SchizophreniaPhase 4QUENCHNCT00779506

Study of the Efficacy and Safety of Quetiapine Fumarate Extended Release (Seroquel XR)

A Phase 4 study testing Quetiapine Fumarate XR in people with Schizophrenia, run by AstraZeneca at 7 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is an 8-week, multi-centre, Open-label, non-comparative study to evaluate the efficacy and safety of Quetiapine XR with daily dose 400mg-800mg used as mono-therapy in the treatment of acute schizophrenic patients. The eligible patient will be assigned to study treatment with Quetiapine XR on Day 1. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Schizophrenia
What is being tested?: Quetiapine Fumarate XR
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 96 participants
Where: 7 sitesSouth Korea
Study dates: Nov 2008to Jul 2009
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Documented clinical diagnosis meeting the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria
PANSS total score of at least 70 at enrolment and at assignment Day 1
CGI Severity of Illness score of at least 4 (moderately ill) at enrolment and at assignment Day 1 and with worsening of the patient's condition during the 3 weeks

Who cannot join

Known intolerance or lack of response to quetiapine fumarate
Administration of a depot antipsychotic injection within one dosing interval (for the depot) before assignment
Substance or alcohol dependence at enrolment
Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by DSM-IV criteria within 4 weeks prior to enrolment

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

South Korea7 sites

Research site
Ansan, Gyeonggi-do
Research site
Bugok, Gyeongsangnam-do
Research site
Gwangju, Gyeonggi-do
Research site
Incheon
Research site
Masan, Gyeongsangnam-do
Research site
Pusan
Research site
Seoul

Other trials in South Korea

About this study

Official title: A 8-week, Multi-Centre, Open-label, Non-comparative, Phase IV Study of the Efficacy and Safety of Quetiapine Fumarate Extended Release (Seroquel XR) With Daily Dose 400mg-800mg in the Treatment of Acute Schizophrenic Patients

PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.

Conditions: Schizophrenia
Being tested: Quetiapine Fumarate XR
Keywords: Acute schizophrenia, PANSS
Medical subject headings: Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Quetiapine Fumarate XRDrug
Also called Seroquel XR
oral, once daily, flexible dose

Study groups in NCT00779506
Study group	Role	What they receive
Quetiapine Fumarate XR	Experimental	Seroquel XR 400-800mg Receives: Drug: Quetiapine Fumarate XR

What is being measured

The primary outcome is the main question the study is designed to answer.

The Change in Positive and Negative Syndrome Scale(PANSS)Total Score
PANSS, a 30-item scale where each symptom is rated on a severity scale ranging from 1 (absent) - 7 (extreme), total score is 30 - 210.
Description of the reporting Groups: Evaluate the efficacy of Quetiapine XR with daily dose 400 mg - 800 mg used as mono-therapy in the treatment of acute schizophrenic patients by evaluation of the change from baseline to Day 57 in total score of PANSS using the last observation carried forward (LOCF) method
Measured: From baseline to Day 57

Secondary outcomes (6)

Positive and Negative Syndrome Scale (PANSS) Positive Score
To evaluate the change of positive symptoms from baseline to Day 57 in PANSS positive score, a 7-item scale where eash symptom is rated on a severity scale ranging from 1 (absent) - 7 (extreme)
Measured: From baseline to Day 57
Positive and Negative Syndrome Scale (PANSS) Negative Score
To evaluate the change of negative symptoms from baseline to Day 57 in PANSS negative score, a 7-item scale where each symptom is rated on a severity scale ranging from 1 (absent) - 7 (extreme)
Measured: From baseline to Day 57
Positive and Negative Syndrome Scale (PANSS) General Psychopathology Score
To evaluate the change of general psychopathology symptoms from baseline to Day 57 in PANSS general score, a 16-item scale where each symptom is rated on a severity scale ranging from 1 (absent) to - 7 (extreme)
Measured: From baseline to Day 57
Clinical Global Impression (CGI) Score
The Clinical Global Impression - Severity (CGI-S) and - illness (CGI-I) is used in this study. The CGI-S is scored to rate the patient's current clinical state. The CGI-I is scored to rate the patient's change from baseline CGI. Each CGI item is scored on a scale from 1 to 7 (CGI-S: 1 = Normal, not ill, 7= Among the most extremely ill patients/ CGI-I: 1= very much improved, 7= very much worse). CGI-I scores greater than 4 indicate worsening, while scores less than 4 indicate improvement
Measured: From baseline to Day 57
Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
To treat depressive symptoms in acute schizophrenic patients by evaluation of the change from baseline to day 67 in MADRS total score, a 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0-6 scale, higher MADRS scores indicate higher levels of depressive symptoms.
Measured: From baseline to Day 57
Global Assessment of Functioning (GAF) Score
To improve functional capability in acute schizophrenic patients by evaluation of the change from baseline to Day 57 in GAF scale score, a single-item rating scale for evaluating the overall functioning on a continuum from psychologic or psychiatric sickness to health.
Measured: From baseline to Day 57

