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Trial record 88 of 582 for:    ESCITALOPRAM

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

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ClinicalTrials.gov 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
Sponsor:
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
HIV
Interventions Drug: Placebo
Drug: Escitalopram
Enrollment 5
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Sugar Pill Active Drug
Hide Arm/Group Description Placebo Escitalopram tablet, 10mg, daily, 9 weeks.
Period Title: Overall Study
Started 3 [1] 2
Completed 0 [1] 0
Not Completed 3 2
[1]
Terminated due to lack of enrollment
Arm/Group Title Sugar Pill Active Drug Total
Hide Arm/Group Description Placebo Escitalopram tablet, 10mg, daily, 9 weeks. Total of all reporting groups
Overall Number of Baseline Participants 3 2 5
Hide Baseline Analysis Population Description
Terminated study. Study terminated prior to interventions
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 2 participants 5 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
3
 100.0%
2
 100.0%
5
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 2 participants 5 participants
Female
3
 100.0%
2
 100.0%
5
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 3 participants 2 participants 5 participants
3 2 5
1.Primary Outcome
Title Reduction in Depressive Symptoms
Hide Description Depressive symptoms were assessed by questionaire at baseline and finally at the end of the study at 9 weeks.
Time Frame 9 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
Terminated due to lack of recruitment. Five subjects were consented for the trial, but were not able to complete study or generate analyzable data.
Arm/Group Title Sugar Pill Active Drug
Hide Arm/Group Description:
Placebo
Escitalopram tablet, 10mg, daily, 9 weeks.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Study was terminated early due to failure to recruit.
Adverse Event Reporting Description Study was terminated before adverse events were noted.No participants were treated therefore no participants were analyzed.
 
Arm/Group Title Sugar Pill Active Drug
Hide Arm/Group Description Placebo Escitalopram tablet, 10mg, daily, 9 weeks.
All-Cause Mortality
Sugar Pill Active Drug
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Sugar Pill Active Drug
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Sugar Pill Active Drug
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0