Ignite Creation Date:
2025-12-26 @ 4:02 PM
Ignite Modification Date:
2026-02-25 @ 3:35 AM
Study NCT ID:
NCT04082806
Status:
COMPLETED
Last Update Posted:
2022-05-12
First Post:
2019-08-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Memory Enhancement by Gamma-hydroxybutyrate vs. Trazodone in Major Depressive Disorder.
Sponsor:
Erich Seifritz
Organization:
Study Overview
Official Title:
Memory Enhancement by Gamma-hydroxybutyrate vs. Trazodone in Major Depressive Disorder.
Status:
COMPLETED
Status Verified Date:
2022-05
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:
30 healthy adults and 30 patients with major depressive disorder, will take part in three single-application pharmacological interventions (GHB vs. Trazodone vs. placebo p.o.) to test potential effects of these drugs on nocturnal memory consolidation. All participants will be assessed with mood state questionnaires, tests of emotional, procedural and declarative memory consolidation, polysomnography, EEG and neuroinflammatory biomarkers. At experimental nights, learning tasks are performed prior to sleep. The next morning, recalling tasks are performed. Each subject will pass through 5 study nights (1 screening, 1 adaptation and 3 experimental nights).
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: