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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
Must not have
Current psychotic features or prior diagnosis of a DSM-IV-TR psychotic spectrum disorder, e.g. schizophrenia, schizoaffective disorder, bipolar I disorder with psychotic features, MDD with psychotic features, or bipolar disorder, e.g. bipolar I disorder without psychotic features, bipolar II disorder and bipolar disorder not otherwise specified (NOS)
Subjects with one or more seizures without clear and resolved etiology and head injury with loss of consciousness for > 5 minutes or requiring hospitalization
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-ketamine (baseline) to one week post-ketamine infusion
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of or currently have a severe mental health condition like schizophrenia or bipolar disorder.
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I've had seizures of unknown cause or a serious head injury.
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I am not taking any medications that are not allowed in the study.
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I do not have any serious, unstable health conditions.
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I have a condition like high blood pressure or diabetes that could affect my brain.
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I am currently in therapy like CBT or IPT for mood or anxiety.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Montgomery-Åsberg Depression Rating Scale (MADRS)
Secondary study objectives
Alcohol Urge Questionnaire (AUQ)
Beck Depression Inventory (BDI)
Brief Psychiatric Rating Scale (BPRS)
+15 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Find a Location

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
2,916 Previous Clinical Trials
2,738,745 Total Patients Enrolled
701 Trials studying Depression
261,091 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
~9 spots leftby Sep 2026
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