Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00352196 · ClinicalTrials.gov registry record · Phase 4
Janssen Asperger's MRS (Magnetic Resonance Spectroscopy Risperidone Study
A Phase 4 study, sponsored by Augusta University.
- Completed
- Registry status
- Phase 4
- Development phase
- 23
- Enrollment target
NCT00352196: Completed Phase 4 study, sponsored by Augusta University.
NCT00352196 is a Phase 4 study that has completed, run by Augusta University. The registered enrollment target is 23 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00352196, a Phase 4 study, has completed, sponsored by Augusta University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 23 participants
- Enrollment target
Study Summary
This study will be an open-label, 12-week trial of risperidone in subjects with Asperger's Disorder, according to Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV) Criteria. The study has two arms, one involving pre- and post-treatment MRS studies, and one without MRS. The MRS arm will study 18-20 subjects ages 6 and above, with a target of 14 completing patients. For both arms, we plan to a enroll at total of 30 patients to achieve completion for 24 patients. The non-MRS arm of the study will include subjects 6-18 years of age, the bulk of which have completed the study as of the writing of this updated revision. Our hypotheses are that treatment of Asperger's patients with a low dose of risperidone will: 1. decrease ratios of N-acetylaspartate (NAA), creatine, phosphocreatine (Cr + PCr), and choline in the prefrontal lobe, and 2. decrease the severity of negative symptoms and overall improve social behavior, and 3. that the two will be correlated. Specific Aims The primary objectives of this trial are to: * Further assess and investigate the utility of risperidone in the treatment Asperger's disorder. * Assess the efficacy of risperidone in normalizing increased frontal lobe metabolites. * Assess the efficacy of risperidone in normalizing symptoms in Asperger's disorder patients using standardized rating scales to assess the impact on negative symptoms and on social interaction. * Determine whether risperidone's effect on clinical improvement of Asperger's disorder, i.e., negative symptoms, is correlated with normalization of frontal lobe metabolites * Accrue safety and tolerability data on risperidone for this population of patients. This information could potentially be used to provide pilot data for a double blind trial
Interventions
- DRUG Risperidone
- OTHER Magnetic Resonance Spectroscopy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2001-11 |
| Est. Completion | 2007-05 |
| Phase | Phase 4 |
What the finished NCT00352196 record still lists
NCT00352196 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which Risperidone is the first listed.
NCT00352196 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00352196 about?
NCT00352196 is a clinical study titled "Janssen Asperger's MRS (Magnetic Resonance Spectroscopy Risperidone Study". This study will be an open-label, 12-week trial of risperidone in subjects with Asperger's Disorder, according to Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV) Criteria. The study has two arms, one involving pre- and post-treatment MRS studies, and one without MRS. The MRS arm wi...
What is the current status of trial NCT00352196?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 23 participants. The study started on 2001-11. Estimated completion is 2007-05.
What interventions are being tested in trial NCT00352196?
The interventions under investigation include: Risperidone (DRUG), Magnetic Resonance Spectroscopy (OTHER).
Who is sponsoring clinical trial NCT00352196?
This trial is sponsored by Augusta University, which has 106 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00352196's enrollment target sits among peer trials
23 1725th of 2000 higher than 270 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03616041 · 23 participants
Capsule Endoscopy for Severe Hematochezia
- NCT04348747 · 23 participants · Phase 2
Dendritic Cell Vaccines Against Her2/Her3 and Pembrolizumab for the Treatment of Brain Metastasis From Triple Negative Breast Cancer or HER2+ Breast Cancer
- NCT04587687 · 23 participants · Phase 2
Brentuximab Vedotin and Bendamustine for the Treatment of Relapsed or Refractory Follicular Lymphoma
- NCT04715022 · 23 participants · Phase 1
Sympathetic-vascular Dysfunction in Obesity and Insulin Resistance (Vitamin C Study)
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia