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Primary end points
Secondary end points
Other investigations:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Escitalopram | Active Comparator | 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. |
|
| Placebo | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Escitalopram | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Montgomery Asberg Depression Scale (MADRS) With a Score of 13 or Higher | 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) | 50 weeks for genotypes 1 or 4 and 26 weeks for patients with genotype 2 or 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Patients Without Depression (Defined as a MADRS Score of 13 or Higher) | 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 | Patients free of depression during 24 or 48 weeks of antiviral therapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Berg, Prof. Dr. | Charité | Study Chair |
| Martin Schaefer, Prof. Dr. | Charite University, Berlin, Germany | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Gastroenterolgy and Rheumatology, Sektion Hepatology | Leipzig | 04103 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25359924 | Derived | Sarkar S, Sarkar R, Berg T, Schaefer M. Sadness and mild cognitive impairment as predictors for interferon-alpha-induced depression in patients with hepatitis C. Br J Psychiatry. 2015 Jan;206(1):45-51. doi: 10.1192/bjp.bp.113.141770. Epub 2014 Oct 30. | |
| 22801672 | Derived | Schaefer M, Sarkar R, Knop V, Effenberger S, Friebe A, Heinze L, Spengler U, Schlaepfer T, Reimer J, Buggisch P, Ockenga J, Link R, Rentrop M, Weidenbach H, Fromm G, Lieb K, Baumert TF, Heinz A, Discher T, Neumann K, Zeuzem S, Berg T. Escitalopram for the prevention of peginterferon-alpha2a-associated depression in hepatitis C virus-infected patients without previous psychiatric disease: a randomized trial. Ann Intern Med. 2012 Jul 17;157(2):94-103. doi: 10.7326/0003-4819-157-2-201207170-00006. |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Escitalopram | 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 : |
| FG001 | Placebo | 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 : |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Escitalopram | 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 : |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Montgomery Asberg Depression Scale (MADRS) With a Score of 13 or Higher | 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) | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | 50 weeks for genotypes 1 or 4 and 26 weeks for patients with genotype 2 or 3 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Escitalopram |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| drug abuse | Psychiatric disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor Dr. Martin Schaefer | Kliniken Essen-Mitte, Department of Psychiatry | +49201-17430001 | m.schaefer@kliniken-essen-mitte.de |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000089983 | Escitalopram |
| C100416 | peginterferon alfa-2a |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009570 | Nitriles |
| D001572 |
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|
| Peginterferon alfa-2a | Drug | Patients with HCV genotype 1 or 4 received treatment for 48 weeks with PEGinterferon-alfa2a, 180 mcg weekly. Patients with genotype 2 or 3 received PEGinterferon-alfa2a, 180 mcg weekly. |
|
|
| Ribavirin | Drug | Patients with HCV genotype 1 or 4 received treatment for 48 weeks with ribavirin, 1000 mg per day (body weight 75 kg) or 1200 mg per day (body weight, 75 kg). Patients with HCV genotype 2 or 3 received ribavirin, 800 mg per day for 24 weeks. |
|
| Incidence of Major Depression Defined by Diagnostic and Statistical Manual IV (DSM-IV) Criteria |
| major depression during 24 or 48 weeks of antiviral therapy |
| Severe Depression Defined as a MADRS Score of 25 or Higher | severe depression during 24 or 48 weeks of antiviral therapy |
| Health Related Quality of Life (HRQOL) Measured by the Short Form 36 (SF-36) | assessed 2,4,12,24 and 48 weeks of antiviral treatment |
| Sustained Virologic Response | (negative Polymerase Chain Reaction (PCR) 6 months after the end of antiviral treatment) | assessed 24 weeks after end of antiviral treatment |
| Tolerability | assessed 2,4,12,24 and for genotype 1 and 4, 48 weeks of antiviral treatment |
| Safety | assessed 2,4,12,24 and for genotype 1 and 4, 48 weeks of antiviral treatment |
| Placebo |
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 : |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
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 :
| OG001 | Placebo | 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 : |
|
|
| Secondary | Proportion of Patients Without Depression (Defined as a MADRS Score of 13 or Higher) | 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 | Number of patients per group who did not develop any depressive episode during 48 weeks of antiviral therapy. | Posted | Number | participants | Patients free of depression during 24 or 48 weeks of antiviral therapy |
|
|
|
| Secondary | Incidence of Major Depression Defined by Diagnostic and Statistical Manual IV (DSM-IV) Criteria | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | major depression during 24 or 48 weeks of antiviral therapy |
|
|
|
| Secondary | Severe Depression Defined as a MADRS Score of 25 or Higher | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | severe depression during 24 or 48 weeks of antiviral therapy |
|
|
|
| Secondary | Health Related Quality of Life (HRQOL) Measured by the Short Form 36 (SF-36) | Not Posted | assessed 2,4,12,24 and 48 weeks of antiviral treatment |
| Secondary | Sustained Virologic Response | (negative Polymerase Chain Reaction (PCR) 6 months after the end of antiviral treatment) | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | assessed 24 weeks after end of antiviral treatment |
|
|
|
| Secondary | Tolerability | Not Posted | assessed 2,4,12,24 and for genotype 1 and 4, 48 weeks of antiviral treatment |
| Secondary | Safety | Not Posted | assessed 2,4,12,24 and for genotype 1 and 4, 48 weeks of antiviral treatment |
| 5 |
| 90 |
| 67 |
| 90 |
| EG001 | Placebo | 5 | 91 | 78 | 91 |
| self-harming behavior | Psychiatric disorders | Systematic Assessment |
|
| renal failure | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| cerebral tumor | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| jaundice | General disorders | Systematic Assessment |
|
| retinopathy | Eye disorders | Systematic Assessment |
|
| glioblastoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| severe depression | Psychiatric disorders | Systematic Assessment |
|
| Dizziness | General disorders |
|
| Anemia | General disorders |
|
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| Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |