University of Iowa Interventional Psychiatry Service Patient Registry

NCT04480918 | Recruiting FDA Drug FDA Device

• 1 other identifier: 202003055
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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").

Conditions

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

Keywords

Electroconvulsive Therapy; Transcranial Magnetic Stimulation; Ketamine; Esketamine

Outcome Measures

Primary Outcomes (2)

• Montgomery-Åsberg Depression Rating Scale (MADRS) Pre-Post Change

  For patients with TRD, the MADRS will be administered. The MADRS contains 10 items, and each item is scored 0-6. These item scores are summed to create a scale score; thus, scale scores range from 0 to 60. A scale score of 0 indicates the absence of depressive symptoms, while a score of 60 indicates severe depression. The primary outcome is the mean change in total MADRS score. A decrease in the mean MADRS score indicates a decrease (or improvement) in depressive symptoms, whereas an increase in the mean MADRS score indicates an increase (or worsening) in depressive symptoms.

  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).

• Yale-Brown Obsessive Compulsive Scale

  For patients with OCD, the YBOCS will be administered. Questions on the YBOCS examine the amount of time spent thinking and acting on obsessions and compulsions, how much impairment or distress is caused, and how much resistance and control the participant has over their thoughts or behavior.

  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).

Secondary Outcomes (5)

• Clinical Global Impression/Severity (CGI) Pre-Post Change

  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).

• Generalized Anxiety Disorder, 7-item (GAD-7) Pre-Post Change

  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).

• Montreal Cognitive Assessment (MoCA) Pre-Post Change

  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).

• Patient Health Questionnaire, 9-item (PHQ-9) Pre-Post Change

  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).

• Temperament and Character Inventory (TCI) Pre-Post Change

  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).

Other Outcomes (12)

• Actigraphy Pre-Post Change

  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).

• Candidate Gene (DNA) Polymorphisms

  The genetic specimen will be obtained within approximately 1 week of starting treatment (likely with the baseline epigenetic sample.

• Electroencephalography (EEG) Pre-Post Change

  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).

Study Arms (1)

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.

Device: Electroconvulsive Therapy (ECT); Device: Transcranial Magnetic Stimulation (TMS); Drug: Ketamine; Drug: Esketamine; Device: Deep Transcranial Magnetic Stimulation (dTMS)

Interventions

Deep Transcranial Magnetic Stimulation (dTMS) DEVICE

TMS for the treatment of OCD

Major Depressive Episode

Electroconvulsive Therapy (ECT) DEVICE

ECT for the treatment of treatment-resistant depression OR Bipolar Disorder in an active major depressive episode

Major Depressive Episode

Transcranial Magnetic Stimulation (TMS) DEVICE

TMS for the treatment of treatment-resistant depression in an active major depressive episode

Major Depressive Episode

Ketamine DRUG

Intravenous ketamine infusion for the treatment of treatment-resistant depression in an active major depressive episode

Major Depressive Episode

Esketamine DRUG

Intranasal esketamine insufflation for the treatment of treatment-resistant depression in an active major depressive episode

Major Depressive Episode

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients (18-99 years old) in a current major depressive episode in the context of major depressive disorder (MDD) or bipolar disorder (BD) will be recruited for this protocol. Adult patients received TMS for OCD will also be recruited. All treatment will be in addition to the patient's clinical care with the University of Iowa's Interventional Psychiatry Service for treatment-resistant major depression or OCD, and the decision to participate, withdraw from participation or not participate will if not affect clinical care decision-making. We appreciate that minority groups tend to be underrepresented in neuropsychiatric research studies. Therefore, we will make a concerted effort to keep the proportion of racial/ethnic minorities recruited consistent with the demographics of the surrounding communities.

You may qualify if:

• 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 may not qualify 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
• 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

Sponsors & Collaborators

• Mark Niciu: lead

Study Sites (1)

University of Iowa Health Care

Iowa City, Iowa, 52242, United States

RECRUITING

Related Publications (10)

• Levy A, Taib S, Arbus C, Peran P, Sauvaget A, Schmitt L, Yrondi A. Neuroimaging Biomarkers at Baseline Predict Electroconvulsive Therapy Overall Clinical Response in Depression: A Systematic Review. J ECT. 2019 Jun;35(2):77-83. doi: 10.1097/YCT.0000000000000570.

