Source Paper
E Berry-Kravis, D Hessl, S Coffey, C Hervey, A Schneider et al.
Journal of Medical Genetics • 2009
Objective: A pilot open label, single dose trial of fenobam, an mGluR5 antagonist, was conducted to provide an initial evaluation of safety and pharmacokinetics in adult males and females with fragile X syndrome (FXS). Methods: Twelve subjects, recruited from two fragile X clinics, received a single oral dose of 50–150 mg of fenobam. Blood for pharmacokinetic testing, vital signs and side effect screening was obtained at baseline and numerous time points for 6 h after dosing. Outcome measures included prepulse inhibition (PPI) and a continuous performance test (CPT) obtained before and after dosing to explore the effects of fenobam on core phenotypic measures of sensory gating, attention and inhibition. Results: There were no significant adverse reactions to fenobam administration. Pharmacokinetic analysis showed that fenobam concentrations were dose dependent but variable, with mean (SEM) peak values of 39.7 (18.4) ng/ml at 180 min after the 150 mg dose. PPI met a response criterion of an improvement of at least 20% over baseline in 6 of 12 individuals (4/6 males and 2/6 females). The CPT did not display improvement with treatment due to ceiling effects. Conclusions: Clinically significant adverse effects were not identified in this study of single dose fenobam across the range of dosages utilised. The positive effects seen in animal models of FXS treated with fenobam or other mGluR5 antagonists, the apparent lack of clinically significant adverse effects, and the potential beneficial clinical effects seen in this pilot trial support further study of the compound in adults with FXS.
Objective: Assessment of attention, impulsivity, and inhibitory control through detection of target stimuli and measurement of hits, omissions, and commission errors in individuals with Fragile X Syndrome
This is a Carolina Fragile X Project Continuous Performance Test protocol using human as the model organism. The procedure involves 31 procedural steps, 9 equipment items, 4 materials. Extracted from a 2009 paper published in Journal of Medical Genetics.
Model and subjects
human • N/A • both • Not specified • Not specified
Study window
~4 week study window | ~46.5 hours hands-on
Core workflow
Screening Visit - Subject Recruitment and Informed Consent • Screening Visit - Medical History and Vital Signs Assessment • Screening Visit - Laboratory Testing
Primary readouts
Key equipment and reagents
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Subjects recruited from fragile X clinics at RUMC and MIND Institute at UCDMC. Informed written consent obtained from subject or parent; assent obtained when subject not legal guardian.
Note: Study approved by institutional review boards at RUMC and UCDMC. Sequence of enrollment and treatment random based on subject contact and scheduling.
“Subjects were recruited from fragile X clinics at Rush University Medical Center (RUMC) and the MIND Institute at University of California at Davis Medical Center (UCDMC). Informed written consent was obtained from either the subject or the parent before participation.”
Comprehensive medical history obtained and vital signs measured during screening visit.
Note: Part of initial screening evaluation
“At the screening visit medical history, exam, vital signs, laboratory testing including routine chemistries, blood counts, thyroid functions, electrocardiogram (ECG), and a pregnancy test (females) were evaluated”
Baseline laboratory tests performed including routine chemistries, blood counts, thyroid functions, and pregnancy test for females.
Note: Significant abnormalities in baseline laboratory tests were exclusion criterion
“laboratory testing including routine chemistries, blood counts, thyroid functions, electrocardiogram (ECG), and a pregnancy test (females) were evaluated”
Carolina Fragile X Project Continuous Performance Test administered to establish baseline performance on attention, impulsivity, and inhibition measures.
Note: Baseline outcome measure obtained at screening visit
“baseline CPT (Carolina Project Fragile X continuous performance test) and prepulse inhibition (PPI) outcome measures were obtained”
Prepulse inhibition test performed to assess sensorimotor gating and inhibitory control at baseline.
Note: Baseline outcome measure obtained at screening visit
“baseline CPT (Carolina Project Fragile X continuous performance test) and prepulse inhibition (PPI) outcome measures were obtained”
Treatment visit scheduled 14-28 days after screening visit.
Note: Timing allows for stable medication baseline and scheduling coordination
“At the treatment visit, 14–28 days after screening, an IV was inserted for blood drawing and the subject received the study medication orally.”
Intravenous catheter inserted for blood drawing and pharmacokinetic sampling.
Note: IV maintained for 6 hours during treatment visit
“At the treatment visit, 14–28 days after screening, an IV was inserted for blood drawing and the subject received the study medication orally.”
Study medication (fenobam) administered orally. Dosage determined by subject gender and enrollment sequence: first subject per gender receives 50 mg, second receives 100 mg, all subsequent subjects receive 150 mg.
Note: Dose escalation based on conference calls confirming absence of adverse events after each subject dosed
“The first subject for each gender was dosed with 50 mg fenobam, the second with 100 mg, and all subsequent subjects with 150 mg.”
