Clinical TrialTreatment-Resistant Depression (TRD)KetamineEsketamineRecruiting

University of Iowa Interventional Psychiatry Service Patient Registry

Prospective observational registry (n=1000) collecting biomarker and clinical outcome data from patients receiving ECT, TMS/dTMS, racemic ketamine infusions, or intranasal esketamine for treatment‑resistant depression and OCD.

Target Enrollment
1000 participants
Study Type
Phase NA observational
Design
Non-randomized

Detailed Description

The University of Iowa Interventional Psychiatry Service Patient Registry prospectively collects clinical, neuroimaging, EEG, cognitive, vocal, autonomic, and genetic/epigenetic data from patients undergoing procedural treatments for treatment‑resistant depression and OCD.

Analyses will seek multimodal biomarkers predictive of treatment response and compare within‑subject and between‑modality changes (e.g., ECT vs TMS vs ketamine) to inform precision treatment selection.

Study Arms & Interventions

Registry cohort

experimental

Prospective observational cohort capturing clinical and biomarker data across procedural treatments (ECT, TMS/dTMS, racemic ketamine infusion, intranasal esketamine).

Interventions

  • Compound
    via Other• per clinical care

    Electroconvulsive therapy (ECT) device procedure captured as part of registry

  • Compound
    via Other• per clinical care

    Transcranial Magnetic Stimulation (TMS) device procedure captured; includes deep TMS (dTMS) for OCD

  • Ketamine
    via IV• per clinical care

    Racemic ketamine infusion (clinical dosing) captured

  • Esketamine
    via Other• per clinical care

    Intranasal esketamine insufflation captured

  • Compound
    via Other• per clinical care

    Other device-based procedural treatments as appropriate

Participants

Ages
18 – 99
Sexes
Male & Female

Inclusion Criteria

  • INCLUSION CRITERIA:
  • 1. 18-99 years of age
  • 2. English-speaker with a level of understanding sufficient to agree to clinical treatment with a treatment modality offered by the Interventional Psychiatry Service, all required research procedures, and sign an informed consent document
  • 3. Clinical diagnosis of a major depressive episode in the context of major depressive disorder or bipolar disorder or treatment-resistant OCD evaluated by a provider on the Interventional Psychiatry Service and felt to be an appropriate candidate for clinical treatment with a treatment modality offered by the Interventional Psychiatry Service.

Exclusion Criteria

  • EXCLUSION CRITERIA:
  • 1. Age less than 18 years
  • 2. A primary neuropsychiatric diagnosis that is not either major depressive disorder or bipolar disorder
  • 3. Serious, unstable medical conditions/problems including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, neurologic, immunologic, or hematologic disease, e.g. uncontrolled asthma, uncontrolled hyper/hypothyroidism or active cancer.
  • 4. Involuntary commitment to psychiatry inpatient units
  • 5. If patients have one or more of the following MRI Exclusion criteria, they will not be able to participate in those aspects of this study:
  • 1. The presence of an implanted device including pacemaker, coronary stent, defibrillator, or neurostimulation device that is not MRI-compatible
  • 2. The presence of ferromagnetic objects in the body, i.e. bullets, shrapnel, and/or metal slivers
  • 3. Clinically-significant claustrophobia
  • 4. Clinically-significant hearing loss
  • 5. Pregnant or nursing women or women of child bearing potential not using at least one medically accepted means of contraception (to include oral, injectable, or implant birth control, condom or diaphragm with spermicide, intrauterine devices (IUD), tubal ligation, abstinence, or partner with vasectomy)
  • 6. The presence of any medical illness likely to alter brain morphology and/or physiology (e.g., hypertension, diabetes) even if controlled by medications

Study Details

Locations

University of Iowa Health Care — Iowa City, Iowa, United States

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