Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00926393
First received: June 19, 2009
Last updated: May 10, 2011
Last verified: May 2011
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00926393

Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Catherine Datto, MD AstraZeneca
  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
Behavioral Symptoms
Mental Disorders
Mood Disorders
Quetiapine
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on November 20, 2014