Trial · NCT00584701
Pharmacogenomics in Autism Treatment
NCT00584701, Phase 2, Phase 3, Completed, University of California, San Francisco; results first posted 2012-07-24
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Pharmacogenomics in Autism Treatment. Trials, record NCT00584701. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00584701
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pharmacogenomics in Autism Treatment
- NCT number
- NCT00584701
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 49 participants, actual
- Lead sponsor
- University of California, San Francisco
- Conditions
- Autism
- Interventions
- Risperidone
- First posted
- 2008-01-02
- Last updated
- 2012-07-24
- Results first posted
- 2012-07-24
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change of ABC - Irritability Subscale Score | Baseline, 8 weeks | Aberrant Behavior Checklist-Irritability (ABC-I)subscale: measure of assessing changes in symptoms of irritability in children with autism (survey that was normed on a developmentally delayed population of children and adults and is usually completed by a parent or caregiver. There are 45 items that are rated on a 4-point scale from "no problem" to "major problem." ABC-I scores ranges from 0 (best) to 45 (worst). A negative change signifies improvement. We measured percent change of ABC-I scores from 8 weeks after risperidone treatment compared to baseline. |
| Secondary | Exon Expression Positively or Negatively Correlated With Percentage Improvement in ABC-I | Baseline, 8 Weeks | Affymetrix GeneChip Human Exon 1.0 ST Arrays (Affymetrix, Santa Clara, CA, USA) were used to obtain gene expression values. Raw data (Affymetrix.CEL files) was imported into Partek Genomics Suite 6.4 (Partek, St Louis, MO, USA). Probe summarization and probe set normalization were performed using robust multichip average, which included background correction, quantile normalization, log2 transformation and median polish probe set summarization. Exons in genes correlated with percentage improvement on the Aberrant Behavior Checklist Irritability subscale were identified. |
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 | Percent Change of ABC - Irritability Subscale Score | Baseline, 8 weeks | percent change in scores | MEAN | |
| SECONDARY | Exon Expression Positively or Negatively Correlated With Percentage Improvement in ABC-I | Baseline, 8 Weeks | Number of Correlated Genes | NUMBER |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change of ABC - Irritability Subscale Score | Active Risperidone | -44.5 | Full Range -95.0 to 6 | percent change in scores | |
| Exon Expression Positively or Negatively Correlated With Percentage Improvement in ABC-I | Risperidone | 5 | Number of Correlated Genes |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Active Risperidone | STARTED | Active Risperidone | 49 | |
| Active Risperidone | COMPLETED | Active Risperidone | 46 | |
| Active Risperidone | NOT COMPLETED | Active Risperidone | 3 | |
| Follow-up | STARTED | Active Risperidone | 46 | |
| Follow-up | COMPLETED | Active Risperidone | 34 | |
| Follow-up | NOT COMPLETED | Active Risperidone | 12 |
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 totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Active Risperidone | ||
| Total, other adverse events | Active Risperidone | 0 | 49 |
| Total, serious adverse events | Active Risperidone | 0 | 49 |
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 |
|---|---|---|---|---|---|
| R21MH080026 | Pharmacogenomics in Autism Treatment | HENDREN, ROBERT LEE | UNIVERSITY OF CALIFORNIA, SAN FRANCISCO | NATIONAL INSTITUTE OF MENTAL HEALTH | 2008 to 2009 |
Source NIH RePORTER
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/NCT00584701
GET https://conductscience.org/api/trials/v1/NCT00584701/registered