University of Iowa Interventional Psychiatry Service Patient Registry
Recruiting · NCT04480918 · Observational (researchers observe without assigning treatment) · Lead sponsor: Mark Niciu
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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").
Who can take part
Inclusion criteria
- 18-99 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 criteria
- 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
- 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:
- 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
Where it is running
2 locations listed across 1 US state.
- University of Iowa Health Care - Iowa City, Iowa, United States
- University of Iowa Health Care - Iowa City, Iowa, United States