Efficacy and Safety of Escitalopram for Prevention of Depression Induced by Peg-Interferon in Hepatitis C Patients
The purpose of this study is to determine whether the use of an antidepressant (escitalopram) can prevent depressive episodes that appear during the treatment with peg-interferon and ribavirin in patients with chronic hepatitis C.
Major Depressive Disorder.
Hepatitis C, Chronic
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Study of the Efficacy and Safety of Escitalopram for the Prevention of Depressive Episodes Induced by Peg-Interferon Alpha2a and Ribavirin in Chronic Hepatitis C Patients. Randomized, Double-Blind, Placebo-Controlled Clinical Trial|
- 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. ] [ Designated as safety issue: No ]
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.
- 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 ] [ Designated as safety issue: Yes ]
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.
- Total Score in the Montgomery-Asberg Depression Rating Scale [ Time Frame: 12 weeks after interferon treatment onset ] [ Designated as safety issue: No ]
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.
- Total Score in the Depression Subscale of the Hospital Anxiety and Depression Scale. [ Time Frame: 12 weeks after interferon treatment onset ] [ Designated as safety issue: No ]
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.
|Study Start Date:||March 2005|
|Study Completion Date:||October 2007|
|Primary Completion Date:||October 2007 (Final data collection date for primary outcome measure)|
Escitalopram, 15 mg/day
15 mg/day starting 2 weeks before and 12 weeks during interferon therapy
Other Name: Cipralex
Placebo Comparator: Placebo pill
Placebo, 15 mg/day, starting 2 weeks before and for 12 weeks during interferon therapy.
Chronic hepatitis C is a prevalent condition, and the main cause of chronic liver diseases, including cirrhosis and cancer. Nowadays, interferon-alfa in combination with ribavirin is the main treatment option for this condition. In the last years, interferon molecule has been modified in order to improve tolerance into pegylated interferon.
Interferon-alfa has been associated with a high prevalence of psychiatric side effects, especially major depression (up to 25% of the cases), which is one of the main concerns about using this treatment. In fact, major depression is one of the main reasons of treatment withdrawal and treatment failure.
Major depression induced by interferon-alfa can be successfully treated with antidepressants, but we don't know if antidepressants can also prevent the development of major depression, and if this can be a safe intervention. In the literature, there is only one controlled trial about this issue, in cancer patients, and some open studies in hepatitis C.
In order to evaluate the efficacy, and safety, of an antidepressant (escitalopram) for preventing peginterferon's induced depressive episodes in patients with chronic hepatitis C, we have designed this 14-weeks placebo-controlled, double-blind, randomized clinical trial. Study interventions will be started two weeks before peginterferon + ribavirin's treatment onset.
Subjects included in the study will be patients with chronic hepatitis C who are going to be treated with peginterferon-alfa2a + ribavirin, and without mental disorders requiring active psychotropic treatment.
The main variables studied will be the appearance of a major depressive episode, following Diagnostic & Statistical Manual of Mental Disorders (DSM-IV) criteria, and the total score on the Montgomery-Asberg Depression Rating Scale, along three assessment points at 4, 8 and 12 weeks of treatment with interferon. There will also be a follow-up period of up to 6 months after treatment with interferon is completed.
|Fundacion Hospital Alcorcon|
|Hospital Nuestra Señora de Sonsoles|
|Hospital Universitari Germans Trias i Pujol|
|Badalona, Spain, 08916|
|Hospital del Mar|
|Hospital Universitario La Paz|
|Hospital Universitario La Princesa|
|Hospital Ramon y Cajal|
|Hospital Puerta de Hierro|
|Hospital Parc Tauli|
|Hospital Universitario de Salamanca|
|Hospital Consorci Sanitari de Terrassa|
|Hospital La Fe|
|Hospital Clínico Universitario|
|Hospital General Universitario|
|Hospital Miguel Servet|
|Principal Investigator:||Crisanto Diez-Quevedo, MD||Germans Trias i Pujol University Hospital|
|Principal Investigator:||Ramon Planas, MD||Germans Trias i Pujol University Hospital|