NCT00882518

Brief Summary

The primary objective of this study is to evaluate the efficacy of quetiapine fumarate extended-release (XR) used as mono-therapy, administered once daily, in the treatment of schizophrenic patient with acute episode.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
388

participants targeted

Target at P50-P75 for phase_3 schizophrenia

Timeline
Completed

Started Apr 2009

Shorter than P25 for phase_3 schizophrenia

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

April 14, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 16, 2009

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

May 15, 2012

Completed
Last Updated

May 15, 2012

Status Verified

April 1, 2012

Enrollment Period

1.2 years

First QC Date

April 14, 2009

Results QC Date

March 7, 2011

Last Update Submit

April 16, 2012

Conditions

Schizophrenia

Keywords

Quetiapine Fumarate (SEROQUEL) Extended-Release (XR)qualified PANSS assessment

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline of the Positive and Negative Syndrome Scale (PANSS) Total Score at the End of Treatment at Day 42

    6 weeks minus baseline.PANSS scale is a 30-item scale where each symptom is rated on a severity scale ranging from 1-7. Total scores range 30-210 from better to worse.

    Baseline and 6 weeks

Secondary Outcomes (8)

  • Change From Baseline in PANSS Positive Subscale Score at the End of Treatment at Day 42

    Baseline and 6 weeks

  • Change From Baseline in PANSS Negative Subscale Score at the End of Treatment at Day 42

    Baseline and 6 weeks

  • Change From Baseline in PANSS General Psychopathological Subscale Score at the End of Treatment at Day 42

    Baseline and 6 weeks

  • Change From Baseline in PANSS Aggression, Hostility Clusters Score at the End of Treatment at Day 42

    Baseline and 6 weeks

  • Change From Baseline in PANSS Depression Clusters Score at the End of Treatment at Day 42

    Baseline and 6 weeks

  • +3 more secondary outcomes

Study Arms (2)

1-Quetiapine Fumarate (SEROQUEL) Extended-Release (XR)

EXPERIMENTAL

Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) extended-release (300 mg/1st day, 600 mg/2nd day, 400 or 600 or 800 mg/3-42 day)

Drug: Quetiapine Fumarate (SEROQUEL) Extended-Release (XR)

2-Chlorpromazine

ACTIVE COMPARATOR

Chlorpromazine (50 or 100 mg/1st day; 100-200 mg/2nd day; 150-300 mg/3rd day; 200-400 mg/4th day; 300 or 400 or 500 or 600 mg/5-42 days)

Drug: Chlorpromazine

Interventions

Quetiapine Fumarate (SEROQUEL) Extended-Release (XR)DRUG

200 mg or 300 mg, oral, single dose

Also known as: Seroquel_XR (Quetiapine Fumarate XR)
1-Quetiapine Fumarate (SEROQUEL) Extended-Release (XR)
ChlorpromazineDRUG

50 mg, oral, double dose

2-Chlorpromazine

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Schizophrenia diagnosis
  • Provision of written informed consent before initiation of any study

You may not qualify if:

  • AIDS and hepatitis B
  • History of seizure disorder
  • Hospitalisation for schizophrenic more than 1 month immediately before enter into study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Research Site

Hunan, Changsha, China

Location

Research Site

Guangzhou, Guangdong, China

Location

Research Site

Baoding, Hebei, China

Location

Research Site

Harbin, Heilongjiang, China

Location

Research Site

Wuhan, Hubei, China

Location

Research Site

Changsha, Hunan, China

Location

Research Site

Nanjing, Jiangsu, China

Location

Research Site

Xi’an, Shanxi, China

Location

Research Site

Kunming, Yunnan, China

Location

Research Site

Beijing, China

Location

Research Site

Shanghai, China

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Quetiapine FumarateChlorpromazine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

DibenzothiazepinesThiazepinesThiepinsSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsPhenothiazines

Results Point of Contact

Title
Gerard Lynch
Organization
AstraZeneca
aztrial_results_posting@astrazeneca.com

Study Officials

  • Niufan Gu

    Shanghai Mental Health Center

    PRINCIPAL INVESTIGATOR

  • Michael Castiglione

    AstraZeneca

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2009

First Posted

April 16, 2009

Study Start

April 1, 2009

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

May 15, 2012

Results First Posted

May 15, 2012

Record last verified: 2012-04

Locations

CN(11)