NCT00352885

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

Completed Phase 4 Results posted Last updated 14 September 2018

What this trial tests

Phase 4 trial testing Escitalopram in Depression in 20 participants. Completed in 17 May 2010.

Timeline

6 October 2006

Primary endpoint
17 May 2010

17 May 2010

Quick facts

Lead sponsor	Emory University
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	single group
Masking	quadruple
Primary purpose	prevention
Enrollment	20
Start date	6 October 2006
Primary completion	17 May 2010
Estimated completion	17 May 2010
Sites	1 location across United States

Drugs / interventions tested

• Escitalopram (escitalopram) — full drug profile →
• Placebo
• IL-2 — full drug profile →

Conditions studied

• Depression — all drugs for Depression →

Sponsor

Emory University

Who can join

Adults 18 to 75, any sex, with Depression. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of IL-2 Treatments Tolerated Primary · Cycle 4 (up to 12 weeks of IL-2 treatment)

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.

Group	Value	95% CI
Escitalopram	18.4	± 8.22
Placebo	19.8	± 8.96

Plasma Concentrations of Adrenocorticotropic Hormone (ACTH) Secondary · Screening and Cycles 1 - 4 (up to 14 weeks)

Adrenocorticotropic hormone (ACTH) is a stress hormone that is synthesized by the pituitary in response to corticotropin-releasing hormone (CRH). ACTH stimulates adrenal cortisol production. ACTH levels vary throughout the day and are highest between 6am and 8am. A typical reference range is 10-50 picograms per milliliter (pg/ml) from blood drawn in the morning. Low levels of ACTH can indicate adrenal insufficiency (including adrenal cancers) while high levels may indicate several diseases or stress. IL-2 treatment stimulates the release of ACTH and this stimulation is dose dependent (rising a

Screening

Group	Value	95% CI
Escitalopram	27.55	± 7.41
Placebo	28.95	± 4.43

Cycle 1

Group	Value	95% CI
Escitalopram	45.66	± 7.58
Placebo	56.60	± 10.46

Cycle 2

Group	Value	95% CI
Escitalopram	112.59	± 73.04
Placebo	75.69	± 20.61

Cycle 3

Group	Value	95% CI
Escitalopram	87.89	± 36.03
Placebo	136.13	± 60.52

Cycle 4

Group	Value	95% CI
Escitalopram	91.25	± 45.23
Placebo	81.23	± 22.08

Plasma Concentrations of Interleukin 6 (IL-6) Secondary · Screening and Cycles 1 - 4 (up to 14 weeks)

Immune system functioning was assessed by measuring plasma concentrations of interleukin 6 (IL-6). IL-6 is a proinflammatory cytokine that is elevated during times of inflammation, infection, in patients with advanced or metastatic cancer, and is also implicated in mood disorders. IL-2 treatments are associated with increased IL 6 levels, in a dose response manner. IL-6 values in healthy individuals are generally less than 16 pg/ml. Blood was drawn for measuring IL-6 at screening (baseline value) and once during days 1-3 of each cycle of the four IL-2 treatments.

Screening

Group	Value	95% CI
Escitalopram	11.68	± 7.09
Placebo	10.12	± 3.36

Cycle 1

Group	Value	95% CI
Escitalopram	290.77	± 81.63
Placebo	270.11	± 71.85

Cycle 2

Group	Value	95% CI
Escitalopram	210.90	± 49.96
Placebo	297.94	± 67.94

Cycle 3

Group	Value	95% CI
Escitalopram	305.41	± 69.95
Placebo	332.49	± 52.54

Cycle 4

Group	Value	95% CI
Escitalopram	283.34	± 67.55
Placebo	308.09	± 57.37

Plasma Concentrations of Cortisol Secondary · Screening and Cycles 1 - 4 (up to 14 weeks)

