Introduction: This 52-week open-label extension (OLE) to a double-blind placebo-controlled recurrence prevention study examined the long-term safety and efficacy of flexibly-dosed paliperidone extended-release (ER) tablets in patients with schizophrenia.

Methods: Patients entering the OLE either entered from the double-blind phase (placebo or paliperidone ER treatment) or entered directly from the run-in or stabilization phase (paliperidone ER) of the earlier study. During the OLE, patients were treated with flexibly-dosed paliperidone ER (3–15 mg/day; 9 mg starting dose). Safety and tolerability assessments included incidence of adverse events and extrapyramidal symptoms. Efficacy was also assessed.

Results: The study population (n=235) was predominantly men (66%), 18–58 years of age. Twelve patients (5%) experienced an adverse event requiring treatment discontinuation. One or more serious treatment-emergent adverse events were reported in 13 patients (6%). There was one death. The mean Positive and Negative Syndrome Scale total score decreased from open-label baseline to endpoint for all groups, regardless of previous double-blind treatment (placebo or paliperidone ER).

Conclusion: This year-long OLE provides information on the long-term safety and tolerability of paliperidone ER in patients with schizophrenia. The resulting safety and tolerability profile was similar to that seen in earlier short-term studies.

Effective treatments for adolescent schizophrenia are needed.

To compare efficacy and safety of two dosing regimens of risperidone.

Double-blind, 8-week study. Patients, 13–17 years, with an acute episode of schizophrenia, randomised 1:1 to risperidone 1.5–6.0 mg/day (regimen A; n=125) or 0.15–0.6 mg/day (regimen B; n=132). Trial registration number: NCT00034749.

Mean total Positive and Negative Syndrome Scale (PANSS) score improved significantly (P<0.001; effect size=0.49) from baseline to end-point for regimen A (mean=96.4 (s.d.=15.39) to mean=72.8 (s.d.=22.52)) compared with regimen B (mean=93.3 (s.d.=14.14) to mean=80.8 (s.d.=24.33)). Treatment-emergent adverse events occurred in 74% (regimen A) and 65% (regimen B) of patients; 4% of patients overall discontinued for adverse events. Mean change in body weight was 3.2 kg (s.d.=3.49) for regimen A and 1.7 kg (s.d.=3.29) for regimen B.

Adolescent patients in the regimen A group showed greater improvement in total PANSS compared with the regimen B group. Treatment was well tolerated.

Investigating the relationship between premorbid functioning and treatment response in schizophrenia is relevant to understanding the illness and predicting treatment outcomes.

To examine the relationship between premorbid characteristics and treatment response of people with recent-onset schizophrenia.

Data came from a large, double-blind trial of recent-onset psychosis treated with a flexible dose of risperidone or haloperidol. Median treatment length was 206 days. Premorbid functioning was categorised using the Cannon-Spoor Premorbid Adjustment Scale.

There were significant differences between the premorbid groups on change on the Positive and Negative Syndrome Scale, Clinical Global Impression severity and cognitive functioning and Extrapyramidal Symptoms Rating Scale. Patients in the ‘stable–good’ premorbid group (n=251) improved more than those in the ‘stable–poor’ (n=198) and ‘declining’ (n=81) groups. The ‘stable–good’ group received the lowest doses of antipsychotic and had the least extrapyramidal symptoms. Patients in the declining’ group had the highest dosages and the most extrapyramidal symptoms.

In first-episode psychosis good premorbid functioning is associated with better response to treatment and fewer extrapyramidal symptoms.

Severe mania is life-threatening, carries an increased risk of suicide and has a serious impact on patients and their families. Efficient and rapid control of episodes of acute mania is needed.

To evaluate the safety and efficacy of risperidone monotherapy for acute mania.

In a 3-week, randomised, double-blind trial, 290 in-patients with bipolar l disorder with current manic or mixed episode and a baseline Young Mania Rating Scale (YMRS) score of 20 or more received flexible doses of risperidone (1–6 mg per day) or placebo.

Risperidone was received by 146 patients and placebo by 144. Their mean baselineYMRS score was 37. 2 (s. e. =0. 5). Significantly greater improvements were observed with risperidone than with placebo at weeks l and 2 and at end-point (total YMRS: P<0. 01). Extrapyramidal symptoms were the most frequently reported adverse events in the risperidone group.

In patients with severe manic symptoms, risperidone produced significant improvements in YMRS scores as early as week 1 and substantial changes at end-point. Treatment was well tolerated.

The extent to which antipsychotics improve patients' well-being is uncertain.

To examine psychopathology and patient-rated functioning and well-being in patients treated with risperidone.

In a 1-year, open-label, international multicentre trial of long-acting risperidone in 615 stable adult patients with schizophrenia, self-rated functioning and well-being were measured every 3 months using the Short Form 36-item questionnaire (SF–36). Psychopathology was quantified using the Positive and Negative Syndrome Scale (PANSS).

Significant improvements were found on the SF–36 mental component summary score and vitality and social functioning scales. PANSS and mental component summary scores were moderately correlated.

Patient-reported functioning and well-being appear to differ from investigator-rated psychotic symptoms. Patient-rated well-being should be assessed with symptoms to help measure treatment outcomes.