Ketamine is not FDA Approved for the treatment of mood disorders associated with

Cancer, Hospice Care or Palliative treatment

Cancer, Hospice and Palliative Care patients sometimes have a limited time and antidepressant often take too long to work. Clinical researchers in La Jolla, CA have presented evidence that Ketamine Treatement may be helpful for depression in Cancer and end of life situations.

49. Psychosomatics. 2015 Jul-Aug;56(4):329-37. doi: 10.1016/j.psym.2014.05.005. Epub
2014 Jun 5.

Ketamine for the treatment of depression in patients receiving hospice care: a
retrospective medical record review of thirty-one cases.

Iglewicz A(1), Morrison K(2), Nelesen RA(3), Zhan T(4), Iglewicz B(5), Fairman
N(6), Hirst JM(3), Irwin SA(7).

Author information:
(1)Department of Psychiatry and Moores Cancer Center, University of California,
La Jolla, CA (AI, RAN, JMH, SAI); San Diego Veterans Affairs Healthcare System,
La Jolla, CA (AI). (2)Department of Internal Medicine and Inpatient Palliative
Medicine Service, University of Colorado, Aurora, CO (KM). (3)Department of
Psychiatry and Moores Cancer Center, University of California, La Jolla, CA (AI,
RAN, JMH, SAI). (4)Division of Biostatistics, Department of Pharmacology and
Experimental Therapeutics, Thomas Jefferson University, Philadelphia, PA (TZ).
(5)Department of Statistics, Temple University, Philadelphia, PA (BI).
(6)Department of Psychiatry and Behavioral Sciences, University of California
Davis School of Medicine, Sacramento, CA (NF). (7)Department of Psychiatry and
Moores Cancer Center, University of California, La Jolla, CA (AI, RAN, JMH, SAI).
Electronic address: sirwin@ucsd.edu.

BACKGROUND: Depression is prevalent in patients receiving hospice care. Standard
antidepressant medications do not work rapidly enough in this setting. Evidence
suggests that ketamine rapidly treats treatment refractory depression in the
general population. Ketamine׳s role for treating depression in the hospice
population warrants further study.
METHODS: A retrospective medical record review of 31 inpatients receiving hospice
care who received ketamine for depression on a clinical basis was conducted. The
primary outcome measure was the Clinical Global Impression Scale, which was used
retrospectively to rate subjects׳ therapeutic improvement, global improvement,
and side effects from ketamine over 21 days. Additionally, time to onset of
therapeutic effect was analyzed.
RESULTS: Using the Clinical Global Impression Scale, ketamine was found to be
significantly therapeutically effective through the first week after ketamine
dosing (p < 0.05), with 93% of patients showing positive results for days 0-3 and
80% for days 4-7 following ketamine dosing. Patients experienced global
improvement during all 4 studied time periods following ketamine dosing (p <
0.05). Significantly more patients had either no side effects or side effects
that did not significantly impair functioning at each of the 4 assessed time
periods following ketamine dosing (p < 0.05). Additionally, significantly more
patients experienced their first therapeutic response during days 0-1 following
ketamine dosing (p < 0.001) than during any other time period.
CONCLUSIONS: These data suggest that ketamine may be a safe, effective, and rapid
treatment for clinical depression in patients receiving hospice care. Blinded,
randomized, and controlled trials are required to substantiate these findings and
support further clinical use of this medication in hospice settings.

PMCID: PMC4308579 [Available on 2016-07-01]
PMID: 25616995 [PubMed - in process]

256. J Palliat Med. 2013 Aug;16(8):958-65. doi: 10.1089/jpm.2012.0617. Epub 2013 Jun
27.

Daily oral ketamine for the treatment of depression and anxiety in patients
receiving hospice care: a 28-day open-label proof-of-concept trial.

Irwin SA(1), Iglewicz A, Nelesen RA, Lo JY, Carr CH, Romero SD, Lloyd LS.

Author information:
(1)The Institute for Palliative Medicine at San Diego Hospice, San Diego,
California 92103, USA. sirwin@ucsd.edu

BACKGROUND: Depression and anxiety are prevalent and undertreated in patients
receiving hospice care. Standard antidepressants do not work rapidly or often
enough to benefit most of these patients. Ketamine has many properties that make
it an interesting candidate for rapidly treating depression and anxiety in
patients receiving hospice care. To test this hypothesis, a 28-day, open-label,
proof-of-concept trial of daily oral ketamine administration was conducted in
order to evaluate the tolerability, potential efficacy, and time to potential
efficacy in treating depression and anxiety in patients receiving hospice care.
METHODS: In this open-label study, 14 subjects with symptoms of depression or
depression mixed with anxiety warranting psychopharmacological intervention
received daily oral doses of ketamine hydrochloride (0.5 mg/kg) over a 28-day
period. The primary outcome measure was the Hospital Anxiety and Depression Scale
(HADS), which was used to rate overall depression and anxiety symptoms at
baseline, and on days 3, 7, 14, 21, and 28.
RESULTS: Over the 28-day trial there was significant improvement in both
depressive symptoms (F5,35=8.03, p=0.002, η(2)=0.534) and symptoms of anxiety
(F5,35=14.275, p<0.001, η(2)=0.67) for the eight subjects that completed the
trial. One hundred percent of subjects completing the trial responded to ketamine
for both anxiety and depression. A significant response in depressive symptoms
occurred by day 14 for depression (mean Δ=3.5, d=1.14, 95% CI=1.09-5.9, p=0.01)
and day 3 for anxiety (mean Δ=2.4, d=0.67, 95% CI=1.0-3.7, p=0.004). These
improvements remained significant through day 28 for both depression (mean Δ=4.0,
d=1.34, 95% CI=2.3-5.9, p=0.001) and anxiety (mean Δ=6.09, d=1.34, 95%
CI=3.6-8.6, p<0.001). Side effects were rare, the most common being diarrhea,
trouble sleeping, and trouble sitting still.
CONCLUSIONS: Patients who received daily oral ketamine experienced a robust
antidepressant and anxiolytic response with few adverse events. The response rate
for depression is similar to those found with IV ketamine; however, the time to
response is more protracted. The findings of the potential efficacy of oral
ketamine for depression and the response of anxiety symptoms are novel. Further
investigation with randomized, controlled clinical trials is necessary to firmly
establish the efficacy and safety of oral ketamine for the treatment of
depression and anxiety in patients receiving hospice care or other subject
populations.

