Efficacy and Safety of SEROQUEL Extended Release (XR) in Acute Schizophrenia

NCT00954122 | Completed Phase 4 Results

• 1 other identifier: D1443L00074
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of the study is to determine whether treatment with quetiapine XR (Seroquel XR) tablets for 3 weeks will improve their agitation when they have acute psychosis.

Conditions

Schizophrenia

Keywords

Acute schizophrenia

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Positive and Negative Syndrome Scale Excited Component (PANSS-EC) Score

  PANSS- Excited Component (EC) subscale score will be calculated by adding together the following item scores: excitement (positive subscale item 4); hostility (positive subscale item 7); tension (general subscale item 4); uncooperativeness (general subscale item 8); poor impulse control (general subscale item 14). This is rated on a 7-point Likert scale from 'absent' to 'extremely severe' (score range 5 to 35 points; mean scores = 20 points clinically corresponds to severe agitation). Lower value gives the better outcome.

  Baseline and Day 21

Secondary Outcomes (6)

• Change From Baseline to Final Visit at Day 21 in PANSS Positive, General Psychopathological Scores.

  Baseline and Day 21

• Change From Baseline to Final Visit at Day 21 in PANSS Negative, General Psychopathological Scores

  Baseline and Day 21

• Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score

  Baseline and Day 21

• Change From Baseline in Clinical Global Impression-Severity Scale (CGI-S)

  Baseline and Day 21

• Change From Baseline in Absolute Clinical Global Impression-Improvement (CGI-I) Scale

  Baseline and Day 21

Study Arms (1)

Quetiapine XR

EXPERIMENTAL

Quetiapine XR 300 mg on day 1, 600 mg on day 2, and 400-800 mg (at investigator's discretion) on day 3 and onwards.

Drug: Quetiapine XR (Seroquel XR)

Interventions

Quetiapine XR (Seroquel XR) DRUG

Tablet, oral, once daily

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:

• Requirement for treatment of acute episode of schizophrenia (according to DSM-IV diagnostic criteria)
• PANSS total score of ³ 75
• CGI \> 4

You may not qualify if:

• Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others
• Substance or alcohol dependence at enrollment

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (2)

Research Site

Johor Bahru, Johor Bahru, Malaysia

Location

Research Site

Kuala Lumpur, Malaysia

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Results Point of Contact

• Title: Gerard Lynch
• Organization: AstraZeneca

clinicaltrialtransparency@astrazeneca.com

4415 09645895

Study Officials

• Ahmad Hatim Sulaiman,, M Psyc

  University of Malaya

  PRINCIPAL INVESTIGATOR

• Badiah Yahya, MD

  Hospital Permai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2009
• First Posted: August 7, 2009
• Study Start: September 1, 2009
• Primary Completion: March 1, 2010
• Study Completion: April 1, 2010
• Last Updated: January 8, 2013
• Results First Posted: January 8, 2013

Record last verified: 2013-01

Locations

MY (2)