platelet citrate serum obtained from venous blood collected onto anticoagulant. The levels of beta-TG and sP-selectin were determined using the immunoenzymatic method, with ELISA Kit reagents. RESULTS: In all the women, both with and without depression, the levels of beta-TG and sP-selectin several times exceeded the accepted norms. The concentration of beta-TG was statistically significantly higher (p < 0.05) in women with depression as compared to those with no depressive disorders. CONCLUSIONS: Menopausal women suffering from depression show enhanced intravascular platelet activation. High beta-TG level in women with depression indicates higher risk of thromboembolic disorders in comparison with depression-free women in menopause.

Oral risperidone plus oral lorazepam versus standard care with intramuscular conventional neuroleptics in the initial phase of treating individuals with acute psychosis.

Although atypical antipsychotics are now considered first line treatments for schizophrenia, intramuscular (i.m.) conventional neuroleptics are often still considered necessary in emergency treatment of acute psychoses. This European, multicentre, open-label, active-controlled trial compared oral risperidone plus oral lorazepam to standard care with i.m. conventional neuroleptics with or without lorazepam in the emergency treatment of acutely psychotic patients. Patients were allowed to choose either oral risperidone (a single dose of 2 mg and 2.0-2.5 mg lorazepam; 121 patients) or standard i.m. treatment (conventional neuroleptic with or without lorazepam; 105 patients). No additional treatment was allowed for 2 h. Primary outcome was the percentage of patients with treatment success (asleep or at least much improved on Clinical Global Impression-global improvement scale) 2 h after treatment initiation. Baseline characteristics were similar in both treatment groups. Oral risperidone plus oral lorazepam was more successful at 2 h (66.9%) and significantly non-inferior compared to standard i.m. care (54.3%; P=0.0003), and the incidence of extrapyramidal symptoms (EPS) was lower (1.7%) compared to standard i.m. care (9.5%). In acutely psychotic patients requiring emergency treatment, oral risperidone/oral lorazepam was at least as effective as i.m. conventional neuroleptic treatment with or without lorazepam. Oral risperidone plus lorazepam rapidly reduces symptoms, including aggression, and causes fewer EPS.

Treatment of schizophrenia with long-acting injectable risperidone: a 12-month open-label trial of the first long-acting second-generation antipsychotic.

BACKGROUND: The long-term safety and efficacy of long-acting injectable risperidone, the first long-acting second-generation antipsychotic, were evaluated in stable patients with schizophrenia. METHOD: After a 2-week run-in period during which patients with DSM-IV schizophrenia received flexible doses of 1 to 6 mg of oral risperidone, patients received injections of 25 mg, 50 mg, or 75 mg of long-acting risperidone every 2 weeks for 12 months. Severity of extrapyramidal symptoms was assessed with the Extrapyramidal Symptom Rating Scale (ESRS), and efficacy was assessed with the Positive and Negative Syndrome Scale (PANSS). This study was conducted from March 29, 1999 to July 19, 2000. RESULTS: The subjects were 615 patients with schizophrenia who received at least 1 injection of long-acting risperidone. The 12-month trial was completed by 65% of patients. Treatment was discontinued because of adverse events in 5% of patients. Extrapyramidal symptoms as adverse events were reported by 25% of the patients. Severity of extrapyramidal symptoms (according to ESRS scores) was low at baseline and decreased in each of the groups during the 12 months. The other most common adverse events were anxiety in 24%, insomnia in 21%, psychosis in 17%, and depression in 14% of the patients. Little pain was associated with the injections. Severity of symptoms of schizophrenia was improved in each group, with significant reductions in PANSS total scores (p <.01) and positive (p <.01) and negative (p <.001) factor scores. CONCLUSION: In terms of both safety and efficacy, symptomatically stable patients with schizophrenia benefit from being switched to long-acting injectable risperidone.

[Safety and efficacy of olanzapine versus perphenazine in patients with schizophrenia: results of multicenter, 18-week, double-blind clinical trial]. / Bezpieczenstwo i skutecznosc leczenia olanzapina--w porównaniu z perfenazyna--chorych na schizofrenie. Wyniki 18-tygodniowego badania wieloosrodkowego w warunkach podwójnie slepej próby.

AIM: The primary objective of the study was to evaluate the severity of extrapyramidal symptoms during treatment with olanzapine (10-20 mg) versus perphenazine (8-40 mg) using the Simpson Angus Scale (SAS). The secondary objective was to assess the safety profile and clinical efficacy of the investigated drugs. MATERIAL AND METHOD: A total of 95 patients with schizophrenia who met the criteria for DSM-IV were randomized to a double-blind, 18 week prospective comparative trail conducted in Poland. The tolerance of treatment was assessed with the use of scales: BAS, SAS and UKU. The efficacy of treatment was evaluated with BPRS, PANSS and CGOI scales. RESULTS: For olanzapine patients, the severity of extrapyramidal symptoms improved after 3 first weeks of treatment, and significantly decreased from the baseline to endpoint. Perphenazine patients showed an increase of extrapyramidal symptoms. The difference of the SAS scores change was statistically significant between olanzapine and perphenazine groups. Akathisia symptoms decreased significantly in the olanzapine group during the treatment period, whereas symptoms of akathisia increased in the perphenazine group. Statistically significant differences of mean change of BAS total score from baseline to endpoint were noted between treatment groups Treatment--emergent adverse events occurred more frequently in patients receiving perphenazine (46%), than in patients receiving olanzapine (17%). The proportion of patients complying with improvement criteria for CGI scale score was statistically greater in the olanzapine group (72.7%) than in the perphenazine group (47.9%). Results of this study showed that the tolerance profile in patients taking olanzapine is superior to perphenazine. CONCLUSIONS: Olanzapine was better tolerated than perphenazine. After olanzapine treatment more subjects fulfilled the criterion of improvement and schizophrenic symptoms were less severe than in patients treated with perphenazine.