Recruiting

Observational Study

Sponsor:

Mark Niciu

Code:

NCT04480918

Conditions

Treatment Resistant Depression

Major Depressive Episode

Major Depression

Major Depressive Disorder

Bipolar Disorder

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Electroconvulsive Therapy (ECT)

Transcranial Magnetic Stimulation (TMS)

Ketamine

Esketamine

Deep Transcranial Magnetic Stimulation (dTMS)

Study Details

Brief 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").

Conditions

Treatment Resistant Depression

Major Depressive Episode

Major Depression

Major Depressive Disorder

Bipolar Disorder

Study ID

NCT04480918

Start date

Nov 2, 2020

Status verified date

Dec, 2025

Completion date

Aug, 2050

Anticipated

Primary completion date

Aug, 2050

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Arms

Major Depressive Episode

After referral to the University of Iowa's Interventional Psychiatry Clinic, the patient will be clinically evaluated and, if appropriate, commence the procedural-based treatment course.

Interventions

Electroconvulsive Therapy (ECT)

ECT for the treatment of treatment-resistant depression OR Bipolar Disorder in an active major depressive episode

Transcranial Magnetic Stimulation (TMS)

TMS for the treatment of treatment-resistant depression in an active major depressive episode

Ketamine

Intravenous ketamine infusion for the treatment of treatment-resistant depression in an active major depressive episode

Esketamine

Intranasal esketamine insufflation for the treatment of treatment-resistant depression in an active major depressive episode

Deep Transcranial Magnetic Stimulation (dTMS)

TMS for the treatment of OCD

Primary outcome measure

  • Montgomery-Åsberg Depression Rating Scale (MADRS) Pre-Post Change [ Time Frame: 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 [ Time Frame: 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). ]

Central Contacts and Locations

Central contacts

Locations

University of Iowa Health Care

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Principal Investigator:

Mark J Niciu, M.D. Ph.D.

More Information

Sponsor

Mark Niciu

Last update posted

Mar 3, 2026

Last verified

Dec, 2025

Keywords

  • Electroconvulsive Therapy
  • Transcranial Magnetic Stimulation
  • Ketamine
  • Esketamine

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Mark Niciu on 2026-03-03.