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Study of Oral Ketamine Versus Placebo for Treating Depression in Patients Undergoing Treatment for Cancer

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ClinicalTrials.gov Identifier: NCT02836288
Recruitment Status : Completed
First Posted : July 19, 2016
Last Update Posted : November 6, 2018
Sponsor:
Collaborator:
Icahn School of Medicine at Mount Sinai
Information provided by (Responsible Party):
Scott A. Irwin, MD, PhD, Cedars-Sinai Medical Center

Brief Summary:

The primary purpose of this study is to see if it is safe to give patients with cancer a low dose of the FDA approved anesthetic drug ketamine at the same time they receive radiation, chemotherapy, and/or surgery for their cancer treatment to treat depression and its effects. Researchers would also like to see if giving ketamine at the same time as cancer treatment is practical and reasonably acceptable to the patient.

Depression has many negative consequences for outcomes in those with cancer. It causes delayed treatments, increases in hospital lengths of stay, decreases in treatment adherence, poorer self-care, and decreased quality of life, even at 3 years post treatment. The presence of depression is the number one predictor of incomplete treatment and difficulty with rehabilitation. Therefore, investigators would also like to see if it is feasible to give patients ketamine during their routine cancer treatment treat depression and its negative effects on cancer treatment outcomes, and also help with anxiety, pain, and quality of life. The study will also use a placebo to compare to the good and/or bad effects of ketamine. A placebo is not an active drug and it will be look the same as ketamine, as a liquid to be taken by mouth.

Ketamine is approved by the U.S. Food and Drug Administration (FDA) as a general anesthetic by itself for some diagnostic and surgical procedures or combined with other general anesthetic agents. It has also been shown to reduce cancer pain. Ketamine is considered experimental in this study because it is not approved by the FDA for the treatment of depression.


Condition or disease Intervention/treatment Phase
Cancer Depression Drug: Ketamine Other: Placebo Early Phase 1

Detailed Description:

This is a prospective, single center, double blind, randomized, two-arm feasibility study of oral ketamine versus placebo for the treatment of depression in depressed patients with cancer undergoing curative intent cancer therapy. Approximately 20 patients with cancer about to undergo cancer therapy will be randomized 1:1 to receive study treatment with one of the following regimens:

Arm A: nightly oral administration of 1.0 mg/kg ketamine Arm B: nightly oral administration of placebo (after completion of Arm B, patients will have the option to receive a nightly oral administration of 1.0 mg/kg ketamine and follow study procedures over again)

Consenting patients will undergo screening procedures, and if eligible, a baseline interview and brief questionnaires regarding depression, mental and emotional health, and quality of life assessments.

Study treatment will be administered for 12 weeks unless the patient experiences unacceptable toxicities, exhibits moderate to severe depressive symptoms, or withdraws consent. Patients on the placebo treatment arm will have the option to receive ketamine and follow all study procedures over again with the ketamine drug after completion of the placebo treatment.

Patients will be asked to complete psychosocial measurements every two weeks while on study treatment and monthly during a five-month follow-up period.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double Blind, Feasibility Study of Oral Ketamine Versus Placebo for Treating Depression in Patients With Cancer
Actual Study Start Date : December 20, 2016
Actual Primary Completion Date : May 29, 2018
Actual Study Completion Date : May 29, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

Arm Intervention/treatment
Experimental: Ketamine
Oral ketamine 1.0 mg/kg mixed with syrup
Drug: Ketamine
Ketamine 1.0 mg/kg mixed with syrup will be given by mouth once a day for 12 weeks.
Other Name: Ketalar

Placebo Comparator: Placebo
Oral placebo (syrup)
Other: Placebo
Placebo syrup will be given by mouth once a day for 12 weeks.

Experimental: Ketamine after placebo
Optional oral Ketamine 1.0 mg/kg mixed with syrup for patients on placebo arm after 12 week treatment is completed.
Drug: Ketamine
Ketamine 1.0 mg/kg mixed with syrup will be given by mouth once a day for 12 weeks.
Other Name: Ketalar

Other: Placebo
Placebo syrup will be given by mouth once a day for 12 weeks.




