Trial · NCT00420459
A Prospective Open-label Study of Aripiprazole in Fragile X Syndrome
NCT00420459, Phase 2, Completed, Indiana University; results first posted 2017-04-18
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Prospective Open-label Study of Aripiprazole in Fragile X Syndrome. Trials, record NCT00420459. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00420459
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Prospective Open-label Study of Aripiprazole in Fragile X Syndrome
- NCT number
- NCT00420459
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 12 participants, actual
- Lead sponsor
- Indiana University
- Conditions
- Fragile X Syndrome
- Interventions
- Aripiprazole
- First posted
- 2007-01-11
- Last updated
- 2017-04-18
- Results first posted
- 2017-04-18
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Aberrant Behavior Checklist | Obtained at Baseline and Week 12 | The Aberrant Behavior Checklist (ABC) is a 58-item measure of maladaptive behaviors and is used as a measure of drug effects. The ABC has 5 subscales: Social Withdrawal (16 items) ranging from 0 (not at all) to 48 (severe), Irritability (15 items) ranging from 0 (not at all) to 45 (severe), Inappropriate Speech (4 items) ranging from 0 (not at all) to 12 (severe), Hyperactivity (16 items) ranging from 0 (not at all) to 48 (severe), and Stereotypy (7 items) ranging from 0 (not at all) to 21 (severe). Items are rated from 0 (not at all) to 3 (severe). |
| Primary | Clinical Global Impressions- Severity | Obtained at Baseline and Week 12 | The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness at the time of rating 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill. |
| Secondary | The Children's Yale-Brown Obsessive Compulsive Scale | Obtained at Baseline and Week 12 | The CY-BOCS PDD has been utilized in a largescale clinical treatment study of repetitive behavior in idiopathic ASDs. CYBOCS-PDD scores range from 0 to 20 and measure repetitive/compulsive behavior and not obsessions. Higher score indicate worse outcome. |
| Secondary | Social Responsiveness Scale | Obtained at Baseline and Week 12 | The 65-item SRS is a standardized measure of the core symptoms of autism. Each item is scored on a 4-point Likert scale. The score of each individual item is summed to create a total raw score. A total scores results are as follows: 0-62: Within normal limits 63-79: Mild range of impairment 80-108: Moderate range of impairment 109-149: Severe range of impairment |
| Secondary | The Vineland Adaptive Behavior Scales | Screen Visit | Vineland Adaptive Behavior Scales are a valid and reliable test to measure a person's adaptive level of functioning. Vineland-II forms aid in diagnosing and classifying intellectual and developmental disabilities and other disorders, such as autism spectrum disorders and developmental delays. The content and scales are organized within a 4 domain structure: Communication, Daily Living, Socialization and Motor Skills. The adaptive behavior composite standard score is computed from the sum of standard scores from the domains and converted into the adaptive behavior composite standard score. Higher scores indicate a higher adaptive level of functioning. |
| Secondary | The Vineland Maladaptive Behavior Subscales | Week 12 | The Vineland Adaptive Behavior Scales include an optional Maladaptive Behavior Index with 27 items. The Maladaptive Behavior Index is a composite of Internalizing, Externalizing, and other types of undesirable behavior that may interfere with the individual's adaptive functioning. The Maladaptive Behavior subscale yields raw scores (0-27). |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Aberrant Behavior Checklist | Obtained at Baseline and Week 12 | units on a scale | MEAN | |
| PRIMARY | Clinical Global Impressions- Severity | Obtained at Baseline and Week 12 | units on a scale | MEAN | |
| SECONDARY | The Children's Yale-Brown Obsessive Compulsive Scale | Obtained at Baseline and Week 12 | units on a scale | MEAN | |
| SECONDARY | Social Responsiveness Scale | Obtained at Baseline and Week 12 | units on a scale | MEAN | |
| SECONDARY | The Vineland Adaptive Behavior Scales | Screen Visit | Data for this outcome measure are unavailable because the data file was lost during a server migration. | ||
| SECONDARY | The Vineland Maladaptive Behavior Subscales | Week 12 | Data for this outcome measure are unavailable because the data file was lost during a server migration. |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Aberrant Behavior Checklist | Open-label Aripiprazole | ABC Irritablity | 7.1 | Standard Deviation 4.4 | units on a scale |
| Aberrant Behavior Checklist | Open-label Aripiprazole | ABC Hyperactivity | 15.6 | Standard Deviation 8.1 | units on a scale |
| Aberrant Behavior Checklist | Open-label Aripiprazole | ABC Social Withdrawall | 9.6 | Standard Deviation 10.7 | units on a scale |
| Aberrant Behavior Checklist | Open-label Aripiprazole | ABC Stereotypy | 7.6 | Standard Deviation 5.6 | units on a scale |
| Aberrant Behavior Checklist | Open-label Aripiprazole | ABC Inappropriate Speech | 4.0 | Standard Deviation 3.2 | units on a scale |
| Clinical Global Impressions- Severity | Open-label Aripiprazole | 3.5 | Standard Deviation 0.5 | units on a scale | |
| The Children's Yale-Brown Obsessive Compulsive Scale | Open-label Aripiprazole | 10.6 | Standard Deviation 5.7 | units on a scale | |
| Social Responsiveness Scale | Open-label Aripiprazole | 90.1 | Standard Deviation 31.6 | units on a scale |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Open-label Aripiprazole | 12 | |
| Overall Study | COMPLETED | Open-label Aripiprazole | 12 | |
| Overall Study | NOT COMPLETED | Open-label Aripiprazole | 0 |
Source ClinicalTrials.gov
Adverse events10
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Tiredness | General disorders | Aripiprazole | 7 | 12 | |
| other | Nausea/Vomiting | Gastrointestinal disorders | Aripiprazole | 4 | 12 | |
| other | Drooling | General disorders | Aripiprazole | 3 | 12 | |
| other | Slurred Speech | General disorders | Aripiprazole | 2 | 12 | |
| other | Increased Anxiety | Psychiatric disorders | Aripiprazole | 2 | 12 | |
| other | Enuresis | Renal and urinary disorders | Aripiprazole | 2 | 12 | |
| other | Diarrhea | Gastrointestinal disorders | Aripiprazole | 1 | 12 | |
| other | Constipation | Gastrointestinal disorders | Aripiprazole | 1 | 12 | |
| other | Akathisia | Nervous system disorders | Aripiprazole | 1 | 12 | |
| other | Increased Appetite | Gastrointestinal disorders | Aripiprazole | 1 | 12 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Aripiprazole | ||
| Total, other adverse events | Aripiprazole | 12 | 12 |
| Total, serious adverse events | Aripiprazole | 0 | 12 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 21318565 | BACKGROUND |
Source PubMed
Grants0
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.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT00420459
GET https://conductscience.org/api/trials/v1/NCT00420459/registered