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TerminatedPhase 2Results posted

Oral Ketamine in the Treatment of Depression and Anxiety in Patients With Cancer

NCT01680172 · Mayo Clinic

Closed to entry
Status
Not accepting participants
Phase 2
Phase
5
Target enrolment
2
Study sites
1 US states

What it is testing

Summary

Depression is common in patients with cancer. Current medications for depression, while effective, take several weeks to take effect. Ketamine has emerged as a drug with promise for cancer patients. In two reported cases, a single dose of ketamine induced rapid and moderately sustained symptom reduction in depression and anxiety with no adverse side effects. Benefit was seen in as little as 1 hour and sustained up to 30 days. This study is a randomized, double-blind, placebo-controlled investigation testing whether a single dose of ketamine improves depression and anxiety relative to placebo in patients with cancer.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Hospital Anxiety and Depression Scale - Anxiety Score (HADS-A)

    Measured over Baseline, 120 minutes

  • Hospital Anxiety Depression Scale- Depression Score (HADS-D)

    Measured over Baseline, 120 minutes

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: * Patients with cancer * Outpatient status at the time of study entry * 18 years of age or older * Life expectancy of at least 1 month * Regular access to a telephone (for safety reasons) * Reliable transportation to follow-up visits * Caregiver observation available for 24 hours after the dose * Histologically-proven malignancy * Depression score of \>11 on the Hospital Anxiety and Depression Scale (HADS) * Provision of informed consent * Able to complete the patient questionnaires alone or with assistance * Able to speak and read English * May receive other psycho-active medications while on the study i.e. opiates, except as defined within the exclusion criteria * May receive psychotherapy from an outside provider at the beginning and/or during the course of the study Exclusion Criteria: * Obvious cognitive dysfunction or Mini Mental Status Exam score \<20 * Antidepressants started or dose changed within 8 weeks of the beginning of the study or during the study * Benzodiazepines prescribed for psychiatric indications that have been started or dose change within 2 weeks of the beginning of study enrollment * Suicidal ideation or a suicide attempt within the last year * Patients with current or past psychosis not from delirium * Females who are pregnant or nursing * Unable to take oral medications * Primary or metastatic brain malignancy * Gastrointestinal tract obstruction * Prior adverse reaction to or other contraindication to ketamine * Substance abuse or dependence, as defined by Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) criteria, within the last 90 days

Where

2 study sites

FacilityCityRegionCountry
Mayo Clinic in ArizonaScottsdaleArizonaUnited States
Yuma Regional Medical CenterYumaArizonaUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT01680172 on ClinicalTrials.gov →

Last updated in the registry 2016-02-29. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits