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

Bipolar Depression Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00926393
• Other study ID #: D1443C00040
• Status: Completed
• Phase: Phase 4
• First received: June 19, 2009
• Last updated: May 10, 2011
• Start date: June 2009
• Est. completion date: August 2009

Study information

• Verified date: May 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 139
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Bipolar Depression
• Bipolar Disorder
• Depression
• Depressive Disorder

Intervention

Drug:
• Quetiapine Immediate Release
Oral, 3 tablets daily: (2 x 25 mg + 1 x 50 mg) at one time each day
• Quetiapine Extended Release
Oral, 3 tablets daily: (2 x 25 mg + 1 x 50 mg) at one time each day

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modified Bond-Lader Visual Analog Scale Score After 50-mg Dose (Day 2)	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.	At 1 hour post-dose, Day 2 (50 mg)	No
Secondary	Modified Bond-Lader Visual Analog Scale Score After 100-mg Dose (Day 3)	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.	At 1 hour post-dose, Day 3 (100 mg)	No
Secondary	Modified Bond-Lader Visual Analog Scale Score After 200-mg Dose (Day 4)	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.	At 1 hour post-dose, Day 4 (200 mg)	No
Secondary	Modified Bond-Lader Visual Analog Scale Score After 300-mg Dose (Day 5)	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.	At 1 hour post-dose, Day 5 (300 mg)	No
Secondary	Modified Bond-Lader Visual Analog Scale Score After 300-mg Dose (Day 6)	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.	At 1 hour post-dose, Day 6 (300 mg)	No
Secondary	Maximum Intensity Modified Bond-Lader Visual Analog Scale Score	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	During Day 2 (50 mg)	No
Secondary	Time to Maximum Intensity Modified Bond-Lader Visual Analog Scale Score	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	During Day 2 (50 mg)	No
Secondary	Area Under the Modified Bond-Lader Visual Analog Scale-time Curve	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	During Day 2 (50 mg)	No
Secondary	Change in Simpson-Angus Scale (SAS) Total Score	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.	Randomization to Day 7	No
Secondary	Change in Barnes Akathisia Rating Scale (BARS) Global Score	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.	Randomization to Day 7	No
Secondary	Change in Abnormal Involuntary Movement Scale (AIMS) Total Score	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.	Randomization to Day 7	No
Secondary	Number of Patients With Potential Extrapyramidal Symptoms (EPS)	Number of patients with adverse events potentially associated with EPS collected by MedDRA Preferred Terms as akathisia, extrapyramidal disorder, restlessness	From start of the study treatment to last dose plus 30 days	No
Secondary	Number of Patients With Potential Somnolence	Number of patients with adverse events potentially associated with somnolence collected by MedDRA Preferred Terms as lethargy, sedation, somnolence	From start of the study treatment to last dose plus 30 days	No