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Increased Mortality in Elderly Patients with Dementia –Related Psychosis
Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. Analyses of seventeen placebo controlled trials (modal duration of 10 weeks) in these patients revealed a risk of death in the drug-treated patients of between 1.6 to 1.7 times that seen in placebo-treated patients. Over the course of a typical 10 week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. RISPERDAL ® CONSTA ® (risperidone) is not approved for the treatment of patients with Dementia-Related Psychosis.
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SUMMARY
JANSSEN, L.P.
RISPERDAL® CONSTA®
(risperidone)
LONG-ACTING INJECTION
RISPERDAL® (risperidone) is a psychotropic agent belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one.
RISPERDAL® CONSTA®(risperidone) is indicated for the treatment of schizophrenia.
The efficacy of RISPERDAL® CONSTA® is based in part on a 12-week, placebo-controlled trial in schizophrenic inpatients or outpatients, along with extrapolation from the established efficacy of oral RISPERDAL® in this population.
The effectiveness of RISPERDAL® CONSTA® in longer-term use, that is, more than 12 weeks, has not been systematically evaluated in controlled trials. However, oral risperidone has been shown to be effective in delaying time to relapse in longer-term use. Patients should be periodically reassessed to determine the need for continued treatment (see DOSAGE AND ADMINISTRATION ).
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NEWS HIGHLIGHTS
Published Studies Related to Risperdal Consta (Risperidone)
Effect of Warm-Supplementing Kidney Yang (WSKY) added to risperidone on quality of life in patients with schizophrenia: a randomized controlled trial. [2009.09.28]
Objective: To evaluate the quality of life, efficacy and safety of Warm-Supplementing Kidney Yang (WSKY) added to risperidone in patients with schizophrenia.Design: A randomized controlled trial.Setting: The outpatient and inpatient departments of three hospitals.Subjects: One hundred and twenty patients with clinically diagnosed schizophrenia with predominantly negative symptoms were included in the study.Intervention: All 120 patients were randomly assigned to double-blind treatment with WSKY group (n = 60) or placebo group (n = 60) added to risperidone for eight weeks.Main measure: The efficacy measures included the World Health Organization Quality of Life Scale (WHOQOL-100), the Positive and Negative Syndrome Scale (PANSS), the Social Disability Screening Schedule and the Hamilton Rating Scale for Depression...
Randomized clinical comparison of perospirone and risperidone in patients with schizophrenia: Kansai Psychiatric Multicenter Study. [2009.06]
AIM: Perospirone is classified as a second-generation antipsychotic agent for the treatment of schizophrenia. Perospirone binds with high affinity to serotonin 5-HT2A receptors and dopamine D2 receptors. There are no reports of clinical comparisons of perospirone and risperidone in multicenter studies. To clarify the clinical traits of perospirone in the treatment of schizophrenia, the clinical efficacies and side-effects of perospirone and risperidone were compared in a randomized clinical multicenter trial... CONCLUSIONS: Perospirone was as effective as risperidone against positive and negative symptoms in patients with schizophrenia. Both antipsychotic agents were equally well-tolerated.
Long-term outcomes in patients with schizophrenia treated with risperidone long-acting injection or oral antipsychotics in Spain: results from the electronic Schizophrenia Treatment Adherence Registry (e-STAR). [2009.06]
BACKGROUND: The electronic Schizophrenia Treatment Adherence Registry (e-STAR) is a prospective, observational study of patients with schizophrenia designed to evaluate long-term treatment outcomes in routine clinical practice... CONCLUSIONS: This 2 year, prospective, observational study showed that, compared to oral antipsychotics, RLAI was associated with better treatment retention, greater improvement in clinical symptoms and functioning, and greater reduction in hospital stays and days in hospital in patients with schizophrenia. Improved treatment adherence, increased efficacy and reduced hospitalization with RLAI offer the opportunity of substantial therapeutic improvement in schizophrenia.
