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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Andrew H Miller, Emory University
ClinicalTrials.gov Identifier:
NCT00352885
First received: July 13, 2006
Last updated: May 26, 2014
Last verified: April 2014
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: IL-2 Neuropsychiatric Symptoms: Mechanism and Prevention

Resource links provided by NLM:


Further study details as provided by Emory University:

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 ]

Enrollment: 20
Study Start Date: January 2006
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
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.
Other Name: Lexapro
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.
Placebo Comparator: B
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.
Other Name: Sugar pill
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 Interleukin (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 Diagnostic and Statistical Manual of Mental Disorders (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Georgia
Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Dominique L. Musselman, MD,MS Emory University
Study Chair: David Lawson, MD Winship Cancer Institute of Emory University
Study Chair: Andrew Miller, MD Emory University
  More Information

No publications provided by Emory University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Andrew H Miller, Professor, Emory University
ClinicalTrials.gov Identifier: NCT00352885     History of Changes
Other Study ID Numbers: IRB00024759, R01MH071580, DATR A3-NSS
Study First Received: July 13, 2006
Results First Received: March 8, 2014
Last Updated: May 26, 2014
Health Authority: United States: Federal Government

Keywords provided by Emory University:
Cancer
IL-2 therapy
Antidepressant
Immune system
Neuroendocrine response

Additional relevant MeSH terms:
Depression
Behavioral Symptoms
Dexetimide
Citalopram
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs

ClinicalTrials.gov processed this record on September 22, 2014