SchizophreniaPhase 3ESPRITNCT00882518
Efficacy and Safety of Quetiapine Fumarate in the Treatment of Schizophrenic Patients
A Phase 3 study testing Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) and Chlorpromazine in people with Schizophrenia, run by AstraZeneca at 11 sites in China.
Trial 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. 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 (SEROQUEL) Extended-Release (XR) and Chlorpromazine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 388 participants
- Where
- 11 sitesChina
- Study dates
- Apr 2009to Jul 2010
- Phase
- Phase 3
- 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
- Schizophrenia diagnosis
- Provision of written informed consent before initiation of any study
Who cannot join
- AIDS and hepatitis B
- History of seizure disorder
- Hospitalisation for schizophrenic more than 1 month immediately before enter into study
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
China11 sites
Research Site
Baoding, Hebei
Research Site
Beijing
Research Site
Changsha, Hunan
Research Site
Guangzhou, Guangdong
Research Site
Harbin, Heilongjiang
Research Site
Hunan, Changsha
Research Site
Kunming, Yunnan
Research Site
Nanjing, Jiangsu
Research Site
Shanghai
Research Site
Wuhan, Hubei
Research Site
Xi’an, Shanxi
About this study
Official title: A 6-Week, Multi-centre, Double-blind, Double-dummy, Chlorpromazine-Controlled Randomised Study to Evaluate the Efficacy and Safety of Quetiapine Fumarate Extended-Release in the Treatment of Schizophrenic Patients With Acute Episode
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.
- Conditions
- Schizophrenia
- Being tested
- Quetiapine Fumarate (SEROQUEL) Extended-Release (XR), Chlorpromazine
- Keywords
- Quetiapine Fumarate (SEROQUEL) Extended-Release (XR), qualified PANSS assessment
- 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 (SEROQUEL) Extended-Release (XR)Drug
Also called Seroquel_XR (Quetiapine Fumarate XR)
200 mg or 300 mg, oral, single dose
ChlorpromazineDrug
50 mg, oral, double dose
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Drug: Chlorpromazine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 6 weeks
Secondary outcomes (8)
Change From Baseline in PANSS Positive Subscale 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. 1 =Absent ,2 =Minimal, 3 =Mild, 4 =Moderate, 5 =Moderate severe, 6 =Severe, 7= Extreme The PANSS positive subscale score is the sum of the 7 positive item scores (ie, delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution and hostility) and ranges from 7 to 49. A negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.
Measured: Baseline and 6 weeks
Change From Baseline in PANSS Negative Subscale 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. 1 =Absent ,2 =Minimal, 3 =Mild, 4 =Moderate, 5 =Moderate severe, 6 =Severe, 7= Extreme The PANSS negative subscale score is the sum of the 7 item scores (blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking), ranges from 7 to 49. A negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.
Measured: Baseline and 6 weeks
Change From Baseline in PANSS General Psychopathological Subscale Score at the End of Treatment at Day 42
The PANSS psychopathological subscale score is the sum of 16 item scores(somatic concern, anxiety, guilt feelings, tension, mannerisms and posturing, depression, motor retardation, uncooperativeness, unusual thought content, disorientation, poor attention, lack of judgment and insight, disturbance of volition, poor impulse control, preoccupation, active social avoidance), ranges from 16 to 112. A negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.
Measured: Baseline and 6 weeks
Change From Baseline in PANSS Aggression, Hostility Clusters 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 (better to worse).
1 =Absent ,2 =Minimal, 3 =Mild, 4 =Moderate, 5 =Moderate severe, 6 =Severe, 7= Extreme
Measured: Baseline and 6 weeks
Change From Baseline in PANSS Depression Clusters 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 (better to worse).
1 =Absent ,2 =Minimal, 3 =Mild, 4 =Moderate, 5 =Moderate severe, 6 =Severe, 7= Extreme
Measured: Baseline and 6 weeks
Number of Patients Achieving a Reduction of at Least 30% From Baseline 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 (better to worse).Total scores range 30-210 from better to worse.
1 =Absent,2 =Minimal, 3 =Mild, 4 =Moderate, 5 =Moderate severe, 6 =Severe, 7= Extreme.
