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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01797380
Recruitment Status : Terminated (Failure to recruit.)
First Posted : February 22, 2013
Results First Posted : May 16, 2013
Last Update Posted : May 27, 2013
Information provided by (Responsible Party):
Duke University

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Depression
Interventions: Drug: Placebo
Drug: Escitalopram

  Participant Flow

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
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 
[1] Terminated due to lack of enrollment

  Baseline Characteristics

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

Baseline Measures
   Sugar Pill   Active Drug   Total 
Overall Participants Analyzed 
[Units: Participants]
 3   2   5 
[Units: Participants]
<=18 years   0   0   0 
Between 18 and 65 years   3   2   5 
>=65 years   0   0   0 
[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

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

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


Responsible Party: Duke University Identifier: NCT01797380     History of Changes
Other Study ID Numbers: Pro00000703
First Submitted: February 20, 2013
First Posted: February 22, 2013
Results First Submitted: February 25, 2013
Results First Posted: May 16, 2013
Last Update Posted: May 27, 2013