Open-Label Pilot Study to Examine the Value of Substituting Quetiapine for Benzodiazepines

This study has been terminated.
(Terminated: recruiting or enrolling participants has halted prematurely)
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT01244711
First received: November 18, 2010
Last updated: March 17, 2015
Last verified: March 2015
Results First Received: December 18, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Major Depression
Generalized Anxiety Disorder
Intervention: Drug: quetiapine

  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
No text entered.

Reporting Groups
  Description
Quetiapine

Dosing will begin with Seroquel-XR 50 mg. at bedtime and will escalate weekly to Seroquel-XR 100mg., Seroquel-XR 200mg. and Seroquel-XR 300 mg depending on clinical response and side effects.

quetiapine: Dosing will begin with Seroquel-XR 50 mg. at bedtime and will escalate weekly to Seroquel-XR 100mg., Seroquel-XR 200mg. and Seroquel-XR 300 mg depending on clinical response and side effects.


Participant Flow:   Overall Study
    Quetiapine  
STARTED     1  
COMPLETED     1  
NOT COMPLETED     0  



  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

Dosing will begin with Seroquel-XR 50 mg. at bedtime and will escalate weekly to Seroquel-XR 100mg., Seroquel-XR 200mg. and Seroquel-XR 300 mg depending on clinical response and side effects.

quetiapine: Dosing will begin with Seroquel-XR 50 mg. at bedtime and will escalate weekly to Seroquel-XR 100mg., Seroquel-XR 200mg. and Seroquel-XR 300 mg depending on clinical response and side effects.


Baseline Measures
    Quetiapine  
Number of Participants  
[units: participants]
  1  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     1  
>=65 years     0  
Age  
[units: years]
Mean (Full Range)
  48    (48 to 48)  
Gender  
[units: participants]
 
Female     0  
Male     1  
Region of Enrollment  
[units: participants]
 
United States     1  



  Outcome Measures

1.  Primary:   Montgomery Asberg Depression Rating Scale (MADRS)   [ Time Frame: 12 weeks ]


  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:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: james kocsis
Organization: Weill Cornell Medical College
phone: 212-746-5913
e-mail: jhk2002@med.cornell.edu


No publications provided


Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT01244711     History of Changes
Other Study ID Numbers: IRUSQUET0483
Study First Received: November 18, 2010
Results First Received: December 18, 2014
Last Updated: March 17, 2015
Health Authority: United States: Food and Drug Administration