We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00926393
First Posted: June 23, 2009
Last Update Posted: May 11, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
AstraZeneca
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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) ]
    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) ]
    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) ]
    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) ]
    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) ]
    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) ]
    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) ]
    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) ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00926393


Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Catherine Datto, MD AstraZeneca
  More Information

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
First Submitted: June 19, 2009
First Posted: June 23, 2009
Results First Submitted: May 4, 2010
Results First Posted: March 31, 2011
Last Update Posted: May 11, 2011
Last Verified: May 2011

Keywords provided by AstraZeneca:
inpatient
bipolar depression
quetiapine
Seroquel IR
Seroquel XR
safety
tolerability

Additional relevant MeSH terms:
Depression
Depressive Disorder
Bipolar Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Bipolar and Related Disorders
Quetiapine Fumarate
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs