University of Iowa Interventional Psychiatry Service Patient Registry

Part of paid clinical trials in Iowa City, Iowa.

Sponsor
Mark Niciu
Study ID
NCT04480918
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Electroconvulsive Therapy (ECT) — DEVICE
    ECT for the treatment of treatment-resistant depression OR Bipolar Disorder in an active major depressive episode
  • Transcranial Magnetic Stimulation (TMS) — DEVICE
    TMS for the treatment of treatment-resistant depression in an active major depressive episode
  • Ketamine — DRUG
    Intravenous ketamine infusion for the treatment of treatment-resistant depression in an active major depressive episode
  • Esketamine — DRUG
    Intranasal esketamine insufflation for the treatment of treatment-resistant depression in an active major depressive episode
  • Deep Transcranial Magnetic Stimulation (dTMS) — DEVICE
    TMS for the treatment of OCD

Study Details

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").

Key Dates

Start date
Nov 2, 2020
Status verified
Dec 2025
Primary completion
Aug 31, 2050
Completion
Aug 31, 2050

Study Design

Enrollment
1,000 participants (estimated)

Arms

  • Arm: Major Depressive Episode
    After referral to the University of Iowa's Interventional Psychiatry Clinic, the patient will be clinically evaluated and, if appropriate, commence the procedural-based treatment course.

Primary Outcome Measure

Montgomery-Åsberg Depression Rating Scale (MADRS) Pre-Post Change [ Time Frame: Pre-assessment will be obtained within approximately 1 week of starting treatment. Post-assessment will be obtained as close as possible following completion of treatment course (usually 4-6 weeks later). ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Iowa Health CareIowa CityIowa52242
Benjamin Pace, M.S.
[email protected]
319-384-9302
Alex Alario, B.S.
[email protected]
319-384-8470
Mark J Niciu, M.D. Ph.D. (PRINCIPAL_INVESTIGATOR)
Nicholas T Trapp, M.D. M.S. (PRINCIPAL_INVESTIGATOR)

Find similar trials in Iowa City, IA

By condition
Bipolar disorderDepression
By specialty
PsychiatryMental healthBehavioral health
By research site
University of Iowa Health Care· Iowa City, IA

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