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NMDA receptor antagonist

Ketamine for Fatigue

Phase 1 & 2

Recruiting

Led By Leorey N Saligan, C.R.N.P.

Research Sponsored by National Institute of Nursing Research (NINR)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

For individuals of childbearing potential; must use at least one of the following highly effective birth control methods for the duration of the study: Prescribed hormonal oral contraceptives, vaginal ring, or transdermal patch. Intrauterine device (IUD). Intrauterine hormone-releasing system (IUS). Depot/implantable hormone (e.g., Depo-provera , Implanon). Bilateral tubal occlusion/ligation.

Have chronic, persistent fatigue for at least 6 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up before and after a dose of ketamine or active placebo at multiple time points (at +40 min, at +80 min, at +120 min, at +230 min, at 24 hours, at 7 days, and at 14 days).

Awards & highlights

Study Summary

This trial will test whether ketamine reduces fatigue in cancer survivors and people with chronic illness. Participants will be screened, then given either ketamine or midazolam through an IV and monitored for side effects. The study lasts 1 month and participants will have 6-8 NIH visits.

Who is the study for?

Adults aged 18-70 with chronic fatigue due to cancer survival or illnesses like lupus, who've had persistent fatigue for over six months. They must be able to consent and have someone accompany them post-drug infusion. Women of childbearing age should use effective birth control.Check my eligibility

What is being tested?

The trial is testing if ketamine can reduce fatigue compared to midazolam (placebo) in cancer survivors and those with chronic illness. Participants will receive one drug first, then the other, while undergoing tests measuring their fatigue levels.See study design

What are the potential side effects?

Possible side effects include vivid dreams, altered perception of time and colors, dizziness, headache, restlessness, nausea or vomiting. Side effects vary from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am using a reliable birth control method during the study.

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I have been feeling very tired for at least 6 months.

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I often feel very tired, more than halfway on a scale.

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I am between 18 and 70 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ before and after a dose of ketamine or active placebo at multiple time points (at +40 min, at +80 min, at +120 min, at +230 min, at 24 hours, at 7 days, and at 14 days).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~before and after a dose of ketamine or active placebo at multiple time points (at +40 min, at +80 min, at +120 min, at +230 min, at 24 hours, at 7 days, and at 14 days).

This trial's timeline: 3 weeks for screening, Varies for treatment, and before and after a dose of ketamine or active placebo at multiple time points (at +40 min, at +80 min, at +120 min, at +230 min, at 24 hours, at 7 days, and at 14 days). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

change in self-reported fatigue score

Secondary outcome measures

change in gene expression or protein levels of pro-inflammatory markers levels and bioenergetic markers

cognition; skeletal muscle strength; motivation

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: KetamineExperimental Treatment1 Intervention

Given intravenously over 40 minutes

Group II: MidazolamActive Control1 Intervention

Given intravenously over 40 minutes

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ketamine

2011

Completed Phase 4

~1090

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institute of Nursing Research (NINR)Lead Sponsor

580 Previous Clinical Trials

10,376,502 Total Patients Enrolled

21 Trials studying Fatigue

5,175 Patients Enrolled for Fatigue

Leorey N Saligan, C.R.N.P.Principal InvestigatorNational Institute of Nursing Research (NINR)

8 Previous Clinical Trials

3,378 Total Patients Enrolled

7 Trials studying Fatigue

3,322 Patients Enrolled for Fatigue

Media Library

Ketamine (NMDA receptor antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT04141696 — Phase 1 & 2

Fatigue Research Study Groups: Ketamine, Midazolam

Fatigue Clinical Trial 2023: Ketamine Highlights & Side Effects. Trial Name: NCT04141696 — Phase 1 & 2

Ketamine (NMDA receptor antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04141696 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are people still being sought out for this clinical trial?

"Yes, the trial is recruiting patients and you can find this information on clinicaltrials.gov. The listing provides the date when the study was first posted (7/26/2021) as well as the date of the most recent update (11/11/2022). Additionally, it states that 59 participants are needed and 1 location is sufficient."

Answered by AI

Might I be a proper candidate for this clinical trial?

"This study requires that potential participants experience fatigue and be between 18-70 years old. Right now, they are looking for a total of 59 individuals to join the trial."

Answered by AI

For this particular research project, is the age limit set at 40 years old or younger?

"According to the eligibility requirements, patients participating in this trial must be aged 18-70. There are 43 separate trials available for those under 18 and 290 for people 65 and older."

Answered by AI

What medical conditions does Ketamine typically help alleviate?

"While it is commonly used to treat seizures, ketamine can also be helpful for patients with amnesia or those that need to undergo a therapeutic procedure."

Answered by AI

Are there any limits as to how many people can join this clinical trial?

"The clinical trial is currently recruiting participants, as noted on clinicaltrials.gov. This study was first posted on July 26th, 2021 and last updated November 11th, 2022. Right now, 59 people are needed to enroll at a single location."

Answered by AI