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NCT02836288 · ClinicalTrials.gov registry record · Early Phase 1

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

A Early Phase 1 study of Depression and Cancer, sponsored by Scott A. Irwin, MD, PhD.

Completed
Registry status
Early Phase 1
Development phase
4
Enrollment target
1
Study location

NCT02836288: Completed Early Phase 1 study of Depression and Cancer, sponsored by Scott A. Irwin, MD, PhD.

NCT02836288 is a Early Phase 1 study of Depression and Cancer that has completed, run by Scott A. Irwin, MD, PhD. The registered enrollment target is 4 participants, below the 786-participant average among 679 other Depression trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02836288, a Early Phase 1 study of Depression and Cancer, has completed, sponsored by Scott A. Irwin, MD, PhD.

COMPLETED
Registry status
Early Phase 1
Development phase
4 participants
Enrollment target
1
Study location

Study Summary

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. Researchers would also like to see if giving ketamine at the same time as cancer treatment is practical and reasonably acceptable to the patient. Depression has many negative consequences for outcomes in those with cancer. It causes delayed treatments, increases in hospital lengths of stay, decreases in treatment adherence, poorer self-care, and decreased quality of life, even at 3 years post treatment. The presence of depression is the number one predictor of incomplete treatment and difficulty with rehabilitation. Therefore, investigators would also like to see if it is feasible to give patients ketamine during their routine cancer treatment treat depression and its negative effects on cancer treatment outcomes, and also help with anxiety, pain, and quality of life. The study will also use a placebo to compare to the good and/or bad effects of ketamine. A placebo is not an active drug and it will be look the same as ketamine, as a liquid to be taken by mouth. Ketamine is approved by the U.S. Food and Drug Administration (FDA) as a general anesthetic by itself for some diagnostic and surgical procedures or combined with other general anesthetic agents. It has also been shown to reduce cancer pain. Ketamine is considered experimental in this study because it is not approved by the FDA for the treatment of depression.

Conditions Studied

Interventions

  • OTHER Placebo
  • DRUG Ketamine

Study Locations (1)

California

  • Cedars-Sinai Medical Center - Los Angeles

Trial Details

FieldValue
Enrollment Target 4 participants
Start Date 2016-12-20
Est. Completion 2018-05-29
Phase Early Phase 1

Sponsor

Scott A. Irwin, MD, PhD

2 total trials

What the Registry Record Tells You About NCT02836288

The ClinicalTrials.gov registry entry for NCT02836288 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 4 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 786-participant average among 679 other Depression trials with a reported enrollment target (99% lower). The listed sponsor is Scott A. Irwin, MD, PhD, which has 2 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Depression appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT02836288 reports 1 study location spanning 1 distinct geographic area - top geographies include California.

Frequently Asked Questions

What is clinical trial NCT02836288 about?

NCT02836288 is a clinical study titled "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. Researchers would also ...

What is the current status of trial NCT02836288?

This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 4 participants. The study started on 2016-12-20. Estimated completion is 2018-05-29.

What conditions does trial NCT02836288 study?

This clinical trial studies the following conditions: Depression, Cancer.

What interventions are being tested in trial NCT02836288?

The interventions under investigation include: Placebo (OTHER), Ketamine (DRUG).

Who is sponsoring clinical trial NCT02836288?

This trial is sponsored by Scott A. Irwin, MD, PhD, which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02836288 being conducted?

This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

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