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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00640601




Registration number
NCT00640601
Ethics application status
Date submitted
17/03/2008
Date registered
21/03/2008
Date last updated
25/06/2012

Titles & IDs
Public title
Study Evaluating the Clinical Benefit of SEROQUEL XR in Subjects With Schizophrenia
Scientific title
A Multicentre, Open-label, Prospective Long-term Study Evaluating the Clinical Benefit and Effectiveness of SEROQUEL XR® (Quetiapine Fumarate Extended-Release Tablets) in Subjects With Schizophrenia
Secondary ID [1] 0 0
D1443L00025
Universal Trial Number (UTN)
Trial acronym
SPECTRUM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Schizophrenia 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Schizophrenia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Quetiapine Fumarate Extended- Release

Treatment: Drugs: Quetiapine Fumarate Extended- Release
Open-label seroquel XR tablets: On Day 1 Patients received 300 mg, on Day 2 600 mg, on Day 3 600-800 mg and between Day 4-168 400-800 mg Seroquel XR, according to clinical judgement of investigator. Dose changes were in 200 mg fixed doses. Investigational product (IP) was supplied in open label wallet blister cards and subjects were instructed to take the IP once daily in the evening.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Subjects With Improved Clinical Benefit From Assessment of Clinical Global Impression-Clinical Benefit (CGI-CB) Scale From Baseline to Week 24 or End of Study
Timepoint [1] 0 0
Baseline to 24 weeks (or end of study)
Secondary outcome [1] 0 0
Change in Clinical Global Impression-Clinical Benefit (CGI-CB) Score
Timepoint [1] 0 0
Baseline to 24 weeks
Secondary outcome [2] 0 0
Change in Positive and Negative Syndrome Scale for Schizophrenia (PANSS) Total Score
Timepoint [2] 0 0
Baseline to 24 weeks
Secondary outcome [3] 0 0
Change in Positive and Negative Syndrome Scale for Schizophrenia (PANSS) Positive Scale Score
Timepoint [3] 0 0
Baseline to 24 weeks
Secondary outcome [4] 0 0
Change in Positive and Negative Syndrome Scale for Schizophrenia (PANSS) Negative Scale Score
Timepoint [4] 0 0
Baseline to 24 weeks
Secondary outcome [5] 0 0
Change in Global Assessment Scale (GAS)
Timepoint [5] 0 0
Baseline to 24 weeks
Secondary outcome [6] 0 0
Change in Clinical Global Impression-Severity (CGI-S) Scale
Timepoint [6] 0 0
Baseline to 24 weeks
Secondary outcome [7] 0 0
Change in Clinical Global Impression-Improvement (CGI-I) Scale
Timepoint [7] 0 0
Day 7 - week 24
Secondary outcome [8] 0 0
Change in Social and Occupational Functioning Assessment Scale (SOFAS)
Timepoint [8] 0 0
Baseline to 24 weeks
Secondary outcome [9] 0 0
Change in Safety Measure: Simpson-Angus Scale (SAS)
Timepoint [9] 0 0
Baseline to 24 weeks
Secondary outcome [10] 0 0
Change in Barnes Akathisia Rating Scale (BARS)
Timepoint [10] 0 0
Baseline to 24 weeks