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2008Jul 2009

First posted24 Oct 2008 (estimated)
Study startNov 2008
Primary completionJul 2009
Study completionJul 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for SchizophreniaStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 96 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00779506
Sponsor's protocol ID: D1443L00062
Acronym: QUENCH
Status last verified: May 2010
First submitted: 22 Oct 2008
Last updated: 23 Nov 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Schizophrenia trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 8-week, Multi-Centre, Open-label, Non-comparative, Phase IV Study of the Efficacy and Safety of Quetiapine Fumarate Extended Release (Seroquel XR) With Daily Dose 400mg-800mg in the Treatment of Acute Schizophrenic Patients
ClinicalTrials.gov ID: NCT00779506
Acronym / sponsor ID: QUENCH / D1443L00062
Conditions: Schizophrenia
Keywords: Acute schizophrenia, PANSS
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 96 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Nov 2008
Primary completion: Jul 2009 (actual)
Study completion: Jul 2009 (actual)
First posted: 24 Oct 2008 (estimated)
Results: Posted 23 Nov 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Quetiapine Fumarate XR	Experimental	Drug: Quetiapine Fumarate XRSeroquel XR 400-800mg

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Documented clinical diagnosis meeting the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria
PANSS total score of at least 70 at enrolment and at assignment Day 1
CGI Severity of Illness score of at least 4 (moderately ill) at enrolment and at assignment Day 1 and with worsening of the patient's condition during the 3 weeks

Key exclusion criteria (4 listed)

Known intolerance or lack of response to quetiapine fumarate
Administration of a depot antipsychotic injection within one dosing interval (for the depot) before assignment
Substance or alcohol dependence at enrolment
Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by DSM-IV criteria within 4 weeks prior to enrolment

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Quetiapine Fumarate XRAlso: Seroquel XRoral, once daily, flexible dose	Drug	Quetiapine Fumarate XR

Primary outcome

The Change in Positive and Negative Syndrome Scale(PANSS)Total Score
Time frame: From baseline to Day 57
PANSS, a 30-item scale where each symptom is rated on a severity scale ranging from 1 (absent) - 7 (extreme), total score is 30 - 210. Description of the reporting Groups: Evaluate the efficacy of Quetiapine XR with daily dose 400 mg - 800 mg used as mono-therapy in the treatment of acute schizophrenic patients by evaluation of the change from baseline to Day 57 in total score of PANSS using the last observation carried forward (LOCF) method

6 secondary outcomes

Positive and Negative Syndrome Scale (PANSS) Positive Score
Time frame: From baseline to Day 57
Positive and Negative Syndrome Scale (PANSS) Negative Score
Time frame: From baseline to Day 57
Positive and Negative Syndrome Scale (PANSS) General Psychopathology Score
Time frame: From baseline to Day 57
Clinical Global Impression (CGI) Score
Time frame: From baseline to Day 57
Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Time frame: From baseline to Day 57
Global Assessment of Functioning (GAF) Score
Time frame: From baseline to Day 57

Results and safety

Results posted to the registry on 23 Nov 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Quetiapine XR	96	67

Primary outcome: The Change in Positive and Negative Syndrome Scale(PANSS)Total Score

Time frame: From baseline to Day 57. Mean (Standard Deviation). Unit: score on a scale

Measure	Quetiapine XR n = 89
Value	-26.8 (4.2)

Population analysed: The MITT set was used for primary analyses (89) participants

6 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Quetiapine XR	0 of 94 (0%)	94 of 94 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Treatment Resistant Disorders
Not yet recruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

YounHoon Kim principal investigator

Inje University

7 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Quetiapine Fumarate XR in people with Schizophrenia, run by AstraZeneca at 7 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Nov 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Change in Positive and Negative Syndrome Scale(PANSS)Total Score (time frame: From baseline to Day 57). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00779506.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2011.