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® (risperidone) is not approved for the treatment of patients with Dementia-Related Psychosis.
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RISPERDAL SUMMARY
RISPERDAL®
(risperidone)
TABLETS/ORAL SOLUTION
RISPERDAL® M-TAB®
(risperidone)
ORALLY DISINTEGRATING TABLETS
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® (risperidone) is indicated for the following:
SCHIZOPHRENIA
RISPERDAL® (risperidone) is indicated for the treatment of schizophrenia.
The efficacy of RISPERDAL® in schizophrenia was established in short-term (6- to 8-weeks) controlled trials of schizophrenic inpatients (see CLINICAL PHARMACOLOGY).
The efficacy of RISPERDAL® in delaying relapse was demonstrated in schizophrenic patients who had been clinically stable for at least 4 weeks before initiation of treatment with RISPERDAL® or an active comparator and who were then observed for relapse during a period of 1 to 2 years (see CLINICAL PHARMACOLOGY - Clinical Trials). Nevertheless, the physician who elects to use RISPERDAL® for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).
BIPOLAR MANIA
Monotherapy
RISPERDAL® is indicated for the short-term treatment of acute manic or mixed episodes associated with Bipolar I Disorder.
The efficacy of RISPERDAL® was established in two placebo-controlled trials (3-week) with patients meeting DSM-IV criteria for Bipolar I Disorder who currently displayed an acute manic or mixed episode with or without psychotic features (see CLINICAL PHARMACOLOGY).
Combination Therapy
The combination of RISPERDAL® with lithium or valproate is indicated for the short-term treatment of acute manic or mixed episodes associated with Bipolar I Disorder.
The efficacy of RISPERDAL® in combination with lithium or valproate was established in one placebo-controlled (3-week) trial with patients meeting DSM-IV criteria for Bipolar I Disorder who currently displayed an acute manic or mixed episode with or without psychotic features (see CLINICAL PHARMACOLOGY).
The effectiveness of RISPERDAL® for longer-term use, that is, for more than 3 weeks of treatment of an acute episode, and for prophylactic use in mania, has not been systematically evaluated in controlled clinical trials. Therefore, physicians who elect to use RISPERDAL® for extended periods should periodically re-evaluate the long-term risks and benefits of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).
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NEWS HIGHLIGHTS
Published Studies Related to Risperdal (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 (Risperidone)
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.
Schizophrenia Risperidone vs Olanzapine Study HGMN [Completed]
Summary of Study Design This is a randomized, double-blind, flexible-dosed, parallel study
exploring the relationship between early response to an antipsychotic medication and
subsequent improvement in psychopathology using the atypical antipsychotic risperidone, and
determining if patients who do not show an early response to risperidone can achieve an
adequate improvement in clinical status following 10 weeks of treatment with olanzapine.
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.
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.
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 3 ratings/reviews, Risperdal has an overall score of 4.67. The effectiveness score is 4.67 and the side effect score is 4.67. The scores are on ten point scale: 10 - best, 1 - worst.
