RecruitingNCT04480918

University of Iowa Interventional Psychiatry Service Patient Registry


Sponsor

Mark Niciu

Enrollment

1,000 participants

Start Date

Nov 2, 2020

Study Type

OBSERVATIONAL

Conditions

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").


Eligibility

Min Age: 18 YearsMax Age: 99 Years

Inclusion Criteria3

  • years of age
  • 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
  • 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 Criteria10

  • Age less than 18 years
  • A primary neuropsychiatric diagnosis that is not either major depressive disorder or bipolar disorder
  • 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.
  • Involuntary commitment to psychiatry inpatient units
  • The presence of an implanted device including pacemaker, coronary stent, defibrillator, or neurostimulation device that is not MRI-compatible
  • The presence of ferromagnetic objects in the body, i.e. bullets, shrapnel, and/or metal slivers
  • Clinically-significant claustrophobia
  • Clinically-significant hearing loss
  • 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)
  • The presence of any medical illness likely to alter brain morphology and/or physiology (e.g., hypertension, diabetes) even if controlled by medications

Interventions

DEVICEElectroconvulsive Therapy (ECT)

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

DEVICETranscranial Magnetic Stimulation (TMS)

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

DRUGKetamine

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

DRUGEsketamine

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

DEVICEDeep Transcranial Magnetic Stimulation (dTMS)

TMS for the treatment of OCD


Locations(1)

University of Iowa Health Care

Iowa City, Iowa, United States

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NCT04480918


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