Neurotrophic Factors and Depression

Phase 4

Completed

• Conditions: Depression
• Interventions: Drug: Placebo; Drug: Escitalopram

• Registration Number: NCT00812994
• Lead Sponsor: University of California, San Francisco

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 Timeline

• Study Start: 2003-01
• Primary Completion: 2006-12
• Study Completion: 2008-11
• Status Verified: 2008-12
• Study First Submitted: 2008-12-19
• Study First Submitted QC: 2008-12-19
• Last Update Submitted: 2008-12-19
• Study First Posted: 2008-12-22
• Last Update Posted: 2008-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Individuals with co-morbid panic disorder were excluded, since they may poorly tolerate typical starting doses of antidepressants , and individuals with co-morbid post-traumatic stress disorder were excluded, since they may have neuroendocrine regulatory responses different from those of depressed subjects without PTSD. Exclusion criteria for both groups included recent (within 6 months) alcohol or drug abuse as defined by DSM-IV criteria, concurrent psychotherapeutic interventions, poor medical health or abnormal clinical labs, active suicidality, and use of medications that could interfere with the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Escitalopram	Escitalopram	-

Primary Outcome Measures

Name	Time	Method
Serum BDNF levels	Baseline, week 4, week 8
Serum allopregnanolone levels	Baseline, week 4, week 8

Secondary Outcome Measures

Name	Time	Method
Montgomery-Asberg Depression Rating Scale	baseline, week 4, week 8
Clinical Global Impression	Baseline, week 4, week 8

Trial Locations

Locations (2)

University of California San Francisco; 🇺🇸 San Francisco, California, United States

UCSF; 🇺🇸 San Francisco, California, United States