A Trial Examining the Efficacy of Escitalopram Oxalate Upon Depressive Symptoms and Fatigue in HIV Seropositive Women

This study has been terminated.
(Failure to recruit.)
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01797380
First received: February 20, 2013
Last updated: May 17, 2013
Last verified: March 2013
Results First Received: February 25, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Depression
HIV
Interventions: Drug: Placebo
Drug: Escitalopram

  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
Sugar Pill Placebo
Active Drug Escitalopram tablet, 10mg, daily, 9 weeks.

Participant Flow:   Overall Study
    Sugar Pill     Active Drug  
STARTED     3 [1]   2  
COMPLETED     0 [1]   0  
NOT COMPLETED     3     2  
[1] Terminated due to lack of enrollment



  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.
Terminated study. Study terminated prior to interventions

Reporting Groups
  Description
Sugar Pill Placebo
Active Drug Escitalopram tablet, 10mg, daily, 9 weeks.
Total Total of all reporting groups

Baseline Measures
    Sugar Pill     Active Drug     Total  
Number of Participants  
[units: participants]
  3     2     5  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     3     2     5  
>=65 years     0     0     0  
Gender  
[units: participants]
     
Female     3     2     5  
Male     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     3     2     5  



  Outcome Measures

1.  Primary:   Reduction in Depressive Symptoms   [ Time Frame: 9 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: Harold Goforth, M.D.
Organization: Duke University Health Systems
phone: 216-636-3999
e-mail: goforth@ccf.org


Publications:

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01797380     History of Changes
Other Study ID Numbers: Pro00000703
Study First Received: February 20, 2013
Results First Received: February 25, 2013
Last Updated: May 17, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board