Eligibility
Key inclusion criteria
* Provision of written informed consent before initiation of any study related procedures.
* Male and female subjects aged 18 to 65 years, inclusive.
* Documented clinical diagnosis meeting the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria for any of the following: Schizophrenia DSM-IV, catatonic 295.20, disorganised 295.10, paranoid 295.30 and undifferentiated 295.90.
* Outpatient status.
* Subjects who in their own and/or in the Principal Investigator's opinion, consider their ongoing antipsychotic treatment inadequate because of insufficient efficacy, poor tolerance, and/or non acceptability of their actual dosage regimen (eg. b.i.d, t.i.d, etc).
* Monotherapy with current antipsychotic for at least 7 days prior to initiating treatment (ie, cannot be on more than one antipsychotic during the 7 day period prior to initiating study medication). Note: Subjects on a b.i.d regimen of seroquel IR for 7 days prior to enrolment are eligible to participate in the study.
* Female subjects of childbearing potential must have a negative serum pregnancy test at enrolment and be willing to use a reliable method of birth control, ie, barrier method, oral contraceptive, implant, dermal contraception, long-term injectable contraceptive, intrauterine device, or tubal ligation during the study.
* Capable to make treatment decisions, including being able to understand and comply with the requirements of the study, and judged as such by the Principal Investigator.
* Be able to read and write either English or French at a grade 7 proficiency level.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* First episode, drug naive schizophrenic subjects.
* Meeting the criteria for any other (than schizophrenia) DSM-IV Axis I diagnosis, concomitant organic mental disorder or mental retardation that in the opinion of the Principal Investigator may interfere with study conduct or interpretation.
* Substance/alcohol dependence or abuse at enrolment [except dependence in full remission (>3 months) and except caffeine and nicotine dependence] as defined by DSM-IV criteria. A urine drug screen will be performed. The Principal Investigator will evaluate the results along with medical history to determine if the patient meets DSM-IV criteria for substance abuse or dependence. However, a single urine toxicology screen for cocaine, heroin, methamphetamine or PCP will lead to exclusion.
* Subjects requiring treatment with another antipsychotic agent than investigational product during study.
* Subjects on seroquel IR once daily.
* Known lack of response to clozapine or treatment with clozapine within 4 weeks prior to enrolment.
* Known intolerance to seroquel IR.
* Subjects requiring treatment with disallowed medication following enrolment into the study.
* Subjects requiring treatment for epilepsy.
* Subjects who pose an imminent risk of suicide or danger to themselves or others, as judged by the Principal Investigator.
* Pregnancy or lactation.
* A thyroid-stimulating hormone (TSH) concentration more than 10% above the upper limit of the normal range of the laboratory used for sample analysis whether or not the patient is being treated for hypothyroidism or hyperthyroidism.
* Use of a depot or long-acting injectable antipsychotic drug within 1 dosing interval before Day 1 of treatment or during treatment.
* Use of drugs that induce or inhibit the hepatic metabolising cytochrome P450 3A4 enzymes within 14 days of the screening assessment period (Day -7 to 0). See Table 5.
* History of idiopathic or drug-induced agranulocytosis.
* A QTc interval longer than 450 msec (calculated using the Fridericia correction for heart rate) or ECG considered to show cardiac abnormality at enrolment as determined by a centrally located, experienced cardiologist, and confirmed by the Principal Investigator as clinically significant.
* Evidence of clinically relevant disease (eg, renal, hepatic, autonomic, endocrine, hematologic or ophthalmologic impairment, significant coronary artery disease, congestive heart failure, cerebrovascular disease, viral hepatitis B or C, acquired immunodeficiency syndrome [AIDS] or cancer) or a clinical finding that is unstable or that, in the opinion of the Principal Investigator, would be negatively affected by the investigational product or that would affect the investigational product.
* Laboratory test results outside the reference range considered by the Principal Investigator to be clinically significant and potentially interfere with the study outcome.
* A patient with Diabetes Mellitus (DM) fulfilling one of the following criteria:

* Unstable DM defined as HbA1c >8.5% at enrolment. Admitted to hospital for treatment of DM or DM related illness in past 12 weeks.
* Not under care of physician responsible for patient's DM care.
* Physician responsible for patient's DM care has not indicated that patient's DM is controlled.
* Physician responsible for patient's DM care has not approved patient's participation in the study.
* Has not been on the same dose of oral hypoglycemic drug(s) and/or diet for the four (4) weeks prior to randomisation. For thiazolidinediones (glitazones) this period should not be less than 8 weeks.
* Taking insulin whose daily dose on one occasion in the past 4 weeks has been more than 10% above or below their mean dose in the preceding 4 weeks.

Note: If a diabetic patient meets one of these criteria the patient is to be excluded even if the treating physician believes the patient is stable and can participate in the study.

* An absolute neutrophil count (ANC) of <1.5 x 109/L
* Inability to accommodate the visit schedule.
* History of non-compliance as judged by the Principal Investigator.
* Previous enrolment in the present study.
* Participation in another clinical study or compassionate use programme within 4 weeks of screening (Day -7 to 0).
* Involvement in the planning and conduct of the study (applies to both AstraZeneca staff or staff at the study site).

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2010
Sample size
Target
Accrual to date
Final
331
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,VIC
Recruitment hospital [1] 0 0
Research Site - Garran
Recruitment hospital [2] 0 0
Research Site - Newcastle
Recruitment hospital [3] 0 0
Research Site - Brisbane
Recruitment hospital [4] 0 0
Research Site - Meadowbrook
Recruitment hospital [5] 0 0
Research Site - Dandenong
Recruitment postcode(s) [1] 0 0
- Garran
Recruitment postcode(s) [2] 0 0
- Newcastle
Recruitment postcode(s) [3] 0 0
- Brisbane
Recruitment postcode(s) [4] 0 0
- Meadowbrook
Recruitment postcode(s) [5] 0 0
- Dandenong
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Alberta
Country [2] 0 0
Canada
State/province [2] 0 0
British Columbia
Country [3] 0 0
Canada
State/province [3] 0 0
New Brunswick
Country [4] 0 0
Canada
State/province [4] 0 0
Newfoundland and Labrador
Country [5] 0 0
Canada
State/province [5] 0 0
Nova Scotia
Country [6] 0 0
Canada
State/province [6] 0 0
Ontario
Country [7] 0 0
Canada
State/province [7] 0 0
Quebec
Country [8] 0 0
Canada
State/province [8] 0 0
Saskatchewan
Country [9] 0 0
Hong Kong
State/province [9] 0 0
HK
Country [10] 0 0
Korea, Republic of
State/province [10] 0 0
Korea

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pierre Chue, MD
Address 0 0
University of Alberta
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00640601