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Haloperidol clinical trials

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NCT ID: NCT04833023 Recruiting - Advanced Cancer Clinical Trials

HALO Trial: Haloperidol vs Olanzapine in Hyperactive Delirium in Palliative Care Patients; A Multi-Centre, Randomised-Controlled Trial

Start date: May 18, 2022
Phase: Phase 3
Study type: Interventional

1. Background and Clinical Need: Delirium is common at the end of life and is challenging to control. There is a clinical need to study the benefits of commonly used drugs like Haloperidol and Olanzapine in the management of hyperactive delirium in advanced cancer or end-stage organ disease patients in a scientifically robust manner. 2. Aims/Hypotheses: The investigators aim to study the effectiveness of Haloperidol compared with Olanzapine in the management of hyperactive delirium in advanced cancer or end-stage organ disease patients receiving palliative care. The investigators hypothesise that Olanzapine is as effective as Haloperidol in the control of hyperactive delirium. 3. Methods: The investigators will conduct a pragmatic, multi-centre, (hospital, inpatient hospice, community hospital) open-label randomised-controlled trial comparing the use of Haloperidol versus Olanzapine in advanced cancer or end-stage organ disease patients with hyperactive delirium. The primary outcome is the change in Richmond Agitation and Sedation Scale (RASS) scores among patients in each treatment group at 8 hours post-drug administration. The secondary outcome is the control of hyperactive delirium at 24, 48 and 72 hours using either Haloperidol or Olanzapine. The mean doses of Haloperidol and Olanzapine used as well as the volume of rescue Midazolam required as well as side-effects of the study medications, survival after enrolment into study will also be studied. 4. Significance to palliative care The results of this study will advance the knowledge of delirium management worldwide with regards to the efficacy of Haloperidol and Olanzapine in managing hyperactive delirium in patients with advanced cancer or end-stage organ disease. Haloperidol is used traditionally in palliative care for managing delirium. However, as a conventional anti-psychotic, it does cause extra-pyramidal side-effects. Olanzapine, a newer atypical anti-psychotic with a more favourable side-effect profile is being used increasingly in the control of delirium. These 2 commonly used drugs have never been compared head to head in a randomised-controlled, multi-centre study.

NCT ID: NCT03754062 Completed - Placebo Clinical Trials

Pharmacological Modulation of Belief Salience

MOBS
Start date: June 1, 2017
Phase: Phase 1
Study type: Interventional

To provide an initial test of the hypothesis that dopamine mediates the motivational salience of stimuli beyond simple stimulus-reinforcement associations, the researchers propose to undertake a study of the modulation of a) levels of agreement or disagreement with; b) the perceived self- relevance; and c) the perceived interest of propositions expressing beliefs and values in healthy male volunteers using Ii) a dopamine antagonist (the D2-blocker haloperidol), and (ii) a dopamine precursor L-Dopa to increase CNS dopamine transmission. The researchers will also administer the Salience Attribution Task (SAT) which will allow researchers to assess reward-learning processing of simple stimuli using a reaction-time game. This task was utilised by Roiser et al in order to explore whether delusions in medicated patients with schizophrenia were related to impairments in associative learning. The authors hypothesised that associative learning was influenced by D2 receptor blockade. The researchers extend this approach to examine the effect of dopamine modulation on the SAT as a measure of associative learning, a basic neuropsychological process that may be involved in the attribution of salience to beliefs. Finally, the researchers will ask participants to perform a within-subjects dictator game to understand the influence of dopaminergic manipulation of the live attribution of harm intention to partners. The task has been previously validated online. Participants will play against 3 partners in a random order in each drug condition. Each partner will play the participant for 6 trials. One partner will always be fair, one will always be unfair, and one will be 50% unfair. We aim to understand whether potentiating dopamine has an additive effect on the harm intention attributions toward partners, regardless of the behaviour of the partner.