Fear ConditioningPhase 4NCT01398514

Influence of Escitalopram on Fear Conditioning

A Phase 4 study testing Escitalopram in people with Fear Conditioning, run by Massachusetts General Hospital.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for: Fear Conditioning
What is being tested?: Escitalopram
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 65 participants
Where: No sites listed yet
Study dates: Oct 2008to Jun 2011
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

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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.

About this study

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

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
Being tested: Escitalopram

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

EscitalopramDrug
Escitalopram 10mg/day or matched pill placebo

Study groups in NCT01398514
Study group	Role	What they receive
Active medication	Experimental	Escitalopram 10mg/day Receives: Drug: Escitalopram
Placebo	Placebo comparator	Matched pill placebo Receives: Drug: Escitalopram

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2008Jun 2011

First posted20 Jul 2011 (estimated)
Study startOct 2008
Primary completionJun 2011
Study completionJun 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Fear ConditioningStudies of the same condition, open and under way.
More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 65 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01398514
Sponsor's protocol ID: 2008-P-001314
Status last verified: Jun 2014
First submitted: 12 Jul 2011
Last updated: 11 Jun 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Fear Conditioning trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01398514
Acronym / sponsor ID: 2008-P-001314
Conditions: Fear Conditioning
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 65 participants (actual)
Lead sponsor: Massachusetts General HospitalUniversity, hospital or other
Collaborators: Forest Laboratories
Study start: Oct 2008
Primary completion: Jun 2011 (actual)
Study completion: Jun 2011 (actual)
First posted: 20 Jul 2011 (estimated)
Results: Posted 27 Sep 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Active medication	Experimental	Drug: EscitalopramEscitalopram 10mg/day
Placebo	Placebo comparator	Drug: EscitalopramMatched pill placebo

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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.

Key exclusion criteria (11 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
EscitalopramEscitalopram 10mg/day or matched pill placebo	Drug	Active medication, Placebo

Primary outcome

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.

Results and safety

Results posted to the registry on 27 Sep 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Active Medication	26	18
Placebo	26	20

Primary outcome: 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). Mean (Standard Error). Unit: micro-Siemens (square rooted)

Measure	Active Medication CS- n = 16	Active Medication CS+ n = 16	Placebo CS- n = 18	Placebo CS+ n = 18
Trial 1	0.745 (0.130)	0.853 (0.853)	0.799 (0.122)	0.717 (0.123)
Trial 2	0.496 (0.103)	0.634 (0.114)	0.386 (0.097)	0.558 (0.108)
Trial 3	0.544 (0.111)	0.520 (0.124)	0.438 (0.105)	0.787 (0.117)
Trial 4	0.374 (0.110)	0.361 (0.116)	0.309 (0.104)	0.510 (0.109)

Primary outcome: 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). Mean (Standard Error). Unit: micro-Siemens (square rooted)

Measure	Active Medication CS- n = 18	Active Medication CS+ n = 18	Placebo CS- n = 20	Placebo CS+ n = 20
Trial 1	0.634 (0.093)	0.574 (0.111)	0.532 (0.088)	0.634 (0.105)
Trial 2	0.419 (0.122)	0.870 (0.113)	0.428 (0.116)	0.817 (0.107)
Trial 3	0.230 (0.119)	0.685 (0.104)	0.331 (0.112)	0.856 (0.099)
Trial 4	0.231 (0.086)	0.626 (0.102)	0.181 (0.082)	0.677 (0.096)
Trial 5	0.281 (0.071)	0.543 (0.118)	0.144 (0.067)	0.714 (0.112)

Adverse events

Time frame: AEs were assessed in the period following randomization/medication initiation, through the experimental portion of the study (14-17 days post medication initiation), and 7 days following medication discontinuation.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Active Medication	0 of 25 (0%)	13 of 25 (52%)	Not reported
Placebo	0 of 26 (0%)	7 of 26 (26.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Fear Conditioning

RecruitingPhase 4
The Effects of Orexin Antagonism on Fear Extinction in PTSD
Insomnia, PTSD
Recruiting
K08 VR Fear Conditioning
Anxiety and Fear, PTSD
Recruiting
Amygdala-Prefrontal in Fear Extinction
Fear Extinction
Recruiting
Stimulation-Induced Changes in Fronto-Limbic Network
Epilepsy, Mental Disorders
RecruitingEarly Phase 1
Cannabidiol Effects on Learning and Anxiety
Anxiety and Fear

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Naomi M Simon, M.D., M.Sc. principal investigator

Massachusetts General Hospital

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Escitalopram in people with Fear Conditioning, run by Massachusetts General Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Sep 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01398514.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2014.