Haldol (Haloperidol) - Summary

HALDOL SUMMARY

HALDOL^® Decanoate 50 (haloperidol)
HALDOL^® Decanoate 100 (haloperidol)
For IM Injection Only

Haloperidol decanoate is the decanoate ester of the butyrophenone, HALDOL (haloperidol). It has a markedly extended duration of effect.

HALDOL Decanoate 50 and HALDOL Decanoate 100 are indicated for the treatment of schizophrenic patients who require prolonged parenteral antipsychotic therapy.

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NEWS HIGHLIGHTS

Published Studies Related to Haldol (Haloperidol)

Effects of risperidone and haloperidol on superoxide dismutase and nitric oxide in schizophrenia. [2012]
Oxidative stress may be involved in the pathophysiology of schizophrenia...

Efficacy and safety of olanzapine in the treatment of Japanese patients with bipolar I disorder in a current manic or mixed episode: a randomized, double-blind, placebo- and haloperidol-controlled study. [2012]
manic/mixed episode... CONCLUSIONS: This was the first study to evaluate an atypical antipsychotic in

Haloperidol prophylaxis decreases delirium incidence in elderly patients after noncardiac surgery: A randomized controlled trial. [2011.11.03]
OBJECTIVES:: To evaluate the efficacy and safety of short-term low-dose intravenous haloperidol for delirium prevention in critically ill elderly patients after noncardiac surgery... CONCLUSIONS:: For elderly patients admitted to intensive care unit after noncardiac surgery, short-term prophylactic administration of low-dose intravenous haloperidol significantly decreased the incidence of postoperative delirium. The therapy was well-tolerated.

A 6-month, randomized, double-blind, placebo-controlled pilot discontinuation trial following response to haloperidol treatment of psychosis and agitation in Alzheimer's disease. [2011.09]
OBJECTIVE: In patients with Alzheimer's disease (AD) with psychosis or agitation that respond to haloperidol treatment, to evaluate the risk of relapse following discontinuation... CONCLUSIONS: Haloperidol open treatment was efficacious, and relapse was greater on placebo than with haloperidol continuation. In patients with AD who have psychosis or agitation and respond to antipsychotic medication, the increased risk of relapse after discontinuation needs to be weighed against the side effects associated with continuing the medication. Copyright (c) 2010 John Wiley & Sons, Ltd.

The GiSAS study: rationale and design of a pragmatic randomized controlled trial on aripiprazole, olanzapine and haloperidol in the long-term treatment of schizophrenia. [2011.09]
Given the controversy about the comparative efficacy of first- compared with second-generation antipsychotics in the treatment of schizophrenia, more large-scale evidence is needed to guide clinicians in their prescriptions. Most randomized controlled trials (RCTs) were conducted in centers of excellence on highly selected samples, poorly representative of real-world patients, and often suffered conflicts of interest as they were sponsored by drug companies.

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Clinical Trials Related to Haldol (Haloperidol)

Lorazepam, Diphenhydramine Hydrochloride, and Haloperidol Gel in Healthy Volunteers [Not yet recruiting]
RATIONALE: Lorazepam, diphenhydramine hydrochloride, and haloperidol gel, when absorbed into the skin, may be an effective treatment for nausea and vomiting. PURPOSE: This clinical trial studies lorazepam, diphenhydramine hydrochloride, and haloperidol gel in healthy volunteers.

Lorazepam, Diphenhydramine Hydrochloride, and Haloperidol Gel in Patients With Nausea [Recruiting]
This randomized clinical trial studies lorazepam, diphenhydramine hydrochloride, and haloperidol gel in patients with nausea. Lorazepam, diphenhydramine hydrochloride, and haloperidol gel, when absorbed into the skin, may be an effective treatment for nausea and vomiting.

