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Trial record 68 of 450 for:    QUETIAPINE

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

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ClinicalTrials.gov Identifier: NCT00926393
Recruitment Status : Completed
First Posted : June 23, 2009
Results First Posted : March 31, 2011
Last Update Posted : May 11, 2011
Sponsor:
Information provided by:
AstraZeneca

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Condition Bipolar Depression
Interventions Drug: Quetiapine Immediate Release
Drug: Quetiapine Extended Release
Enrollment 139
Recruitment Details A 7-day, inpatient, multicenter, double-blind, double-dummy, randomized, parallel group, Phase IV study was done to compare the tolerability of quetiapine IR with quetiapine XR during initial dose escalation in patients with bipolar depression. In total 139 patients were randomized in 15 centers in the USA between June and August 2009.
Pre-assignment Details Patients must have DSM-IV-TR documented bipolar I or bipolar II, most recent episode depressed, and outpatient status at enrollment . Patients must not have another current, major disorder that is symptomatic or has required treatment within 6 months of enrollment.
Arm/Group Title Quetiapine IR Quetiapine XR
Hide Arm/Group Description Quetiapine fumarate Immediate Release Quetiapine fumarate Extended Release
Period Title: Overall Study
Started 69 70
Completed 67 67
Not Completed 2 3
Reason Not Completed
Withdrawal by Subject             1             2
Adverse Event             1             1
Arm/Group Title Quetiapine IR Quetiapine XR Total
Hide Arm/Group Description Quetiapine fumarate Immediate Release Quetiapine fumarate Extended Release Total of all reporting groups
Overall Number of Baseline Participants 69 70 139
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 69 participants 70 participants 139 participants
18-39 28 31 59
40-50 41 39 80
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 69 participants 70 participants 139 participants
Female
32
  46.4%
34
  48.6%
66
  47.5%
Male
37
  53.6%
36
  51.4%
73
  52.5%
1.Primary Outcome
Title Modified Bond-Lader Visual Analog Scale Score After 50-mg Dose (Day 2)
Hide Description 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.
Time Frame At 1 hour post-dose, Day 2 (50 mg)
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (MITT) analysis data set included all randomized patients who received study treatment, classified according to their randomized treatment and provided the Modified Bond-Lader VAS score at baseline (pre-dose at Day 1 or Day 2) and at least 1 hour after 50 mg dose administration.
Arm/Group Title Quetiapine IR Quetiapine XR
Hide Arm/Group Description:
Quetiapine fumarate Immediate Release
Quetiapine fumarate Extended Release
Overall Number of Participants Analyzed 65 69
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on scale
45.022
(38.287 to 51.758)
32.472
(25.935 to 39.009)
2.Secondary Outcome
Title Modified Bond-Lader Visual Analog Scale Score After 100-mg Dose (Day 3)
Hide Description 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.
Time Frame At 1 hour post-dose, Day 3 (100 mg)
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (MITT) analysis data set included all randomized patients who received study treatment, classified according to their randomized treatment and provided the Modified Bond-Lader VAS score at baseline (pre-dose at Day 1 or Day 2) and at least 1 hour after 50 mg dose administration.
Arm/Group Title Quetiapine IR Quetiapine XR
Hide Arm/Group Description:
Quetiapine fumarate Immediate Release
Quetiapine fumarate Extended Release
Overall Number of Participants Analyzed 65 69
Least Squares Mean (Standard Error)
Unit of Measure: units on scale
51.521  (3.341) 29.146  (3.239)
3.Secondary Outcome
Title Modified Bond-Lader Visual Analog Scale Score After 200-mg Dose (Day 4)
Hide Description 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.
Time Frame At 1 hour post-dose, Day 4 (200 mg)
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (MITT) analysis data set included all randomized patients who received study treatment, classified according to their randomized treatment and provided the Modified Bond-Lader VAS score at baseline (pre-dose at Day 1 or Day 2) and at least 1 hour after 50 mg dose administration.
Arm/Group Title Quetiapine IR Quetiapine XR
Hide Arm/Group Description:
Quetiapine fumarate Immediate Release
Quetiapine fumarate Extended Release
Overall Number of Participants Analyzed 65 69
Least Squares Mean (Standard Error)
Unit of Measure: units on scale
48.336  (3.703) 30.130  (3.609)
4.Secondary Outcome
Title Modified Bond-Lader Visual Analog Scale Score After 300-mg Dose (Day 5)
Hide Description 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.
