Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2025-12-31 @ 9:46 AM
Study NCT ID:
NCT05280756
Status:
COMPLETED
Last Update Posted:
2025-05-07
First Post:
2022-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Home-based tDCS for Prevention of Suicidal Ideation
Sponsor:
University of Rochester
Organization:
Study Overview
Official Title:
Home-based Transcranial Direct-current Stimulation (tDCS) for Prevention of Suicidal Ideation
Status:
COMPLETED
Status Verified Date:
2025-05
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:
Risk for suicide is elevated in the period after discharge from hospital among adults with major affective disorder. The primary objective of this study is to investigate the feasibility of delivering tDCS sessions for high-risk patients for suicide at home in the days following discharge from an emergency department or inpatient unit. This is a single-center, randomized, sham-controlled, double-blind clinical study. We plan to assess up to 80 adult patients for eligibility over 12 months of which 20 will be enrolled and randomized. Clinical assessments will be performed at baseline, post-treatment day 14 (14 days after the first tDCS session), and follow-up day 30 and 60 (30 and 60 days after the first tDCS session, respectively).
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: