Evaluating the Effectiveness of Escitalopram in Preventing or Reducing Depressive Symptoms in People Receiving Interleukin-2 Treatment
Recruitment status was Recruiting
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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 |
- Number of IL-2 treatments tolerated [ Time Frame: Measured over 5 months of treatment ] [ Designated as safety issue: No ]
- 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 |
|---|---|
|
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.
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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 |
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| Contact: Erica C. Bruce, MPH | 404-712-9614 | ecbruce@emory.edu |
| Contact: Carol Hill, RN | 404-778-4907 | carol.hill@emoryhealthcare.org |
| United States, Georgia | |
| Winship Cancer Institute | Recruiting |
| Atlanta, Georgia, United States, 30322 | |
| 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 National Institute of Mental Health (NIMH)
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Dominique L. Musselman, Emory University |
| ClinicalTrials.gov Identifier: | NCT00352885 History of Changes |
| Other Study ID Numbers: | R01 MH071580, DATR A3-NSS |
| Study First Received: | July 13, 2006 |
| Last Updated: | March 17, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Mental Health (NIMH):
|
Cancer IL-2 therapy Antidepressant Immune system Neuroendocrine response |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Behavioral Symptoms Mood Disorders Mental Disorders Dexetimide Citalopram Interleukin-2 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 Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Serotonin Agents Antineoplastic Agents Analgesics, Non-Narcotic |
ClinicalTrials.gov processed this record on May 22, 2013