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Risperdal Consta (Risperidone) - Summary

 
 



WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of 17 placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death 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. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. RISPERDAL® CONSTA® (risperidone) is not approved for the treatment of patients with dementia-related psychosis. [See Warnings and Precautions]

 

SUMMARY

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 ).


See all Risperdal Consta indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Risperdal Consta (Risperidone)

Risperidone versus risperidone plus sodium valproate for treatment of bipolar disorders: a randomized, double-blind clinical-trial. [2014]
CONCLUSIONS: Risperidone can be effective and well tolerated in both acute manic

A head-to-head comparison of aripiprazole and risperidone for safety and treating autistic disorders, a randomized double blind clinical trial. [2014]
Aripiprazole and risperidone are the only FDA approved medications for treating irritability in autistic disorder, however there are no head-to-head data comparing these agents. This is the first prospective randomized clinical trial comparing the safety and efficacy of these two medications in patients with autism spectrum disorders...

Paliperidone palmitate versus risperidone long-acting injection in markedly-to-severely ill schizophrenia subjects: onset of efficacy with recommended initiation regimens. [2014]
antipsychotics in markedly-to-severely ill schizophrenia subjects... CONCLUSIONS: Using the recommended dosing regimens for PP and RLAI, both PP and

Double-blind, placebo-controlled trial of risperidone plus amantadine in children with autism: a 10-week randomized study. [2013]
risperidone for treatment of autism... CONCLUSIONS: The present study suggests that amantadine may be a potential

Memantine add-on to risperidone for treatment of negative symptoms in patients with stable schizophrenia: randomized, double-blind, placebo-controlled study. [2013]
We aimed to evaluate the efficacy of memantine add-on in the treatment of primary negative symptoms of patients with stable schizophrenia. In a double-blind placebo-controlled clinical trial, 40 patients with schizophrenia (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition) who were stabilized on risperidone for a minimum of 8 weeks were randomized to either memantine (20 mg) or placebo in addition to risperidone, 6 mg/d, for eight weeks...

more studies >>

Clinical Trials Related to Risperdal Consta (Risperidone)

Observational Study in Patients With Schizophrenia Treated With Long-Acting Risperidone Injection (RISPERDAL CONSTA) [Completed]
The purpose of this study is to examine treatment practices of adult schizophrenia patients by their own doctors, and to assess patient outcomes when treated with long-acting risperidone injection over a two-year period of observation.

Bioequivalence Test for Risperdal 2mg of Janssen Korea [Completed]
The purpose of this study was to conduct the bioequivalence (biological equivalence of two preparations of a drug) test in healthy adults with "Risperdal OD Tab. 2mg" of Janssen Korea as the investigational drug and "Risperdal Quicklet Tab. 2mg" as the control drug.

A 4-week Study of Mifepristone in the Prevention of Risperidone-induced Weight Gain in Healthy Male Volunteers [Completed]
This is a 28-day, single-center, double-blind, placebo-controlled inpatient study of the administration of risperidone alone or in combination with mifepristone in healthy adult male volunteers to determine the average change in absolute weight at Day 28 compared to baseline.

A Double-blind, Placebo Controlled Trial of Risperidone for the Treatment of Anorexia Nervosa [Active, not recruiting]
The aim of this pilot study is to determine the safety and efficacy of risperidone for the treatment of anorexia nervosa. Hypothesis 1: Subjects on risperidone will show a more significant decrease in body image

distortion and Eating Disorder Inventory - 2 scores than subjects on placebo.

Hypothesis 2: Subjects on risperidone will reach and maintain at or above 90% Ideal body weight sooner than controls.

Oral Versus Injectable Risperidone for Treating First-Episode Schizophrenia [Completed]
This study will determine the effectiveness of oral risperidone versus long-acting injectable risperidone in treating people with first-episode schizophrenia.

more trials >>

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 >>


PATIENT REVIEWS / RATINGS / COMMENTS

Based 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.

 

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.

 

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.

See all Risperdal Consta reviews / ratings >>

Page last updated: 2015-08-10

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