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Orap (Pimozide) - Summary

 
 



ORAP SUMMARY

ORAP® (pimozide) is an orally active antipsychotic agent of the diphenylbutylpiperidine series.

ORAP (pimozide) is indicated for the suppression of motor and phonic tics in patients with Tourette's Disorder who have failed to respond satisfactorily to standard treatment. ORAP is not intended as a treatment of first choice nor is it intended for the treatment of tics that are merely annoying or cosmetically troublesome. ORAP should be reserved for use in Tourette's Disorder patients whose development and/or daily life function is severely compromised by the presence of motor and phonic tics.

Evidence supporting approval of pimozide for use in Tourette's Disorder was obtained in two controlled clinical investigations which enrolled patients between the ages of 8 and 53 years. Most subjects in the two trials were 12 or older.


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NEWS HIGHLIGHTS

Media Articles Related to Orap (Pimozide)

Agoraphobia
Source: MedicineNet Panic Disorder Specialty [2014.02.04]
Title: Agoraphobia
Category: Diseases and Conditions
Created: 10/10/2002 12:00:00 AM
Last Editorial Review: 2/4/2014 12:00:00 AM

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Published Studies Related to Orap (Pimozide)

Pimozide augmentation of clozapine inpatients with schizophrenia and schizoaffective disorder unresponsive to clozapine monotherapy. [2011.05]
Despite its superior efficacy, clozapine is helpful in only a subset of patients with schizophrenia unresponsive to other antipsychotics.However, given the lack of evidence to guide clinicians and patients when clozapine does not work well, more controlled trials of innovative strategies are warranted.

Quantitative determination of pimozide in human plasma by liquid chromatography-mass spectrometry and its application in a bioequivalence study. [2010.04.06]
A simple, sensitive and specific LC-ESI/MS method was developed for the determination of pimozide in human plasma. Pimozide and cinnarizine (internal standard) were isolated from plasma samples by liquid-liquid extraction...

Pimozide for tics in Tourette's syndrome. [2009.04.15]
CONCLUSIONS: Pimozide is an effective treatment for tics in Tourette Syndrome, though the number of trials comparing its effect to placebo and other drugs is limited. Trials of longer duration (minimum six months) are needed to investigate the longer-term effects of pimozide compared to atypical neuroleptics. Future trials should use the Yale Global Tic Severity Scale to assess the main outcome measure, and quantify adverse events with the Extrapyramidal Symptoms Rating Scale.

Placebo-controlled study of pimozide augmentation of fluoxetine in body dysmorphic disorder. [2005.02]
CONCLUSIONS: Pimozide augmentation of fluoxetine treatment for body dysmorphic disorder was not more effective than placebo, even in more delusional patients. Further studies of augmentation for SRIs are needed.

Tic reduction with risperidone versus pimozide in a randomized, double-blind, crossover trial. [2004.02]
CONCLUSIONS: In this study, risperidone appeared superior to pimozide for tic suppression but was associated with greater weight gain.

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Clinical Trials Related to Orap (Pimozide)

Effectiveness of Pimozide in Augmenting the Effects of Clozapine in the Treatment of Schizophrenia [Recruiting]
This study will assess the effectiveness of pimozide in enhancing the effects of clozapine in the treatment of schizophrenia.

Efficacy of Pimozide Augmentation for Clozapine Partial Response [Recruiting]
This is a 12 week outpatient study for patients with schizophrenia who are on Clozapine, but continue to experience symptoms. The purpose of this project is to find out if small doses of pimozide (an antipsychotic medication, taken by mouth) will be helpful in reducing symptoms (such as hearing voices, having trouble in organizing your thoughts, lack of interest in life events and social activities), compared to placebo (an inactive substance, "sugar pill"), when added to clozapine in patients with schizophrenia.

You will be asked to come in once a week to meet with the research staff and study doctor. You will continue to see your regular clinician during this study for all normal appointments. You will remain on your current medications throughout the study. During the study you will be randomly selected to be put on a small dose of Pimozide or placebo.

Phase II Pilot Controlled Study of Short Vs Longer Term Pimozide (Orap) Therapy in Tourette Syndrome [Completed]
OBJECTIVES: I. Determine whether the time period between randomization and endpoint is longer in the short term pimozide therapy or longer term therapy in patients with Tourette syndrome.

II. Determine whether tic severity, medication side effects, academic performance and psychosocial functioning are better in the short term pimozide therapy or longer term pimozide therapy.

Clinical Trial to Evaluate the Efficacy of Treatment vs Discontinuation in a First Episode of Non-affective Psychosis [Recruiting]
The purpose of this study is to assess if patients who continue with antipsychotic treatment for 12 or more months show the same risk of relapse (measured by PANSS) that patients with the same medical condition who have followed a discontinuation treatment scheme based in the presence of prodromes.

The candidates should accomplish the following criteria: first episode of non-affective psychosis who have followed antipsychotic treatment for 12 months and who have already shown remission criteria.

Antipsychotic Polypharmacy in Schizophrenia [Recruiting]
The literature suggests that when a patient is prescribed more than one antipsychotic for at least 30 days, he or she is likely to continue on that combination. In this 12 week study 100 adult patients being treated on more than one antipsychotic medication for at least 30 days will be recruited. In order to control for the natural course of the illness, patients will be randomly assigned to one of two groups: the first group will continue the second medication hidden in a capsule at the same dose, while the second group will be given an

inactive capsule (placebo) - the capsules in both group will be identical such that neither

the patient nor the treating doctor will be able to identify the group assignment.

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Reports of Suspected Orap (Pimozide) Side Effects

Fear (3)Suicidal Ideation (3)Depression (3)Anxiety (3)Rhabdomyolysis (2)Inappropriate Antidiuretic Hormone Secretion (2)Vomiting (2)Hyponatraemia (2)Diarrhoea (2)Abdominal Pain (1)more >>


Page last updated: 2014-02-04

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