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STAR*D Alcohol: Treatment of Depression Concurrent With Alcohol Abuse

This study has been completed.
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT00369746
First received: August 24, 2006
Last updated: April 9, 2014
Last verified: December 2011
Results First Received: November 23, 2011  
Study Type: Observational
Study Design: Observational Model: Case Control;   Time Perspective: Prospective
Conditions: Major Depressive Disorder
Alcohol Use Disorder
Intervention: Drug: citalopram

  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
Participants were recruited from all participants entering the Sequenced Treatment Alternatives to Relieve Depression clinical trial.

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
Alcohol Abuse or Dependence Subjects with alcohol abuse or dependence and Major Depression
Major Depression Only Major Depression without alcohol abuse disorder

Participant Flow:   Overall Study
    Alcohol Abuse or Dependence   Major Depression Only
STARTED   138   536 
COMPLETED   138   536 
NOT COMPLETED   0   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
Alcohol Abuse or Dependence Subjects with alcohol abuse or dependence
Major Depression Only Major Depression without alcohol abuse disorder
Total Total of all reporting groups

Baseline Measures
   Alcohol Abuse or Dependence   Major Depression Only   Total 
Overall Participants Analyzed 
[Units: Participants]
 138   536   674 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   138   536   674 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 36.7  (12.3)   39.5  (13.4)   38.9  (13.2) 
Gender 
[Units: Participants]
     
Female   77   134   211 
Male   61   402   463 
Region of Enrollment 
[Units: Participants]
     
United States   138   536   674 


  Outcome Measures
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1.  Primary:   Quick Inventory of Depression- Self Report 16   [ Time Frame: study exit visit, at Week 12 ]

2.  Secondary:   Timeline Follow Back (TLFB) Average Drinks Per Drinking Day   [ Time Frame: 30 days ]

3.  Secondary:   Quantitative Substance Use Inventory ((SUI)   [ Time Frame: 30 days ]

4.  Secondary:   Timeline Follow Back (TLFB) Drinking Days Per 30 Days   [ Time Frame: 30 days ]

5.  Secondary:   Timeline Follow Back (TLFB) Maximum Drinks Per Drinking Day   [ Time Frame: 30 days ]


  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: Patrick J. McGrath, M.D.
Organization: New York State Psychiatric Institute
phone: 646-774-8076
e-mail: mcgrath@nyspi.columbia.edu



Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00369746     History of Changes
Other Study ID Numbers: #5173
R01AA013303 ( US NIH Grant/Contract Award Number )
Study First Received: August 24, 2006
Results First Received: November 23, 2011
Last Updated: April 9, 2014