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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
Sponsor:
Collaborators:
Hoffmann-La Roche
H. Lundbeck A/S
Information provided by:
Germans Trias i Pujol Hospital

Study Type Interventional
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
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
Hide Arm/Group Description 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
Arm/Group Title Escitalopram Placebo Total
Hide Arm/Group Description 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
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
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
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
Number Analyzed 67 participants 66 participants 133 participants
Female
28
  41.8%
25
  37.9%
53
  39.8%
Male
39
  58.2%
41
  62.1%
80
  60.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Spain Number Analyzed 67 participants 66 participants 133 participants
67 66 133
1.Primary Outcome
Title 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.
Hide Description

At least five of the symptoms have been present during the same 1-week period: depressed mood, loss of interest or pleasure, weight or appetite changes, insomnia, agitation or retardation, fatigue, feelings of worthlessness or guilt, diminished ability to think or concentrate, recurrent thoughts of death.

At least one of the symptoms is either depressed mood or loss of interest. Diagnoses were made by a trained psychiatrist who applied the mood disorders module from the Structured Clinical Interview for DSM-IV Axis I Disorders, non-patient edition (SCID-I/NP) at each study evaluation.
Time Frame First three months of interferon treatment.
Hide Outcome Measure Data
Hide Analysis Population Description
One of 67 patients allocated to the escitalopram group and 3 of 66 in placebo did not receive the first dose of study medications. Consequently, 66 patients treated with escitalopram and 63 with placebo were included in the intention to treat analysis, with a procedure of last observation carried forward (LOCF).
Arm/Group Title Escitalopram Placebo
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 66 63
Measure Type: Number
Unit of Measure: Participants
5 2
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Escitalopram, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.441
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.400
Confidence Interval (2-Sided) 95%
0.075 to 2.141
Estimation Comments [Not Specified]
2.Primary Outcome
Title Number of Participants With Sustained Hepatitis C Viral Response (Negativization of Serum Hepatitis C Virus Ribonucleic Acid).
Hide Description

Number of participants with negativization of serum hepatitis C Virus Ribonucleic Acid (HCV RNA) 6 months after concluding antiviral therapy (sustained viral response).

Negativization was defined as the absence of detectable levels of serum HCV RNA using a polymerase chain reaction.
Time Frame Six months after the end of interferon treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with available data for viral response 6 months after completion of interferon treatment were compared between treatment groups.
Arm/Group Title Escitalopram Placebo
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 53 54
Measure Type: Number
Unit of Measure: Participants
36 38
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Escitalopram, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
3.Secondary Outcome
Title Total Score in the Montgomery-Asberg Depression Rating Scale
Hide Description

The MADRS is a 10-item scale, clinician-administered, which is sensitive to symptom change during antidepressant treatment. It has been frequently used to measure depressive symptoms during interferon-alpha therapy and exhibits improved internal consistency in patients with co-morbid medical conditions compared with other clinician-administered questionnaires.

Items are rated on a scale of 0-6. Scores range from 0 to 60, higher scores meaning higher levels of depression.
Time Frame 12 weeks after interferon treatment onset
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Escitalopram Placebo
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 66 63
Mean (Standard Error)
Unit of Measure: Scores on a scale
3.82  (0.57) 4.38  (0.63)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Escitalopram, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.443
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
4.Secondary Outcome
Title Total Score in the Depression Subscale of the Hospital Anxiety and Depression Scale.
Hide Description

The Hospital Anxiety and Depression Scale (HADS) is 14-item scale, patient-administered, that allows two independent scores of depression and anxiety. It has been specially designed to apply in patients with comorbid medical conditions as it excludes somatic or vegetative symptoms from the depression subscale.

We present data of de depression subscale. The seven-item Depression subscale yields a score of 0-21, with higher scores meaning higher levels of depressive symptoms.
Time Frame 12 weeks after interferon treatment onset
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Escitalopram Placebo
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 66 63
Mean (Standard Error)
Unit of Measure: Scores on a Scale
2.25  (0.34) 2.13  (0.33)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Escitalopram, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.930
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Time Frame First three months of antiviral treatment
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Escitalopram Placebo
Hide Arm/Group Description 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
All-Cause Mortality
Escitalopram Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Escitalopram Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/66 (0.00%)   0/63 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Escitalopram Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   60/66 (90.91%)   58/66 (87.88%) 
Blood and lymphatic system disorders     
Anemia * 1  5/66 (7.58%)  8/63 (12.70%) 
Leukopenia / neutropenia * 1  7/66 (10.61%)  4/63 (6.35%) 
Gastrointestinal disorders     
Diarrhea * 1  13/66 (19.70%)  10/63 (15.87%) 
Dry mouth * 1  14/66 (21.21%)  17/63 (26.98%) 
Loss of appetite * 1  14/66 (21.21%)  10/63 (15.87%) 
Nausea or vomiting * 1  23/66 (34.85%)  21/63 (33.33%) 
General disorders     
Dizziness * 1  9/66 (13.64%)  3/63 (4.76%) 
Fatigue * 1  32/66 (48.48%)  32/63 (50.79%) 
Fever * 1  7/66 (10.61%)  6/63 (9.52%) 
Flu-like symptoms * 1  9/66 (13.64%)  12/63 (19.05%) 
Musculoskeletal and connective tissue disorders     
Muscle or joint pain * 1  22/66 (33.33%)  32/63 (50.79%) 
Nervous system disorders     
Headache * 1  18/66 (27.27%)  19/63 (30.16%) 
Psychiatric disorders     
Anxiety * 1  10/66 (15.15%)  11/63 (17.46%) 
Irritability * 1  10/66 (15.15%)  14/63 (22.22%) 
Sleep disorders * 1  23/66 (34.85%)  23/63 (36.51%) 
Reproductive system and breast disorders     
Sexual dysfunction * 1  9/66 (13.64%)  3/63 (4.76%) 
Respiratory, thoracic and mediastinal disorders     
Breathing problems * 1  16/66 (24.24%)  25/63 (39.68%) 
Skin and subcutaneous tissue disorders     
Hair loss * 1  9/66 (13.64%)  6/63 (9.52%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, SNOMED CT
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.
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
Layout table for Results Point of Contact information
Name/Title: Crisanto Diez-Quevedo
Organization: Hospital Universitari Germans Trias i Pujol, Autonomous University of Barcelona
Phone: +34934978814
EMail: cdiezquevedo.germanstrias@gencat.cat
Publications of Results:
Diez-Quevedo C, Masnou H, Planas R, Castellví P, Giménez D, Morillas RM, Martín-Santos R, Navinés R, Solà R, Giner P, Ardèvol M, Costa J, Diago M, Pretel J. Prophylactic treatment with escitalopram of pegylated interferon alfa-2a-induced depression in hepatitis C: a 12-week, randomized, double-blind, placebo-controlled trial. J Clin Psychiatry. 2011 Apr;72(4):522-8. doi: 10.4088/JCP.09m05282blu. Epub 2010 Oct 5.
Layout table for additonal information
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