SchizophreniaPhase 4SCORENCT00255515
Seroquel® Combined With Cognitive Remediation Therapy to Conventional Treatment in Patients With Schizophrenia
A Phase 4 study testing Quetiapine fumarate and conventional treatment for schizophrenia in people with Schizophrenia, run by AstraZeneca at 15 sites in Sweden.
Trial summary
The purpose of this study is to compare efficacy of quetiapine fumarate combined with Cognitive Remediation Therapy (CRT) to conventional treatment by evaluating change in social outcome in patients with schizophrenia. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Quetiapine fumarate and conventional treatment for schizophrenia
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 15 sitesSweden
- Study dates
- Sep 2005to Dec 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Signed informed consent
- Documented clinical diagnosis of schizophrenia or schizoaffective disorder for at least 2 years.
- Clinically stable and in an outpatient setting before entering the study (visit 1).
Who cannot join
- Use of clozapine and quetiapine within two months prior to visit 1.
- If total points are ≤ 55 Intelligence quotient (IQ) according to score of WAIS-III test at visit 1.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Sweden15 sites
Research Site
Eskilstuna
Research Site
Gothenburg
Research Site
Hisingsbacka
Research Site
Huddinge
Research Site
Jönköping
Research Site
Lidingö
Research Site
Limhamn
Research Site
Lund
Research Site
Malmö
Research Site
Norsborg
Research Site
Nyköping
Research Site
Stockholm
Research Site
Trollhättan
Research Site
Umeå
Research Site
Västerås
About this study
Official title: An Open, Randomised, Parallel, Three Treatment Groups, Multicentre, Phase IV Study - in Real Life - to Compare the Change in Social Outcome of Quetiapine Fumarate (Seroquel®) Combined With Cognitive Remediation Therapy to Conventional Treatment in Patients With Schizophrenia.
The purpose of this study is to compare efficacy of quetiapine fumarate combined with Cognitive Remediation Therapy (CRT) to conventional treatment by evaluating change in social outcome in patients with schizophrenia.
- Conditions
- Schizophrenia
- Being tested
- Quetiapine fumarate, conventional treatment for 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 fumarateDrug
Also called Seroquel
oral
conventional treatment for schizophreniaDrug
various standard therapies
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | quetiapine fumarate Receives: Drug: Quetiapine fumarate |
| 2 | Active comparator | Conventional treatment for schizophrenia Receives: Drug: conventional treatment for schizophrenia |
| 3 | Experimental | quetiapine fumarate + Cognitive Remediation Therapy Receives: Drug: Quetiapine fumarate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Social outcome measured by Strauss-Carpenter scale
Measured: change from baseline to last visit and end of CRT
Secondary outcomes (3)
Change in PANSS total score
Measured: change from baseline to visit 2, from baseline to end of CRT and from baseline to last visit
Change in PANSS positive, negative and general psychopathology symptom subscales
Measured: change from baseline to visit 2, from baseline to end of CRT and from baseline to last visit
Change in cognition as measured by a Cognitive Battery of Tests
Measured: change from baseline to end of CRT and from baseline to last visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2005 (estimated)
- Study startSep 2005
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Leif Lindström,, Principal investigator, Västerås
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00255515
- Sponsor's protocol ID
- D1449L00004
- Other IDs
- SCORE
- Acronym
- SCORE
- Status last verified
- Mar 2009
- First submitted
- 17 Nov 2005
- Last updated
- 25 Mar 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Randomised, Parallel, Three Treatment Groups, Multicentre, Phase IV Study - in Real Life - to Compare the Change in Social Outcome of Quetiapine Fumarate (Seroquel®) Combined With Cognitive Remediation Therapy to Conventional Treatment in Patients With Schizophrenia.
- ClinicalTrials.gov ID
- NCT00255515
- Acronym / sponsor ID
- SCORE / D1449L00004
- Conditions
- Schizophrenia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Sep 2005
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 21 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare efficacy of quetiapine fumarate combined with Cognitive Remediation Therapy (CRT) to conventional treatment by evaluating change in social outcome in patients with schizophrenia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Quetiapine fumaratequetiapine fumarate |
| 2 | Active comparator | Drug: conventional treatment for schizophreniaConventional treatment for schizophrenia |
| 3 | Experimental | Drug: Quetiapine fumaratequetiapine fumarate + Cognitive Remediation Therapy |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Signed informed consent
- Documented clinical diagnosis of schizophrenia or schizoaffective disorder for at least 2 years.
- Clinically stable and in an outpatient setting before entering the study (visit 1).
Key exclusion criteria (2 listed)
- Use of clozapine and quetiapine within two months prior to visit 1.
- If total points are ≤ 55 Intelligence quotient (IQ) according to score of WAIS-III test at visit 1.
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 fumarateAlso: Seroqueloral | Drug | 1, 3 |
| conventional treatment for schizophreniavarious standard therapies | Drug | 2 |
Primary outcome
Social outcome measured by Strauss-Carpenter scale
Time frame: change from baseline to last visit and end of CRT
3 secondary outcomes
Change in PANSS total score
Time frame: change from baseline to visit 2, from baseline to end of CRT and from baseline to last visit
Change in PANSS positive, negative and general psychopathology symptom subscales
Time frame: change from baseline to visit 2, from baseline to end of CRT and from baseline to last visit
Change in cognition as measured by a Cognitive Battery of Tests
Time frame: change from baseline to end of CRT and from baseline to last visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2009.
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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.
Leif Lindström, principal investigator
Västerås
15 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 and conventional treatment for schizophrenia in people with Schizophrenia, run by AstraZeneca at 15 sites in Sweden.
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 2 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 25 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Sweden. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Social outcome measured by Strauss-Carpenter scale (time frame: change from baseline to last visit and end of CRT). 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 25 Mar 2009.