Phase 2
Completed N=133
Efficacy and Safety of Escitalopram for Prevention of Depression Induced by Peg-Interferon in Hepatitis C Patients
Major Depressive Disorder · Hepatitis C, Chronic
Source: ClinicalTrials.gov NCT00166296 ↗
Enrolled (actual)
133
Serious AEs
0.0%
Results posted
Mar 2011
Primary outcomePrimary: 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. — 5; 2 Participants — p=0.441
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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. |
5; 2 | 0.441 |
| PRIMARY Number of Participants With Sustained Hepatitis C Viral Response (Negativization of Serum Hepatitis C Virus Ribonucleic Acid). |
36; 38 | >0.05 |
| SECONDARY Total Score in the Montgomery-Asberg Depression Rating Scale |
3.82; 4.38 | 0.443 |
| SECONDARY Total Score in the Depression Subscale of the Hospital Anxiety and Depression Scale. |
2.25; 2.13 | 0.930 |
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 monoamineoxidase inhibitors -MAOIs-).
Data sourced from ClinicalTrials.gov (NCT00166296). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.