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Study Comparing the Tolerability of Seroquel IR With Seroquel XR in Patients With Bipolar Depression

Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Bipolar Depression

Intervention: Quetiapine Immediate Release (Drug); Quetiapine Extended Release (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Catherine Datto, MD, Study Director, Affiliation: AstraZeneca

Summary

The purpose of the study is to compare the sedation profile one hour after dose administration between Seroquel IR and Seroquel XR.

Clinical Details

Official title: A Phase IV, Multi-center, Double-blind, Double-dummy, Randomized, Parallel-group Study to Compare the Tolerability of Quetiapine Fumarate Immediate Release (Seroquel IR) With Quetiapine Fumarate Extended Release (Seroquel XR) During Initial Dose Escalation in Patients With Bipolar Depression

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Primary outcome: Modified Bond-Lader Visual Analog Scale Score After 50-mg Dose (Day 2)

Secondary outcome:

Modified Bond-Lader Visual Analog Scale Score After 100-mg Dose (Day 3)

Modified Bond-Lader Visual Analog Scale Score After 200-mg Dose (Day 4)

Modified Bond-Lader Visual Analog Scale Score After 300-mg Dose (Day 5)

Modified Bond-Lader Visual Analog Scale Score After 300-mg Dose (Day 6)

Maximum Intensity Modified Bond-Lader Visual Analog Scale Score

Time to Maximum Intensity Modified Bond-Lader Visual Analog Scale Score

Area Under the Modified Bond-Lader Visual Analog Scale-time Curve

Change in Simpson-Angus Scale (SAS) Total Score

Change in Barnes Akathisia Rating Scale (BARS) Global Score

Change in Abnormal Involuntary Movement Scale (AIMS) Total Score

Number of Patients With Potential Extrapyramidal Symptoms (EPS)

Number of Patients With Potential Somnolence

Eligibility

Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- DSM-IV-TR documented bipolar I or bipolar II, most recent episode depressed

- Outpatient status as enrollment

Exclusion Criteria:

- Other than bipolar disorder under study, patients must not have another current,

major disorder that is symptomatic or has required treatment within 6 months of enrollment.

Locations and Contacts

Additional Information

Starting date: June 2009
Last updated: May 10, 2011

Page last updated: August 23, 2015

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