| | Risperdal review by 30 year old female patient | | | Rating |
| Overall rating: | |   |
| Effectiveness: | | Considerably Effective |
| Side effects: | | Moderate Side Effects | | |
Treatment Info |
| Condition / reason: | | Anxiety |
| Dosage & duration: | | 1 mg a day and as needed taken every day for the period of for 3+ years-currently, various doses |
| Other conditions: | | bipolar disorder, add, hypothyroid |
| Other drugs taken: | | Lamictal, Neurontin, Strattera, Levothyroid, Klonopin | | |
Reported Results |
| Benefits: | | In the case of a panic attack, this would soothe the anxiety and calm me down-a numbing sensation--a highly effective anti-psychotic in several situations--kept a low-level feeling of calmness and barrier to anxiety/stress |
| Side effects: | | Unfortunately, weight gain was a marked side effect, and led me to take a lower dose--also in high doses, I almost felt like a zombie--totally numb and emotionless--a disturbing concept. |
| Comments: | | Prescribed by my psychiatrist to use in various doses over several years of use to use for anxiety and panic, and in conjunction with Klonopin as an effective measure to reduce a mixed/manic episode of bipolar disorder in an acute situation, and also at a low-level dose every day to reduce the chance of episodes from occuring. Good tool in anger management as well. |
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| | Risperdal review by 33 year old male patient | | | Rating |
| Overall rating: | | |
| Effectiveness: | | Ineffective |
| Side effects: | | Extremely Severe Side Effects | | |
Treatment Info |
| Condition / reason: | | Anxiety |
| Dosage & duration: | | 2 mg taken daily for the period of 2 Years |
| Other conditions: | | Social Phobia |
| Other drugs taken: | | Pacitane 2 mg | | |
Reported Results |
| Benefits: | | NONE AT ALL |
| Side effects: | | See below |
| Comments: | | An old and STUPID psychiatrist in Asha Hospital, Hyderabad had put me on Risperidone 2 mg, Pacitane 2 mg from past 2 years as I was suffering with anxiety and social phobia. I do not have any symptoms of Schizophrenia nor Bopolar disorder and I stopped taking the med since 4 months worrying about the serious side effects..The result is..it just RUINED my life in every aspect. I can't feel ANYTHING. I feel nothing in my brain..unable to sense pleasure..lost my unique nature..lost my personality and identity..not getting any thoughts..consciousness is reduced..not able to concentrate on any particular thing..unable to form clear ideas..difficulty understand simple things..chronic sleeplessness..stiff muscles..numbness on the hands..weight gain..sensory loss..memory shot..hearing is badly damaged..dim and blurred vision...no sexual desire at all and lot more..My FUCKING psychiatrist doesn't even let me know of these siide effects and just told me to continue the medication for two years and no need to consult him..I never know why he had put me on Risperidone.This med is really FUCKING..I never suggest this med to anyone at all and I want to file the lawsuit against the company who manufactured this ROGUE drug with these many dangerous and life threattening side effects.I will report to FDA, United States to put it in block list and RUIN their business completely.They are playing with the valuable lives of the patients with their stupid formulas and creating the FUCKING drugs..Do they bring back the life to normal once the brain got permanently damaged???? |
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| | Risperdal review by 33 year old male patient | | | Rating |
| Overall rating: | | |
| Effectiveness: | | Ineffective |
| Side effects: | | Extremely Severe Side Effects | | |
Treatment Info |
| Condition / reason: | | Anxiety |
| Dosage & duration: | | 2 mg taken daily for the period of 2 Years |
| Other conditions: | | Social Phobia |
| Other drugs taken: | | Pacitane 2 mg | | |
Reported Results |
| Benefits: | | NONE AT ALL |
| Side effects: | | See below |
| Comments: | | An old and STUPID psychiatrist in Asha Hospital, Hyderabad had put me on Risperidone 2 mg, Pacitane 2 mg from past 2 years as I was suffering with anxiety and social phobia. I do not have any symptoms of Schizophrenia nor Bopolar disorder and I stopped taking the med since 4 months worrying about the serious side effects..The result is..it just RUINED my life in every aspect. I can't feel ANYTHING. I feel nothing in my brain..unable to sense pleasure..lost my unique nature..lost my personality and identity..not getting any thoughts..consciousness is reduced..not able to concentrate on any particular thing..unable to form clear ideas..difficulty understand simple things..chronic sleeplessness..stiff muscles..numbness on the hands..weight gain..sensory loss..memory shot..hearing is badly damaged..dim and blurred vision...no sexual desire at all and lot more..My FUCKING psychiatrist doesn't even let me know of these siide effects and just told me to continue the medication for two years and no need to consult him..I never know why he had put me on Risperidone.This med is really FUCKING..I never suggest this med to anyone at all and I want to file the lawsuit against the company who manufactured this ROGUE drug with these many dangerous and life threattening side effects.I will report to FDA, United States to put it in block list and RUIN their business completely.They are playing with the valuable lives of the patients with their stupid formulas and creating the FUCKING drugs..Do they bring back the life to normal once the brain got permanently damaged???? |
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Page last updated: 2009-10-20
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