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

This study has been completed.
Sponsor:
Collaborators:
National Alliance for Research on Schizophrenia and Depression
AstraZeneca
Information provided by (Responsible Party):
Dr. Keming Gao, University Hospital Case Medical Center
ClinicalTrials.gov Identifier:
NCT00671853
First received: May 1, 2008
Last updated: September 30, 2013
Last verified: January 2013
Results First Received: April 16, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Conditions: Bipolar Disorder
Anxiety
Anxiety Disorders
Substance Use Disorders
Interventions: Drug: Quetiapine XR
Drug: Placebo for quetiapine XR

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The study consent 120 subjects. However, 29 subjects were considered screening failures and were not randomized.

Reporting Groups
  Description
Quetiapine XR Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day
Placebo for Quetiapine XR Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day

Participant Flow:   Overall Study
    Quetiapine XR     Placebo for Quetiapine XR  
STARTED     46     45  
COMPLETED     26     18  
NOT COMPLETED     20     27  
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
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Quetiapine XR Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day
Placebo for Quetiapine XR Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day
Total Total of all reporting groups

Baseline Measures
    Quetiapine XR     Placebo for Quetiapine XR     Total  
Number of Participants  
[units: participants]
  46     45     91  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     46     45     91  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  38.0  ± 12     37.4  ± 11.3     37.7  ± 11.6  
Gender  
[units: participants]
     
Female     22     21     43  
Male     24     24     48  
Region of Enrollment  
[units: participants]
     
United States     46     45     91  



  Outcome Measures
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1.  Primary:   Change in the 17 Item Hamilton Rating Scale for Depression (HAM-D-17) Score   [ Time Frame: Week 0 - Week 8 ]

2.  Secondary:   Response Rate (≥ 50% Improvement) on Hamilton Rating Scale for Depression (HAM-D-17)   [ Time Frame: Week 0 - Week 8 ]

3.  Secondary:   Remission Rate (≤ 7) on Hamilton Rating Scale for Depression (HAM-D-17)   [ Time Frame: Week 0 - Week 8 ]

4.  Secondary:   Change in Clinical Global Impressions of Improvement or Severity (CGI-I or S) Score   [ Time Frame: Week 0 - Week 8 ]

5.  Secondary:   Change in the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Score   [ Time Frame: Week 0 - Week 8 ]

6.  Secondary:   Change in Hamilton Rating Scale for Anxiety (HAM-A)   [ Time Frame: Week 0 - Week 8 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Kemp Gao
Organization: University Hospitals Case Medical Center
phone: 216-844-2865
e-mail: keming.gao@UHhopsitals.org


No publications provided


Responsible Party: Dr. Keming Gao, University Hospital Case Medical Center
ClinicalTrials.gov Identifier: NCT00671853     History of Changes
Other Study ID Numbers: 10-06-19
Study First Received: May 1, 2008
Results First Received: April 16, 2012
Last Updated: September 30, 2013
Health Authority: United States: Food and Drug Administration