Study Evaluating the Clinical Benefit of SEROQUEL XR in Subjects With Schizophrenia

NCT00640601 | Completed Phase 3 Results

• 1 other identifier: D1443L00025
• Study Type: interventional
• Target: 331
• Locations: 4 countries
• Sites: 36

Brief Summary

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.

Conditions

Schizophrenia

Keywords

Seroquel; schizophrenia; Extended Release

Outcome Measures

Primary Outcomes (1)

• 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

  Proportional change in CGI-CB score The CGI-CB scale is used to evaluate investigator's global weighted impression of efficacy and interference of adverse events (AEs) from enrolment to every visit. The score ranges from 1 to 10. The lower the score the better the outcome, e.g.: a score of 1 means that there is marked therapeutic effect with no burden of AEs. A score of 10 signifies that the burden of AEs outweighs the therapeutic effect, or no therapeutic effect with high burden of AEs. A change score for each subject will be calculated by subtracting the baseline score from the visit score.

  Baseline to 24 weeks (or end of study)

Secondary Outcomes (10)

• Change in Clinical Global Impression-Clinical Benefit (CGI-CB) Score

  Baseline to 24 weeks

• Change in Positive and Negative Syndrome Scale for Schizophrenia (PANSS) Total Score

  Baseline to 24 weeks

• Change in Positive and Negative Syndrome Scale for Schizophrenia (PANSS) Positive Scale Score

  Baseline to 24 weeks

• Change in Positive and Negative Syndrome Scale for Schizophrenia (PANSS) Negative Scale Score

  Baseline to 24 weeks

• Change in Global Assessment Scale (GAS)

  Baseline to 24 weeks

Interventions

Quetiapine Fumarate Extended- Release DRUG

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.

Also known as: Seroquel XR®

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (36)

Research Site

Garran, Australian Capital Territory, Australia

Location

Research Site

Newcastle, New South Wales, Australia

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Brisbane, Queensland, Australia

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Meadowbrook, Queensland, Australia

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Dandenong, Victoria, Australia

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Calgary, Alberta, Canada

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Claresholm, Alberta, Canada

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Red Deer, Alberta, Canada

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Vancouver, British Columbia, Canada

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Victoria, British Columbia, Canada

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Miramichi, New Brunswick, Canada

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St. John's, Newfoundland and Labrador, Canada

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Sydney, Nova Scotia, Canada

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Belleville, Ontario, Canada

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Brantford, Ontario, Canada

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Chatham, Ontario, Canada

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Cornwall, Ontario, Canada

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Greater Sudbury, Ontario, Canada

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London, Ontario, Canada

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Markham, Ontario, Canada

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Mississauga, Ontario, Canada

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Newmarket, Ontario, Canada

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Oakville, Ontario, Canada

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Orléans, Ontario, Canada

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Toronto, Ontario, Canada

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Windsor, Ontario, Canada

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Gatineau, Quebec, Canada

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Greenfield Park, Quebec, Canada

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Montreal, Quebec, Canada

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Québec, Quebec, Canada

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Rouyn-Noranda, Quebec, Canada

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Verdun, Quebec, Canada

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Prince Albert, Saskatchewan, Canada

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Saskatoon, Saskatchewan, Canada

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Hong Kong, Hong Kong

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Seoul, Korea, South Korea

Location

Related Publications (1)

• Chue P, Malla A, Bouchard RH, Lessard S, Ganesan S, Stip E, Johnson S, Chen E, Ahn YM, Kim YS, Robinson G, Schweikert C, Gendron A, Eriksson H; SPECTRUM XR Study Group. The long-term clinical benefit and effectiveness of switching to once-daily quetiapine extended release in patients with schizophrenia. Curr Med Res Opin. 2013 Mar;29(3):227-39. doi: 10.1185/03007995.2012.762903. Epub 2013 Jan 22.

  PMID: 23281876 DERIVED

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Limitations and Caveats

The open-label design and lack of a placebo group constitute potential limitations. In addition, the small sample size of some of the subgroups may limit conclusions drawn from subgroup analyses.

Results Point of Contact

• Title: Gerard Lynch
• Organization: AstraZeneca

aztrial_results_posting@astrazeneca.com

441625 518062

Study Officials

• Pierre Chue, MD

  University of Alberta

  PRINCIPAL INVESTIGATOR

• Willie Early, MD

  AstraZeneca

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2008
• First Posted: March 21, 2008
• Study Start: March 1, 2008
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: June 25, 2012
• Results First Posted: June 22, 2012

Record last verified: 2012-06

Locations

KR (1); CA (29); HK (1); AU (5)