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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Andrew H Miller, Emory University
ClinicalTrials.gov Identifier:
NCT00352885
First received: July 13, 2006
Last updated: October 2, 2014
Last verified: October 2014
Results First Received: March 8, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Double Blind (Subject, Caregiver, 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  
Number of Participants  
[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.   Safety Issue:   No

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.   Safety Issue:   No

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

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

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.   Safety Issue:   No

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


  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


No publications provided by Emory University

Publications automatically indexed to this study:

Responsible Party: Andrew H Miller, Emory University
ClinicalTrials.gov Identifier: NCT00352885     History of Changes
Other Study ID Numbers: IRB00024759, R01MH071580, DATR A3-NSS
Study First Received: July 13, 2006
Results First Received: March 8, 2014
Last Updated: October 2, 2014
Health Authority: United States: Federal Government