What this study is
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").
What's being tested
- Electroconvulsive Therapy (ECT)
Intervention · DEVICE
ECT for the treatment of treatment-resistant depression OR Bipolar Disorder in an active major depressive episode
- Transcranial Magnetic Stimulation (TMS)
Intervention · DEVICE
TMS for the treatment of treatment-resistant depression in an active major depressive episode
- Ketamine
Intervention · DRUG
Intravenous ketamine infusion for the treatment of treatment-resistant depression in an active major depressive episode
- Esketamine
Intervention · DRUG
Intranasal esketamine insufflation for the treatment of treatment-resistant depression in an active major depressive episode
- Deep Transcranial Magnetic Stimulation (dTMS)
Intervention · DEVICE
TMS for the treatment of OCD
Study details
- Sponsor
- Mark Niciu
- Conditions
- Treatment Resistant Depression · Major Depressive Episode · Major Depression · Major Depressive Disorder · Bipolar Disorder · Bipolar Depression · Obsessive-Compulsive Disorder
- Enrolling
- 1,000 people
- Starts
- 2020-11-02
- Est. completion
- 2050-08
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 99 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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.
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openUniversity of Iowa Health Care
Iowa City, Iowa, United States
- Benjamin Pace, M.S. · Contact319-384-9302benjamin-pace@uiowa.edu
- Alex Alario, B.S. · Contact319-384-8470alexandra-alario@uiowa.edu
- Mark J Niciu, M.D. Ph.D. · Principal investigator
- Nicholas T Trapp, M.D. M.S. · Principal investigator
Recruiting
Study team
Sponsor
Mark Niciu
Study ID 202003055
Principal investigator
Mark J Niciu, M.D., Ph. D.
University of Iowa Hospitals & Clinics
Principal investigator
Nicholas T Trapp, M.D., M.S.
University of Iowa Hospitals & Clinics
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.