Influence of Escitalopram on Fear Conditioning
This study has been completed.
Sponsor:
Massachusetts General Hospital
Collaborator:
Forest Laboratories
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01398514
First received: July 12, 2011
Last updated: July 19, 2011
Last verified: July 2011
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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 |
|---|---|---|
|
Effect of Lexapro(Escitalopram)on Learning Health Controls |
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 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.
- 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.
| 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:
- Male or female outpatients 18 to 75 years of age
- 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:
- 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.
- 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).
- 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.
- Current claustrophobia is exclusionary.
- Patients currently taking any narcotic will be excluded.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Naomi Simon, M.D., M.Sc., Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT01398514 History of Changes |
| Other Study ID Numbers: | 2008-P-001314 |
| Study First Received: | July 12, 2011 |
| Last Updated: | July 19, 2011 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Dexetimide Citalopram Antiparkinson Agents Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Parasympatholytics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
Muscarinic Antagonists Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Serotonin Agents |
ClinicalTrials.gov processed this record on May 16, 2013