  PMID: 30628993 BACKGROUND

• Cash RFH, Cocchi L, Anderson R, Rogachov A, Kucyi A, Barnett AJ, Zalesky A, Fitzgerald PB. A multivariate neuroimaging biomarker of individual outcome to transcranial magnetic stimulation in depression. Hum Brain Mapp. 2019 Nov 1;40(16):4618-4629. doi: 10.1002/hbm.24725. Epub 2019 Jul 22.

  PMID: 31332903 BACKGROUND

• Iseger TA, Padberg F, Kenemans JL, Gevirtz R, Arns M. Neuro-Cardiac-Guided TMS (NCG-TMS): Probing DLPFC-sgACC-vagus nerve connectivity using heart rate - First results. Brain Stimul. 2017 Sep-Oct;10(5):1006-1008. doi: 10.1016/j.brs.2017.05.002. Epub 2017 May 12.

  PMID: 28545770 BACKGROUND

• Cabrerizo M, Cabrera A, Perez JO, de la Rua J, Rojas N, Zhou Q, Pinzon-Ardila A, Gonzalez-Arias SM, Adjouadi M. Induced effects of transcranial magnetic stimulation on the autonomic nervous system and the cardiac rhythm. ScientificWorldJournal. 2014;2014:349718. doi: 10.1155/2014/349718. Epub 2014 Jul 17.

  PMID: 25136660 BACKGROUND

• Zarate CA Jr, Mathews DC, Furey ML. Human biomarkers of rapid antidepressant effects. Biol Psychiatry. 2013 Jun 15;73(12):1142-55. doi: 10.1016/j.biopsych.2012.11.031. Epub 2013 Jan 29.

  PMID: 23374639 BACKGROUND

• Niciu MJ, Mathews DC, Nugent AC, Ionescu DF, Furey ML, Richards EM, Machado-Vieira R, Zarate CA Jr. Developing biomarkers in mood disorders research through the use of rapid-acting antidepressants. Depress Anxiety. 2014 Apr;31(4):297-307. doi: 10.1002/da.22224. Epub 2013 Dec 18.

  PMID: 24353110 BACKGROUND

• Pinna M, Manchia M, Oppo R, Scano F, Pillai G, Loche AP, Salis P, Minnai GP. Clinical and biological predictors of response to electroconvulsive therapy (ECT): a review. Neurosci Lett. 2018 Mar 16;669:32-42. doi: 10.1016/j.neulet.2016.10.047. Epub 2016 Oct 25.

  PMID: 27793702 BACKGROUND

• Kerwin LJ, Keller CJ, Wu W, Narayan M, Etkin A. Test-retest reliability of transcranial magnetic stimulation EEG evoked potentials. Brain Stimul. 2018 May-Jun;11(3):536-544. doi: 10.1016/j.brs.2017.12.010. Epub 2017 Dec 29.

  PMID: 29342443 BACKGROUND

• Minelli A, Abate M, Zampieri E, Gainelli G, Trabucchi L, Segala M, Sartori R, Gennarelli M, Conca A, Bortolomasi M. Seizure Adequacy Markers and the Prediction of Electroconvulsive Therapy Response. J ECT. 2016 Jun;32(2):88-92. doi: 10.1097/YCT.0000000000000274.

  PMID: 26397151 BACKGROUND

• Smith M, Dietrich BJ, Bai EW, Bockholt HJ. Vocal pattern detection of depression among older adults. Int J Ment Health Nurs. 2020 Jun;29(3):440-449. doi: 10.1111/inm.12678. Epub 2019 Dec 6.

  PMID: 31811697 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

blood, saliva and cheek swabs for epi/genetic expression

MeSH Terms

Conditions

Depressive Disorder, Treatment-Resistant; Depressive Disorder, Major; Bipolar Disorder; Obsessive-Compulsive Disorder

Interventions

Transcranial Magnetic Stimulation; Ketamine; Esketamine

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Bipolar and Related Disorders; Anxiety Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karin Nielsen, MS

CONTACT

319-384-6521; karin-nielsen@uiowa.edu

Emerson Buse, BA

CONTACT

319-353-8536; emerson-buse@uiowa.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 2, 2020
• First Posted: July 22, 2020
• Study Start: November 2, 2020
• Primary Completion (Estimated): August 1, 2050
• Study Completion (Estimated): August 1, 2050
• Last Updated: March 3, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)