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Trial record 16 of 889 for:    "Depressive Disorder" [DISEASE] AND MADRS

Escitalopram for the Prevention of PEGASYS-associated Depression in Hepatitis C Virus-infected Patients (CIPPAD)

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ClinicalTrials.gov Identifier: NCT00136318
Recruitment Status : Completed
First Posted : August 29, 2005
Results First Posted : March 21, 2013
Last Update Posted : March 21, 2013
Sponsor:
Information provided by (Responsible Party):
M. Schaefer, MD, Charite University, Berlin, Germany

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Prevention
Condition Depression
Interventions Drug: Escitalopram
Drug: Placebo
Drug: Peginterferon alfa-2a
Drug: Ribavirin
Enrollment 208
Recruitment Details A total of 208 of the 300 patients screened were enrolled between August 2004 and September 2008 in different centers in the pre-observation period. Overall 181 patients started the treatment period by taking escitalopram or placebo.
Pre-assignment Details A total of 208 of the 300 patients screened were enrolled between August 2004 and September 2008. 92 patients did not meet the inclusion criteria, had exclusion criteria or did not want to participate in the trial.27 patients stopped the trial during the preobservation period before the trial started by taking antidepressant or placebo therapy.
Arm/Group Title Escitalopram Placebo
Hide Arm/Group Description

After the preobservation period,patients received escitalopram, 10 mg per day. During treatment period, all patients began receiving antiviral therapy with PEG-interferon plus ribavirin with continuous concomitant administration of escitalopram.

Peginterferon alfa-2a :

Escitalopram :

Ribavirin :

After the preobservation period, patients received placebo. After 2 weeks of antidepressant pretreatment, all patients began receiving antiviral therapy with PEG-interferon plus ribavirin with continuous concomitant administration of placebo.

Peginterferon alfa-2a :

Placebo :

Ribavirin :

Period Title: Overall Study
Started 90 [1] 91 [1]
Completed 83 [2] 84
Not Completed 7 7
Reason Not Completed
Adverse Event             5             5
Withdrawal by Subject             2             2
[1]
Took first dose of study medication
[2]
reached end-point of antiviral treatment
Arm/Group Title Escitalopram Placebo Total
Hide Arm/Group Description

After the preobservation period,patients received escitalopram, 10 mg per day. During treatment period, all patients began receiving antiviral therapy with PEG-interferon plus ribavirin with continuous concomitant administration of escitalopram.

Peginterferon alfa-2a :

Escitalopram :

Ribavirin :

After the preobservation period, patients received placebo. After 2 weeks of antidepressant pretreatment, all patients began receiving antiviral therapy with PEG-interferon plus ribavirin with continuous concomitant administration of placebo.

Peginterferon alfa-2a :

Placebo :

Ribavirin :

Total of all reporting groups
Overall Number of Baseline Participants 90 91 181
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 90 participants 91 participants 181 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
84
  93.3%
84
  92.3%
168
  92.8%
>=65 years
6
   6.7%
7
   7.7%
13
   7.2%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 90 participants 91 participants 181 participants
46.2  (11) 48.5  (11) 47.4  (11)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 90 participants 91 participants 181 participants
Female
42
  46.7%
43
  47.3%
85
  47.0%
Male
48
  53.3%
48
  52.7%
96
  53.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Germany Number Analyzed 90 participants 91 participants 181 participants
90 91 181
1.Primary Outcome
Title Montgomery Asberg Depression Scale (MADRS) With a Score of 13 or Higher
Hide Description Clinically relevant depression (MADRS score of 13 or higher) during antiviral treatment presented as "percentage of participants" with "MADRS scores > 13" (entire time period: from starting study medication until end of antiviral treatment = 48 weeks in patients with genotype 1 or 4 and 24 weeks for patients with genotype 2 or 3)
Time Frame 50 weeks for genotypes 1 or 4 and 26 weeks for patients with genotype 2 or 3
Hide Outcome Measure Data
Hide Analysis Population Description
The final analysis included only patients who received at least one of escitalopram or placebo. Between group differences for the primary outcome parameters were calculated with a chi-square test. For the primary end point (MADRS score of 13 or higher), we treated missing MADRS assessments by multiple imputation.
Arm/Group Title Escitalopram Placebo
Hide Arm/Group Description:

After the preobservation period, patients received escitalopram, 10 mg per day. During treatment period, all patients began receiving antiviral therapy with PEG-interferon plus ribavirin with continuous concomitant administration of escitalopram.

