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Quetiapine Extended Release (XR) in Bipolar Patients With Comorbid Generalized Anxiety Disorder (GAD)

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.
 
ClinicalTrials.gov Identifier: NCT00671853
Recruitment Status : Completed
First Posted : May 5, 2008
Results First Posted : October 11, 2013
Last Update Posted : December 29, 2016
Sponsor:
Collaborators:
National Alliance for Research on Schizophrenia and Depression
AstraZeneca
Information provided by (Responsible Party):
Keming Gao, University Hospitals Cleveland Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions Bipolar Disorder
Anxiety
Anxiety Disorders
Substance Use Disorders
Interventions Drug: Quetiapine XR
Drug: Placebo for quetiapine XR
Enrollment 120
Recruitment Details  
Pre-assignment Details The study consent 120 subjects. However, 29 subjects were considered screening failures and were not randomized.
Arm/Group Title Quetiapine XR Placebo for Quetiapine XR
Hide Arm/Group Description Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day
Period Title: Overall Study
Started 46 45
Completed 26 18
Not Completed 20 27
Reason Not Completed
Lack of Efficacy             3             7
Adverse Event             7             1
Withdrawal by Subject             1             5
Lost to Follow-up             8             8
Physician Decision             0             2
Non-adherence with study procedures             1             4
Arm/Group Title Quetiapine XR Placebo for Quetiapine XR Total
Hide Arm/Group Description Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day Total of all reporting groups
Overall Number of Baseline Participants 46 45 91
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants 45 participants 91 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
46
 100.0%
45
 100.0%
91
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 46 participants 45 participants 91 participants
38.0  (12) 37.4  (11.3) 37.7  (11.6)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants 45 participants 91 participants
Female
22
  47.8%
21
  46.7%
43
  47.3%
Male
24
  52.2%
24
  53.3%
48
  52.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 46 participants 45 participants 91 participants
46 45 91
1.Primary Outcome
Title Change in the 17 Item Hamilton Rating Scale for Depression (HAM-D-17) Score
Hide Description A score of 0-7 is considered to be normal. Hamilton Rating Scale total score ranges from 0-57 where higher scores are indicative of more depression.
Time Frame Week 0 - Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Quetiapine XR Placebo for Quetiapine XR
Hide Arm/Group Description:
Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day
Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day
Overall Number of Participants Analyzed 46 45
Mean (Standard Deviation)
Unit of Measure: units on a scale
-9.91  (16.45) -7.41  (8.13)
2.Secondary Outcome
Title Response Rate (≥ 50% Improvement) on Hamilton Rating Scale for Depression (HAM-D-17)
Hide Description A score of 0-7 is considered to be normal. Hamilton Rating Scale total score ranges from 0-57 where higher scores are indicative of more depression.
Time Frame Week 0 - Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Quetiapine XR Placebo for Quetiapine XR
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 46 45
Measure Type: Number
Unit of Measure: participants
12 11
3.Secondary Outcome
Title Remission Rate (≤ 7) on Hamilton Rating Scale for Depression (HAM-D-17)
Hide Description A score of 0-7 is considered to be normal. Hamilton Rating Scale total score ranges from 0-57 where higher scores are indicative of more depression. Remission is defined by the number of participants with Hamilton Rating Scale for Depression score equal to or less than 7.
Time Frame Week 0 - Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Quetiapine XR Placebo for Quetiapine XR
Hide Arm/Group Description:
Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day
Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day
Overall Number of Participants Analyzed 46 45
Measure Type: Number
Unit of Measure: Participants
6 6
4.Secondary Outcome
Title Change in Clinical Global Impressions of Improvement or Severity (CGI-I or S) Score
Hide Description

The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment.

1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill.
Time Frame Week 0 - Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Quetiapine XR Placebo for Quetiapine XR
Hide Arm/Group Description:
Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day
Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day
Overall Number of Participants Analyzed 46 45
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.10  (1.16) -0.8  (1.21)
5.Secondary Outcome
Title Change in the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Score
Hide Description This assessment degree of enjoyment and satisfaction experienced by subjects in various areas of daily functioning. The minimum raw score on the Q-LES-Q-SF is 14, and the maximum score is 70 with a higher score indicating less enjoyment and satisfaction.
Time Frame Week 0 - Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Quetiapine XR Placebo for Quetiapine XR
Hide Arm/Group Description:
Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day
Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day
Overall Number of Participants Analyzed 46 45
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.11  (0.22) -0.06  (0.52)
6.Secondary Outcome
Title Change in Hamilton Rating Scale for Anxiety (HAM-A)
Hide Description The scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety).Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe
Time Frame Week 0 - Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Quetiapine XR Placebo for Quetiapine XR
Hide Arm/Group Description:
Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day
Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day
Overall Number of Participants Analyzed 46 45
Mean (Standard Deviation)
Unit of Measure: units on a scale
-9.54  (7.58) -8.25  (8.70)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Quetiapine XR Placebo for Quetiapine XR
Hide Arm/Group Description Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day
All-Cause Mortality
Quetiapine XR Placebo for Quetiapine XR
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Quetiapine XR Placebo for Quetiapine XR
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/46 (0.00%)      0/45 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Quetiapine XR Placebo for Quetiapine XR
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   44/46 (95.65%)      37/45 (82.22%)    
Ear and labyrinth disorders     
Dry Mouth  27/46 (58.70%)  27 9/45 (20.00%)  9
Gastrointestinal disorders     
Diarrhea  1/46 (2.17%)  1 3/45 (6.67%)  3
Nausea  3/46 (6.52%)  3 2/45 (4.44%)  2
Stomach Upset  3/46 (6.52%)  3 5/45 (11.11%)  5
General disorders     
Dizziness  8/46 (17.39%)  8 8/45 (17.78%)  8
Headache  7/46 (15.22%)  7 3/45 (6.67%)  3
Increased Appetite  1/46 (2.17%)  1 4/45 (8.89%)  4
Psychiatric disorders     
Sedation  4/46 (8.70%)  4 14/45 (31.11%)  14
[Not Specified]
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Kemp Gao
Organization: University Hospitals Cleveland Medical Center
Phone: 216-844-2865
EMail: keming.gao@UHhopsitals.org
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Keming Gao, University Hospitals Cleveland Medical Center
ClinicalTrials.gov Identifier: NCT00671853    
Other Study ID Numbers: 10-06-19
First Submitted: May 1, 2008
First Posted: May 5, 2008
Results First Submitted: April 16, 2012
Results First Posted: October 11, 2013
Last Update Posted: December 29, 2016