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Search / Trial NCT04480918

University of Iowa Interventional Psychiatry Service Patient Registry

Launched by MARK NICIU · Jul 16, 2020

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Electroconvulsive Therapy Transcranial Magnetic Stimulation Ketamine Esketamine

ClinConnect Summary

The University of Iowa is conducting a clinical trial to study new treatment options for people struggling with severe depression that hasn’t responded to other therapies, as well as for those with Obsessive-Compulsive Disorder (OCD). The trial is looking at different treatment methods, such as electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), and ketamine treatments. Researchers will collect various types of information, called biomarkers, to see how these treatments affect participants. This information could help doctors find the most effective treatments for individuals in the future.

To participate in this trial, individuals should be between 18 and 99 years old, speak English, and have a diagnosis of major depressive disorder, bipolar disorder, or treatment-resistant OCD. Participants can expect to undergo various tests and assessments before, during, and after their treatment to track their progress and gather useful data. It's important to note that certain medical conditions or devices may prevent someone from joining, so potential participants will need to discuss their health history with the study team. This research aims to improve treatment options for those who need it most.

Gender

ALL

Eligibility 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:
  • 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

About Mark Niciu

Mark Niciu is a dedicated clinical trial sponsor committed to advancing medical research and improving patient outcomes through innovative studies. With a focus on psychiatric and neurobiological disorders, Niciu collaborates with leading researchers and institutions to develop and evaluate novel therapeutic interventions. His expertise in clinical trial design and execution ensures rigorous methodologies and adherence to regulatory standards, fostering an environment of scientific integrity and ethical responsibility. By prioritizing patient safety and efficacy, Mark Niciu aims to contribute meaningful insights to the medical community and enhance treatment options for those in need.

Locations

Iowa City, Iowa, United States

Patients applied

0 patients applied

Trial Officials

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

Principal Investigator

University of Iowa Hospitals & Clinics

Nicholas T Trapp, M.D., M.S.

Principal Investigator

University of Iowa Hospitals & Clinics

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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