Peginterferon alfa-2a :

Escitalopram :

Ribavirin :

After the preobservation period, patients received placebo. After 2 weeks of antidepressant pretreatment, all patients began receiving antiviral therapy with PEG-interferon plus ribavirin with continuous concomitant administration of placebo.

Peginterferon alfa-2a :

Placebo :

Ribavirin :

Overall Number of Participants Analyzed 90 91
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
32
(21 to 43)
59
(48 to 69)
2.Secondary Outcome
Title Proportion of Patients Without Depression (Defined as a MADRS Score of 13 or Higher)
Hide Description Number of patients who did not develop at any time of antiviral treatment (up to 48 weeks) a MADRS score of 13 or more as a sign of clinically relevant depression
Time Frame Patients free of depression during 24 or 48 weeks of antiviral therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Number of patients per group who did not develop any depressive episode during 48 weeks of antiviral therapy.
Arm/Group Title Escitalopram Placebo
Hide Arm/Group Description:

After the preobservation period,patients received escitalopram, 10 mg per day. During treatment period, all patients began receiving antiviral therapy with PEG-interferon plus ribavirin with continuous concomitant administration of escitalopram.

Peginterferon alfa-2a :

Escitalopram :

Ribavirin :

After the preobservation period, patients received placebo. After 2 weeks of antidepressant pretreatment, all patients began receiving antiviral therapy with PEG-interferon plus ribavirin with continuous concomitant administration of placebo.

Peginterferon alfa-2a :

Placebo :

Ribavirin :

Overall Number of Participants Analyzed 90 91
Measure Type: Number
Unit of Measure: participants
60 40
3.Secondary Outcome
Title Incidence of Major Depression Defined by Diagnostic and Statistical Manual IV (DSM-IV) Criteria
Hide Description [Not Specified]
Time Frame major depression during 24 or 48 weeks of antiviral therapy
Hide Outcome Measure Data
Hide Analysis Population Description
The final analysis included only patients who received at least 1 dose of escitalopram or placebo. Between-group differences for the secondary outcome parameters were calculated with a chi-square test.
Arm/Group Title Escitalopram Placebo
Hide Arm/Group Description:

After the preobservation period,patients received escitalopram, 10 mg per day. During treatment period, all patients began receiving antiviral therapy with PEG-interferon plus ribavirin with continuous concomitant administration of escitalopram.

Peginterferon alfa-2a :

Escitalopram :

Ribavirin :

After the preobservation period, patients received placebo. After 2 weeks of antidepressant pretreatment, all patients began receiving antiviral therapy with PEG-interferon plus ribavirin with continuous concomitant administration of placebo.

Peginterferon alfa-2a :

Placebo :

Ribavirin :

Overall Number of Participants Analyzed 90 91
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
8
(4 to 15)
17
(12 to 28)
4.Secondary Outcome
Title Severe Depression Defined as a MADRS Score of 25 or Higher
Hide Description [Not Specified]
Time Frame severe depression during 24 or 48 weeks of antiviral therapy
Hide Outcome Measure Data
Hide Analysis Population Description
The final analysis included only patients who received at least 1 dose of escitalopram or placebo. Between-group differences for the secondary outcome parameters were calculated with a chi-square test.
Arm/Group Title Escitalopram Placebo
Hide Arm/Group Description:

After the preobservation period,patients received escitalopram, 10 mg per day. During treatment period, all patients began receiving antiviral therapy with PEG-interferon plus ribavirin with continuous concomitant administration of escitalopram.

