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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)
Double-blind placebo-controlled randomized efficacy and safety trial of add-on
treatment of dimebon plus risperidone in schizophrenic patients during transition
from acute psychotic episode to remission. [2012]
CONCLUSION: Dimebon as add-on therapy to antipsychotic treatment in the period of
Cost and cost-effectiveness in a randomized trial of long-acting risperidone for
schizophrenia. [2012]
CONCLUSIONS: Patients with unstable schizophrenia were randomized in a practical
Early treatment with risperidone for subsyndromal delirium after on-pump cardiac
surgery in the elderly: a randomized trial. [2012]
clinical delirium in elderly patients who underwent on-pump cardiac surgery... CONCLUSION: Administration of risperidone to elderly patients who experienced
A double-blind placebo controlled trial of Ginkgo biloba added to risperidone in
patients with autistic disorders. [2012]
Ginkgo biloba has been reported to affect the neurotransmitter system and to have
antioxidant properties that could impact the pathogenesis of Autism Spectrum
Disorder. Based on these studies, we decided to assess the effectiveness of
Ginkgo biloba extract (Ginko T.D., Tolidaru, Iran) as an adjunctive agent to
risperidone in the treatment of autism.
Therapeutic effects of cerebrolysin added to risperidone in patients with
schizophrenia dominated by negative symptoms. [2012]
negative symptoms... CONCLUSION: Cerebrolysin added to risperidone did not augment the efficacy of
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.
Oral Versus Injectable Risperidone for Treating First-Episode Schizophrenia [Recruiting]
This study will determine the effectiveness of oral risperidone versus long-acting
injectable risperidone in treating people with first-episode schizophrenia.
High Dose Risperidone Consta for Patients With Schizophrenia With Poor Response to Risperidone [Recruiting]
The purpose of this study is to look at two doses of long-acting injectable risperidone
(Risperdal Consta). The study will use a usual dose of Risperdal Consta (50 mg given every
two weeks) or a higher dose (75 mg-100 mg given every two weeks) to see which one is better
at improving symptoms of schizophrenia or schizoaffective disorder.
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.
Reports of Suspected Risperdal Consta (Risperidone) Side Effects
Hospitalisation (49),
Drug Ineffective (35),
Weight Increased (35),
Inappropriate Schedule of Drug Administration (32),
Psychotic Disorder (32),
Product Quality Issue (30),
Condition Aggravated (28),
Gait Disturbance (28),
Depression (27),
Abnormal Behaviour (27), more >>
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 3 ratings/reviews, Risperdal Consta has an overall score of 6. The effectiveness score is 6.67 and the side effect score is 6.67. The scores are on ten point scale: 10 - best, 1 - worst.
| | Risperdal Consta review by 27 year old female patient | | | Rating |
| Overall rating: | |   |
| Effectiveness: | | Considerably Effective |
| Side effects: | | No Side Effects | | |
Treatment Info |
| Condition / reason: | | psychotic symptoms |
| Dosage & duration: | | 1 mg taken twice a day for the period of 2 years - currently |
| Other conditions: | | depression |
| Other drugs taken: | | Fluoxetine | | |
Reported Results |
| Benefits: | | Psychotic thoughts went away. No longer thought people were out to get me. Became less suspicious of people. Iritability decreaed while on this medication. This medication has worked wonders for me. |
| Side effects: | | None at all for me. I have tolerated this medication very well. |
| Comments: | | Started this medication in October 2008 for my suspiciousness of people (thought people were out to get me). Began at 0.25 mg once a day for a week, then increased to 0.5 mg a day at night. 3 weeks later (1 month from the time of starting risperidone), increased to 1 mg every night. Stayed on 1 mg for a few months when the symptoms came back. Dose increased to 1.5 mg a day. Depression set in (for outside life factors...not due to medication) and fluoetime added at 10 mg a day and risperidone decreased to 1 mg a day due to flueoxetine increasing the levels of risperidone. Depression still there and psychotic symptoms came back. At next vist (1 month) flueoxetine increased to 20 mg every morning and risperidone increased back to 1.5 mg a day. Two months later psychotic symptoms would come back in the middle of the day (as if the medication was wearing off). Rispreridone dosage changed to 1 mg twice a day. Which is still the current dosage I am on. |
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| | Risperdal Consta review by 25 year old male patient | | | Rating |
| Overall rating: | | |
| Effectiveness: | | Marginally Effective |
| Side effects: | | Moderate Side Effects | | |
Treatment Info |
| Condition / reason: | | bipolar |
| Dosage & duration: | | 4mgs taken 5 years for the period of 5 years |
| Other conditions: | | N/A |
| Other drugs taken: | | Lithium | | |
Reported Results |
| Benefits: | | depression lessened |
| Side effects: | | headaches after 4 years, no control over breathing, the drug created inner emotions and feeling that weren't present before starting taking the medication, the bi-treatment of lithium and risperidone also created feeling of excessive sleepiness, created a weight gain of more than my normal size, colors of objects turn more bland and life seems more pointless when taking risperidone during the day. Taking the medication at bedtime turned out to be better. Smoke 2 packs a day after taking the medication at night and waking up the next day. Less able to control emotions. |
| Comments: | | I had more energy than others when i was younger and the doctors and parents wanted to punish me for it by putting me on medication. Havn't been able to get off them since because they are addicting and mind warping. |
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| | Risperdal Consta review by 25 year old male patient | | | Rating |
| Overall rating: | | |
| Effectiveness: | | Marginally Effective |
| Side effects: | | Moderate Side Effects | | |
Treatment Info |
| Condition / reason: | | bipolar |
| Dosage & duration: | | 4mgs taken 5 years for the period of 5 years |
| Other conditions: | | N/A |
| Other drugs taken: | | Lithium | | |
Reported Results |
| Benefits: | | depression lessened |
| Side effects: | | headaches after 4 years, no control over breathing, the drug created inner emotions and feeling that weren't present before starting taking the medication, the bi-treatment of lithium and risperidone also created feeling of excessive sleepiness, created a weight gain of more than my normal size, colors of objects turn more bland and life seems more pointless when taking risperidone during the day. Taking the medication at bedtime turned out to be better. Smoke 2 packs a day after taking the medication at night and waking up the next day. Less able to control emotions. |
| Comments: | | I had more energy than others when i was younger and the doctors and parents wanted to punish me for it by putting me on medication. Havn't been able to get off them since because they are addicting and mind warping. |
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Page last updated: 2013-02-10
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