Ignite Creation Date:
2024-05-05 @ 9:06 PM
Last Modification Date:
2024-10-26 @ 9:59 AM
Study NCT ID:
NCT00812994
Status:
COMPLETED
Last Update Posted:
2008-12-22
First Post:
2008-12-19
Brief Title:
Neurotrophic Factors and Depression
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
Blood Levels of Neurosteroids and Neurotrophic Factors in Normal Controls and in Patients With Major Depression
Status:
COMPLETED
Status Verified Date:
2008-12
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:
LexBDNF
Brief Summary:
Study intended to determine if there are baseline differences in serum neurosteroid levels and neurotrophic factor BDNF levels in healthy controls vs unmedicated depressed subjects and whether the levels of these change with antidepressant treatment Study also intended to determine if baseline neurosteroid BDNF levels and the change in these levels with treatment are correlated with clinical antidepressant response to escitalopram Lexapro
Detailed Description:
The study was approved by the UCSF Committee on Human Research and all participants gave informed consent The depressed subjects began treatment with placebo for one week followed by escitalopram for eight weeks 10 mg per day x 4 weeks followed by 20 mg per day x 4 weeks as tolerated in a double-blind fixed-order within-subject cross-over manner The depressed subjects and the psychiatric rater were unaware of the study design and the sequence and duration of treatments Depressed and control subjects underwent venipuncture to obtain blood for assays The controls underwent venipuncture once and the depressed subjects had venipuncture just prior to beginning active escitalopram treatment and again after 8 weeks of escitalopram treatment Blood was also collected at Weeks 4 and 8 of treatment in the depressed subjects for assay of citalopram and citalopram metabolites to gauge medication compliance Finally depression severity and global clinical change were assessed in the depressed subjects at Baseline and at the end of Week 8 of escitalopram treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None