Time Frame At 1 hour post-dose, Day 5 (300 mg)
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (MITT) analysis data set included all randomized patients who received study treatment, classified according to their randomized treatment and provided the Modified Bond-Lader VAS score at baseline (pre-dose at Day 1 or Day 2) and at least 1 hour after 50 mg dose administration.
Arm/Group Title Quetiapine IR Quetiapine XR
Hide Arm/Group Description:
Quetiapine fumarate Immediate Release
Quetiapine fumarate Extended Release
Overall Number of Participants Analyzed 65 69
Least Squares Mean (Standard Error)
Unit of Measure: units on scale
49.414  (4.347) 32.626  (4.258)
5.Secondary Outcome
Title Modified Bond-Lader Visual Analog Scale Score After 300-mg Dose (Day 6)
Hide Description 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.
Time Frame At 1 hour post-dose, Day 6 (300 mg)
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (MITT) analysis data set included all randomized patients who received study treatment, classified according to their randomized treatment and provided the Modified Bond-Lader VAS score at baseline (pre-dose at Day 1 or Day 2) and at least 1 hour after 50 mg dose administration.
Arm/Group Title Quetiapine IR Quetiapine XR
Hide Arm/Group Description:
Quetiapine fumarate Immediate Release
Quetiapine fumarate Extended Release
Overall Number of Participants Analyzed 65 69
Least Squares Mean (Standard Error)
Unit of Measure: units on scale
48.959  (4.015) 30.144  (3.910)
6.Secondary Outcome
Title Maximum Intensity Modified Bond-Lader Visual Analog Scale Score
Hide Description 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 Frame During Day 2 (50 mg)
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (MITT) analysis data set included all randomized patients who received study treatment, classified according to their randomized treatment and provided the Modified Bond-Lader VAS score at baseline (pre-dose at Day 1 or Day 2) and at least 1 hour after 50 mg dose administration.
Arm/Group Title Quetiapine IR Quetiapine XR
Hide Arm/Group Description:
Quetiapine fumarate Immediate Release
Quetiapine fumarate Extended Release
Overall Number of Participants Analyzed 65 69
Least Squares Mean (Standard Error)
Unit of Measure: units on scale
99.929  (1.353) 96.937  (1.313)
7.Secondary Outcome
Title Time to Maximum Intensity Modified Bond-Lader Visual Analog Scale Score
Hide Description 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
Time Frame During Day 2 (50 mg)
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (MITT) analysis data set included all randomized patients who received study treatment, classified according to their randomized treatment and provided the Modified Bond-Lader VAS score at baseline (pre-dose at Day 1 or Day 2) and at least 1 hour after 50 mg dose administration.
Arm/Group Title Quetiapine IR Quetiapine XR
Hide Arm/Group Description:
Quetiapine fumarate Immediate Release
Quetiapine fumarate Extended Release
Overall Number of Participants Analyzed 65 69
Least Squares Mean (Standard Error)
Unit of Measure: Hours
3.685  (0.246) 4.254  (0.239)
8.Secondary Outcome
Title Area Under the Modified Bond-Lader Visual Analog Scale-time Curve
Hide Description 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
Time Frame During Day 2 (50 mg)
Hide Outcome Measure Data
Hide Analysis Population Description
The randomized safety analysis data set included all patients who received at 1 dose of randomized study treatment during the Randomized treatment Phase, classified according to actual treatment taken.
Arm/Group Title Quetiapine IR Quetiapine XR
Hide Arm/Group Description:
Quetiapine fumarate Immediate Release
Quetiapine fumarate Extended Release
Overall Number of Participants Analyzed 65 69
Least Squares Mean (Standard Error)
Unit of Measure: mm * hour
1061.12  (31.559) 988.842  (30.612)
9.Secondary Outcome
Title Change in Simpson-Angus Scale (SAS) Total Score
Hide Description 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.
Time Frame Randomization to Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
The randomized safety analysis data set included all patients who received at 1 dose of randomized study treatment during the Randomized treatment Phase, classified according to actual treatment taken.
Arm/Group Title Quetiapine IR Quetiapine XR
Hide Arm/Group Description:
Quetiapine fumarate Immediate Release
Quetiapine fumarate Extended Release
Overall Number of Participants Analyzed 69 70
Mean (Standard Deviation)
Unit of Measure: units on scale
-0.1  (0.8) 0.1  (0.5)
10.Secondary Outcome
Title Change in Barnes Akathisia Rating Scale (BARS) Global Score
Hide Description 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.
