Trial record 67 of 546 for: "Viral Infectious Disease" | "Peginterferon alfa-2a"
Escitalopram for the Prevention of PEGASYS-associated Depression in Hepatitis C Virus-infected Patients (CIPPAD)
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|ClinicalTrials.gov Identifier: NCT00136318|
Recruitment Status : Completed
First Posted : August 29, 2005
Results First Posted : March 21, 2013
Last Update Posted : March 21, 2013
Charite University, Berlin, Germany
Information provided by (Responsible Party):
M. Schaefer, MD, Charite University, Berlin, Germany
|Study Design||Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Outcomes Assessor); Primary Purpose: Prevention|
Drug: Peginterferon alfa-2a
|Recruitment Details||A total of 208 of the 300 patients screened were enrolled between August 2004 and September 2008 in different centers in the pre-observation period. Overall 181 patients started the treatment period by taking escitalopram or placebo.|
|Pre-assignment Details||A total of 208 of the 300 patients screened were enrolled between August 2004 and September 2008. 92 patients did not meet the inclusion criteria, had exclusion criteria or did not want to participate in the trial.27 patients stopped the trial during the preobservation period before the trial started by taking antidepressant or placebo therapy.|
Random assignment of patients before the preobservation period followed by patient withdrawal from the trial independent of antidepressant treatment weakens the strength of the randomization.