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NMDA Receptor Antagonist

Ketamine for Treatment-Resistant Depression

Phase 2
Recruiting
Led By Mark J Niciu, M.D. Ph.D.
Research Sponsored by Mark Niciu
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Past failure of greater than or equal to one standard antidepressant trial based on the Antidepressant Treatment History Form (ATHF)
21 to 65 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-ketamine (baseline) to one week post-ketamine infusion
Awards & highlights

Study Summary

This trial is testing whether the antidepressant effects of ketamine are greater in people with a family history of alcohol use disorder, who may respond differently to both alcohol and ketamine.

Who is the study for?
This trial is for adults aged 21-65 with treatment-resistant major depressive disorder (MDD), who have failed at least one antidepressant trial. Participants must not be pregnant, nursing, or without contraception if of childbearing potential. They should have no lifetime substance use disorders (except nicotine/caffeine), no alcohol use disorder history, and must be social drinkers without significant health issues that MRI can't accommodate.Check my eligibility
What is being tested?
The study tests the effects of a single dose of ketamine in those with a family history positive (FHP) or negative (FHN) for alcoholism on depression symptoms and brain glutamate levels using MRI. It involves an initial medication-free period followed by controlled alcohol and ketamine infusions during advanced imaging to observe changes in the brain's response.See study design
What are the potential side effects?
Ketamine may cause psychotomimetic side effects like hallucinations or dissociation, especially shortly after infusion. Alcohol infusion could lead to typical intoxication effects such as impaired coordination and judgment. Both substances might also trigger nausea or mood alterations.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have tried at least one antidepressant that didn't work for me.
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I am between 21 and 65 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-ketamine (baseline) to one week post-ketamine infusion
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-ketamine (baseline) to one week post-ketamine infusion for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Montgomery-Åsberg Depression Rating Scale (MADRS)
Secondary outcome measures
Alcohol Urge Questionnaire (AUQ)
Balloon Analogue Risk Task (BART)
Beck Depression Inventory (BDI)
+25 more

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Who is running the clinical trial?

Mark NiciuLead Sponsor
1 Previous Clinical Trials
1,000 Total Patients Enrolled
1 Trials studying Depression
1,000 Patients Enrolled for Depression
National Institute of Mental Health (NIMH)NIH
2,775 Previous Clinical Trials
2,673,684 Total Patients Enrolled
665 Trials studying Depression
251,358 Patients Enrolled for Depression
Mark J Niciu, M.D. Ph.D.Principal InvestigatorUniversity of Iowa Health Care (UIHC)

Media Library

Ketamine (NMDA Receptor Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT02122562 — Phase 2
Depression Research Study Groups:
Depression Clinical Trial 2023: Ketamine Highlights & Side Effects. Trial Name: NCT02122562 — Phase 2
Ketamine (NMDA Receptor Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02122562 — Phase 2

Frequently Asked Questions

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

Has this remedy been approved by the federal government?

"The safety of this treatment was adjudicated to be a 2, as Phase 2 trials suggest the presence of some clinical data supporting its security but no evidence yet for effectiveness."

Answered by AI

Are there any specific criteria which make someone eligible to enroll in this experiment?

"Eligibility for this clinical trial requires that participants have a diagnosis of alcoholism, and are between 21 and 65 years old. In total, 60 individuals will be admitted to the study."

Answered by AI

To what extent is enrollment to this medical experiment open?

"Affirmative. According to clinicaltrials.gov, this medical investigation initiated on April 23rd 2014 and recently updated on August 25th 2022 is actively recruiting patients from a single location with the aim of finding 60 participants in total."

Answered by AI

Is this research endeavor currently in need of participants?

"The medical study, which was originally made available on April 23rd 2014 has been recently updated as of August 25th 2022 and is now actively enrolling participants."

Answered by AI

Does the age requirement for enrollment in this trial extend beyond 70 years?

"This medical trial has specified that suitable candidates must be between 21 and 65 years of age. Alternatively, there are 217 trials designed specifically for minors while 1187 studies have been developed to serve patients older than 65."

Answered by AI

Who else is applying?

What site did they apply to?
University of Iowa Health Care
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
~2 spots leftby Sep 2024