Randomized, placebo-controlled trial of risperidone for acute treatment of bipolar anxiety. [2009.06]
BACKGROUND: The treatment of bipolar disorder is often complicated by the presence of a co-occuring anxiety disorder. Although second generation antipsychotics are being used with increasing frequency in bipolar patients, their anxiolytic effects have not been well studied in this population... CONCLUSIONS: Risperidone monotherapy was not an effective anxiolytic for bipolar patients with comorbid panic disorder or GAD in doses of 0.5-4 mg/day over 8 weeks of treatment. The efficacy of other second generation antipsychotics and mood stabilizers on anxiety in patients with bipolar disorder and a co-occuring anxiety disorder should be investigated in double-blind, placebo-controlled studies.
A comparison of low-dose risperidone to paroxetine in the treatment of panic attacks: a randomized, single-blind study. [2009.05.26]
BACKGROUND: Because a large proportion of patients with panic attacks receiving approved pharmacotherapy do not respond or respond poorly to medication, it is important to identify additional therapeutic strategies for the management of panic symptoms. This article describes a randomized, rater-blind study comparing low-dose risperidone to standard-of-care paroxetine for the treatment of panic attacks... CONCLUSION: We can identify no difference in the efficacy of paroxetine and low-dose risperidone in the treatment of panic attacks. Low-dose risperidone appears to be tolerated equally well as paroxetine. Low-dose risperidone may be an effective treatment for anxiety disorders in which panic attacks are a significant component. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT100457106.
Clinical Trials Related to Risperdal Consta (Risperidone)
Evaluation of the Usefulness to Doctors of the Risperdal® Consta® Treatment Guidebook Over a Three-Month Period During Which Adult Patients With Schizophrenia or Schizoaffective Disorder Are Switching From Daily Doses or Risperidone Tablets to Long-Acting Risperidone by Injection [Completed]
The purpose of this study is to assess the usefulness of the Risperdal® Consta® Treatment
Guidebook in helping the doctor switch the adult patient from taking risperidone tablets
daily by mouth to taking long-acting risperidone by injection. The study will also evaluate
the effectiveness and safety of long-acting risperidone and its effect on patient
satisfaction.
Risperdal Consta for Bipolar Disorder [Active, not recruiting]
We are recruiting 50 consenting adult subjects with DSM-IV TR diagnoses of bipolar disorder
who are about to initiate or switch their current antipsychotic agent. Patients are titrated
and cross-tapered during a 3 month titration and stabilization phase. Presently 4 of the 11
subjects enrolled have transitioned successfully and are in Phase III of the study. After
transitioning into the next phase, they will be followed for an additional 12 months.
Clinical outcomes such as study drop out, adverse events, worsening of symptoms, crisis
interventions, need for additional medication, hospitalizations etc. will be evaluated from
months 3 to 15 (visits 8-20). The time to clinical events will be used to evaluate if the
long acting injectable form of risperidone has an advantage over the oral second generation
antipsychotic agents in terms of treatment continuity and clinical stability.
A Study of How Long it Takes a Patient to Relapse After Switching From an Oral Antipsychotic to One of Two Doses of Long-Acting Risperidone Injections in Patients With Schizophrenia or Schizoaffective Disorder [Completed]
The purpose of this study is to assess the time for patients to relapse when switched from an
oral antipsychotic to one of two doses of long-acting risperidone injection (shots).
Risperidone has been used successfully to treat schizophrenia and schizoaffective disorder.
A Prospective Study of Risperdal® (Risperidone) for the Treatment of Behavioral Disorder Following Psychological Therapy for Challenging Behavior in Learning Disabled Children [Completed]
The purpose of this study is to assess whether risperidone (an antipsychotic medication) is
safe and effective in treating behaviour disorder in learning disabled children, which does
not improve with psychological therapy.
Risperidone (Risperdal) Augmentation in Depressed Partial Responders to SRI Treatment [Withdrawn]
This is a study of the chemistry of depression in people who are taking an antidepressant but
it is not working well. The changes in brain chemicals that occur when an SSRI type
antidepressant is supplemented with risperidone (Risperdal®) will be studied. Spinal fluid
is used to measure chemical levels of dopamine, serotonin, and other chemicals thought to be
involved in depression. The study has potential to help understand and treat depression.
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Page last updated: 2009-10-20
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