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NMDA Receptor Antagonist

Ketamine-assisted psychotherapy for Depression (KReDO Trial)

Phase 2
Waitlist Available
Led By Eric T Dobson, MD
Research Sponsored by Medical University of South Carolina
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline measured at week 2-8, 10, 12, and 16
Awards & highlights

KReDO Trial Summary

This trial is testing whether ketamine, given as an injection along with weekly therapy, can help people with a history of opioid addiction who haven't abused opioids in at least 3 months and are currently experiencing depression.

Eligible Conditions
  • Depression
  • Opioid Use Disorder

KReDO Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline measured at week 2-8, 10, 12, and 16
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline measured at week 2-8, 10, 12, and 16 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Beck Depression Inventory
Brief Pain Inventory (BPI)
Five Facets of Mindfulness Questionnaire (FFMQ)
+7 more

KReDO Trial Design

1Treatment groups
Experimental Treatment
Group I: Ketamine-assisted psychotherapyExperimental Treatment1 Intervention
Subjects will receive 8 weekly intramuscular injections of ketamine hydrochloride starting at 0.5 mg/kg and increasing to a maximum dose of 1.5 mg/kg or a total dose of 60 mg, whichever is lower. Ketamine administration will be accompanied by psychotherapy before, after and during the session.

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Who is running the clinical trial?

Medical University of South CarolinaLead Sponsor
932 Previous Clinical Trials
7,394,385 Total Patients Enrolled
41 Trials studying Depression
6,953 Patients Enrolled for Depression
Eric T Dobson, MDPrincipal InvestigatorMedical University of South Carolina

Frequently Asked Questions

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

What are the qualifying criteria for enlisting in this clinical experiment?

"This medical experiment is recruiting 10 individuals with opioid addiction and sustained recovery aged 18-64. To qualify, applicants must fulfil the following prerequisites: conform to DSM-5 criteria of Major Depressive Disorder (no psychotic features), present a score of at least 20 on MADRS indicating moderate or severe depression, remain on steady doses of psychotropic drugs such as antidepressants and anxiolytics for four weeks before beginning the study, and be between ages 18 to 64 years old."

Answered by AI

Has the FDA validated Ketamine-assisted psychotherapy as an acceptable therapeutic approach?

"Based on the Phase 2 clinical trial data, our team at Power rated Ketamine-assisted psychotherapy as a safety of 2. Since this is in the second phase of development, there are some indications that it can be administered safely; however, no efficacy claims have been made yet."

Answered by AI

Are there any open enrollment periods for this experiment?

"Yes, the information on clinicaltrials.gov confirms that this medical study is actively recruiting participants. This research was initially published on 13th January 2022 and last updated 22nd August of the same year. The investigators are searching for 10 individuals from 1 site to join the trial."

Answered by AI

How many participants have been recruited to this research project?

"Affirmative. According to the information recorded on clinicaltrials.gov, this medical investigation is actively recruiting suitable candidates. It was first posted on January 13th 2022 and most recently modified August 22nd 2022 with a need for 10 volunteers from one location."

Answered by AI

Does this medical experiment permit the enrollment of seniors aged 70 and above?

"The parameters for this study require that applicants be between 18 and 64 years old. For those younger than the minimum age, there are 417 alternative studies available while 1,494 are accessible to individuals who exceed the upper limit of participation."

Answered by AI

Who else is applying?

What state do they live in?
Michigan
Other
South Carolina
Georgia
How old are they?
18 - 65
What site did they apply to?
Medical University of South Carolina Centerspace
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+
Recent research and studies
clinicaltrials.govStudy
KAP for Depression in Abstinent Opioid Users
Eric Dobson, MD 2022. "KAP for Depression in Abstinent Opioid Users". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05193318.
~2 spots leftby Apr 2025
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