PMCID: PMC3717203
PMID: 23805864 [PubMed - indexed for MEDLINE]

327. J Palliat Med. 2012 Apr;15(4):400-3. doi: 10.1089/jpm.2011.0314. Epub 2012 Apr 2.

Mood and pain responses to repeat dose intramuscular ketamine in a depressed
patient with advanced cancer.

Zanicotti CG(1), Perez D, Glue P.

Author information:
(1)Department of Psychological Medicine, Dunedin School of Medicine, University
of Otago, Dunedin, New Zealand. claudiagrott@hotmail.com

Depression is highly prevalent in patients with advanced cancer, commonly
affecting quality of life. Considering the response delay with conventional
antidepressants and the short life expectancy for these patients, treatments for
Major Depressive Disorder (MDD) with faster onset of action are desirable. In
this case report, a female patient with metastatic ovarian cancer presented rapid
and sustained response to intramuscular (IM) injections of ketamine (1mg/kg).
Over a course of six treatments, her mood response was identical on each occasion
and provided remission of her depressive symptoms. Pain was also improved,
although for a shorter duration. These findings support the use of IM ketamine as
a possible antidepressant option for this population.

PMID: 22468772 [PubMed - indexed for MEDLINE]

385. J Palliat Med. 2010 Jul;13(7):903-8. doi: 10.1089/jpm.2010.9808.

Oral ketamine for the rapid treatment of depression and anxiety in patients
receiving hospice care.

Irwin SA(1), Iglewicz A.

Author information:
(1)Institute for Palliative Medicine at San Diego Hospice, Palliative Care
Psychiatry, San Diego, California 92103, USA. sirwin@sdhospice.org

Depression is prevalent and undertreated in patients receiving hospice care.
Standard antidepressants do not work rapidly or often enough to benefit most of
these patients. Here, two cases are reported in which a single oral dose of
ketamine provided rapid and moderately sustained symptom relief for both
depression and anxiety. In addition, no adverse effects were noted. Further
investigation with randomized, controlled clinical trials is necessary to firmly
establish the effectiveness of oral ketamine for the treatment of depression and
anxiety in patients receiving hospice care. Ketamine may be a promising safe,
effective, and cost-effective rapid treatment for depression and anxiety in this
population.

PMCID: PMC3120058
PMID: 20636166 [PubMed - indexed for MEDLINE]

427. J Palliat Med. 2008 Nov;11(9):1268-71. doi: 10.1089/jpm.2008.9828.

Intravenous ketamine "burst" for refractory depression in a patient with advanced
cancer.

Stefanczyk-Sapieha L(1), Oneschuk D, Demas M.

Author information:
(1)Palliative Medicine, University Health Network, Toronto General Hospital
Toronto, Ontario, Canada. msapieha@hotmail.com

Major Depressive Disorder (MDD) is prevalent in patients with advanced cancer,
and can have a negative impact on patients' quality of life. Available
antidepressants, often have delayed benefits of several weeks, and therefore are
of limited utility in the palliative care setting. Psychostimulants provide more
rapid onset of action, but frequently require dose escalation because of problems
with tolerance. There is a growing body of evidence that N-methyl-D-aspartate
(NMDA) receptor antagonists, such as ketamine, signficantly and rapidly improve
depressive symptoms in treatment resistant depression. However, studies conducted
to date have not included advanced cancer patients. We report on a case where
intravenous ketamine 'bursts' (0.5 mg/kg infused over 60 minutes) were used to
treat an intractable MDD in a patient with metastatic prostate cancer. Initial
positive response was not sustained, and response to a repeat treatment was even
more transient. Adverse effects were mild and self-limiting. We conclude that a
well-designed, randomized study of IV ketamine "bursts" in cancer patients
suffering from depression is needed to further establish the role and appropriate
dosing of ketamine in this patient population. Given that ketamine can be used as
an adjuvant for difficult pain syndromes in cancer patients, it would be of
interest to assess its impact on the mood in patients receiving this treatment
for pain.

PMID: 19021495 [PubMed - indexed for MEDLINE]