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
  Purpose

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.


Condition Intervention Phase
Fear Conditioning
Drug: Escitalopram
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
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

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • 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.



Enrollment: 65
Study Start Date: October 2008
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active medication
Escitalopram 10mg/day
Drug: Escitalopram
Escitalopram 10mg/day or matched pill placebo
Placebo Comparator: Placebo
Matched pill placebo
Drug: Escitalopram
Escitalopram 10mg/day or matched pill placebo

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01398514

Sponsors and Collaborators
Massachusetts General Hospital
Forest Laboratories
Investigators
Principal Investigator: Naomi M Simon, M.D., M.Sc. Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Naomi M. Simon, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01398514     History of Changes
Other Study ID Numbers: 2008-P-001314
Study First Received: July 12, 2011
Results First Received: July 25, 2013
Last Updated: June 5, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Citalopram
Dexetimide
Anti-Dyskinesia Agents
Antidepressive Agents
Antidepressive Agents, Second-Generation
Antiparkinson Agents
Autonomic Agents
Central Nervous System Agents
Cholinergic Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Parasympatholytics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014