Quetiapine Extended Release (XR) for the Management of Psychotic Aggression or Agitation in Adult Acute Psychiatry
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00986167|
Recruitment Status : Unknown
Verified September 2009 by Bayside Health.
Recruitment status was: Not yet recruiting
First Posted : September 29, 2009
Last Update Posted : September 29, 2009
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia Psychosis||Drug: Quetiapine XR||Phase 4|
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).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||72 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Determining the Efficacy and Tolerance of Quetiapine Extended Release (XR) for the Management of Psychotic Aggression or Agitation in Adult Acute Psychiatry|
|Study Start Date :||October 2009|
|Estimated Primary Completion Date :||October 2010|
|Estimated Study Completion Date :||October 2010|
Experimental: Quetiapine XR
The study population will be patients admitted to the acute psychiatry inpatient wards of St Vincent's or the Alfred and determined by a Psychiatrist to be experiencing a psychotic illness (including mania with psychotic features and drug-induced psychosis) and acting in an aggressive manner (determined by a score of at least 1 on the OAS).
Drug: Quetiapine XR
The daily dose of oral Quetiapine XR at the start of therapy is 300 mg on Day 1, 600 mg on Day 2 and up to 800 mg after Day 2. The dose will be adjusted within the usual effective dose range of 400 to 800 mg/day, depending on the clinical response and tolerability of the individual patient.
Other Name: Seroquel XR
- The primary efficacy variable is the change in aggression between admission and day 8 of treatment with Quetiapine XR as measured by the OAS. [ Time Frame: Daily from baseline to day 8 ]
- Measuring psychotic symptomatology change from baseline in BPRS-Total Score in aggressive, psychotic patients managed with Quetiapine XR [ Time Frame: Baseline, day 4, day 8 ]
- Measuring the incidence of adverse events (including Extrapyramidal symptoms) by the change from baseline in SAS and BAS and subjective reports [ Time Frame: Baseline, day 3, 4, 5, 7, 8 ]
- Measuring the incidence of concomitant benzodiazepine and other permitted medication use [ Time Frame: Daily ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00986167
|St Vincent's Hospital, Melbourne||Not yet recruiting|
|Fitzroy, Victoria, Australia, 3065|
|Contact: David Castle +61 3 92884711 David.CASTLE@svhm.org.au|
|Contact: Peter Bosanac +61 3 92884329 Peter.BOSANAC@svhm.org.au|
|Principal Investigator: David Castle, Prof|
|Alfred Psychiatry Research Centre||Not yet recruiting|
|Melbourne, Victoria, Australia, 3004|
|Contact: Jayashri Kulkarni, Prof. +61 3 90766564 email@example.com|
|Contact: Anthony de Castella +61 3 90766564 firstname.lastname@example.org|
|Principal Investigator: Jayashri Kulkarni, Prof|
|Principal Investigator:||Jayashri Kulkarni, Prof||Alfred Psychiatry Research Centre|