Evaluating the Effectiveness of Escitalopram in Preventing or Reducing Depressive Symptoms in People Receiving Interleukin-2 Treatment - Full Text View

Sponsored by:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00352885

Purpose

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.

Condition	Intervention	Phase
Depression	Drug: Escitalopram Drug: Placebo Drug: IL-2	Phase IV

MedlinePlus related topics: Antidepressants Depression

Drug Information available for: Escitalopram Benzetimide Citalopram Citalopram hydrobromide Dexetimide Escitalopram oxalate Interleukin-2

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Efficacy Study
Official Title:	IL-2 Neuropsychiatric Symptoms: Mechanism and Prevention

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:

Number of IL-2 treatments tolerated [ Time Frame: Measured over 5 months of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Neuroendocrine system functioning and stress hormone levels [ Time Frame: Measured over 5 months of IL-2 treatment ] [ Designated as safety issue: No ]
Immune system functioning [ Time Frame: Measured over 5 months of IL-2 treatment ] [ Designated as safety issue: No ]
Serotonin metabolism [ Time Frame: Measured over 5 months of IL-2 treatment ] [ Designated as safety issue: No ]
Cognitive functioning, as assessed by computerized neuropsychological testing [ Time Frame: Measured on Day 2 of each IL-2 cycle ] [ Designated as safety issue: No ]
Genetic polymorphisms [ Time Frame: Measured before and after IL-2 treatment ] [ Designated as safety issue: No ]

Estimated Enrollment:	75
Study Start Date:	January 2006
Estimated Study Completion Date:	November 2010
Estimated Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental Participants will receive escitalopram and IL-2 treatment	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: 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.
B: Placebo Comparator Participants will receive placebo and IL-2 treatment	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.

Arms

Assigned Interventions

A: Experimental

Participants will receive escitalopram and IL-2 treatment

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: 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.

B: Placebo Comparator

Participants will receive placebo and IL-2 treatment

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.

Detailed Description:

Melanoma is the most serious type of skin cancer, affecting nearly 54,000 people in the United States each year. Melanomas often develop in pre-existing moles or as new moles on the body. If left untreated, the cancerous cells can spread throughout the body. Fortunately, melanoma can be cured if a person is diagnosed and treated early. Typical treatments include surgery, amputation, chemotherapy, and immunotherapy. Interleukin-2 (IL-2) treatment, a type of immunotherapy, uses the body's immune system to slow or stop the spread of cancer cells to other parts of the body. However, IL-2 treatment is typically associated with severe side effects, including depression, fatigue, and difficulty thinking. This study will evaluate whether escitalopram, an antidepressant, can help improve treatment-related depressive symptoms, reduce stress hormone levels, and increase the number of treatment cycles among people with metastatic melanoma who are receiving IL-2 treatment.

Participation in this double-blind study will last up to 18 weeks and will include 5 to 14 study visits. Participants will complete four 1-week cycles of IL-2 treatment over a 12-week period. Two weeks prior to starting IL-2 treatment, participants will undergo a psychiatric interview; a computerized thinking test; questionnaires; and blood, urine, and saliva collection. Participants will also be randomly assigned to start receiving either escitalopram or placebo for the entire duration of the study. The dosage of escitalopram or placebo will vary depending on the symptom severity of each participant. Immediately prior to IL-2 treatment, participants will undergo preliminary IL-2 procedures, which will include a medical history review, physical exam, and blood collection. These same procedures will occur every day that the participant is in the hospital for IL-2 treatment. Participants will stay in the hospital when receiving all four IL-2 treatment cycles. During these hospital stays, participants will complete repeat questionnaires and computerized tasks. Blood collection will occur at selected times as well. A follow-up visit will occur 4 weeks after the final treatment dose of IL-2.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosed with cancer and beginning IL-2 treatment
Willing to use an effective form of birth control throughout the study if sexually active

Exclusion Criteria:

Diagnosed with major depression or experiencing significant depressive symptoms or a Hamilton Rating Scale-Depression score of 18 or higher
Brain metastases, history of a brain injury, or seizure disorders
Meets DSM-IV criteria for substance abuse or dependence within 3 months of study entry
Suicidal, psychotic, or received psychiatric hospitalization within 12 months of study entry
Past or current history of schizophrenia or bipolar disorder
Pregnant or planning on becoming pregnant within 1 to 2 years
Evidence of untreated or poorly controlled infectious, hormone, heart, blood, kidney, liver, or neurological disease
Use of antidepressants, glucocorticoids, guanethidine, centrally acting alpha-antagonists, beta-blockers, or anticonvulsants
Clinically significant eye abnormalities
A score lower than 28 on the Mini Mental Status Exam (MMSE)
Prior history of severe adverse events associated with escitalopram or other selective serotonin reuptake inhibitor (SSRI) antidepressants
Diagnosed with type 1 or type 2 diabetes
Any condition that might make the participant unsuitable for enrollment or that could interfere with study participation

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00352885

Contacts

Contact: Erica C. Bruce, MPH	404-712-9614	ecbruce@emory.edu
Contact: Carol Hill, RN	404-778-4907	carol.hill@emoryhealthcare.org

Locations

United States, Georgia
Winship Cancer Institute	Recruiting
Atlanta, Georgia, United States, 30322

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:	Dominique L. Musselman, MD,MS	Emory University
Study Chair:	David Lawson, MD	Emory University
Study Chair:	Andrew Miller, MD	Emory University

More Information

Responsible Party:	Emory University ( Dominique L. Musselman )
Study ID Numbers:	R01 MH071580, DATR A3-NSS
Study First Received:	July 13, 2006
Last Updated:	August 19, 2008
ClinicalTrials.gov Identifier:	NCT00352885
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):

Cancer
IL-2 therapy
Antidepressant
Immune system
Neuroendocrine response

Study placed in the following topic categories:

Depression
Interleukin-2
Dexetimide
Depressive Disorder

Citalopram
Serotonin
Behavioral Symptoms

Additional relevant MeSH terms:

Parasympatholytics
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cholinergic Antagonists
Antineoplastic Agents
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Psychotropic Drugs
Antiparkinson Agents
Cholinergic Agents
Serotonin Uptake Inhibitors

Pharmacologic Actions
Muscarinic Antagonists
Serotonin Agents
Sensory System Agents
Analgesics, Non-Narcotic
Autonomic Agents
Therapeutic Uses
Analgesics
Peripheral Nervous System Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on January 30, 2009