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

NCT00352885 | Completed Phase 4 Results DMC FDA Drug

• 3 other identifiers: IRB00024759R01MH071580DATR A3-NSS
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Depression

Keywords

Cancer; IL-2 therapy; Antidepressant; Immune system; Neuroendocrine response

Outcome Measures

Primary Outcomes (1)

• Number of IL-2 Treatments Tolerated

  The mean number of IL-2 doses tolerated (out of the possible 60 total doses) are presented for each study arm. The standard high dose regimen of IL-2 includes 15 doses per cycle. The dose of IL-2 is reduced, or treatment is stopped entirely, if the side effects become severe. This analysis includes the total number of doses taken at the end of Cycle 4, by all participants who began the trial, regardless of how many cycles each participant completed.

  Cycle 4 (up to 12 weeks of IL-2 treatment)

Secondary Outcomes (5)

• Plasma Concentrations of Adrenocorticotropic Hormone (ACTH)

  Screening and Cycles 1 - 4 (up to 14 weeks)

• Plasma Concentrations of Interleukin 6 (IL-6)

  Screening and Cycles 1 - 4 (up to 14 weeks)

• Plasma Concentrations of Cortisol

  Screening and Cycles 1 - 4 (up to 14 weeks)

• Hamilton Depression Rating Scale (HAM-D) Score

  Screening and Cycles 1 - 4 (up to 14 weeks)

• Genetic Polymorphisms

  Screening and After Cycle 4 (up to 14 weeks)

Study Arms (2)

Escitalopram

EXPERIMENTAL

Participants will receive escitalopram and IL-2 treatment

Drug: Escitalopram; Drug: IL-2

Placebo

PLACEBO COMPARATOR

Participants will receive placebo and IL-2 treatment

Drug: Placebo; Drug: IL-2

Interventions

Escitalopram DRUG

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.

Also known as: Lexapro

Escitalopram

Placebo DRUG

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.

Also known as: Sugar pill

Placebo

IL-2 DRUG

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.

Escitalopram; Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Location

Related Publications (3)

• Musselman D, Royster EB, Wang M, Long Q, Trimble LM, Mann TK, Graciaa DS, McNutt MD, Auyeung NS, Oliver L, Lawson DH, Miller AH. The impact of escitalopram on IL-2-induced neuroendocrine, immune, and behavioral changes in patients with malignant melanoma: preliminary findings. Neuropsychopharmacology. 2013 Sep;38(10):1921-8. doi: 10.1038/npp.2013.85. Epub 2013 Apr 10.

  PMID: 23575741 RESULT

• Vita G, Compri B, Matcham F, Barbui C, Ostuzzi G. Antidepressants for the treatment of depression in people with cancer. Cochrane Database Syst Rev. 2023 Mar 31;3(3):CD011006. doi: 10.1002/14651858.CD011006.pub4.

  PMID: 36999619 DERIVED

• McNutt MD, Liu S, Manatunga A, Royster EB, Raison CL, Woolwine BJ, Demetrashvili MF, Miller AH, Musselman DL. Neurobehavioral effects of interferon-alpha in patients with hepatitis-C: symptom dimensions and responsiveness to paroxetine. Neuropsychopharmacology. 2012 May;37(6):1444-54. doi: 10.1038/npp.2011.330. Epub 2012 Feb 22.

  PMID: 22353759 DERIVED

MeSH Terms

Conditions

Depression; Neoplasms

Interventions

Escitalopram; Sugars; Interleukin-2

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Carbohydrates; Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Lymphokines; Proteins; Biological Factors

Limitations and Caveats

Barriers to recruitment included: patient refusal of IL-2 treatment, hesitation to join a placebo-controlled trial or take an antidepressant, depression requiring open-label, antidepressant treatment, reluctance to delay IL-2 treatment for two weeks.

Results Point of Contact

• Title: Bobbi Woolwine
• Organization: Emory University

bwoolwi@emory.edu

404-712-9620

Study Officials

• Dominique L. Musselman, MD,MS

  Emory University

  PRINCIPAL INVESTIGATOR

• David Lawson, MD

  Emory University

  STUDY CHAIR

• Andrew Miller, MD

  Emory University

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 13, 2006
• First Posted: July 17, 2006
• Study Start: October 6, 2006
• Primary Completion: May 17, 2010
• Study Completion: May 17, 2010
• Last Updated: September 14, 2018
• Results First Posted: June 27, 2014

Record last verified: 2018-08

Locations

US (1)