Phase 3 N=53 Treatment

Biological Markers of Response to Treatment in Major Depressive Disorder

Major Depressive Disorder

Bottom Line

View on ClinicalTrials.gov: NCT00361218 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2013

Primary outcome: Primary: Serum Brain-derived Neurotrophic Factor (BDNF) Levels — 6077.270; 4393.24 pg/mL

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: open-label selective serotonin reuptake inhibitor (SSRI) (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Massachusetts General Hospital
Primary completion: Dec 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Serum Brain-derived Neurotrophic Factor (BDNF) Levels	6077.270; 4393.24	—
PRIMARY Quantitative Electroencephalogram (QEEG) Parameters as Predictors of Response	—	—

Summary

The purpose of this study is to find out if two tests are useful in predicting whether someone with depression will get better when he or she is treated with an FDA approved antidepressant medication (either citalopram or escitalopram).

Eligibility Criteria

Inclusion Criteria

Ages 18-65
Meet criteria for current Major Depressive Disorder
Antidepressant medication-free for at least 2 weeks prior to the start of the study

Exclusion Criteria

Pregnant or breastfeeding women
Anyone who is suicidal
Anyone with an unstable medical condition (cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological), substance abuse problem within the past 6 months, psychoses (past or current), hypothyroidism, or hypomania
Anyone currently taking an SSRI
Past intolerance to Lexapro or Celexa

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00361218). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.