Time Frame Randomization to Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
The randomized safety analysis data set included all patients who received at 1 dose of randomized study treatment during the Randomized treatment Phase, classified according to actual treatment taken.
Arm/Group Title Quetiapine IR Quetiapine XR
Hide Arm/Group Description:
Quetiapine fumarate Immediate Release
Quetiapine fumarate Extended Release
Overall Number of Participants Analyzed 69 70
Mean (Standard Deviation)
Unit of Measure: units on scale
-0.07  (0.43) -0.09  (0.45)
11.Secondary Outcome
Title Change in Abnormal Involuntary Movement Scale (AIMS) Total Score
Hide Description 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.
Time Frame Randomization to Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
The randomized safety analysis data set included all patients who received at 1 dose of randomized study treatment during the Randomized treatment Phase, classified according to actual treatment taken.
Arm/Group Title Quetiapine IR Quetiapine XR
Hide Arm/Group Description:
Quetiapine fumarate Immediate Release
Quetiapine fumarate Extended Release
Overall Number of Participants Analyzed 69 70
Mean (Standard Deviation)
Unit of Measure: units on scale
-0.01  (0.3) -0.04  (0.4)
12.Secondary Outcome
Title Number of Patients With Potential Extrapyramidal Symptoms (EPS)
Hide Description Number of patients with adverse events potentially associated with EPS collected by MedDRA Preferred Terms as akathisia, extrapyramidal disorder, restlessness
Time Frame From start of the study treatment to last dose plus 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
The randomized safety analysis data set included all patients who received at 1 dose of randomized study treatment during the Randomized treatment Phase, classified according to actual treatment taken.
Arm/Group Title Quetiapine IR Quetiapine XR
Hide Arm/Group Description:
Quetiapine fumarate Immediate Release
Quetiapine fumarate Extended Release
Overall Number of Participants Analyzed 69 70
Measure Type: Number
Unit of Measure: Patients
8 2
13.Secondary Outcome
Title Number of Patients With Potential Somnolence
Hide Description Number of patients with adverse events potentially associated with somnolence collected by MedDRA Preferred Terms as lethargy, sedation, somnolence
Time Frame From start of the study treatment to last dose plus 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Quetiapine IR Quetiapine XR
Hide Arm/Group Description:
Quetiapine fumarate Immediate Release
Quetiapine fumarate Extended Release
Overall Number of Participants Analyzed 69 70
Measure Type: Number
Unit of Measure: Patients
11 12
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Quetiapine IR Quetiapine XR
Hide Arm/Group Description Quetiapine fumarate Immediate Release Quetiapine fumarate Extended Release
All-Cause Mortality
Quetiapine IR Quetiapine XR
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Quetiapine IR Quetiapine XR
Affected / at Risk (%) Affected / at Risk (%)
Total   0/69 (0.00%)   3/70 (4.29%) 
Nervous system disorders     
Convulsion  1  0/69 (0.00%)  1/70 (1.43%) 
Psychiatric disorders     
Depression  1  0/69 (0.00%)  1/70 (1.43%) 
Suicide Attempt  1  0/69 (0.00%)  1/70 (1.43%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Quetiapine IR Quetiapine XR
Affected / at Risk (%) Affected / at Risk (%)
Total   33/69 (47.83%)   29/70 (41.43%) 
Cardiac disorders     
Tachycardia  1  6/69 (8.70%)  3/70 (4.29%) 
Gastrointestinal disorders     
Dry Mouth  1  9/69 (13.04%)  15/70 (21.43%) 
Nausea  1  1/69 (1.45%)  4/70 (5.71%) 
General disorders     
Fatigue  1  3/69 (4.35%)  6/70 (8.57%) 
Metabolism and nutrition disorders     
Increased Appetite  1  11/69 (15.94%)  11/70 (15.71%) 
Nervous system disorders     
Dizziness  1  11/69 (15.94%)  4/70 (5.71%) 
Headache  1  8/69 (11.59%)  4/70 (5.71%) 
Somnolence  1  5/69 (7.25%)  7/70 (10.00%) 
Sedation  1  4/69 (5.80%)  5/70 (7.14%) 
Akathisia  1  4/69 (5.80%)  1/70 (1.43%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The PI agrees to collaborate in good faith with AstraZeneca with regards to the contents and formation of any publication or disclosure to be made by the PI and to pay due consideration to the comments, views and opinions offered by AstraZeneca
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Gerard Lynch
Organization: AstraZeneca
EMail: AZTrial_Results_Posting@astrazeneca.com
Layout table for additonal information
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