Schizophrenia Clinical Trial
Official title:
Determining the Efficacy and Tolerance of Quetiapine Extended Release (XR) for the Management of Psychotic Aggression or Agitation in Adult Acute Psychiatry
This study is a multi-site study examining the use of Quetiapine XR for psychotic aggression in an acute psychiatric setting. The study aims to demonstrate that management with Quetiapine XR significantly reduces aggressive behaviour in acute patients with psychosis, significantly reduces psychotic symptoms and decreases the requirement for sedation using benzodiazepines.
Aggression is a common occurrence in acute psychiatry as the experience of schizophrenia or
related psychotic symptoms significantly increases the risk of aggressive behaviour. This can
have detrimental effects on the provision of therapy and safety for staff and other patients.
Current practice in managing aggression in acute psychiatry often involves the addition of a
sedating antipsychotic or benzodiazepine to a main atypical antipsychotic that is continued
as a primary treatment.
Quetiapine IR (immediate release) has been found effective in the treatment and management of
schizophrenia. Quetiapine acts in the brain on cell receptors to which serotonin (a chemical
produced in the brain) binds. Serotonin is proposed to play a significant role in impulsive
aggression. Additionally, sedation is a side effect of Quetiapine, which may also facilitate
its use in aggression. However, Quetiapine is not commonly used in the management of
aggression in acute psychiatry due to the amount of time required to achieve an optimal dose
(up to 5 days).
Quetiapine XR (extended release) is an extended release formulation of Quetiapine that can be
initiated at a higher dose, a therapeutic dose can be achieved more rapidly and is taken once
per day instead of twice.
This study is a multi-site study examining the use of Quetiapine XR for psychotic aggression
in an acute psychiatric setting. The study aims to demonstrate that management with
Quetiapine XR significantly reduces aggressive behaviour in acute patients with psychosis,
significantly reduces psychotic symptoms and decreases the requirement for sedation using
benzodiazepines.
The participants will be in-patients experiencing psychotic aggression (determined by
psychiatrist). For those patients experiencing aggression (which is not severe enough to
require intramuscular injection), the treating clinician will make a decision whether or not
to treat with Quetiapine XR. Those patients meeting inclusion/exclusion criteria will be
observed over 8 days using measures that rate symptoms, aggression and possible side effects
(these include observation, questionnaire and review of patient files).
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