RECRUITING

University of Iowa Interventional Psychiatry Service Patient Registry

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Conditions

Treatment Resistant DepressionMajor Depressive EpisodeMajor DepressionMajor Depressive DisorderBipolar DisorderBipolar DepressionObsessive-Compulsive DisorderElectroconvulsive TherapyTranscranial Magnetic StimulationKetamineEsketamine

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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").

Official Title

University of Iowa Interventional Psychiatry Service Patient Registry

Quick Facts

Study Start:2020-11-02
Study Completion:2050-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04480918

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 99 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. 18-99 years of age
  2. 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. 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.
  1. 1. Age less than 18 years
  2. 2. A primary neuropsychiatric diagnosis that is not either major depressive disorder or bipolar disorder
  3. 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. 4. Involuntary commitment to psychiatry inpatient units
  5. 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:
  6. 1. The presence of an implanted device including pacemaker, coronary stent, defibrillator, or neurostimulation device that is not MRI-compatible
  7. 2. The presence of ferromagnetic objects in the body, i.e. bullets, shrapnel, and/or metal slivers
  8. 3. Clinically-significant claustrophobia
  9. 4. Clinically-significant hearing loss
  10. 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)
  11. 6. The presence of any medical illness likely to alter brain morphology and/or physiology (e.g., hypertension, diabetes) even if controlled by medications

Contacts and Locations

Study Contact

Alexandra A Alario, B.S.
CONTACT
319-384-8470
alexandra-alario@uiowa.edu
Benjamin D Pace, M.S.
CONTACT
319-384-9302
benjamin-pace@uiowa.edu

Principal Investigator

Mark J Niciu, M.D., Ph. D.
PRINCIPAL_INVESTIGATOR
University of Iowa
Nicholas T Trapp, M.D., M.S.
PRINCIPAL_INVESTIGATOR
University of Iowa

Study Locations (Sites)

University of Iowa Health Care
Iowa City, Iowa, 52242
United States

Collaborators and Investigators

Sponsor: Mark Niciu

  • Mark J Niciu, M.D., Ph. D., PRINCIPAL_INVESTIGATOR, University of Iowa
  • Nicholas T Trapp, M.D., M.S., PRINCIPAL_INVESTIGATOR, University of Iowa

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-11-02
Study Completion Date2050-08

Study Record Updates

Study Start Date2020-11-02
Study Completion Date2050-08

Terms related to this study

Keywords Provided by Researchers

  • Electroconvulsive Therapy
  • Transcranial Magnetic Stimulation
  • Ketamine
  • Esketamine

Additional Relevant MeSH Terms

  • Treatment Resistant Depression
  • Major Depressive Episode
  • Major Depression
  • Major Depressive Disorder
  • Bipolar Disorder
  • Bipolar Depression
  • Obsessive-Compulsive Disorder