Study Comparing the Tolerability of Seroquel IR With Seroquel XR in Patients With Bipolar Depression
This study has been completed.
Sponsor:
AstraZeneca
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00926393
First received: June 19, 2009
Last updated: May 10, 2011
Last verified: May 2011
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Purpose
The purpose of the study is to compare the sedation profile one hour after dose administration between Seroquel IR and Seroquel XR.
| Condition | Intervention | Phase |
|---|---|---|
|
Bipolar Depression |
Drug: Quetiapine Immediate Release Drug: Quetiapine Extended Release |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) |
| 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 |
Resource links provided by NLM:
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- Modified Bond-Lader Visual Analog Scale Score After 50-mg Dose (Day 2) [ Time Frame: At 1 hour post-dose, Day 2 (50 mg) ] [ Designated as safety issue: No ]The Modified Bond-Lader Visual Analog Scale (VAS) uses a 100 mm line, each with a set of opposing adjectives at either end:Alert (=0) - Drowsy (=100); If patient is sleeping the Bond-Lader VAS will be assign a score of 100.
Secondary Outcome Measures:
- Modified Bond-Lader Visual Analog Scale Score After 100-mg Dose (Day 3) [ Time Frame: At 1 hour post-dose, Day 3 (100 mg) ] [ Designated as safety issue: No ]The Modified Bond-Lader Visual Analog Scale (VAS) uses a 100 mm line, each with a set of opposing adjectives at either end:Alert (=0) - Drowsy (=100); If patient is sleeping the Bond-Lader VAS will be assign a score of 100.
- Modified Bond-Lader Visual Analog Scale Score After 200-mg Dose (Day 4) [ Time Frame: At 1 hour post-dose, Day 4 (200 mg) ] [ Designated as safety issue: No ]The Modified Bond-Lader Visual Analog Scale (VAS) uses a 100 mm line, each with a set of opposing adjectives at either end:Alert (=0) - Drowsy (=100); If patient is sleeping the Bond-Lader VAS will be assign a score of 100.
- Modified Bond-Lader Visual Analog Scale Score After 300-mg Dose (Day 5) [ Time Frame: At 1 hour post-dose, Day 5 (300 mg) ] [ Designated as safety issue: No ]The Modified Bond-Lader Visual Analog Scale (VAS) uses a 100 mm line, each with a set of opposing adjectives at either end:Alert (=0) - Drowsy (=100); If patient is sleeping the Bond-Lader VAS will be assign a score of 100.
- Modified Bond-Lader Visual Analog Scale Score After 300-mg Dose (Day 6) [ Time Frame: At 1 hour post-dose, Day 6 (300 mg) ] [ Designated as safety issue: No ]The Modified Bond-Lader Visual Analog Scale (VAS) uses a 100 mm line, each with a set of opposing adjectives at either end:Alert (=0) - Drowsy (=100); If patient is sleeping the Bond-Lader VAS will be assign a score of 100.
- Maximum Intensity Modified Bond-Lader Visual Analog Scale Score [ Time Frame: During Day 2 (50 mg) ] [ Designated as safety issue: No ]The Maximum Intensity Modified Bond-Lader VAS after dose (MaxIntVAS) is calculated as maximum possible value of VAS during that day at any from 1, 2, 3, 4, 5, 12, 13, 14 hours post-dose assessments
- Time to Maximum Intensity Modified Bond-Lader Visual Analog Scale Score [ Time Frame: During Day 2 (50 mg) ] [ Designated as safety issue: No ]Time (Tmax) to Maximum Intensity Modified Bond-Lader VAS after dose is corresponding assessment time (one from 1, 2, 3, 4, 5, 12, 13, 14 hours post-dose) of MaxIntVas
- Area Under the Modified Bond-Lader Visual Analog Scale-time Curve [ Time Frame: During Day 2 (50 mg) ] [ Designated as safety issue: No ]Area under the Modified Bond-Lader VAS-time curve is calculated by the linear trapezoidal formula which equals sum of (Ck+Ck+1)/2 multiplied by the time interval between k and k+1 observations, where Ck and Ck+1 are the corresponding the intensity of sedation evaluations measured by the Modified Bond-Lader VAS from 1 to 14 hours post-dose
- Change in Simpson-Angus Scale (SAS) Total Score [ Time Frame: Randomization to Day 7 ] [ Designated as safety issue: No ]SAS total score is the sum of the 10 individual-item scores (range:0-40), with the score for each item ranging from 0 to 4, higher scores indicate greater severity of Parkinsonian symptoms. Change : total score at day 7 minus total score at randomization. Increase in Change of total score indicates an increase in extrapyramidal motor symptoms.
- Change in Barnes Akathisia Rating Scale (BARS) Global Score [ Time Frame: Randomization to Day 7 ] [ Designated as safety issue: No ]BARS global score is the 4th individual-item score on the BARS scale,the Global Assessment of Akathisia, with the score ranging from 0 to 5. Change : score at day 7 minus score at randomization. Increase in Change of BARS global score indicates an increase in akathisia.
- Change in Abnormal Involuntary Movement Scale (AIMS) Total Score [ Time Frame: Randomization to Day 7 ] [ Designated as safety issue: No ]AIMS total score is the sum of the 10 individual-item scores (range:0-40), with the score for each item ranging from 0 to 4. Change : total score at day 7 minus total score at randomization. Increase in Change of total score indicates an increase in abnormal voluntary movements.
- Number of Patients With Potential Extrapyramidal Symptoms (EPS) [ Time Frame: From start of the study treatment to last dose plus 30 days ] [ Designated as safety issue: No ]Number of patients with adverse events potentially associated with EPS collected by MedDRA Preferred Terms as akathisia, extrapyramidal disorder, restlessness
- Number of Patients With Potential Somnolence [ Time Frame: From start of the study treatment to last dose plus 30 days ] [ Designated as safety issue: No ]Number of patients with adverse events potentially associated with somnolence collected by MedDRA Preferred Terms as lethargy, sedation, somnolence
| Enrollment: | 139 |
| Study Start Date: | June 2009 |
| Study Completion Date: | August 2009 |
| Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Quetiapine Immediate Release (IR)
Quetiapine 25, 100, 200 and 300 mg
|
Drug: Quetiapine Immediate Release
Oral, 3 tablets daily: (2 x 25 mg + 1 x 50 mg) at one time each day
Other Name: Seroquel IR
|
|
Active Comparator: Quetiapine Extended Release (XR)
Quetiapine 50, 200, 300
|
Drug: Quetiapine Extended Release
Oral, 3 tablets daily: (2 x 25 mg + 1 x 50 mg) at one time each day
Other Name: Seroquel XR
|
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations More Information
No publications provided by AstraZeneca
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Hans Eriksson, MD, Medical Science Sr Director, AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT00926393 History of Changes |
| Other Study ID Numbers: | D1443C00040 |
| Study First Received: | June 19, 2009 |
| Results First Received: | May 4, 2010 |
| Last Updated: | May 10, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by AstraZeneca:
|
inpatient bipolar depression quetiapine Seroquel IR |
Seroquel XR safety tolerability |
Additional relevant MeSH terms:
|
Bipolar Disorder Depression Depressive Disorder Affective Disorders, Psychotic Mood Disorders Mental Disorders Behavioral Symptoms Quetiapine |
Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Psychotropic Drugs |
ClinicalTrials.gov processed this record on May 19, 2013