Blood sample collected immediately before fenobam administration (0 min) for pharmacokinetic baseline.
Note: First of 10 blood draws during 6-hour observation period
“Blood for pharmacokinetic testing, blood pressure, heart rate and side effect screening was obtained at 0, 15, 30, 45, 60, 120, 180, 240, 300, and 360 min after dosing.”
Blood sample collected and vital signs (blood pressure, heart rate) measured 15 minutes after fenobam administration.
Note: Part of pharmacokinetic and safety monitoring protocol
“Blood for pharmacokinetic testing, blood pressure, heart rate and side effect screening was obtained at 0, 15, 30, 45, 60, 120, 180, 240, 300, and 360 min after dosing.”
Blood sample collected and vital signs measured 30 minutes after fenobam administration.
Note: Part of pharmacokinetic and safety monitoring protocol
“Blood for pharmacokinetic testing, blood pressure, heart rate and side effect screening was obtained at 0, 15, 30, 45, 60, 120, 180, 240, 300, and 360 min after dosing.”
Blood sample collected and vital signs measured 45 minutes after fenobam administration.
Note: Part of pharmacokinetic and safety monitoring protocol
“Blood for pharmacokinetic testing, blood pressure, heart rate and side effect screening was obtained at 0, 15, 30, 45, 60, 120, 180, 240, 300, and 360 min after dosing.”
Blood sample collected and vital signs measured 60 minutes after fenobam administration.
Note: PPI assessment performed after this 60 min blood sampling
“Blood for pharmacokinetic testing, blood pressure, heart rate and side effect screening was obtained at 0, 15, 30, 45, 60, 120, 180, 240, 300, and 360 min after dosing.”
Prepulse inhibition test performed after 60 minute blood sampling to assess medication effects on sensorimotor gating and inhibitory control.
Note: Performed after 60 min blood draw, before CPT
“Post-treatment PPI was performed after the 60 min blood sampling, followed by CPT.”
Deliver 10 trials of startle stimulus alone (50 ms, 105 dB SPL white noise pulses) while subject watches silent movie. Digitized orbicularis oculi EMG peak magnitudes recorded between 20-200 ms post-stimulus onset and averaged across trials.
Note: Part of 30-trial PPI protocol; EMG data used to calculate baseline startle response
“Startle stimuli (SS) were 50 ms 105 db SPL white noise pulses and acoustic prepulses (PP) are 25 ms 75 db SPL 1 kHz tones. These trials are delivered while participants watch a silent movie to maintain compliance and interest in the procedure.”
Deliver 10 trials with 120 ms prepulse interval (25 ms, 75 dB SPL, 1 kHz tone followed by 50 ms, 105 dB SPL white noise startle stimulus). Digitized orbicularis oculi EMG peak magnitudes recorded between 20-200 ms post-startle onset and averaged across trials.
Note: 120 ms interval has excellent test-retest reliability (ICC 0.85 for FXS, 0.88 for controls); primary trial type for responder determination
“we eliminated the 60 ms trial type and added two trials per type, resulting in a protocol with 30 total trials (10 with SS alone, 10 with 120 ms prepulse and 10 with 240 ms prepulse)”
Deliver 10 trials with 240 ms prepulse interval (25 ms, 75 dB SPL, 1 kHz tone followed by 50 ms, 105 dB SPL white noise startle stimulus). Digitized orbicularis oculi EMG peak magnitudes recorded between 20-200 ms post-startle onset and averaged across trials.
Note: 240 ms interval has good test-retest reliability; included for comprehensive PPI assessment
“we eliminated the 60 ms trial type and added two trials per type, resulting in a protocol with 30 total trials (10 with SS alone, 10 with 120 ms prepulse and 10 with 240 ms prepulse)”
Blood sample collected and vital signs measured 120 minutes after fenobam administration.
Note: Part of pharmacokinetic and safety monitoring protocol
“Blood for pharmacokinetic testing, blood pressure, heart rate and side effect screening was obtained at 0, 15, 30, 45, 60, 120, 180, 240, 300, and 360 min after dosing.”
Carolina Fragile X Project Continuous Performance Test administered after PPI assessment. Subject responds to target stimuli by pressing mouse button. Number of correct hits, omissions (lack of reaction to target), and commissions (reaction to non-target) recorded.
Note: Performed after PPI; commission errors are primary focus of analysis as more reliable marker of abnormal performance
“Post-treatment PPI was performed after the 60 min blood sampling, followed by CPT.”
Blood sample collected and vital signs measured 180 minutes after fenobam administration.
Note: Part of pharmacokinetic and safety monitoring protocol
“Blood for pharmacokinetic testing, blood pressure, heart rate and side effect screening was obtained at 0, 15, 30, 45, 60, 120, 180, 240, 300, and 360 min after dosing.”
