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Atypical Antipsychotic
Seroquel XR for Schizophrenia
Phase 3
Waitlist Available
Led By Roch-Hugo Bouchard, MD, FRCPC
Research Sponsored by Corporation de Recherche en Neuropsycho Pharmacologie de Quebec
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up the matrics consensus battery will be performed at the baseline visit and at the end of study visit.
Awards & highlights
Study Summary
This research will explore whether Quetiapine XR used primarily to treat psychosis may also cover for comorbid anxiety disorder and offer advantages in patients with schizophrenia and comorboid anxiety disorder. Preliminary data on pharmacological properties of Quetiapine and its metabolites and intuitive impression from our clinical experience lead to believe that Seroquel XR use in monotherapy may offer advantages over other antipsychotics in treating co-morbid anxiety disorder in patients suffering from schizophrenia. This open label switch study conducted in a schizophrenic population intends to verify this hypothesis.
Eligible Conditions
- Schizophrenia
- Anxiety
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ evaluated at each visit over 6 months: day 1, day 7, day 14, month 1, month 2, month 3 and month 6.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~evaluated at each visit over 6 months: day 1, day 7, day 14, month 1, month 2, month 3 and month 6.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Anxiety disorder
Secondary outcome measures
Tolerability and safety
Other outcome measures
Cognition
Side effects data
From 2008 Phase 3 trial • 450 Patients • NCT0038906426%
Somnolence
17%
Dry Mouth
13%
Dizziness
12%
Headache
9%
Nausea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Quetiapine XR
Trial Design
1Treatment groups
Experimental Treatment
Group I: Seroquel XRExperimental Treatment1 Intervention
Quetiapine XR will be titrated according to the following pattern: Seroquel XR 300 mg on day 1 and Seroquel XR 600 mg on day 2. On day 3, the dosage could be either maintained at 600 mg/day or continued up to 800 mg/day or if the 600 mg dose is not tolerated, the dose could then be reduced to 400 mg/day. Following this, subjects will be flexibly dosed, according to clinical judgment of the investigator, between 400 mg/day and 800 mg/day with minimum dose adjustments of 200 mg/day. This adjustment can be performed at anytime during the study but should not take place within a week from last cognitive assessment, planned at month 6. An overlap of at least 4 days but not more than 2 weeks with the previous antipsychotic will be allowed with decreasing doses on a two-week period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Quetiapine
FDA approved
Find a Location
Who is running the clinical trial?
Corporation de Recherche en Neuropsycho Pharmacologie de QuebecLead Sponsor
Roch-Hugo Bouchard, MD, FRCPCPrincipal InvestigatorLaval University
Frequently Asked Questions
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