NCT00812994

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_4 depression

Timeline
Completed

Started Jan 2003

Longer than P75 for phase_4 depression

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 19, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 22, 2008

Completed
Last Updated

December 22, 2008

Status Verified

December 1, 2008

Enrollment Period

3.9 years

First QC Date

December 19, 2008

Last Update Submit

December 19, 2008

Conditions

Depression

Keywords

DepressionBDNFneurotrophic factorneurosetroidallopregnanolone

Outcome Measures

Primary Outcomes (2)

  • Serum BDNF levels

    Baseline, week 4, week 8

  • Serum allopregnanolone levels

    Baseline, week 4, week 8

Secondary Outcomes (2)

  • Montgomery-Asberg Depression Rating Scale

    baseline, week 4, week 8

  • Clinical Global Impression

    Baseline, week 4, week 8

Study Arms (2)

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Escitalopram

EXPERIMENTAL
Drug: Escitalopram

Interventions

EscitalopramDRUG

SSRI antidepressant

Also known as: Lexapro
Escitalopram
PlaceboDRUG
Placebo

Eligibility Criteria

Age22 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of California San Francisco

San Francisco, California, 94143-0984, United States

Location

UCSF

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Depression

Interventions

Escitalopram

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic ChemicalsNitrilesBenzofuransHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Owen M Wolkowitz, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 19, 2008

First Posted

December 22, 2008

Study Start

January 1, 2003

Primary Completion

December 1, 2006

Study Completion

November 1, 2008

Last Updated

December 22, 2008

Record last verified: 2008-12

Locations

US(2)