Trial · NCT01120626
Randomized Controlled Study of Donepezil in Fragile X Syndrome
NCT01120626, Phase 2, Completed, Stanford University; results first posted 2016-03-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Randomized Controlled Study of Donepezil in Fragile X Syndrome. Trials, record NCT01120626. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01120626
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Randomized Controlled Study of Donepezil in Fragile X Syndrome
- NCT number
- NCT01120626
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 45 participants, actual
- Lead sponsor
- Stanford University
- Conditions
- Fragile X Syndrome
- Interventions
- donepezil, sugar pill
- First posted
- 2010-05-11
- Last updated
- 2016-03-17
- Results first posted
- 2016-03-17
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Contingency Naming Test (CNT) Performance Score | Week 12 | Week 12 Contingency Naming Test (CNT) performance score on Rule 2 (naming shapes) and on Rule 3 (If the inside shape matches the outside shape, name the color, otherwise, name the outside shape). Performance score is the number of correct responses per minute, calculated by dividing the number of correct responses by the time taken to complete the 27 items, and multiplying by 60. Higher scores indicate faster and more accurate responding. |
| Secondary | Aberrant Behavior Checklist (ABC) | Week 12 | The Aberrant Behavior Checklist is a 58-item symptom checklist for assessing problem behaviors. The ABC was rated by each participant's parent. Each item is rated on a four-point Likert scale ranging from 0 (not at all a problem) to 3 (the problem is severe in degree). The ABC Total score (range 0-174) is the sum of all individual item scores. Higher score indicates more maladaptive behaviors/worse outcome. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Contingency Naming Test (CNT) Performance Score | Week 12 | 41 of 42 randomized participants completed the 12-week randomized controlled trial. 37 of 42 randomized participants completed CNT Rule 2 at week 12. 34 of 42 randomized participants completed CNT Rule 3 at week 12. | correct responses per minute | MEAN |
| SECONDARY | Aberrant Behavior Checklist (ABC) | Week 12 | 41 of 42 randomized participants completed the 12-week randomized controlled trial. 39 of 42 participants were administered the ABC at week 12. | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Contingency Naming Test (CNT) Performance Score | Donepezil | CNT Performance Score Rule 2 | 37.05 | Standard Deviation 14.60 | correct responses per minute |
| Contingency Naming Test (CNT) Performance Score | Sugar Pill | CNT Performance Score Rule 2 | 40.50 | Standard Deviation 31.11 | correct responses per minute |
| Contingency Naming Test (CNT) Performance Score | Donepezil | CNT Performance Score Rule 3 | 66.94 | Standard Deviation 46.92 | correct responses per minute |
| Contingency Naming Test (CNT) Performance Score | Sugar Pill | CNT Performance Score Rule 3 | 61.56 | Standard Deviation 23.06 | correct responses per minute |
| Aberrant Behavior Checklist (ABC) | Donepezil | 17.56 | Standard Deviation 13.65 | units on a scale | |
| Aberrant Behavior Checklist (ABC) | Sugar Pill | 24.43 | Standard Deviation 23.27 | units on a scale |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Donepezil | 20 | |
| Overall Study | STARTED | Sugar Pill | 22 | |
| Overall Study | COMPLETED | Donepezil | 19 | |
| Overall Study | COMPLETED | Sugar Pill | 22 | |
| Overall Study | NOT COMPLETED | Donepezil | 1 | |
| Overall Study | NOT COMPLETED | Sugar Pill | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Donepezil | ||
| Total, all-cause mortality | Sugar Pill | ||
| Total, other adverse events | Donepezil | 0 | 20 |
| Total, other adverse events | Sugar Pill | 0 | 22 |
| Total, serious adverse events | Donepezil | 0 | 20 |
| Total, serious adverse events | Sugar Pill | 0 | 22 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R34MH085899 | Augmentation of the Cholinergic System in Fragile X Syndrome: A Double-Blind Plac | REISS, ALLAN L | STANFORD UNIVERSITY | NATIONAL INSTITUTE OF MENTAL HEALTH | 2009 to 2011 |
Source NIH RePORTER
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Donepezil vs Sugar Pill: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01120626
GET https://conductscience.org/api/trials/v1/NCT01120626/registered