Measured: Baseline and 6 weeks
Percentage of Patients With Clinical Global Impression (CGI) Global Improvement Rating Less Than or Equal to 3 at the End of Treatment at Day 42
6 weeks minus baseline. The number of patients with CGI Global Improvement (CGI-I) rating at least "minimally improved" at the end of treatment at Day 42 was counted, and then got the proportion among all the patients.CGI-I is scored to rate the patient's change from baseline CGI on a seven-point scale (1="Very much improved", 7="Very much worse".)
Measured: Baseline and 6 weeks
Change in the CGI Severity of Illness Score From Baseline at the End of Treatment at Day 42
6 weeks minus baseline The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale rating the severity of the patient's illness. The patient is assessed on severity of mental illness at the time of rating 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill.
Measured: Baseline and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionJul 2010
- Study completionJul 2010
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 388 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Niufan Gu, Principal investigator, Shanghai Mental Health CenterMichael Castiglione, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00882518
- Sponsor's protocol ID
- D1444C00008
- Acronym
- ESPRIT
- Status last verified
- Apr 2012
- First submitted
- 14 Apr 2009
- Last updated
- 15 May 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 6-Week, Multi-centre, Double-blind, Double-dummy, Chlorpromazine-Controlled Randomised Study to Evaluate the Efficacy and Safety of Quetiapine Fumarate Extended-Release in the Treatment of Schizophrenic Patients With Acute Episode
- ClinicalTrials.gov ID
- NCT00882518
- Acronym / sponsor ID
- ESPRIT / D1444C00008
- Conditions
- Schizophrenia
- Keywords
- Quetiapine Fumarate (SEROQUEL) Extended-Release (XR), qualified PANSS assessment
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 388 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 16 Apr 2009 (estimated)
- Results
- Posted 15 May 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1-Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) | Experimental | Drug: Quetiapine Fumarate (SEROQUEL) Extended-Release (XR)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) |
| 2-Chlorpromazine | Active comparator | Drug: ChlorpromazineChlorpromazine (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) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Schizophrenia diagnosis
- Provision of written informed consent before initiation of any study
Key exclusion criteria (3 listed)
- AIDS and hepatitis B
- History of seizure disorder
- Hospitalisation for schizophrenic more than 1 month immediately before enter into study
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 (SEROQUEL) Extended-Release (XR)Also: Seroquel_XR (Quetiapine Fumarate XR)200 mg or 300 mg, oral, single dose | Drug | 1-Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) |
| Chlorpromazine50 mg, oral, double dose | Drug | 2-Chlorpromazine |
Primary outcome
Change From Baseline of the Positive and Negative Syndrome Scale (PANSS) Total Score at the End of Treatment at Day 42
Time frame: Baseline and 6 weeks
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.
8 secondary outcomes
Change From Baseline in PANSS Positive Subscale Score at the End of Treatment at Day 42
Time frame: Baseline and 6 weeks
Change From Baseline in PANSS Negative Subscale Score at the End of Treatment at Day 42
Time frame: Baseline and 6 weeks
Change From Baseline in PANSS General Psychopathological Subscale Score at the End of Treatment at Day 42
Time frame: Baseline and 6 weeks
Change From Baseline in PANSS Aggression, Hostility Clusters Score at the End of Treatment at Day 42
Time frame: Baseline and 6 weeks
Change From Baseline in PANSS Depression Clusters Score at the End of Treatment at Day 42
Time frame: Baseline and 6 weeks
Number of Patients Achieving a Reduction of at Least 30% From Baseline PANSS Total Score at the End of Treatment at Day 42
Time frame: Baseline and 6 weeks
Percentage of Patients With Clinical Global Impression (CGI) Global Improvement Rating Less Than or Equal to 3 at the End of Treatment at Day 42
Time frame: Baseline and 6 weeks
Change in the CGI Severity of Illness Score From Baseline at the End of Treatment at Day 42
Time frame: Baseline and 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Niufan Gu principal investigator
Shanghai Mental Health Center
Michael Castiglione study director
AstraZeneca
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) and Chlorpromazine in people with Schizophrenia, run by AstraZeneca at 11 sites in China.
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 2 inclusion and 3 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 15 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in China. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 15 May 2012). 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?
Change From Baseline of the Positive and Negative Syndrome Scale (PANSS) Total Score at the End of Treatment at Day 42 (time frame: Baseline and 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 May 2012.