Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT03973268 · ClinicalTrials.gov registry record · Phase 1

Mechanism of Action Underlying Ketamine's Antidepressant Effects: The AMPA Throughput Theory in Patients With Treatment-Resistant Major Depression

A Phase 1 study of Depression and Major Depressive Disorder, sponsored by National Institute of Mental Health (NIMH).

Recruiting
Registry status
Phase 1
Development phase
70
Enrollment target
1
Study location

NCT03973268: Recruiting Phase 1 study of Depression and Major Depressive Disorder, sponsored by National Institute of Mental Health (NIMH).

NCT03973268 is a Phase 1 study of Depression and Major Depressive Disorder that is actively recruiting participants, run by National Institute of Mental Health (NIMH). The registered enrollment target is 70 participants, below the 786-participant average among 679 other Depression trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT03973268, a Phase 1 study of Depression and Major Depressive Disorder, is actively recruiting participants, sponsored by National Institute of Mental Health (NIMH).

RECRUITING
Registry status
Phase 1
Development phase
70 participants
Enrollment target
1
Study location

Study Summary

Background: Most drugs that treat mood disorders take a long time to work. Ketamine works within hours. A dose can last for a week or more. Certain receptors in the brain might help ketamine work. A drug that blocks these receptors might affect how it works. Objective: To see if the antidepressant response of ketamine is linked to AMPA receptors. Eligibility: Adults ages 18-70 with major depression disorder without psychotic features Design: Participants will be screened under protocol 01-M-0254. They will have blood tests and a physical exam. Participants will stay at the NIH Clinical Center for 5 weeks. Phase 1 lasts 4 weeks. For 2 weeks, participants will taper off their psychiatric medicine. Then they will have the following tests: * Blood draws * Psychological tests * MRI: Participants will lie in a machine that takes pictures of their brain. * MEG: Participants will lie down and do tasks. A cone lowered on their head will record brain activity. * Optional sleep tests: Electrodes on the scalp and body and belts around the body will monitor participants while they sleep. * Optional TMS: Participants will do tasks while a wire coil is held on their scalp. An electrical current will pass through the coil that affects brain activity. For phase 2, on day 0 participants will take the study drug or a placebo orally. While having a MEG, they will get ketamine infused into a vein in one arm while blood is drawn from a vein in the other arm. On day 1, participants will again take the study drug or a placebo orally. On days 3-7, they will repeat many of the phase 1 tests. Days 8 and 9 are optional and include an open label ketamine treatment and many of the phase 1 tests.

Primary Outcome

Clinical rating scale of depression

Conditions Studied

Depression Major Depressive Disorder Major Depression

Interventions

  • DEVICE Arm 1, 2, 3 device interventions
  • OTHER Arm 2 Interventions
  • DRUG Arm 1, 2, 3 drug Interventions
  • DRUG Arm 1 and 2 Interventions

Study Locations (1)

Maryland

  • National Institutes of Health Clinical Center - Bethesda

Trial Details

FieldValue
Enrollment Target 70 participants
Start Date 2020-01-21
Est. Completion 2027-02-01
Phase Phase 1
National Institute of Mental Health (NIMH)

343 total trials

What NCT03973268 shows while recruiting

NCT03973268 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 786-participant average among 679 other Depression trials with a reported enrollment target (91% lower).

The record links to 3 conditions, with Depression appearing as the primary indexed condition, and to 4 interventions - of which Arm 1, 2, 3 device interventions is the first listed.

NCT03973268 reports a single indexed study location in Maryland.

Frequently Asked Questions

What is clinical trial NCT03973268 about?

NCT03973268 is a clinical study titled "Mechanism of Action Underlying Ketamine's Antidepressant Effects: The AMPA Throughput Theory in Patients With Treatment-Resistant Major Depression". Background: Most drugs that treat mood disorders take a long time to work. Ketamine works within hours. A dose can last for a week or more. Certain receptors in the brain might help ketamine work. A drug that blocks these receptors might affect how it works. Objective: To see if the antidepressan...

What is the current status of trial NCT03973268?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 70 participants. The study started on 2020-01-21. Estimated completion is 2027-02-01.

What conditions does trial NCT03973268 study?

This clinical trial studies the following conditions: Depression, Major Depressive Disorder, Major Depression.

What interventions are being tested in trial NCT03973268?

The interventions under investigation include: Arm 1, 2, 3 device interventions (DEVICE), Arm 2 Interventions (OTHER), Arm 1, 2, 3 drug Interventions (DRUG), Arm 1 and 2 Interventions (DRUG).

Who is sponsoring clinical trial NCT03973268?

This trial is sponsored by National Institute of Mental Health (NIMH), which has 343 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03973268 being conducted?

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

Learn More About Clinical Trials

Similar trials for Depression

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03973268's enrollment target sits among peer trials

70 407th of 679 higher than 266 of 679 other Depression trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Depression trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT00969111 · 70 participants · NA

    Postoperative or Salvage Radiotherapy (RT) for Node Negative Prostate Cancer Following Radical Prostatectomy

  • NCT01712620 · 70 participants · Phase 2

    Spironolactone for Pulmonary Arterial Hypertension

  • NCT02143830 · 70 participants · Phase 2

    HSCT for Patients With Fanconi Anemia Using Risk-Adjusted Chemotherapy

  • NCT02601339 · 70 participants

    NIRS Monitoring in Premature Infants

Similar registry start date

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

  • NCT07125183 · started 2026-12 · Phase 2

    Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma

  • NCT07292298 · started 2026-11 · Phase 2

    Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates

  • NCT06358040 · started 2026-10 · NA

    Opioid Dispenser for Microdiscectomy/Laminectomy

More recruiting context for NCT03973268

Source: ClinicalTrials.gov NCT03973268, the US trial registry maintained by the National Library of Medicine. NCT03973268 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.