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Efficacy and Safety of Escitalopram for Prevention of Depression Induced by Peg-Interferon in Hepatitis C Patients

This study has been completed.
Sponsor:
Collaborators:
Hoffmann-La Roche
H. Lundbeck A/S
Information provided by:
Germans Trias i Pujol Hospital
ClinicalTrials.gov Identifier:
NCT00166296
First received: September 9, 2005
Last updated: March 4, 2011
Last verified: March 2011
History of Changes
Results First Received: February 8, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions: Major Depressive Disorder.
Hepatitis C, Chronic
Interventions: Drug: Escitalopram
Drug: Placebo

  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
Participants were recruited among chronic hepatitis C patients between 18 and 65 years old, referred by general practitioners between March 2005 and July 2006 to gastroenterology outpatient units in 15 academic general hospitals in Spain, who were suitable to initiate treatment with pegylated interferonalfa-2a and ribavirin.

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
Escitalopram Patients treated with 15 mg/day of Escitalopram since 2 weeks before starting pegylated interferon and ribavirin until week 12 of antiviral treatment
Placebo Patients treated with placebo since 2 weeks before starting pegylated interferon and ribavirin until week 12 of antiviral treatment

Participant Flow:   Overall Study
    Escitalopram     Placebo  
STARTED     67 [1]   66 [1]
ANALYZED     66 [2]   63 [2]
COMPLETED     60 [3]   57 [3]
NOT COMPLETED     7     9  
Withdrawal by Subject                 1                 3  
Adverse Event                 2                 4  
Lost to Follow-up                 4                 2  
[1] Randomized patients
[2] Patients who did receive at least the first dose of study medications, included in the analysis
[3] Patients who completed both trial medication and interferon+ribavirin treatment for 12 weeks



  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.
No text entered.

Reporting Groups
  Description
Escitalopram Patients treated with 15 mg/day of Escitalopram since 2 weeks before starting pegylated interferon and ribavirin until week 12 of antiviral treatment
Placebo Patients treated with placebo since 2 weeks before starting pegylated interferon and ribavirin until week 12 of antiviral treatment
Total Total of all reporting groups

Baseline Measures
    Escitalopram     Placebo     Total  
Number of Participants  
[units: participants]
 		  67     66     133  
Age  
[units: participants]
 		     
Between 18 and 65 years     67     66     133  
Age  
[units: years]
Mean (Standard Deviation) 		  46.7  (10.6)     44.8  (10.8)     45.8  (10.7)  
Gender  
[units: participants]
 		     
Female     28     25     53  
Male     39     41     80  
Region of Enrollment  
[units: participants]
 		     
Spain     67     66     133  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants Who Developed a Major Depressive Episode According to Diagnostic & Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) Criteria During the First 12 Weeks of Antiviral Treatment.   [ Time Frame: First three months of interferon treatment. ]
  Show Outcome Measure 1

2.  Primary:   Number of Participants With Sustained Hepatitis C Viral Response (Negativization of Serum Hepatitis C Virus Ribonucleic Acid).   [ Time Frame: Six months after the end of interferon treatment ]
  Show Outcome Measure 2

3.  Secondary:   Total Score in the Montgomery-Asberg Depression Rating Scale   [ Time Frame: 12 weeks after interferon treatment onset ]
  Show Outcome Measure 3

4.  Secondary:   Total Score in the Depression Subscale of the Hospital Anxiety and Depression Scale.   [ Time Frame: 12 weeks after interferon treatment onset ]
  Show Outcome Measure 4


  Serious Adverse Events
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  Other Adverse Events
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  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
The low depression rate found may have underpowered the study. Selection of a much less depressive sample than in other studies. Limitation to the first 12 weeks of antiviral treatment.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Crisanto Diez-Quevedo
Organization: Hospital Universitari Germans Trias i Pujol, Autonomous University of Barcelona
phone: +34934978814
e-mail: cdiezquevedo.germanstrias@gencat.cat


Publications of Results:


Responsible Party: Crisanto Diez-Quevedo, Germans Trias i Pujol Hospital
ClinicalTrials.gov Identifier: NCT00166296     History of Changes
Other Study ID Numbers: PSQHEPGTP1
EudraCT number: 2004-002982-19
Study First Received: September 9, 2005
Results First Received: February 8, 2011
Last Updated: March 4, 2011
Health Authority: Spain: Spanish Agency of Medicines