Quetiapine Extended Release (XR) for the Management of Psychotic Aggression or Agitation in Adult Acute Psychiatry

NCT00986167 | Unknown Phase 4 DMC

• 1 other identifier: D1443C00043
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Schizophrenia; Psychosis

Keywords

Psychosis; Aggression; Acute; Quetiapine XR

Outcome Measures

Primary Outcomes (1)

• The primary efficacy variable is the change in aggression between admission and day 8 of treatment with Quetiapine XR as measured by the OAS.

  Daily from baseline to day 8

Secondary Outcomes (3)

• Measuring psychotic symptomatology change from baseline in BPRS-Total Score in aggressive, psychotic patients managed with Quetiapine XR

  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

  Baseline, day 3, 4, 5, 7, 8

• Measuring the incidence of concomitant benzodiazepine and other permitted medication use

  Daily

Study Arms (1)

Quetiapine XR

EXPERIMENTAL

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

Interventions

Quetiapine XR DRUG

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.

Also known as: Seroquel XR

Quetiapine XR

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or Females aged 18-65 years;
• Determined by a psychiatrist to be experiencing acute psychotic symptoms (includes mania with psychotic features and drug-induced psychosis);
• Determined by a psychiatrist to have acted aggressively (score of \> 1 on the OAS);
• Inpatient status at enrollment;
• Patient agreement to take oral medication;
• Provision of written informed consent when considered able to provide consent by the treating team;
• Female patients of childbearing potential must be using a reliable method of contraception and have a negative urine human chorionic gonadotropin (HCG) test at enrollment.

You may not qualify if:

• Pregnancy or lactation;
• Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others;
• Known intolerance or lack of response to quetiapine fumarate or any other atypical psychotics, as judged by the investigator;
• Use of any of the following cytochrome P450 3A4 inhibitors in the 14 days preceding enrolment including but not limited to: ketoconazole, itraconazole, fluconazole, erythromycin, clarithromycin, troleandomycin, indinavir, nelfinavir, ritonavir, fluvoxamine and saquinavir;
• Use of any of the following cytochrome P450 inducers in the 14 days preceding enrolment including but not limited to: phenytoin, carbamazepine, barbiturates, rifampin, St. John's Wort, and glucocorticoids;
• Administration of a depot antipsychotic injection within one dosing interval (for the depot) prior to being recruited for the trial;
• Patients receiving treatment with an antipsychotic other than Seroquel XR (either IM or oral) within one dosing interval prior to being recruited for the trial;
• Patients receiving treatment with mood stabiliser or anti-depressant medication within 7 days prior to treatment with Seroquel XR;
• Substance or alcohol abuse or dependence at enrolment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by DSM-IV criteria;
• Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment;
• Unstable or inadequately treated renal, hepatic, cardiovascular, respiratory, cerebrovascular, or other serious progressive physical disease as judged by the investigator;
• Involvement in the planning and conduct of the study;
• Previous enrolment in the present study;
• Participation in another drug trial within 4 weeks prior enrolment into this study or longer in accordance with local requirements;
• A patient with Diabetes Mellitus (DM) fulfilling one of the following criteria:

Sponsors & Collaborators

• Bayside Health: lead
• AstraZeneca: collaborator

Study Sites (2)

St Vincent's Hospital, Melbourne

Fitzroy, Victoria, 3065, Australia

Location

Alfred Psychiatry Research Centre

Melbourne, Victoria, 3004, Australia

Location

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders; Aggression

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior; Social Behavior

Study Officials

• Jayashri Kulkarni, Prof

  Alfred Psychiatry Research Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: September 11, 2009
• First Posted: September 29, 2009
• Study Start: October 1, 2009
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: September 29, 2009

Record last verified: 2009-09

Locations

AU (2)