Clinical trial NCT01398514: Influence of Escitalopram on Fear Conditioning
Official title: Pharmacologic Influence of Escitalopram on the Reduction of Fear Acquisition and Triggered Renewal During Fear Conditioning: a Model for the Prevention and Persistence of Learned Fear and Anxiety in Response to Trauma and Stress
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Fear Conditioning
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Forest Laboratories
First posted: 2011-07-20
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of the study is to learn how differences in learning under mildly-stressful circumstances may be changed by taking an antidepressant medication. This medication is called Lexapro (Escitalopram). The investigators will also examine the impact of any anxiety, depression, and stress related symptoms on learning processes. The investigators will also look at the response of these symptoms to Lexapro.


Eligibility criteria: Inclusion Criteria:

1. Male or female outpatients 18 to 75 years of age
2. Must have no current DSM-IV Axis I diagnosis as measured by the SCID (Structured Clinical Interview for DSM-IV-TR axis 1 disorders) with a trained study investigator. Past history of anxiety disorders, major depressive episodes or substance abuse disorders at least six months prior to baseline are not exclusionary.

Exclusion Criteria:

1. Patients will be excluded from entry into the study for current serious medical conditions or other conditions deemed likely to result in surgery or hospitalization.
2. Patients with a history of trauma resulting in head injury related seizures, or with epilepsy (except a prior history of febrile seizures of infancy which are not exclusionary).
3. Pregnant or lactating women or those of childbearing potential not using medically accepted forms of contraception will be excluded.
4. Concurrent use of other antidepressants, benzodiazepines or antipsychotic medications.
5. Patients with a history of hypersensitivity to escitalopram are excluded.
6. Individuals must have discontinued MAO inhibitors more than 14 days before starting study drug.
7. Additional contraindicated drugs during the study are pimozide, furazolidine, isocarboxazid, lazabemide, and St. John's Wort.
8. Participants meeting DSM-IV or SCID criteria for a substance use disorder in the last six months other than nicotine dependence and those with a positive toxicology screen at baseline consistent with evidence of current substance abuse or dependence as determined by clinical interview.
9. A lifetime history of Bipolar or any psychotic disorder is excluded.
10. Current claustrophobia is exclusionary.
11. Patients currently taking any narcotic will be excluded.

Primary outcomes:
measure: Physiological Reactivity as Measured by Square-root Transformed Skin Conductance Conditioned Response in Early Extinction Trials 1 to 4
timeFrame: Day 2 of Fear Conditioning Paradigm (15 to 18 days post medication initiation)
measure: Physiological Reactivity as Measured by Square-root Transformed Skin Conductance Conditioned Response in Acquisition Trials 1 to 5
timeFrame: Baseline on Day 1 of Fear Conditioning Paradigm (14 to 17 days post medication initiation)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Massachusetts General Hospital
name: Naomi M Simon, M.D., M.Sc.
role: PRINCIPAL_INVESTIGATOR
References: