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Trial record 81 of 1136 for:    IFNA2 AND Antiviral Agents

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 : March 30, 2011
Sponsor:
Collaborators:
Hoffmann-La Roche
H. Lundbeck A/S
Information provided by:
Germans Trias i Pujol Hospital

Tracking Information
First Submitted Date  ICMJE September 9, 2005
First Posted Date  ICMJE September 14, 2005
Results First Submitted Date  ICMJE February 8, 2011
Results First Posted Date  ICMJE March 30, 2011
Last Update Posted Date March 30, 2011
Study Start Date  ICMJE March 2005
Actual Primary Completion Date October 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 4, 2011)
  • 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. ]
    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 ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 9, 2005)
  • Major depressive episode following DSM-IV criteria during the first three months of interferon treatment.
  • Viral response (HCV) at end of interferon treatment and after six months.
  • Adverse side effects at any point during treatment.
Change History Complete list of historical versions of study NCT00166296 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 4, 2011)
  • Total Score in the Montgomery-Asberg Depression Rating Scale [ Time Frame: 12 weeks after interferon treatment onset ]
    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 ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 9, 2005)
  • Total score in the Montgomery-Asberg Depression Rating Scale at baseline, and 4, 8 and 12 weeks after interferon treatment onset.
  • Number of patients withdrawn from interferon due to depressive episode.
  • Anxiety and Depression scores of the Hospital Anxiety and Depression Scale at baseline and after 4, 8 and 12 weeks of interferon treatment onset.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Escitalopram for Prevention of Depression Induced by Peg-Interferon in Hepatitis C Patients
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Major Depressive Disorder.
  • Hepatitis C, Chronic
Intervention  ICMJE
  • Drug: Escitalopram
    15 mg/day starting 2 weeks before and 12 weeks during interferon therapy
    Other Name: Cipralex
  • Drug: Placebo
    Placebo, 15 mg/day, starting 2 weeks before and for 12 weeks during interferon therapy.
Study Arms  ICMJE
  • Experimental: Escitalopram
    Escitalopram, 15 mg/day
    Intervention: Drug: Escitalopram
  • Placebo Comparator: Placebo pill
    Placebo
    Intervention: Drug: Placebo
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 17, 2007)
133
Original Enrollment  ICMJE
 (submitted: September 9, 2005)
120
Actual Study Completion Date  ICMJE October 2007
Actual Primary Completion Date October 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with chronic hepatitis C who are going to initiate treatment with peginterferon alfa2a + ribavirin.
  • Age 18-65 years.
  • Signed informed consent.
  • If female, they are not in fertile period or they use barrier contraceptives.
  • Patients able to understand and fill written questionnaires.

Exclusion Criteria:

  • Hepatic cirrhosis or carcinoma.
  • Less than 4000/mm3 leucocytes, or less than 70000/mm3 platelets.
  • Hemoglobin less than 11 g/dL (females) or 12 (males).
  • Any risk factor for hemolysis.
  • Comorbid severe medical conditions (kidney, immune system, lung, heart, thyroid, etc).
  • Baseline mental disorders that require antidepressants (depressive disorders and anxiety disorders).
  • Other baseline mental disorders (delirium, substance use disorders).
  • Mental disorders at any time (dementia, psychotic disorders, bipolar disorders.
  • Contraindications of escitalopram (hypersensibility, diabetes, patients using serotoninergic agents, drugs that enhance the risk of bleeding, or monoamineoxidase inhibitors -MAOIs-).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00166296
Other Study ID Numbers  ICMJE PSQHEPGTP1
EudraCT number: 2004-002982-19
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Crisanto Diez-Quevedo, Germans Trias i Pujol Hospital
Study Sponsor  ICMJE Germans Trias i Pujol Hospital
Collaborators  ICMJE
  • Hoffmann-La Roche
  • H. Lundbeck A/S
Investigators  ICMJE
Principal Investigator: Crisanto Diez-Quevedo, MD Germans Trias i Pujol University Hospital
Principal Investigator: Ramon Planas, MD Germans Trias i Pujol University Hospital
PRS Account Germans Trias i Pujol Hospital
Verification Date March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP