RecruitingPhase not listed

University of Iowa Interventional Psychiatry Service Patient Registry

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 99 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Infusions

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "These treatments include electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), racemic ketamine infusion and intranasal esketamine insufflation."
  • "ECT, TMS, racemic ketamine infusions and intranasal esketamine insufflations, offer exciting opportunities for biomarker discovery due their procedural nature (obviating concerns for treatment non-adherence in non-supervised settings), more rapid-onset, and larger effect sizes than typically seen with traditional antidepressant medications or evidence-based psychotherapies."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at treatments for depression that has not improved with treatment and obsessive-compulsive disorder (OCD), which causes unwanted thoughts and repeated actions. Treatments include electrical therapy (ECT), magnetic therapy (TMS), ketamine given through a vein, and esketamine given through the nose. Researchers will study brain and body measures to look for signs of how people respond to treatment.

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").

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 18 to 99 years old.
  • Speak and understand English well enough to agree to treatment and all study procedures and sign a consent form.
  • Have a current episode of major depression as part of major depressive disorder or bipolar disorder, or have OCD that has not improved with treatment.
  • Be checked by an Interventional Psychiatry Service provider who finds that a treatment offered by the service is right for you.

Who can't join

  • Be younger than 18.
  • Have a main mental health or brain-related diagnosis other than major depressive disorder or bipolar disorder. This rule is listed even though the entry rules also include OCD.
  • Have a serious, unstable medical problem, such as uncontrolled asthma, uncontrolled thyroid disease, or active cancer.
  • Be required to stay in a hospital psychiatric unit against your will.
  • For MRI brain scans only: have an implanted device that is not MRI-safe, or metal in your body that is attracted to magnets, such as bullets or metal pieces.
  • For MRI brain scans only: have a serious fear of enclosed spaces or significant hearing loss.
  • For MRI brain scans only: be pregnant or nursing, or be able to become pregnant without using at least one accepted birth control method.
  • For MRI brain scans only: have an illness that may change brain structure or function, such as high blood pressure or diabetes, even if controlled with medicine.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (1)

IA