Cortisol is a steroid hormone made in the adrenal glands in response to fear or stressful situations. A typical reference range is 6-23 micrograms/deciliter (mcg/dL) from blood drawn in the morning. Low levels of cortisol can indicate Addison's disease or a problem with the pituitary gland, while high levels may indicate tumors of the adrenal gland, among other illnesses, or increased stress. Chronic elevation of cortisol is associated with reduced immune function and increased risk of heart disease. IL-2 treatment stimulates the release of cortisol and this stimulation is dose dependent (risi

Screening

Group	Value	95% CI
Escitalopram	11.51	± 2.06
Placebo	10.62	± 1.27

Cycle 1

Group	Value	95% CI
Escitalopram	20.60	± 1.47
Placebo	17.78	± 1.58

Cycle 2

Group	Value	95% CI
Escitalopram	19.53	± 2.53
Placebo	18.46	± 1.79

Cycle 3

Group	Value	95% CI
Escitalopram	22.44	± 2.39
Placebo	19.11	± 1.15

Cycle 4

Group	Value	95% CI
Escitalopram	20.58	± 2.63
Placebo	18.86	± 1.29

Hamilton Depression Rating Scale (HAM-D) Score Secondary · Screening and Cycles 1 - 4 (up to 14 weeks)

Hamilton Depression Rating Scale (HAM-D) is a 21-item, observer-rated scale which quantifies the severity of depressive symptoms, including depressed mood, loss of interest in usually pleasurable activities, insomnia, anorexia, fatigue, weight loss, and psychomotor retardation or agitation. Participants rate the severity of their symptoms on a scale of 0-2 or 0-4 (depending on the item), where 0 means that the symptom is absent. Total scores are calculated by summing the first 17 items for a total score between 0 and 50. For this study a score of 0-6 indicates a normal state, a score of 7-17 i

Screening

Group	Value	95% CI
Escitalopram	7.77	± 1.27
Placebo	6.45	± 1.51

Cycle 1

Group	Value	95% CI
Escitalopram	11.56	± 2.24
Placebo	12.73	± 1.63

Cycle 2

Group	Value	95% CI
Escitalopram	12.33	± 1.69
Placebo	15.00	± 2.05

Cycle 3

Group	Value	95% CI
Escitalopram	14.56	± 1.61
Placebo	16.64	± 2.38

Cycle 4

Group	Value	95% CI
Escitalopram	14.56	± 1.77
Placebo	16.00	± 2.45

Adverse events — posted to ClinicalTrials.gov

Time frame: Data were collected for adverse events from the screening visit through the end of IL-2 treatment (up to 14 weeks).. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Escitalopram

Serious: 5/9 (56%)

Deaths: 0/9

Placebo

Serious: 3/11 (27%)

Deaths: 0/11

Serious adverse events (1 terms)

Reaction	System	Escitalopram	Placebo
Progression of melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—

Other adverse events (2 terms — click to expand)

Reaction	System	Escitalopram	Placebo
major depression	Psychiatric disorders	—	—
cardiac effect	Cardiac disorders	—	—

Most-reported serious reactions: Progression of melanoma.

Data from ClinicalTrials.gov NCT00352885 adverse events section.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Antidepressants for the treatment of depression in people with cancer.
   Ostuzzi G, Matcham F, Dauchy S, Barbui C, et al · · 2018 · cited 89× · PMID 29683474 · DOI 10.1002/14651858.cd011006.pub3
2. Antidepressants for the treatment of depression in people with cancer.
   Ostuzzi G, Matcham F, Dauchy S, Barbui C, et al · · 2015 · cited 38× · PMID 26029972 · DOI 10.1002/14651858.cd011006.pub2
3. Neurobehavioral effects of interferon-α in patients with hepatitis-C: symptom dimensions and responsiveness to paroxetine.
   McNutt MD, Liu S, Manatunga A, Royster EB, et al · · 2012 · cited 37× · PMID 22353759 · DOI 10.1038/npp.2011.330
4. Antidepressants for the treatment of depression in people with cancer.
   Vita G, Compri B, Matcham F, Barbui C, et al · · 2023 · cited 31× · PMID 36999619 · DOI 10.1002/14651858.cd011006.pub4