Effectiveness of Escitalopram in Preventing or Reducing Depressive Symptoms in People Receiving Interleukin-2 Treatment

PHASE4CompletedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

October 6, 2006

Primary Completion Date

May 17, 2010

Study Completion Date

May 17, 2010

Conditions
Depression
Interventions
DRUG

Escitalopram

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.

DRUG

Placebo

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.

DRUG

IL-2

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.

Trial Locations (1)

30322

Winship Cancer Institute, Atlanta

All Listed Sponsors
collaborator

National Institute of Mental Health (NIMH)

NIH

lead

Emory University

OTHER

NCT00352885 - Effectiveness of Escitalopram in Preventing or Reducing Depressive Symptoms in People Receiving Interleukin-2 Treatment | Biotech Hunter | Biotech Hunter