Major Depressive Disorder Clinical Trial
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
Verified date | August 2020 |
Source | Germans Trias i Pujol Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 133 |
Est. completion date | October 2007 |
Est. primary completion date | October 2007 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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-). |
Country | Name | City | State |
---|---|---|---|
Spain | Fundacion Hospital Alcorcon | Alcorcon | |
Spain | Hospital Nuestra Señora de Sonsoles | Avila | |
Spain | Hospital Universitari Germans Trias i Pujol | Badalona | |
Spain | Hospital del Mar | Barcelona | |
Spain | Hospital Puerta de Hierro | Madrid | |
Spain | Hospital Ramon y Cajal | Madrid | |
Spain | Hospital Universitario La Paz | Madrid | |
Spain | Hospital Universitario La Princesa | Madrid | |
Spain | Hospital Parc Tauli | Sabadell | |
Spain | Hospital Universitario de Salamanca | Salamanca | |
Spain | Hospital Consorci Sanitari de Terrassa | Tarrasa | |
Spain | Hospital Clínico Universitario | Valencia | |
Spain | Hospital General Universitario | Valencia | |
Spain | Hospital La Fe | Valencia | |
Spain | Hospital Miguel Servet | Zaragoza |
Lead Sponsor | Collaborator |
---|---|
Germans Trias i Pujol Hospital | H. Lundbeck A/S, Hoffmann-La Roche |
Spain,
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 hep — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 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. |
First three months of interferon treatment. | |
Primary | Number of Participants With Sustained Hepatitis C Viral Response (Negativization of Serum Hepatitis C Virus Ribonucleic Acid). | 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. |
Six months after the end of interferon treatment | |
Secondary | Total Score in the Montgomery-Asberg Depression Rating Scale | 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. |
12 weeks after interferon treatment onset | |
Secondary | Total Score in the Depression Subscale of the Hospital Anxiety and Depression Scale. | 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. |
12 weeks after interferon treatment onset |
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