Influence of Escitalopram on Fear Conditioning

NCT01398514 | Completed Phase 4 Results

• 1 other identifier: 2008-P-001314
• Study Type: interventional
• Target: 65
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Fear Conditioning

Outcome Measures

Primary Outcomes (2)

• Physiological Reactivity as Measured by Square-root Transformed Skin Conductance Conditioned Response in Early Extinction Trials 1 to 4

  Three-way interaction between group (active vs. placebo), CS (+ vs. -), and trials (1 - 4). CS+ refers to the conditioned stimulus associated with the unconditioned stimulus (electric shock). Higher numbers reflect higher skin conductance response to the CS+ (conditioned stimulus). CS- refers to the stimulus not associated with the unconditioned stimulus. Higher numbers reflect higher skin conductance response to a CS-. Square-root transformed skin conductance conditioned response are reported for trials 1 to 4 of the Early Extinction Phase.

  Day 2 of Fear Conditioning Paradigm (15 to 18 days post medication initiation)

• Physiological Reactivity as Measured by Square-root Transformed Skin Conductance Conditioned Response in Acquisition Trials 1 to 5

  Three-way interaction between group (active vs. placebo), CS (+ vs. -), and trials (1 - 5). CS+ refers to the conditioned stimulus associated with the unconditioned stimulus (electric shock). Higher numbers reflect higher skin conductance response to the CS+ (conditioned stimulus). CS- refers to the stimulus not associated with the unconditioned stimulus. Higher numbers reflect higher skin conductance response to a CS-. Square-root transformed skin conductance conditioned response are reported for trials 1 to 5 of the Acquisition Phase.

  Baseline on Day 1 of Fear Conditioning Paradigm (14 to 17 days post medication initiation)

Study Arms (2)

Active medication

EXPERIMENTAL

Escitalopram 10mg/day

Drug: Escitalopram

Placebo

PLACEBO COMPARATOR

Matched pill placebo

Drug: Escitalopram

Interventions

Escitalopram DRUG

Escitalopram 10mg/day or matched pill placebo

Active medication; Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female outpatients 18 to 75 years of age

You may not qualify if:

• 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.
• Pregnant or lactating women or those of childbearing potential not using medically accepted forms of contraception will be excluded.
• Concurrent use of other antidepressants, benzodiazepines or antipsychotic medications.
• Patients with a history of hypersensitivity to escitalopram are excluded.
• Individuals must have discontinued MAO inhibitors more than 14 days before starting study drug.
• Additional contraindicated drugs during the study are pimozide, furazolidine, isocarboxazid, lazabemide, and St. John's Wort.
• 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.
• A lifetime history of Bipolar or any psychotic disorder is excluded.
• Patients currently taking any narcotic will be excluded.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Forest Laboratories: collaborator

MeSH Terms

Interventions

Escitalopram

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Naomi Simon
• Organization: Massachusetts General Hospital

nsimon@partners.org

617-726-7913

Study Officials

• Naomi M Simon, M.D., M.Sc.

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 12, 2011
• First Posted: July 20, 2011
• Study Start: October 1, 2008
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: June 11, 2014
• Results First Posted: September 27, 2013

Record last verified: 2014-06