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

NCT01680172 | Terminated Phase 2 Results

• 1 other identifier: 12-001156
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Cancer; Depression; Anxiety

Keywords

cancer; depression; anxiety; palliative care

Outcome Measures

Primary Outcomes (2)

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

  Hospital Anxiety and Depression Scale (HADS) is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 (no symptoms) and 21 (severe symptoms) for either anxiety or depression. Cut-offs for identifying psychiatric distress has been reported in the literature to be \>10 for anxiety and \>8 for depression.

  Baseline, 120 minutes

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

  Hospital Anxiety and Depression Scale (HADS) is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 (no symptoms) and 21 (severe symptoms) for either anxiety or depression. Cut-offs for identifying psychiatric distress has been reported in the literature to be \>10 for anxiety and \>8 for depression.

  Baseline, 120 minutes

Study Arms (2)

Ketamine

EXPERIMENTAL

Single dose of ketamine (0.5 mg/kg)

Drug: Ketamine

Placebo

PLACEBO COMPARATOR

Single dose of placebo

Drug: Placebo

Interventions

Ketamine DRUG

Single dose (0.5 mg/kg) of liquid ketamine 10mg/mL solution taken by mouth

Also known as: Ketalar

Ketamine

Placebo DRUG

Single dose of liquid placebo solution taken by mouth

Placebo

Eligibility Criteria

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

You may qualify if:

• Patients with cancer
• Outpatient status at the time of study entry
• 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

You may not qualify if:

• May receive psychotherapy from an outside provider at the beginning and/or during the course of the study
• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (2)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Yuma Regional Medical Center

Yuma, Arizona, 85364, United States

Location

MeSH Terms

Conditions

Neoplasms; Depression; Anxiety Disorders

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Intervention Hierarchy (Ancestors)

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

Limitations and Caveats

The study was terminated due to slow accrual rate. Data analysis limited to 5 participants.

Results Point of Contact

• Title: Robert Bright, MD
• Organization: Mayo Clinic

bright.robert@mayo.edu

480-301-4853

Study Officials

• Robert P. Bright, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 4, 2012
• First Posted: September 7, 2012
• Study Start: August 1, 2012
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: February 29, 2016
• Results First Posted: February 29, 2016

Record last verified: 2016-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)