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Influence of Escitalopram on Fear Conditioning

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ClinicalTrials.gov Identifier: NCT01398514
Recruitment Status : Completed
First Posted : July 20, 2011
Results First Posted : September 27, 2013
Last Update Posted : June 11, 2014
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Naomi M. Simon, Massachusetts General Hospital

Tracking Information
First Submitted Date  ICMJE July 12, 2011
First Posted Date  ICMJE July 20, 2011
Results First Submitted Date  ICMJE July 25, 2013
Results First Posted Date  ICMJE September 27, 2013
Last Update Posted Date June 11, 2014
Study Start Date  ICMJE October 2008
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 25, 2013)
  • 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) ]
    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) ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 19, 2011)
  • 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) ]
    Differences in physiological reactivity between the active vs. placebo conditions will be used to assess for the impact of Escitalopram on fear conditioning.
  • 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) ]
    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.
Change History Complete list of historical versions of study NCT01398514 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Influence of Escitalopram on Fear Conditioning
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Fear Conditioning
Intervention  ICMJE Drug: Escitalopram
Escitalopram 10mg/day or matched pill placebo
Study Arms  ICMJE
  • Experimental: Active medication
    Escitalopram 10mg/day
    Intervention: Drug: Escitalopram
  • Placebo Comparator: Placebo
    Matched pill placebo
    Intervention: Drug: Escitalopram
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 19, 2011)
65
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2011
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01398514
Other Study ID Numbers  ICMJE 2008-P-001314
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Naomi M. Simon, Massachusetts General Hospital
Study Sponsor  ICMJE Massachusetts General Hospital
Collaborators  ICMJE Forest Laboratories
Investigators  ICMJE
Principal Investigator: Naomi M Simon, M.D., M.Sc. Massachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date June 2014

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