Clinical TrialDepressive DisordersKetaminePlaceboKetamineCompleted

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

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

Target Enrollment
4 participants
Study Type
Phase I interventional
Design
Randomized, quadruple Blind

Detailed Description

Prospective, single-centre, double-blind, randomised, parallel two-arm feasibility study assessing nightly oral ketamine 1.0 mg/kg versus placebo for depression in patients undergoing curative-intent cancer therapy.

Study treatment given once daily for 12 weeks with psychosocial and symptom measures every two weeks during treatment and monthly during a five-month follow-up; placebo arm participants may opt to receive open-label ketamine after completion.

Study Protocol

Preparation

sessions

Dosing

84 sessions

Integration

sessions

Study Arms & Interventions

Ketamine

experimental

Nightly oral ketamine 1.0 mg/kg for 12 weeks (mixed with syrup).

Interventions

  • Ketamine1 mg/kg
    via Oral• daily• 84 doses total

    Nightly oral administration for 12 weeks; mixed with syrup.

Placebo

placebo

Nightly oral placebo syrup for 12 weeks; option to receive ketamine after completion.

Interventions

  • Placebo
    via Oral• daily• 84 doses total

    Placebo syrup once daily for 12 weeks; identical appearance to ketamine; option to receive ketamine after completion.

Ketamine after placebo

experimental

Optional open-label nightly ketamine 1.0 mg/kg for participants who completed placebo arm.

Interventions

  • Ketamine1 mg/kg
    via Oral• daily• 84 doses total

    Optional open-label administration after placebo period.

Participants

Ages
18 – 99
Sexes
Male & Female

Inclusion 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

  • 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)

Study Details

Locations

Cedars-Sinai Medical Center — Los Angeles, California, United States

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