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RecruitingN/A

University of Iowa Interventional Psychiatry Service Patient Registry

NCT04480918 · Mark Niciu

Recruiting
Status
Accepting participants
Not applicable
Phase
1,000
Target enrolment
1
Study sites
1 US states

What it is testing

Summary

The purpose of this study is to examine the effects of interventional/procedural therapies for treatment-resistant depression (TRD) and Obsessive-Compulsive Disorder (OCD). These treatments include electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), racemic ketamine infusion and intranasal esketamine insufflation. The investigators will obtain various indicators, or biomarkers, of a depressed individuals' state before, during, and/or after these treatments. Such biomarkers include neurobehavioral testing, neuroimaging, electroencephalography, cognitive testing, vocal recordings, epi/genetic testing, and autonomic nervous system measures (i.e. "fight-or-flight" response). The results obtained from this study may provide novel antidepressant treatment response biomarkers, with the future goal of targeting a given treatment to an individual patient ("personalized medicine").

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Montgomery-Åsberg Depression Rating Scale (MADRS) Pre-Post Change

    Measured over Pre-assessment will be obtained within approximately 1 week of starting treatment. Post-assessment will be obtained as close as possible following completion of treatment course (usually 4-6 weeks later).

  • Yale-Brown Obsessive Compulsive Scale

    Measured over Pre-assessment will be obtained within approximately 1 week of starting treatment. Post-assessment will be obtained as close as possible following completion of treatment course (usually 4-6 weeks later).

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 99 Years
Ages
All
Sex
Not accepted
Healthy volunteers
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: 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

Where

1 study site

FacilityCityRegionCountry
University of Iowa Health CareIowa CityIowaUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT04480918 on ClinicalTrials.gov →

Last updated in the registry 2026-03-03. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits