CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 20 enrolled
Drug / intervention
Escitalopram +2 moredrug
Likely dose
Escitalopram 10 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00352885
NCT00352885Phase 4Completed
CompareCT.gov

IL-2 Neuropsychiatric Symptoms: Mechanism and Prevention

Emory University·interventional·Posted Jul 17, 2006·Updated Sep 14, 2018

In Brief

A Phase 4 clinical trial evaluating Escitalopram, Placebo, and 1 other intervention for Depression. Completed, enrolled 20 participants across 1 site.

Detailed Summary

This study will determine the effectiveness of an antidepressant in preventing or reducing depressive symptoms in people with melanoma who are receiving Interleukin-2 (IL-2) treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDepression
CountriesUnited States
CollaboratorsNational Institute of Mental Health (NIMH)

Timeline

Phase 4CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 17, 2006
Enrollment StartOct 6, 2006
Primary CompletionMay 17, 2010
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 20.0 years ago

Interventions

Escitalopramdrug

Participants will begin medication approximately 2 weeks before their first scheduled IL-2 treatment. The dosage for the first week will be 10 mg per day. If 10 mg is well tolerated by the participant, the dosage will be increased to 20 mg per day. The dosage for the remainder of the study will be 20 mg per day.

Placebodrug

Participants will begin the placebo approximately 2 weeks before their first scheduled IL-2 treatment. The dosage for the first week will be 1 pill per day, if 1 pill is well tolerated by the participant the dosage will be increased to 2 pills per day. Two pills per day will be the dosage for the reminder of the study.

IL-2drug

IL-2 is a 12-week treatment regimen with intravenous (IV) IL-2. There will be one cycle every 3 weeks for a total of four cycles. One cycle is 720,000 units/kg every 8 hours for 5 days.