Preventing ICU Subsyndromal Delirium Conversion to Delirium With Haloperidol [Recruiting]
About one-third of the patients who develop mild, acute confusion (i. e., subsyndromal delirium) will go on to develop a severe acute confusional state (i. e. delirium). Delirium refers to a temporary change in the way a person thinks about things. Delirium occurs in patients admitted to the hospital particularly those patients that are very sick, who are given a number of medications, and who are not able to sleep normally. It affects their behavior, their understanding of the people and things around them, and their ability to make decisions. While ICU doctors do everything possible to eliminate the factors that may cause delirium, delirium may cause a person to become very agitated which if not controlled is dangerous to their safety as well as the safety of those around them. As well, if delirium develops in patients in the ICU, it may increase the risk for death, keep patients in both the ICU and hospital for longer and send patients to a long term care facility rather than home after they are discharged from the hospital. A recent medical report found that patients in the ICU who develop subsyndromal delirium have a mortality rate, a length of stay in both the ICU and the hospital, and a transfer rate to a long term care facility that is nearly as great as patients with delirium and greater than patients who develop neither subsyndromal delirium or delirium. Recent studies in non-ICU patients suggest that if a patient who is at high risk for developing delirium receives a medication called an antipsychotic (e. g. haloperidol) they may not be as likely to develop delirium or if they do develop delirium it will not last as long. No studies have evaluated the effect of administering an antipsychotic in patients in the ICU who have subsyndromal delirium. Another study completed in the ICUs at Tufts Medical Center found that there may be an association between the development of delirium in patients with subsyndromal delirium and the use of haloperidol. However, this small study had many limitations and thus it is not currently known whether using haloperidol in patients with subsyndromal delirium will actually cause fewer of these patients to develop delirium. Haloperidol makes a person sleepy and helps control behavior like agitation. Haloperidol is the drug that is used most often to help control delirium in the ICU. This prospective, double-blind, randomized controlled study will determine if haloperidol administered through the vein four times daily (1mg IV q6h) to patients who have subsyndromal delirium, and who are on a breathing machine and being cared for by the Medical ICU service at Tufts Medical Center, will help prevent patients from developing delirium. A total of 68 participants will be enrolled. Exclusion criteria are extensive and include conditions that could affect the ability to determine if delirium is present or increase the risk for side effects related to the administration of haloperidol. Patients older than 80 will be excluded from the study. Study medication (i. e. haloperidol) will be administered until one the following occurs: 1) delirium develops (that is confirmed by a staff psychiatrist or his designate, 2) the patient is discharged from the ICU at Tufts Medical Center, 3) the patient has received haloperidol or placebo for 10 days or 4) an adverse event potentially attributable to the study drug is experienced by a patient that is deemed, in the opinion of a pulmonologist member of the investigative team to warrant discontinuation of therapy. Haloperidol may cause unwanted side effects such as low blood pressure, twitching, and an unsafe abnormal heart rhythm. Patients with chronic confusion (e. g., a dementia such as Alzheimer's Disease) should not receive haloperidol and will not be included in this study. Patients will be carefully monitored for side effects that are potentially related to haloperidol. Patients who become confusion-free in the ICU before they leave the ICU (i. e., have no subsyndromal delirium) will be asked to provide consent for all research activities that occured in the ICU. If patients where cognition is regained (ie. no subsyndromal delirium or delirium) are not willing to provide consent then any study data collected from them while they were in the ICU will be destroyed and they will not be approached to participate in the post-ICU component of the study. This study also seeks to understand how the use of haloperidol in the ICU in patients with subsyndromal delirium may have affect memory, emotional status, happiness, ability to function, and quality of sleep in patients after they leave the ICU. Patients (that do not have delirium based on CAM screening at the time the 3-10 day and 6 month assessments are attempted) will be approached to participate in this post-ICU component of the study.

Methylphenidate, Rivastigmine or Haloperidol in Hypoactive Delirium in Intensive Care Patients [Terminated]
The purpose of this pilot-trial is the feasibility of a large randomized, placebo controlled, doubleblind clinical trial to investigate the use of methylphenidate, rivastigmine or haloperidol in hypoactive ICU-delirium. In addition we will compare duration of delirium, severity of delirium, length of ICU/hospital stay and side effects between the different interventions.

Haloperidol vs Olanzapine for the Management of ICU Delirium [Recruiting]
The purpose of this randomized clinical trial is to determine whether haloperidol is superior to olanzapine for the treatment of ICU acquired delirium. The hypothesis is that haloperidol is in fact superior to olanzapine in treating ICU acquired delirium and sustaining delirium free time.

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Reports of Suspected Haldol (Haloperidol) Side Effects

Somnolence (40),  Self Injurious Behaviour (38),  Fall (34),  Multiple Drug Overdose Intentional (34),  Sopor (29),  Psychotic Disorder (27),  Suicide Attempt (27),  Electrocardiogram QT Prolonged (21),  Extrapyramidal Disorder (21),  Death (20), more >>

PATIENT REVIEWS / RATINGS / COMMENTS

Haldol review by medical professional caring for 23 year old female patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		No Side Effects
		Treatment Info
Condition / reason:		psychotic out nof control patient
Dosage & duration:		5mg taken given on a prn basis for the period of given on a prn basis
Other conditions:		borderline personality disorder
Other drugs taken:		ativan,
		Reported Results
Benefits:		Was able to gain control after receiving the injection form of the medication.Was helpful in decreasing aggitation,psychosis,delusions.At the end of the required time in seclusion and after giving medication time to take effect patient was able to return to facility population without any further problems.Was able to maintain in a calm manner,much less aggitated and was able to meet to staff to discuss delional ideas.
Side effects:		Drownsy but no untoward effects.Patient was able to be put on routine dose of this medication after effectivness of medication was evaluated to help prevent further problems.When routine dosage was begun patient was given routine medications for any side effects.
Comments:		Patient became aggiatated,delusional and psychotic and needed to be medicated for safty of patient and others.Required seclusion for decrease stimuli for mediation to take effect.Patient was medicated and given the quiet of seclusion and was monitored for saftey.At the end of seclusion time was released and placed back into the facility mileu.