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A Study of Quetiapine and Mirtazapine for the Treatment of Alcohol Dependency

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:
NCT01165541
First received: July 16, 2010
Last updated: February 13, 2014
Last verified: February 2014
Results First Received: December 19, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Alcohol Dependence
Interventions: Drug: Mirtazapine
Drug: Quetiapine fumarate extended release (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
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Reporting Groups
  Description
Entire Study Population Quetiapine fumarate extended release (Quetiapine XR): Quetiapine fumarate extended release 50-400mg/d first for 7 weeks; then Quetiapine XR plus mirtazapine: Quetiapine fumarate extended release (50-400mg) plus mirtazapine (7.5-45mg) for 7 weeks.

Participant Flow for 2 periods

Period 1:   Quetiapine XR Monotherapy
    Entire Study Population  
STARTED     20  
COMPLETED     16  
NOT COMPLETED     4  

Period 2:   Quetiapine XR and Mirtazepine
    Entire Study Population  
STARTED     16  
COMPLETED     11  
NOT COMPLETED     5  



  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.
Entire study population

Reporting Groups
  Description
Entire Study Population Quetiapine fumarate extended release (Quetiapine XR): Quetiapine fumarate extended release 50-400mg/d first for 7 weeks; then Quetiapine XR and mirtazapine: Quetiapine fumarate extended release (50-400mg) and mirtazapine (7.5-45mg) for 7 weeks.

Baseline Measures
    Entire Study Population  
Number of Participants  
[units: participants]
  20  
Age  
[units: years]
Mean ± Standard Deviation
  48.1  ± 10.1  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     20  
>=65 years     0  
Gender  
[units: participants]
 
Female     6  
Male     14  
Region of Enrollment  
[units: participants]
 
United States     20  



  Outcome Measures

1.  Primary:   Number of Very Heavy Drinking Days Per Week   [ Time Frame: 14 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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Mary Brunette, MD
Organization: Geisel School of Medicine At Dartmouth
phone: 603-271-7642
e-mail: mary.brunette@dartmouth.edu


No publications provided


Responsible Party: Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT01165541     History of Changes
Other Study ID Numbers: QM1
Study First Received: July 16, 2010
Results First Received: December 19, 2013
Last Updated: February 13, 2014
Health Authority: United States: Institutional Review Board