Ignite Creation Date:
2024-05-06 @ 2:58 PM
Last Modification Date:
2024-10-26 @ 1:40 PM
Study NCT ID:
NCT04480918
Status:
RECRUITING
Last Update Posted:
2023-05-09
First Post:
2020-07-02
Brief Title:
University of Iowa Interventional Psychiatry Service Patient Registry
Sponsor:
Mark Niciu
Organization:
University of Iowa
Study Overview
Official Title:
University of Iowa Interventional Psychiatry Service Patient Registry
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to examine the effects of interventionalprocedural 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 andor after these treatments Such biomarkers include neurobehavioral testing neuroimaging electroencephalography cognitive testing vocal recordings epigenetic testing and autonomic nervous system measures ie 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
Detailed Description:
Treatment response biomarkers in TRD and OCD have been and will remain an active area of research Interventional treatments in psychiatry eg 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 Although no well-replicated TRD biomarkers have been approved for standard clinical use several potential biomarkers have been investigated across multiple modalities ie neuroimaging12 autonomic function34 genetics5-7 electroencephalography EEG 89 and computational analysis of behavior or speech10 These studies have promising early results but often insufficient predictive power at the subject-level The investigators anticipate that combinatorial multimodal biomarkers will enhance predictive power and as a result improve treatment personalization in major depression
The University of Iowa Interventional Psychiatry Service Patient Registry systematically collects data from TRD and OCD patients undergoing procedural treatments for major depression First the investigators seek to replicate andor extend discoveries from prior investigations eg TMS-induced autonomic changes as positive predictors of antidepressant efficacy The investigators will also compare and contrast differences not only in response to a given therapy but also how individual subjects respond across different treatment modalities eg how does functional connectivity in the brain change in response to an effective course of TMS as opposed to ECT Such findings could inform the future development of clinical guidelines this is especially critical as some of these treatment modalities have only recently been approved for TRD by the US Food and Drug Administration eg intermittent theta burst stimulation iTBS and intranasal esketamine insufflation and dTMS for OCD
Next a longitudinal database may also be valuable for future biomarker discovery andor replication in independent samples ie an epigenetic signature of antidepressant treatment response to an interventional modality identified by another research group Similarly this patient registry could be valuable for collaborative research with other institutions administering interventional treatments in psychiatry
The University of Iowa Interventional Psychiatry Service Patient Registry systematically collects data from TRD and OCD patients undergoing procedural treatments for major depression First the investigators seek to replicate andor extend discoveries from prior investigations eg TMS-induced autonomic changes as positive predictors of antidepressant efficacy The investigators will also compare and contrast differences not only in response to a given therapy but also how individual subjects respond across different treatment modalities eg how does functional connectivity in the brain change in response to an effective course of TMS as opposed to ECT Such findings could inform the future development of clinical guidelines this is especially critical as some of these treatment modalities have only recently been approved for TRD by the US Food and Drug Administration eg intermittent theta burst stimulation iTBS and intranasal esketamine insufflation and dTMS for OCD
Next a longitudinal database may also be valuable for future biomarker discovery andor replication in independent samples ie an epigenetic signature of antidepressant treatment response to an interventional modality identified by another research group Similarly this patient registry could be valuable for collaborative research with other institutions administering interventional treatments in psychiatry
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None