Trial of Citalopram for the Prevention of Depression

• Status: Completed
• Trial end date: 2012-03-01
• Target enrollment: 0
• Participant gender: All

Summary

With the improved prognosis of human immunodeficiency virus (HIV) infection, end stage liver disease due to hepatitis C (HCV) now represents a major cause of morbidity and mortality in people with HIV. Treatment for HCV has become increasingly important as a means of preventing the consequences of chronic HCV infection. Paradoxically, co-infected patients have low rates of treatment initiation and completion in large part because they have a high risk of developing neuropsychiatric symptoms while receiving PEG-interferon (PEG-IFN). There are a large number of co-infected individuals in Canada who could benefit from HCV therapy if tolerability could be improved. This trial will address whether prophylactic use of antidepressants in HIV-HCV infected patients initiating HCV therapy can prevent the development of neuropsychiatric side effects and thus permit more patients to receive full treatment for HCV.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Marina Klein
• Collaborators: CIHR Canadian HIV Trials Network; Ontario HIV Treatment Network; Schering-Plough
• Treatments: Citalopram; Dexetimide; Interferons; Peginterferon alfa-2b; Ribavirin

Criteria

Inclusion Criteria:

• HIV+ adults with chronic HCV infection requiring therapy and with no contraindications to PEG-IFN/ribavirin will be enrolled.

Exclusion Criteria:

• Subjects with prior suicide attempt, active depression, treatment with antidepressants within 6 months of study entry or with other psychiatric disorders will be excluded.