Phase 4
Completed N=139
Study Comparing the Tolerability of Seroquel IR With Seroquel XR in Patients With Bipolar Depression
Source: ClinicalTrials.gov NCT00926393 ↗Enrolled (actual)
139
Serious AEs
2.2%
Results posted
Mar 2011
Primary outcomePrimary: Modified Bond-Lader Visual Analog Scale Score After 50-mg Dose (Day 2) — 45.022; 32.472 units on scale
Summary
The purpose of the study is to compare the sedation profile one hour after dose administration between Seroquel IR and Seroquel XR.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Modified Bond-Lader Visual Analog Scale Score After 50-mg Dose (Day 2) |
45.022; 32.472 | — |
| SECONDARY Modified Bond-Lader Visual Analog Scale Score After 100-mg Dose (Day 3) |
51.521; 29.146 | — |
| SECONDARY Modified Bond-Lader Visual Analog Scale Score After 200-mg Dose (Day 4) |
48.336; 30.130 | — |
| SECONDARY Modified Bond-Lader Visual Analog Scale Score After 300-mg Dose (Day 5) |
49.414; 32.626 | — |
| SECONDARY Modified Bond-Lader Visual Analog Scale Score After 300-mg Dose (Day 6) |
48.959; 30.144 | — |
| SECONDARY Maximum Intensity Modified Bond-Lader Visual Analog Scale Score |
99.929; 96.937 | — |
| SECONDARY Time to Maximum Intensity Modified Bond-Lader Visual Analog Scale Score |
3.685; 4.254 | — |
| SECONDARY Area Under the Modified Bond-Lader Visual Analog Scale-time Curve |
1061.12; 988.842 | — |
| SECONDARY Change in Simpson-Angus Scale (SAS) Total Score |
-0.1; 0.1 | — |
| SECONDARY Change in Barnes Akathisia Rating Scale (BARS) Global Score |
-0.07; -0.09 | — |
| SECONDARY Change in Abnormal Involuntary Movement Scale (AIMS) Total Score |
-0.01; -0.04 | — |
| SECONDARY Number of Patients With Potential Extrapyramidal Symptoms (EPS) |
8; 2 | — |
| SECONDARY Number of Patients With Potential Somnolence |
11; 12 | — |
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.
Data sourced from ClinicalTrials.gov (NCT00926393). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.