SchizophreniaPhase 3NCT00852631

Seroquel XR in Adults With Schizophrenia

A Phase 3 study testing Quetiapine fumarate (Seroquel) in people with Schizophrenia, run by AstraZeneca at 3 sites in Thailand.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

The purpose of this study is to evaluate the efficacy of Seroquel XR in schizophrenia patients with acute worsening symptoms. Consequently, to assess whether the study drug is safe and acceptable on the daily dose basis, orally given, up to 600 mg once a day for 42 days. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Schizophrenia
What is being tested?: Quetiapine fumarate (Seroquel)
Type of treatment: Pill or oral medicine
How many people: 28 participants
Where: 3 sitesThailand
Study dates: Feb 2009to May 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
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Patient meets the DSM-IV criteria for schizophrenia
Patient has a PANSS total score ≥ 70 at baseline
Patient has a CGI-S score of ≥ 4(moderately ill) at baseline
Patient is healthy on the basis of physical examination and vital signs at baseline

Who cannot join

Positive urine drug screen for Opiates, amphetamine, barbiturate, cocaine, cannabis, or ecstasy abuse
Has history of neuroleptic malignant syndrome, seropositive for anti-HIV, hepatitis B or C virus antigen
Patient with unstable or inadequately treated Diabetes Mellitus
Use of potent cytochrome P450 inhibitors or inducer within 14 days before baseline

Trial locations and contacts

3 sites in 1 country.

Thailand3 sites

Research Site
Bangkok
Research Site
Chiang Mai
Research Site
Songkhla

Other trials in Thailand

About this study

Official title: Open-label Multicentre Study on Efficacy and Safety of Oral Quetiapine (Seroquel XR) in Adults With Schizophrenia

Conditions: Schizophrenia
Being tested: Quetiapine fumarate (Seroquel)
Keywords: Quetiapine efficacy in schizophrenia
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)Drug
Also called Seroquel XR
600mg Extended release tablet, oral, once daily

What is being measured

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

Change in Positive and Negative Syndrome Scale (PANSS) Total Score
Change in Positive and Negative Syndrome Scale Total Score from Day 1 (baseline) to Day 42 (final visit) or withdrawal. Minimum value of total PANSS is 30 , Maximum is 210.
Minimum value considered better is score decreased from baseline at least 30%.
Measured: From Day 1 (baseline) to Day 42

Secondary outcomes (2)

Change in Clinical Global Impression - Severity of Illness (CGI-S) Score
Clinical Global Impression - Severity of Illness. Maximum possible value is 7 (worst outcome), the minimum is 1 (best outcome). Values are considered better outcome: decrease from baseline > 1 score.
Measured: From Day 1 (Baseline) to Day 42
Clinical Global Impression - Severity of Illness (CGI-S) Score
Clinical Global Impression - Severity of Illness. Maximum possible value is 7 (worst outcome), the minimum is 1 (best outcome). Values are considered better outcome: decrease from baseline > 1 score.
Measured: Day 14

Timeline

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

Feb 2009May 2010

First posted27 Feb 2009 (estimated)
Study startFeb 2009
Primary completionMay 2010
Study completionMay 2010

Why it stopped: The study was prematurely terminated due to insufficient recruitment.

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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00852631
Sponsor's protocol ID: D1443L00060
Status last verified: May 2012
First submitted: 26 Feb 2009
Last updated: 17 Jul 2012
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

RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Deep Brain Stimulation for Treatment-Resistant Schizophrenia
Treatment Resistant Disorders
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion

All Schizophrenia trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Open-label Multicentre Study on Efficacy and Safety of Oral Quetiapine (Seroquel XR) in Adults With Schizophrenia
ClinicalTrials.gov ID: NCT00852631
Acronym / sponsor ID: D1443L00060
Conditions: Schizophrenia
Keywords: Quetiapine efficacy in schizophrenia
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: The study was prematurely terminated due to insufficient recruitment.
Enrolment: 28 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Feb 2009
Primary completion: May 2010 (actual)
Study completion: May 2010 (actual)
First posted: 27 Feb 2009 (estimated)
Results: Posted 17 Jul 2012

Clinical summary

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

Study design

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

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Patient meets the DSM-IV criteria for schizophrenia
Patient has a PANSS total score ≥ 70 at baseline
Patient has a CGI-S score of ≥ 4(moderately ill) at baseline
Patient is healthy on the basis of physical examination and vital signs at baseline

Key exclusion criteria (4 listed)

Positive urine drug screen for Opiates, amphetamine, barbiturate, cocaine, cannabis, or ecstasy abuse
Has history of neuroleptic malignant syndrome, seropositive for anti-HIV, hepatitis B or C virus antigen
Patient with unstable or inadequately treated Diabetes Mellitus
Use of potent cytochrome P450 inhibitors or inducer within 14 days before baseline

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)Also: Seroquel XR600mg Extended release tablet, oral, once daily	Drug	–

Primary outcome

Change in Positive and Negative Syndrome Scale (PANSS) Total Score
Time frame: From Day 1 (baseline) to Day 42
Change in Positive and Negative Syndrome Scale Total Score from Day 1 (baseline) to Day 42 (final visit) or withdrawal. Minimum value of total PANSS is 30 , Maximum is 210. Minimum value considered better is score decreased from baseline at least 30%.

2 secondary outcomes

Change in Clinical Global Impression - Severity of Illness (CGI-S) Score
Time frame: From Day 1 (Baseline) to Day 42
Clinical Global Impression - Severity of Illness (CGI-S) Score
Time frame: Day 14

Results and safety

Results posted to the registry on 17 Jul 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Seroquel XR	28	17

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

Time frame: From Day 1 (baseline) to Day 42. Mean (Standard Deviation). Unit: Scores on a scale

Measure	Seroquel XR n = 28
Day 1 (Baseline) (n= 28)	85.3 (28.8)
Day 42 (n= 17)	48.5 (28.6)

Population analysed: The number of patient at Day 42 (n= 17) is different than at Baseline (n= 28), because some of them withdraw/terminate during the study.

2 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
Seroquel XR	1 of 28 (3.6%)	14 of 28 (50%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Schizophrenia

RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Deep Brain Stimulation for Treatment-Resistant Schizophrenia
Treatment Resistant Disorders
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion

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.

Thawatchai Leelahanaj, MD principal investigator

Phramongkutklao Hospital, Bangkok, Thailand

3 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) in people with Schizophrenia, run by AstraZeneca at 3 sites in Thailand.

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 4 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: stopped early, as of the sponsor's last update on 17 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Thailand. 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 17 Jul 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 in Positive and Negative Syndrome Scale (PANSS) Total Score (time frame: From Day 1 (baseline) to Day 42). 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 NCT00852631.

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 17 Jul 2012.