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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):
Keming Gao, University Hospitals Cleveland Medical Center
ClinicalTrials.gov Identifier:
NCT00671853
First received: May 1, 2008
Last updated: November 9, 2016
Last verified: November 2016
Results First Received: April 16, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (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

  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
No text entered.

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 
Overall Participants Analyzed 
[Units: Participants]
 46   45   91 
Age 
[Units: Participants]
Count of 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 
[Units: Years]
Mean (Standard Deviation)
 38.0  (12)   37.4  (11.3)   37.7  (11.6) 
Gender 
[Units: Participants]
Count of Participants
     
Female      22  47.8%      21  46.7%      43  47.3% 
Male      24  52.2%      24  53.3%      48  52.7% 
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 Cleveland Medical Center
phone: 216-844-2865
e-mail: 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     History of Changes
Other Study ID Numbers: 10-06-19
Study First Received: May 1, 2008
Results First Received: April 16, 2012
Last Updated: November 9, 2016