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Evaluating the Effectiveness of Escitalopram in Preventing or Reducing Depressive Symptoms in People Receiving Interleukin-2 Treatment

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00352885
First Posted: July 17, 2006
Last Update Posted: October 9, 2014
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.
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Andrew H Miller, Emory University
Results First Submitted: March 8, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Depression
Interventions: Drug: Escitalopram
Drug: Placebo
Drug: IL-2

  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
Escitalopram Participants will receive escitalopram 10-20 mg/day 2 weeks before and during IL-2 treatment
Placebo Participants will receive placebo 2 weeks before and during IL-2 treatment

Participant Flow:   Overall Study
    Escitalopram   Placebo
STARTED   9   11 
COMPLETED   4   3 
NOT COMPLETED   5   8 



  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.
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Reporting Groups
  Description
Escitalopram Participants will receive escitalopram and IL-2 treatment
Placebo Participants will receive placebo and IL-2 treatment
Total Total of all reporting groups

Baseline Measures
   Escitalopram   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 9   11   20 
Age 
[Units: Years]
Mean (Standard Deviation)
 50.8  (8.4)   44.6  (16.1)   47.4  (13.3) 
Gender 
[Units: Participants]
     
Female   2   8   10 
Male   7   3   10 


  Outcome Measures

1.  Primary:   Number of IL-2 Treatments Tolerated   [ Time Frame: Measured over 5 months of treatment ]

2.  Secondary:   Neuroendocrine System Functioning and Stress Hormone Levels   [ Time Frame: Measured over 5 months of IL-2 treatment ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

3.  Secondary:   Immune System Functioning   [ Time Frame: Measured over 5 months of IL-2 treatment ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

4.  Secondary:   Serotonin Metabolism   [ Time Frame: Measured over 5 months of IL-2 treatment ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

5.  Secondary:   Serotonin Metabolism   [ Time Frame: Measured over 5 months of IL-2 treatment ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

6.  Secondary:   Cognitive Functioning, as Assessed by Computerized Neuropsychological Testing   [ Time Frame: Measured on Day 2 of each IL-2 cycle ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

7.  Secondary:   Genetic Polymorphisms   [ Time Frame: Measured before and after IL-2 treatment ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  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: Bobbi Woolwine
Organization: Emory University
phone: 404-712-9620
e-mail: bwoolwi@emory.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Andrew H Miller, Emory University
ClinicalTrials.gov Identifier: NCT00352885     History of Changes
Other Study ID Numbers: IRB00024759
R01MH071580 ( U.S. NIH Grant/Contract )
DATR A3-NSS
First Submitted: July 13, 2006
First Posted: July 17, 2006
Results First Submitted: March 8, 2014
Results First Posted: June 27, 2014
Last Update Posted: October 9, 2014