Who is sponsoring NCT00166296?

NCT00166296 is sponsored by Germans Trias i Pujol Hospital.

What condition does NCT00166296 study?

NCT00166296 studies Major Depressive Disorder, Hepatitis C, Chronic.

What drugs are being tested in NCT00166296?

Interventions: Escitalopram, Placebo.

What is the status of NCT00166296?

NCT00166296 is currently COMPLETED.

Last reviewed 2020-08-05 · How we verify

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

NCT00166296 Phase 2 COMPLETED Results posted

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.

Details

Lead sponsor	Germans Trias i Pujol Hospital
Phase	Phase 2
Status	COMPLETED
Enrolment	133
Start date	2005-03
Completion	2007-10

Conditions

Major Depressive Disorder
Hepatitis C, Chronic

Interventions

Escitalopram
Placebo

Primary outcomes

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. — 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). — 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.

Countries

Spain