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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Basic Science
Condition Fear Conditioning
Intervention Drug: Escitalopram
Enrollment 65
Recruitment Details Participants free of DSM-IV Axis I disorders with varying levels of subsyndromal anxiety were recruited by advertisements (e.g., postings on Craigslist, postings on Massachusetts General Hospital research participation registry) from March 2009 through April 2011.
Pre-assignment Details 65 participants signed consent and were screened for enrollment. 10 participants did not meet study entry criteria due to exclusionary psychiatric conditions. Of the 55 eligible participants, 3 withdrew and 1 was lost to follow up. 52 participants were randomly assigned to a treatment arm. Fourteen were excluded from analyses.
Arm/Group Title Active Medication Placebo
Hide Arm/Group Description Escitalopram 10mg/day Matched pill placebo
Period Title: Overall Study
Started 26 26
Completed 18 20
Not Completed 8 6
Reason Not Completed
Adverse Event             1             0
Non-compliance with study procedures             2             0
Physiologic non-responsiveness             1             3
Failure to show a conditioned response             4             3
Arm/Group Title Active Medication Placebo Total
Hide Arm/Group Description Escitalopram 10mg/day Matched pill placebo Total of all reporting groups
Overall Number of Baseline Participants 26 26 52
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 26 participants 52 participants
<=18 years
1
   3.8%
0
   0.0%
1
   1.9%
Between 18 and 65 years
25
  96.2%
26
 100.0%
51
  98.1%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 26 participants 26 participants 52 participants
34.04  (11.56) 30.46  (11.46) 32.25  (11.54)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 26 participants 52 participants
Female
14
  53.8%
12
  46.2%
26
  50.0%
Male
12
  46.2%
14
  53.8%
26
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 26 participants 26 participants 52 participants
26 26 52
1.Primary Outcome
Title Physiological Reactivity as Measured by Square-root Transformed Skin Conductance Conditioned Response in Early Extinction Trials 1 to 4
Hide Description

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.

Time Frame Day 2 of Fear Conditioning Paradigm (15 to 18 days post medication initiation)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active Medication CS- Active Medication CS+ Placebo CS- Placebo CS+
Hide Arm/Group Description:
Escitalopram 10mg/day
Matched pill placebo
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 16 16 18 18
Mean (Standard Error)
Unit of Measure: micro-Siemens (square rooted)
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)
2.Primary Outcome
Title Physiological Reactivity as Measured by Square-root Transformed Skin Conductance Conditioned Response in Acquisition Trials 1 to 5
Hide Description

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.

Time Frame Baseline on Day 1 of Fear Conditioning Paradigm (14 to 17 days post medication initiation)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active Medication CS- Active Medication CS+ Placebo CS- Placebo CS+
Hide Arm/Group Description:
Escitalopram 10mg/day
Matched pill placebo
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 18 18 20 20
Mean (Standard Error)
Unit of Measure: micro-Siemens (square rooted)
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)
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.
Adverse Event Reporting Description AEs were defined as any untoward or unfavorable medical occurrence in a human subject. SAEs event were defined as any event temporally associated with the subject’s participation that: results in death, is life-threatening, results in inpatient hospitalization, results in significant disability, or results in a congenital anomaly or birth defect
 
Arm/Group Title Active Medication Placebo
Hide Arm/Group Description Escitalopram 10mg/day Matched pill placebo
All-Cause Mortality
Active Medication Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Active Medication Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/25 (0.00%)      0/26 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Active Medication Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   13/25 (52.00%)      7/26 (26.92%)    
Gastrointestinal disorders     
Appetite decrease  1  2/25 (8.00%)  2 0/26 (0.00%)  0
Constipation  1  1/25 (4.00%)  1 0/26 (0.00%)  0
Diarrhea  1  0/25 (0.00%)  0 1/26 (3.85%)  1
Weightloss  1  1/25 (4.00%)  1 0/26 (0.00%)  0
Dry Mouth  1  1/25 (4.00%)  1 0/26 (0.00%)  0
General disorders     
Vivid or Disturbing Dreams  1  1/25 (4.00%)  1 1/26 (3.85%)  1
Fatigue  1  1/25 (4.00%)  1 0/26 (0.00%)  0
Sedation / Drowsiness  1  3/25 (12.00%)  3 0/26 (0.00%)  0
Insomnia  1  3/25 (12.00%)  3 0/26 (0.00%)  0
Sweating / Hot Flashes  1  1/25 (4.00%)  1 0/26 (0.00%)  0
Head cold * 1  0/25 (0.00%)  0 1/26 (3.85%)  1
Nervous system disorders     
Tremor / Shakiness  1  1/25 (4.00%)  1 0/26 (0.00%)  0
Jitteriness / Restlessness  1  1/25 (4.00%)  1 2/26 (7.69%)  2
Headache  1  3/25 (12.00%)  3 1/26 (3.85%)  1
Lightheadedness * 1  0/25 (0.00%)  0 1/26 (3.85%)  1
Muscle cramping / spasm  1  0/25 (0.00%)  0 1/26 (3.85%)  1
Psychiatric disorders     
Anxiety / Nervousness  1  2/25 (8.00%)  2 0/26 (0.00%)  0
Difficulty Concentrating  1  1/25 (4.00%)  1 0/26 (0.00%)  0
Irritability  1  0/25 (0.00%)  0 1/26 (3.85%)  1
Reproductive system and breast disorders     
Sexual Dysfunction  1  2/25 (8.00%)  2 0/26 (0.00%)  0
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MGH IRB 4.12.07
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The sponsor shall require the PI to furnish the sponsor with a copy of any proposed publication at least 60 days prior to submission. The sponsor shall be entitled to review such proposed publications. The PI shall give due regard to the sponsor's comments on the proposed publication. If the sponsor reasonably believes a patent application claiming an invention should be filed prior to such publication, such submission shall not be submitted until applicable patent applications have been filed.
Results Point of Contact
Name/Title: Dr. Naomi Simon
Organization: Massachusetts General Hospital
Phone: 617-726-7913
Responsible Party: Naomi M. Simon, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01398514     History of Changes
Other Study ID Numbers: 2008-P-001314
First Submitted: July 12, 2011
First Posted: July 20, 2011
Results First Submitted: July 25, 2013
Results First Posted: September 27, 2013
Last Update Posted: June 11, 2014