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

NCT02836288 | Completed Early Phase 1 DMC FDA Drug

• 1 other identifier: IIT2015-23-IRWIN-KETTREAT
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer; Depression

Keywords

Ketamine; Treatment of Depression

Outcome Measures

Primary Outcomes (7)

• Proportion of patients pre-screened that were potentially eligible for study participation.

  24 months

• Proportion of patients that were potentially eligible who were approached.

  24 months

• Proportion of approached patients that decline study participation and why.

  24 months

• Proportion of approached patients that agreed to participate

  24 months

• Proportion of approached that were randomized.

  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.

  24 months

• Proportion of patients evaluable.

  24 months

Secondary Outcomes (3)

• Adverse events related to study treatment.

  10 months

• Patient-reported Frequency, Intensity and Burden of Side Effects (FIBSER) scores.

  10 months

• Treatment expectancy and satisfaction as measured by the credibility/expectancy questionnaire (CEQ).

  10 months

Other Outcomes (5)

• Changes in scores for QIDS-SR-16 questionnaire.

  10 months

• Changes in scores for Pain VAS questionnaire.

  10 months

• Changes in scores for HADS questionnaire.

  10 months

Study Arms (3)

Ketamine

EXPERIMENTAL

Oral ketamine 1.0 mg/kg mixed with syrup

Drug: Ketamine

Placebo

PLACEBO COMPARATOR

Oral placebo (syrup)

Other: Placebo

Ketamine after placebo

EXPERIMENTAL

Optional oral Ketamine 1.0 mg/kg mixed with syrup for patients on placebo arm after 12 week treatment is completed.

Drug: Ketamine; Other: Placebo

Interventions

Ketamine DRUG

Ketamine 1.0 mg/kg mixed with syrup will be given by mouth once a day for 12 weeks.

Also known as: Ketalar

Ketamine; Ketamine after placebo

Placebo OTHER

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

Ketamine after placebo; Placebo

Eligibility Criteria

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

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Scott A. Irwin, MD, PhD: lead
• Icahn School of Medicine at Mount Sinai: collaborator

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Neoplasms; Depression

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Scott Irwin, MD, PhD

  Cedars-Sinal Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor, Psychiatry & Behavioral Neurosciences

Study Record Dates

• First Submitted: July 14, 2016
• First Posted: July 19, 2016
• Study Start: December 20, 2016
• Primary Completion: May 29, 2018
• Study Completion: May 29, 2018
• Last Updated: November 6, 2018

Record last verified: 2018-11

Locations

US (1)