Quetiapine Extended Release (XR) in Bipolar Patients With Comorbid Generalized Anxiety Disorder (GAD)
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ClinicalTrials.gov Identifier: NCT00671853 |
Recruitment Status :
Completed
First Posted : May 5, 2008
Results First Posted : October 11, 2013
Last Update Posted : December 29, 2016
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Sponsor:
University Hospitals Cleveland Medical Center
Collaborators:
National Alliance for Research on Schizophrenia and Depression
AstraZeneca
Information provided by (Responsible Party):
Keming Gao, University Hospitals Cleveland Medical Center
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Study Type | Interventional |
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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 |
Participant Flow
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 |
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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 |
Baseline Characteristics
Arm/Group Title | Quetiapine XR | Placebo for Quetiapine XR | Total | |
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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 | |
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[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 46 participants | 45 participants | 91 participants | |
<=18 years |
0 0.0%
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0 0.0%
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0 0.0%
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Between 18 and 65 years |
46 100.0%
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45 100.0%
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91 100.0%
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>=65 years |
0 0.0%
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0 0.0%
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0 0.0%
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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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 |
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Number Analyzed | 46 participants | 45 participants | 91 participants | |
Female |
22 47.8%
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21 46.7%
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43 47.3%
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Male |
24 52.2%
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24 53.3%
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48 52.7%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 46 participants | 45 participants | 91 participants |
46 | 45 | 91 |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
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):
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 |