Peginterferon alfa-2a :

Escitalopram :

Ribavirin :

After the preobservation period, patients received placebo. After 2 weeks of antidepressant pretreatment, all patients began receiving antiviral therapy with PEG-interferon plus ribavirin with continuous concomitant administration of placebo.

Peginterferon alfa-2a :

Placebo :

Ribavirin :

Overall Number of Participants Analyzed 90 91
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
1
(0.3 to 6)
12
(7 to 21)
5.Secondary Outcome
Title Health Related Quality of Life (HRQOL) Measured by the Short Form 36 (SF-36)
Hide Description [Not Specified]
Time Frame assessed 2,4,12,24 and 48 weeks of antiviral treatment
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Sustained Virologic Response
Hide Description (negative Polymerase Chain Reaction (PCR) 6 months after the end of antiviral treatment)
Time Frame assessed 24 weeks after end of antiviral treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The final analysis included only patients who received at least 1 dose of escitalopram or placebo. Between-group differences for the secondary outcome parameters were calculated with a chi-square test.
Arm/Group Title Escitalopram Placebo
Hide Arm/Group Description:

After the preobservation period,patients received escitalopram, 10 mg per day. During treatment period, all patients began receiving antiviral therapy with PEG-interferon plus ribavirin with continuous concomitant administration of escitalopram.

Peginterferon alfa-2a :

Escitalopram :

Ribavirin :

After the preobservation period, patients received placebo. After 2 weeks of antidepressant pretreatment, all patients began receiving antiviral therapy with PEG-interferon plus ribavirin with continuous concomitant administration of placebo.

Peginterferon alfa-2a :

Placebo :

Ribavirin :

Overall Number of Participants Analyzed 90 91
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
56
(46 to 66)
46
(37 to 57)
7.Secondary Outcome
Title Tolerability
Hide Description [Not Specified]
Time Frame assessed 2,4,12,24 and for genotype 1 and 4, 48 weeks of antiviral treatment
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Safety
Hide Description [Not Specified]
Time Frame assessed 2,4,12,24 and for genotype 1 and 4, 48 weeks of antiviral treatment
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Escitalopram Placebo
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
Escitalopram Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Escitalopram Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   5/90 (5.56%)   5/91 (5.49%) 
Eye disorders     
retinopathy   0/90 (0.00%)  1/91 (1.10%) 
General disorders     
jaundice   1/90 (1.11%)  0/91 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
renal failure   1/90 (1.11%)  0/91 (0.00%) 
cerebral tumor   1/90 (1.11%)  0/91 (0.00%) 
glioblastoma   0/90 (0.00%)  1/91 (1.10%) 
Psychiatric disorders     
drug abuse   1/90 (1.11%)  0/91 (0.00%) 
self-harming behavior   1/90 (1.11%)  0/91 (0.00%) 
severe depression   0/90 (0.00%)  3/91 (3.30%) 
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Escitalopram Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   67/90 (74.44%)   78/91 (85.71%) 
General disorders     
Fatigue  44/90 (48.89%)  55/91 (60.44%) 
Dizziness  13/90 (14.44%)  23/91 (25.27%) 
Anemia  16/90 (17.78%)  20/91 (21.98%) 
Random assignment of patients before the preobservation period followed by patient withdrawal from the trial independent of antidepressant treatment weakens the strength of the randomization.
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: Professor Dr. Martin Schaefer
Organization: Kliniken Essen-Mitte, Department of Psychiatry
Phone: +49201-17430001
EMail: m.schaefer@kliniken-essen-mitte.de
Layout table for additonal information
Responsible Party: M. Schaefer, MD, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT00136318     History of Changes
Other Study ID Numbers: ML18075
First Submitted: August 26, 2005
First Posted: August 29, 2005
Results First Submitted: October 25, 2012
Results First Posted: March 21, 2013
Last Update Posted: March 21, 2013