Blood sample collected and vital signs measured 240 minutes after fenobam administration.
Note: Part of pharmacokinetic and safety monitoring protocol
“Blood for pharmacokinetic testing, blood pressure, heart rate and side effect screening was obtained at 0, 15, 30, 45, 60, 120, 180, 240, 300, and 360 min after dosing.”
Blood sample collected and vital signs measured 300 minutes after fenobam administration.
Note: Part of pharmacokinetic and safety monitoring protocol
“Blood for pharmacokinetic testing, blood pressure, heart rate and side effect screening was obtained at 0, 15, 30, 45, 60, 120, 180, 240, 300, and 360 min after dosing.”
Final blood sample collected and vital signs measured 360 minutes (6 hours) after fenobam administration.
Note: Final pharmacokinetic and safety monitoring measurement; end of 6-hour observation period
“Blood for pharmacokinetic testing, blood pressure, heart rate and side effect screening was obtained at 0, 15, 30, 45, 60, 120, 180, 240, 300, and 360 min after dosing.”
Structured interview with subject and family members asking about specific symptoms relevant to fenobam effects: aggression, fatigue, hyperactivity, anxiety and fidgetiness, increase in self-stimulation, odd behavior, inappropriate laughter, dizziness, vertigo, nausea, paresthesia, and headache.
Note: Conducted at multiple time points during 6-hour observation period
“Our side effects screening protocol involved asking both the subject and family members if the subject was having any of a structured list of symptoms relevant to potential effects of fenobam (aggression, fatigue, hyperactivity, anxiety and fidgetiness, increase in self stimulation, odd behaviour, inappropriate laughter, dizziness, vertigo, nausea, paraesthesia, and headache)”
Physician and family members directly observe subject for symptoms and behavioral changes throughout treatment visit.
Note: Complements structured symptom assessment
“and direct observation by the physician and family for the above symptoms and other behavioural changes”
Conference calls held after each subject dosed to confirm absence of adverse events and justify dose escalation or maintenance for subsequent subject of same gender.
Note: Determines dosing for next subject based on safety profile
“Conference calls were held after each subject was dosed, to confirm absence of adverse events and justify dose escalation or maintenance for the subsequent subject of that gender.”
Fenobam concentrations measured from plasma samples using LC/MS/MS with positive ion detection. Assay validated for human application.
Note: Samples analyzed post-study; comparison samples obtained from three healthy adult male volunteers over 24 hours
“Fenobam concentrations from plasma samples were measured with MS-MS based assays validated for human application, using positive ion liquid chromatography/mass spectrometry/mass spectrometry (LC/MS/MS).”
PPI calculated as: 100 × [(mean response magnitude in startle stimulus alone trials – mean response magnitude in prepulse trials) / mean response magnitude in startle stimulus alone trials]
Note: Calculation performed for each prepulse interval (120 ms and 240 ms)
“PPI was calculated as: 100 × [(mean response magnitude in the startle stimulus alone trials – mean response magnitude in the prepulse trials)/mean response magnitude in the startle stimulus alone trials].”
Subjects with PPI improvement of 20% or greater on 120 ms trials (most reliable trial latency) compared to baseline are classified as responders.
Note: 20% improvement threshold determined a priori based on group differences from prior study and literature review
“we determined a priori that subjects with PPI improvement of 20% on the 120 ms trials (the most reliable trial latency) or more would be considered responders.”
For FXCPT, tabulate number of correct hits on target stimuli, omissions (lack of reaction to target indicating attention deficit), and commissions (reaction to non-target indicating impulsivity/poor inhibitory control).
Note: Commission score is primary focus of analysis as more reliable marker of abnormal performance
“the number of correct hits on a target stimuli, omissions involving lack of reaction to a target (attention deficit), and commissions involving reacting to a non-target (impulsivity, poor inhibitory control) were tabulated.”
One sample exact binomial 95% confidence interval computed for proportion of positive PPI response. One sample two-sided exact hypothesis test used to compare proportion of positive response to null proportion of 2/13 (15.4%) from prior untreated FXS study.
Note: Positive response defined as 20% or greater PPI improvement over baseline
“For statistical analysis of PPI data, a positive response was defined as a 20% or greater improvement over baseline. One sample exact binomial 95% confidence interval was computed for the proportion of positive response.”
This section explains what the experiment is doing, which readouts matter, what the data artifacts usually look like, and how the analysis should flow from raw capture to reported result.
Assessment of attention, impulsivity, and inhibitory control through detection of target stimuli and measurement of hits, omissions, and commission errors in individuals with Fragile X Syndrome
Objective
Assessment of attention, impulsivity, and inhibitory control through detection of target stimuli and measurement of hits, omissions, and commission errors in individuals with Fragile X Syndrome
Subjects
From paperhuman • N/A • both • Not specified • Not specified
Cohort notes
From paperSubjects recruited from fragile X clinics at Rush University Medical Center (RUMC) and MIND Institute at University of California at Davis Medical Center (UCDMC).
