Phase 4 N=40 Randomized Double-blind Treatment

Depression, Epinephrine, and Platelet Function

Major Depressive Disorder

Bottom Line

View on ClinicalTrials.gov: NCT00166114 ↗

Enrolled (actual)

Serious AEs

2.5%

Results posted

Jul 2015

Primary outcome: Primary: Response of Participants, Defined by Change in the 21-item Hamilton Depression Rating Scale (HDRS) From Baseline to Week8 — 5; 9; 2; 4 participants — p=.918

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Escitalopram (Drug); Desipramine (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Emory University
Primary completion: Jan 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Response of Participants, Defined by Change in the 21-item Hamilton Depression Rating Scale (HDRS) From Baseline to Week8	5; 9; 2; 4	.918

Summary

Men and women who have suffered sexual and/or physical abuse before the age of 12 are at increased risk for anxiety and mood disorders, other serious psychiatric disorders, and likely medical illnesses. What is not known is whether adult survivors of childhood adversity experience heightened negative emotions and increased physical responses due to altered norepinephrine or serotonin systems in their brains and bodies. The investigators expect to see that survivors of childhood adversity experience heightened negative emotions and increased physical responses to stress.

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Individuals who are suicidal, psychotic, or with bipolar depression
alcohol or substance abuse or
regularly use medications which alter mood or blood vessel function (zolpidem or zalpelon, aspirin, nonsteroidal antiinflammatory drugs, sympatholytics, theophylline, central acting agonists, beta-blockers, coumadin, nitrates, triazolobenzodiazapines, or use steroids (testosterone-patch or pill form), use tryptophan or monoamine oxidase inhibitors (MAOIs),
have narrow-angle glaucoma, liver disease,
severe allergies (especially to antidepressants similar to escitalopram or desipramine)
seizures, or a serious medical disorder (e.g. hypothyroidism) that is unstable or is untreated.
Depressed patients with a prior history of severe adverse events associated with SSRIs or TCAs will not be accepted into the study.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00166114). 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.