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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02836288
• Date of registration: 14/07/2016
• Prospective Registration: Yes
• Primary sponsor: Scott A. Irwin, MD, PhD
• Public title: Study of Oral Ketamine Versus Placebo for Treating Depression in Patients Undergoing Treatment for Cancer
• Scientific title: A Randomized, Double Blind, Feasibility Study of Oral Ketamine Versus Placebo for Treating Depression in Patients With Cancer
• Date of first enrolment: December 20, 2016
• Target sample size: 4
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02836288
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Early Phase 1

Countries of recruitment

United States

Contacts

• Name: Scott Irwin, MD, PhD
• Affiliation: Cedars-Sinal Medical Center

Key inclusion & exclusion 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:

- 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)



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Cancer

Depression

Intervention(s)

Other: Placebo

Drug: Ketamine

Primary Outcome(s)

Proportion of approached patients that agreed to participate [Time Frame: 24 months]

Proportion of approached patients that decline study participation and why. [Time Frame: 24 months]

Proportion of patients pre-screened that were potentially eligible for study participation. [Time Frame: 24 months]

Proportion of patients that were potentially eligible who were approached. [Time Frame: 24 months]

Proportion of patients evaluable. [Time Frame: 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. [Time Frame: 24 months]

Proportion of approached that were randomized. [Time Frame: 24 months]

Secondary Outcome(s)

Treatment expectancy and satisfaction as measured by the credibility/expectancy questionnaire (CEQ). [Time Frame: 10 months]

Adverse events related to study treatment. [Time Frame: 10 months]

Patient-reported Frequency, Intensity and Burden of Side Effects (FIBSER) scores. [Time Frame: 10 months]

Secondary ID(s)

IIT2015-23-IRWIN-KETTREAT

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Icahn School of Medicine at Mount Sinai