Clinical trial · Interventional
Oral Ketamine in the Treatment of Depression and Anxiety in Patients With Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow enrollment
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anxiety | — | UNRESOLVED | — |
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Depression | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ketamine | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Ketamine
- description
- Single dose of ketamine (0.5 mg/kg)
- interventionNames
- Drug: Ketamine
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Single dose of placebo
- interventionNames
- Drug: Placebo
Primary outcomes (2)
- measure
- Hospital Anxiety and Depression Scale - Anxiety Score (HADS-A)
- timeFrame
- Baseline, 120 minutes
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available