Screening Visit - Subject Recruitment and Informed Consent (Not specified)
Screening Visit - Medical History and Vital Signs Assessment (Not specified)
Screening Visit - Laboratory Testing (Not specified)
Screening Visit - Baseline CPT Administration (Not specified)
PPI (Prepulse Inhibition) - percentage inhibition of startle response at 120 ms and 240 ms prepulse intervals
From paperPPI data: One sample exact binomial 95% confidence interval computed for proportion of positive response (≥20% improvement over baseline on 120 ms trials).
Artifact type
Endpoint measurements summarized by group or timepoint
Comparison focus
Compare endpoint magnitude between groups, timepoints, or both
FXCPT (Carolina Fragile X Project Continuous Performance Test) - number of correct hits on target stimuli
From paperPPI data: One sample exact binomial 95% confidence interval computed for proportion of positive response (≥20% improvement over baseline on 120 ms trials).
Artifact type
Endpoint measurements summarized by group or timepoint
Comparison focus
Compare endpoint magnitude between groups, timepoints, or both
FXCPT - number of omissions (lack of reaction to target, indicating attention deficit)
From paperPPI data: One sample exact binomial 95% confidence interval computed for proportion of positive response (≥20% improvement over baseline on 120 ms trials).
Artifact type
Endpoint measurements summarized by group or timepoint
Comparison focus
Compare endpoint magnitude between groups, timepoints, or both
FXCPT - number of commissions (reaction to non-target, indicating impulsivity and poor inhibitory control)
From paperPPI data: One sample exact binomial 95% confidence interval computed for proportion of positive response (≥20% improvement over baseline on 120 ms trials).
Artifact type
Endpoint measurements summarized by group or timepoint
Comparison focus
Compare endpoint magnitude between groups, timepoints, or both
PPI (Prepulse Inhibition) - percentage inhibition of startle response at 120 ms and 240 ms prepulse intervals
From paperRaw artifact
Per-sample or per-animal endpoint measurements collected during the experiment
Processed artifact
Structured table with cleaned measurements ready for comparison
Final reported form
Summary statistics and between-group or across-timepoint comparisons
FXCPT (Carolina Fragile X Project Continuous Performance Test) - number of correct hits on target stimuli
From paperRaw artifact
Per-sample or per-animal endpoint measurements collected during the experiment
Processed artifact
Structured table with cleaned measurements ready for comparison
Final reported form
Summary statistics and between-group or across-timepoint comparisons
FXCPT - number of omissions (lack of reaction to target, indicating attention deficit)
From paperRaw artifact
Per-sample or per-animal endpoint measurements collected during the experiment
Processed artifact
Structured table with cleaned measurements ready for comparison
Final reported form
Summary statistics and between-group or across-timepoint comparisons
FXCPT - number of commissions (reaction to non-target, indicating impulsivity and poor inhibitory control)
From paperRaw artifact
Per-sample or per-animal endpoint measurements collected during the experiment
Processed artifact
Structured table with cleaned measurements ready for comparison
Final reported form
Summary statistics and between-group or across-timepoint comparisons
Acquisition
Collect raw experimental outputs with enough metadata to preserve sample identity, condition, and timing.
Preprocessing / cleaning
PPI data: One sample exact binomial 95% confidence interval computed for proportion of positive response (≥20% improvement over baseline on 120 ms trials).
Scoring or quantification
Quantify the primary readouts for this experiment: PPI (Prepulse Inhibition) - percentage inhibition of startle response at 120 ms and 240 ms prepulse intervals; FXCPT (Carolina Fragile X Project Continuous Performance Test) - number of correct hits on target stimuli; FXCPT - number of omissions (lack of reaction to target, indicating attention deficit); FXCPT - number of commissions (reaction to non-target, indicating impulsivity and poor inhibitory control).
Statistical comparison
Statistical method not yet structured for this page.
Reporting output
Report representative outputs alongside summary comparisons for PPI (Prepulse Inhibition) - percentage inhibition of startle response at 120 ms and 240 ms prepulse intervals, FXCPT (Carolina Fragile X Project Continuous Performance Test) - number of correct hits on target stimuli, FXCPT - number of omissions (lack of reaction to target, indicating attention deficit), FXCPT - number of commissions (reaction to non-target, indicating impulsivity and poor inhibitory control).
Source links and direct wording from the methods section for validation and deeper review.
Citation
E Berry-Kravis et al. (2009). A pilot open label, single dose trial of fenobam in adults with fragile X syndrome. Journal of Medical Genetics
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