Efficacy and Safety of Escitalopram for Prevention of Depression Induced by Peg-Interferon in Hepatitis C Patients
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ClinicalTrials.gov Identifier: NCT00166296 |
Recruitment Status :
Completed
First Posted : September 14, 2005
Results First Posted : March 30, 2011
Last Update Posted : August 17, 2020
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Sponsor:
Germans Trias i Pujol Hospital
Collaborators:
Hoffmann-La Roche
H. Lundbeck A/S
Information provided by:
Germans Trias i Pujol Hospital
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Prevention |
Conditions |
Major Depressive Disorder Hepatitis C, Chronic |
Interventions |
Drug: Escitalopram Drug: Placebo |
Enrollment | 133 |
Participant Flow
Recruitment Details | 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 |
Arm/Group Title | Escitalopram | Placebo |
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Patients treated with 15 mg/day of Escitalopram since 2 weeks before starting pegylated interferon and ribavirin until week 12 of antiviral treatment | Patients treated with placebo since 2 weeks before starting pegylated interferon and ribavirin until week 12 of antiviral treatment |
Period Title: Overall Study | ||
Started | 67 [1] | 66 [1] |
ANALYZED | 66 [2] | 63 [2] |
Completed | 60 [3] | 57 [3] |
Not Completed | 7 | 9 |
Reason Not Completed | ||
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
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Baseline Characteristics
Arm/Group Title | Escitalopram | Placebo | Total | |
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Patients treated with 15 mg/day of Escitalopram since 2 weeks before starting pegylated interferon and ribavirin until week 12 of antiviral treatment | Patients treated with placebo since 2 weeks before starting pegylated interferon and ribavirin until week 12 of antiviral treatment | Total of all reporting groups | |
Overall Number of Baseline Participants | 67 | 66 | 133 | |
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[Not Specified]
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Age, Customized
Measure Type: Number Unit of measure: Participants |
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Between 18 and 65 years | Number Analyzed | 67 participants | 66 participants | 133 participants |
67 | 66 | 133 | ||
Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 67 participants | 66 participants | 133 participants | |
46.7 (10.6) | 44.8 (10.8) | 45.8 (10.7) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 67 participants | 66 participants | 133 participants | |
Female |
28 41.8%
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25 37.9%
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53 39.8%
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Male |
39 58.2%
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41 62.1%
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80 60.2%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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Spain | Number Analyzed | 67 participants | 66 participants | 133 participants |
67 | 66 | 133 |
Outcome Measures
Adverse Events
Limitations and Caveats
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
Results Point of Contact
Name/Title: | Crisanto Diez-Quevedo |
Organization: | Hospital Universitari Germans Trias i Pujol, Autonomous University of Barcelona |
Phone: | +34934978814 |
EMail: | cdiezquevedo.germanstrias@gencat.cat |
Responsible Party: | Crisanto Diez-Quevedo, Germans Trias i Pujol Hospital |
ClinicalTrials.gov Identifier: | NCT00166296 |
Other Study ID Numbers: |
PSQHEPGTP1 EudraCT number: 2004-002982-19 |
First Submitted: | September 9, 2005 |
First Posted: | September 14, 2005 |
Results First Submitted: | February 8, 2011 |
Results First Posted: | March 30, 2011 |
Last Update Posted: | August 17, 2020 |