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| Name | Class |
|---|---|
| Forest Laboratories | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active medication | Experimental | Escitalopram 10mg/day |
|
| Placebo | Placebo Comparator | Matched pill placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Escitalopram | Drug | Escitalopram 10mg/day or matched pill placebo |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Baseline on Day 1 of Fear Conditioning Paradigm (14 to 17 days post medication initiation) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Naomi M Simon, M.D., M.Sc. | Massachusetts General Hospital | Principal Investigator |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Active Medication | Escitalopram 10mg/day |
| FG001 | Placebo | Matched pill placebo |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Active Medication | Escitalopram 10mg/day |
| BG001 | Placebo | Matched pill placebo |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Error | micro-Siemens (square rooted) | Day 2 of Fear Conditioning Paradigm (15 to 18 days post medication initiation) |
|
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.
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
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active Medication | Escitalopram 10mg/day |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appetite decrease | Gastrointestinal disorders | MGH IRB 4.12.07 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Naomi Simon | Massachusetts General Hospital | 617-726-7913 | nsimon@partners.org |
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| ID | Term |
|---|---|
| D000089983 | Escitalopram |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009570 | Nitriles |
| D001572 |
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| Physiologic non-responsiveness |
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| Failure to show a conditioned response |
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| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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| OG001 | Active Medication CS+ | Matched pill placebo |
| OG002 | Placebo CS- |
| OG003 | Placebo CS+ |
|
|
| Primary | 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. | Posted | Mean | Standard Error | micro-Siemens (square rooted) | Baseline on Day 1 of Fear Conditioning Paradigm (14 to 17 days post medication initiation) |
|
|
|
| 0 |
| 25 |
| 13 |
| 25 |
| EG001 | Placebo | Matched pill placebo | 0 | 26 | 7 | 26 |
| Tremor / Shakiness | Nervous system disorders | MGH IRB 4.12.07 | Systematic Assessment |
|
| Anxiety / Nervousness | Psychiatric disorders | MGH IRB 4.12.07 | Systematic Assessment |
|
| Jitteriness / Restlessness | Nervous system disorders | MGH IRB 4.12.07 | Systematic Assessment |
|
| Vivid or Disturbing Dreams | General disorders | MGH IRB 4.12.07 | Systematic Assessment |
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| Fatigue | General disorders | MGH IRB 4.12.07 | Systematic Assessment |
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| Headache | Nervous system disorders | MGH IRB 4.12.07 | Systematic Assessment |
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| Sedation / Drowsiness | General disorders | MGH IRB 4.12.07 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MGH IRB 4.12.07 | Systematic Assessment |
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| Difficulty Concentrating | Psychiatric disorders | MGH IRB 4.12.07 | Systematic Assessment |
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| Sexual Dysfunction | Reproductive system and breast disorders | MGH IRB 4.12.07 | Systematic Assessment |
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| Insomnia | General disorders | MGH IRB 4.12.07 | Systematic Assessment |
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| Sweating / Hot Flashes | General disorders | MGH IRB 4.12.07 | Systematic Assessment |
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| Lightheadedness | Nervous system disorders | MGH IRB 4.12.07 | Non-systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | MGH IRB 4.12.07 | Systematic Assessment |
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| Weightloss | Gastrointestinal disorders | MGH IRB 4.12.07 | Systematic Assessment |
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| Muscle cramping / spasm | Nervous system disorders | MGH IRB 4.12.07 | Systematic Assessment |
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| Head cold | General disorders | MGH IRB 4.12.07 | Non-systematic Assessment |
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| Irritability | Psychiatric disorders | MGH IRB 4.12.07 | Systematic Assessment |
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| Dry Mouth | Gastrointestinal disorders | MGH IRB 4.12.07 | Systematic Assessment |
|
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.
| Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| Trial 2 |
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| Trial 3 |
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| Trial 4 |
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| Trial 5 |
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