Influence of Escitalopram on Fear Conditioning

This study has been completed.
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Naomi M. Simon, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01398514
First received: July 12, 2011
Last updated: June 5, 2014
Last verified: June 2014

July 12, 2011
June 5, 2014
October 2008
June 2011   (final data collection date for primary outcome measure)
  • Physiological Reactivity as Measured by Square-root Transformed Skin Conductance Conditioned Response in Early Extinction Trials 1 to 4 [ Time Frame: Day 2 of Fear Conditioning Paradigm (15 to 18 days post medication initiation) ] [ Designated as safety issue: No ]

    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.

  • Physiological Reactivity as Measured by Square-root Transformed Skin Conductance Conditioned Response in Acquisition Trials 1 to 5 [ Time Frame: Baseline on Day 1 of Fear Conditioning Paradigm (14 to 17 days post medication initiation) ] [ Designated as safety issue: No ]

    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.

  • Physiological reactivity as measured by skin conductance, heart rate, and corrugator EMG [ Time Frame: Day 2 of Fear Conditioning Paradigm (15 to 18 days post medication initiation) ] [ Designated as safety issue: No ]
    Differences in physiological reactivity between the active vs. placebo conditions will be used to assess for the impact of Escitalopram on fear renewal and reinstatement.
  • Physiological reactivity as measured by skin conductance, heart rate, and corrugator EMG [ Time Frame: Day 1 of Fear Conditioning Paradigm (14 to 17 days post medication initiation) ] [ Designated as safety issue: No ]
    Differences in physiological reactivity between the active vs. placebo conditions will be used to assess for the impact of Escitalopram on fear conditioning.
Complete list of historical versions of study NCT01398514 on ClinicalTrials.gov Archive Site
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Influence of Escitalopram on Fear Conditioning
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

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Fear Conditioning
Drug: Escitalopram
Escitalopram 10mg/day or matched pill placebo
  • Experimental: Active medication
    Escitalopram 10mg/day
    Intervention: Drug: Escitalopram
  • Placebo Comparator: Placebo
    Matched pill placebo
    Intervention: Drug: Escitalopram
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
65
June 2011
June 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01398514
2008-P-001314
No
Naomi M. Simon, Massachusetts General Hospital
Massachusetts General Hospital
Forest Laboratories
Principal Investigator: Naomi M Simon, M.D., M.Sc. Massachusetts General Hospital
Massachusetts General Hospital
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP