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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

Tracking Information
First Submitted Date  ICMJE July 14, 2016
First Posted Date  ICMJE July 19, 2016
Last Update Posted Date November 6, 2018
Actual Study Start Date  ICMJE December 20, 2016
Actual Primary Completion Date May 29, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 14, 2016)
  • Proportion of patients pre-screened that were potentially eligible for study participation. [ Time Frame: 24 months ]
  • Proportion of patients that were potentially eligible who were approached. [ Time Frame: 24 months ]
  • Proportion of approached patients that decline study participation and why. [ Time Frame: 24 months ]
  • Proportion of approached patients that agreed to participate [ Time Frame: 24 months ]
  • Proportion of approached that were randomized. [ Time Frame: 24 months ]
  • 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 ]
  • Proportion of patients evaluable. [ Time Frame: 24 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 14, 2016)
  • Adverse events related to study treatment. [ Time Frame: 10 months ]
  • Patient-reported Frequency, Intensity and Burden of Side Effects (FIBSER) scores. [ Time Frame: 10 months ]
  • Treatment expectancy and satisfaction as measured by the credibility/expectancy questionnaire (CEQ). [ Time Frame: 10 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: July 14, 2016)
  • Changes in scores for QIDS-SR-16 questionnaire. [ Time Frame: 10 months ]
  • Changes in scores for Pain VAS questionnaire. [ Time Frame: 10 months ]
  • Changes in scores for HADS questionnaire. [ Time Frame: 10 months ]
  • Changes in scores for UW-QOL questionnaire. [ Time Frame: 10 months ]
  • Changes in scores for SRA questionnaire. [ Time Frame: 10 months ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Study of Oral Ketamine Versus Placebo for Treating Depression in Patients Undergoing Treatment for Cancer
Official Title  ICMJE A Randomized, Double Blind, Feasibility Study of Oral Ketamine Versus Placebo for Treating Depression in Patients With Cancer
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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Cancer
  • Depression
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: Ketamine
    Oral ketamine 1.0 mg/kg mixed with syrup
    Intervention: Drug: Ketamine
  • Placebo Comparator: Placebo
    Oral placebo (syrup)
    Intervention: Other: Placebo
  • 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.
    Interventions:
    • Drug: Ketamine
    • Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 5, 2018)
4
Original Estimated Enrollment  ICMJE
 (submitted: July 14, 2016)
20
Actual Study Completion Date  ICMJE May 29, 2018
Actual Primary Completion Date May 29, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02836288
Other Study ID Numbers  ICMJE IIT2015-23-IRWIN-KETTREAT
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Scott A. Irwin, MD, PhD, Cedars-Sinai Medical Center
Study Sponsor  ICMJE Scott A. Irwin, MD, PhD
Collaborators  ICMJE Icahn School of Medicine at Mount Sinai
Investigators  ICMJE
Principal Investigator: Scott Irwin, MD, PhD Cedars-Sinal Medical Center
PRS Account Cedars-Sinai Medical Center
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP