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Clinical Trial Name - Efficacy and Safety of Escitalopram for Prevention of Depression Induced by Peg-Interferon in Hepa
| Original Study ID : PSQHEPGTP1 |
| Secondary ID : EudraCT number: 2004-002982-19 |
| NCT ID : NCT00166296 |
| Brief Title : Efficacy and Safety of Escitalopram for Prevention of Depression Induced by Peg-Interferon in Hepatitis C Patients |
| 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 |
| 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. |
| Source : Germans Trias i Pujol Hospital |
| 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 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. |
| Overall Status : Completed |
| Start Date : March 2005 |
| End Date : October 2007 |
| Completion Date : October 2007 |
| Official Title : Phase 2 |
| Phase : Interventional |
| Study Design : Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Enrollment : 133 |
| Verification Date : March 2008 |
| First Received Date : September 9, 2005 |
| Trial Eligibility |
| Criteria : 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 IMAOs). |
| Gender : Both |
| Minimum Age : 18 Years |
| Maximum Age : 65 Years |
| Healthy Volunteers : No |
| Facilities |
| Facility Name : Hospital Universitari Germans Trias i Pujol |
| City : Badalona |
| Zip Code : 08916 |
| Country : Spain |
| Facility Name : Hospital Universitario de Salamanca |
| City : Salamanca |
| Zip Code : 08916 |
| Country : Spain |
| Facility Name : Fundacion Hospital Alcorcon |
| City : Alcorcon |
| Zip Code : 08916 |
| Country : Spain |
| Facility Name : Hospital Puerta de Hierro |
| City : Madrid |
| Zip Code : 08916 |
| Country : Spain |
| Facility Name : Hospital Universitario La Paz |
| City : Madrid |
| Zip Code : 08916 |
| Country : Spain |
| Facility Name : Hospital Universitario La Princesa |
| City : Madrid |
| Zip Code : 08916 |
| Country : Spain |
| Facility Name : Hospital Ramon y Cajal |
| City : Madrid |
| Zip Code : 08916 |
| Country : Spain |
| Facility Name : Hospital del Mar |
| City : Barcelona |
| Zip Code : 08916 |
| Country : Spain |
| Facility Name : Hospital Consorci Sanitari de Terrassa |
| City : Tarrasa |
| Zip Code : 08916 |
| Country : Spain |
| Facility Name : Hospital Miguel Servet |
| City : Zaragoza |
| Zip Code : 08916 |
| Country : Spain |
| Facility Name : Hospital Parc Tauli |
| City : Sabadell |
| Zip Code : 08916 |
| Country : Spain |
| Facility Name : Hospital General Universitario |
| City : Valencia |
| Zip Code : 08916 |
| Country : Spain |
| Facility Name : Hospital Clínico Universitario |
| City : Valencia |
| Zip Code : 08916 |
| Country : Spain |
| Facility Name : Hospital La Fe |
| City : Valencia |
| Zip Code : 08916 |
| Country : Spain |
| Facility Name : Hospital Nuestra Señora de Sonsoles |
| City : Avila |
| Zip Code : 08916 |
| Country : Spain |
| Refferances |
| PMID : 15669887 |
| Citation : Raison CL, Borisov AS, Broadwell SD, Capuron L, Woolwine BJ, Jacobson IM, Nemeroff CB, Miller AH. Depression during pegylated interferon-alpha plus ribavirin therapy: prevalence and prediction. J Clin Psychiatry. 2005 Jan;66(1):41-8. |
| PMID : 12399946 |
| Citation : Hauser P, Khosla J, Aurora H, Laurin J, Kling MA, Hill J, Gulati M, Thornton AJ, Schultz RL, Valentine AD, Meyers CA, Howell CD. A prospective study of the incidence and open-label treatment of interferon-induced major depressive disorder in patients with hepatitis C. Mol Psychiatry. 2002;7(9):942-7. |
| PMID : 11015632 |
