Clinical trial NCT00926393: Study Comparing the Tolerability of Seroquel IR With Seroquel XR in Patients With Bipolar Depression
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bipolar Depression
Keywords: inpatient
bipolar depression
quetiapine
Seroquel IR
Seroquel XR
safety
tolerability
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-06-23
Enrollment: 139
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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


Eligibility 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.

Primary outcomes:
measure: Modified Bond-Lader Visual Analog Scale Score After 50-mg Dose (Day 2)
timeFrame: At 1 hour post-dose, Day 2 (50 mg)
Secondary outcomes:
measure: Modified Bond-Lader Visual Analog Scale Score After 100-mg Dose (Day 3)
timeFrame: At 1 hour post-dose, Day 3 (100 mg)
measure: Modified Bond-Lader Visual Analog Scale Score After 200-mg Dose (Day 4)
timeFrame: At 1 hour post-dose, Day 4 (200 mg)
measure: Modified Bond-Lader Visual Analog Scale Score After 300-mg Dose (Day 5)
timeFrame: At 1 hour post-dose, Day 5 (300 mg)
measure: Modified Bond-Lader Visual Analog Scale Score After 300-mg Dose (Day 6)
timeFrame: At 1 hour post-dose, Day 6 (300 mg)
measure: Maximum Intensity Modified Bond-Lader Visual Analog Scale Score
timeFrame: During Day 2 (50 mg)
measure: Time to Maximum Intensity Modified Bond-Lader Visual Analog Scale Score
timeFrame: During Day 2 (50 mg)
measure: Area Under the Modified Bond-Lader Visual Analog Scale-time Curve
timeFrame: During Day 2 (50 mg)
measure: Change in Simpson-Angus Scale (SAS) Total Score
timeFrame: Randomization to Day 7
measure: Change in Barnes Akathisia Rating Scale (BARS) Global Score
timeFrame: Randomization to Day 7
measure: Change in Abnormal Involuntary Movement Scale (AIMS) Total Score
timeFrame: Randomization to Day 7
measure: Number of Patients With Potential Extrapyramidal Symptoms (EPS)
timeFrame: From start of the study treatment to last dose plus 30 days
measure: Number of Patients With Potential Somnolence
timeFrame: From start of the study treatment to last dose plus 30 days
Other outcomes:
Locations:
Study officials:
affiliation: AstraZeneca
name: Catherine Datto, MD
role: STUDY_DIRECTOR
References:
citation: Riesenberg RA, Baldytcheva I, Datto C. Self-reported sedation profile of quetiapine extended-release and quetiapine immediate-release during 6-day initial dose escalation in bipolar depression: a multicenter, randomized, double-blind, phase IV study. Clin Ther. 2012 Nov;34(11):2202-11. doi: 10.1016/j.clinthera.2012.09.002. Epub 2012 Oct 8.