NCT04480918 University of Iowa Interventional Psychiatry Service Patient Registry
| NCT ID | NCT04480918 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Mark Niciu |
| Condition | Treatment Resistant Depression |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2020-11-02 |
| Primary Completion | 2050-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2020-11-02 with a primary completion date of 2050-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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").
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
Contact & Investigator
Mark J Niciu, M.D., Ph. D.
PRINCIPAL INVESTIGATOR
University of Iowa Hospitals & Clinics
Frequently Asked Questions
Who can join the NCT04480918 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying Treatment Resistant Depression. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04480918 currently recruiting?
Yes, NCT04480918 is actively recruiting participants. Contact the research team at karin-nielsen@uiowa.edu for enrollment information.
Where is the NCT04480918 trial being conducted?
This trial is being conducted at Iowa City, United States.
Who is sponsoring the NCT04480918 clinical trial?
NCT04480918 is sponsored by Mark Niciu. The principal investigator is Mark J Niciu, M.D., Ph. D. at University of Iowa Hospitals & Clinics. The trial plans to enroll 1,000 participants.
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