| Citation : Hauser P, Soler R, Reed S, Kane R, Gulati M, Khosla J, Kling MA, Valentine AD, Meyers CA. Prophylactic treatment of depression induced by interferon-alpha. Psychosomatics. 2000 Sep-Oct;41(5):439-41. No abstract available. |
| PMID : 11799348 |
| Citation : Bonaccorso S, Marino V, Puzella A, Pasquini M, Biondi M, Artini M, Almerighi C, Verkerk R, Meltzer H, Maes M. Increased depressive ratings in patients with hepatitis C receiving interferon-alpha-based immunotherapy are related to interferon-alpha-induced changes in the serotonergic system. J Clin Psychopharmacol. 2002 Feb;22(1):86-90. |
| PMID : 11926717 |
| Citation : Gleason OC, Yates WR, Isbell MD, Philipsen MA. An open-label trial of citalopram for major depression in patients with hepatitis C. J Clin Psychiatry. 2002 Mar;63(3):194-8. |
| PMID : 11274622 |
| Citation : Musselman DL, Lawson DH, Gumnick JF, Manatunga AK, Penna S, Goodkin RS, Greiner K, Nemeroff CB, Miller AH. Paroxetine for the prevention of depression induced by high-dose interferon alfa. N Engl J Med. 2001 Mar 29;344(13):961-6. |
| PMID : 11197246 |
| Citation : Ho SB, Nguyen H, Tetrick LL, Opitz GA, Basara ML, Dieperink E. Influence of psychiatric diagnoses on interferon-alpha treatment for chronic hepatitis C in a veteran population. Am J Gastroenterol. 2001 Jan;96(1):157-64. |
| PMID : 15220690 |
| Citation : Rowan PJ, Tabasi S, Abdul-Latif M, Kunik ME, El-Serag HB. Psychosocial factors are the most common contraindications for antiviral therapy at initial evaluation in veterans with chronic hepatitis C. J Clin Gastroenterol. 2004 Jul;38(6):530-4. |
| PMID : 15245784 |
| Citation : Loftis JM, Socherman RE, Howell CD, Whitehead AJ, Hill JA, Dominitz JA, Hauser P. Association of interferon-alpha-induced depression and improved treatment response in patients with hepatitis C. Neurosci Lett. 2004 Jul 22;365(2):87-91. |
| PMID : 15885349 |
| Citation : Schaefer M, Schwaiger M, Garkisch AS, Pich M, Hinzpeter A, Uebelhack R, Heinz A, van Boemmel F, Berg T. Prevention of interferon-alpha associated depression in psychiatric risk patients with chronic hepatitis C. J Hepatol. 2005 Jun;42(6):793-8. Epub 2005 Apr 2. |
| PMID : 12540795 |
| Citation : Schaefer M, Schmidt F, Folwaczny C, Lorenz R, Martin G, Schindlbeck N, Heldwein W, Soyka M, Grunze H, Koenig A, Loeschke K. Adherence and mental side effects during hepatitis C treatment with interferon alfa and ribavirin in psychiatric risk groups. Hepatology. 2003 Feb;37(2):443-51. |
| OutComes |
| Primary OutComes |
| Secondary OutComes |
| Measure : Total score in the Montgomery-Asberg Depression Rating Scale at baseline, and 4, 8 and 12 weeks after interferon treatment onset. |
| Time Frame : First 3 months of interferon therapy. |
| Safety issue : No |
| Measure : Number of patients withdrawn from interferon due to depressive episode. |
| Time Frame : First 3 months of interferon therapy. |
| Safety issue : No |
| Measure : Anxiety and Depression scores of the Hospital Anxiety and Depression Scale at baseline and after 4, 8 and 12 weeks of interferon treatment onset. |
| Time Frame : First 3 months of interferon therapy. |
| Safety issue : No |
| Interventions |
| Type : Drug |
| Name : Escitalopram |
| Description : 15 mg/day starting 2 weeks before and 12 weeks during interferon therapy |
| Type : Drug |
| Name : Placebo |
| Description : Placebo, 15 mg/day, starting 2 weeks before and for 12 weeks during interferon therapy. |
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