Primary Outcome Measures :
  1. Proportion of patients pre-screened that were potentially eligible for study participation. [ Time Frame: 24 months ]
  2. Proportion of patients that were potentially eligible who were approached. [ Time Frame: 24 months ]
  3. Proportion of approached patients that decline study participation and why. [ Time Frame: 24 months ]
  4. Proportion of approached patients that agreed to participate [ Time Frame: 24 months ]
  5. Proportion of approached that were randomized. [ Time Frame: 24 months ]
  6. Proportions of patients discontinuing prematurely from study treatment for any reason, including side effects attributed to ketamine or side effects attributed to placebo, documenting reasons for dropout. [ Time Frame: 24 months ]
  7. Proportion of patients evaluable. [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. Adverse events related to study treatment. [ Time Frame: 10 months ]
  2. Patient-reported Frequency, Intensity and Burden of Side Effects (FIBSER) scores. [ Time Frame: 10 months ]
  3. Treatment expectancy and satisfaction as measured by the credibility/expectancy questionnaire (CEQ). [ Time Frame: 10 months ]

Other Outcome Measures:
  1. Changes in scores for QIDS-SR-16 questionnaire. [ Time Frame: 10 months ]
  2. Changes in scores for Pain VAS questionnaire. [ Time Frame: 10 months ]
  3. Changes in scores for HADS questionnaire. [ Time Frame: 10 months ]
  4. Changes in scores for UW-QOL questionnaire. [ Time Frame: 10 months ]
  5. Changes in scores for SRA questionnaire. [ Time Frame: 10 months ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ability to understand and the willingness to sign a written informed consent.
  • Subject receiving or within twelve weeks of having received curative intent cancer treatment with radiation and/or chemotherapy
  • Age ≥ 18 years.
  • Has moderate to severe depression according to Quick Inventory of Depressive Symptomatology-Self Rated 16 (QIDS-SR-16) scores of ≥ 11 AND a Hospital Anxiety and Depression Scale (HADS) Depression subscale score of ≥ 8.
  • Documented adequate liver function within the screening period as defined by:
  • ALT < 5 X institutional upper limit of normal (ULN)
  • AST < 5 X institutional ULN
  • Total bilirubin < 5 X institutional ULN
  • Both men and women of all races and ethnic groups are eligible for this trial.
  • Use of other antidepressants is permitted if dose has been the same for at least 12 weeks prior to study entry and still meet inclusion #4.
  • Women of child-bearing potential and men with partners of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating and the study physician immediately. Urine pregnancy testing will be done throughout the trial for women of childbearing potential.
  • Must read and understand English fluently.

Exclusion Criteria:

  • Receiving another investigational agent on a clinical trial that prohibits participation in other studies of investigational agents.
  • Meets MINI International Neuropsychiatric Interview (MINI Plus), criteria for diagnoses of schizophrenia, bipolar illness, delirium or psychosis.
  • Has high Suicidal Risk Assessment (SRA) scores ≥ 10.
  • Use of monoamine oxidase inhibitors within 14 days of study entry.
  • History of allergic reactions or hypersensitivity to ketamine.
  • Documented history of severe cardiac insufficiency (NYHA III or IV), with uncontrolled and/or unstable cardiac or coronary artery disease.
  • Documented history of significant tachyarrhythmia, severe angina, or myocardial ischemia
  • Documented history of poorly controlled hypertension (Systolic Blood Pressure > 180 mmHG or Diastolic Blood Pressure > 100 mmHG), with or without antihypertensives.
  • If a woman is or becomes pregnant or is nursing at any time before or during the treatment period, she will be excluded from the study.
  • Score of ≥ 8 on the WHO Alcohol Use Disorders Identification Test (AUDIT)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02836288


Locations
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United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Sponsors and Collaborators
Scott A. Irwin, MD, PhD
Icahn School of Medicine at Mount Sinai
Investigators
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Principal Investigator: Scott Irwin, MD, PhD Cedars-Sinal Medical Center

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Responsible Party: Scott A. Irwin, MD, PhD, Associate Professor, Psychiatry & Behavioral Neurosciences, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT02836288     History of Changes
Other Study ID Numbers: IIT2015-23-IRWIN-KETTREAT
First Posted: July 19, 2016    Key Record Dates
Last Update Posted: November 6, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Scott A. Irwin, MD, PhD, Cedars-Sinai Medical Center:
Ketamine
Treatment of Depression
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action