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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 is a Phase 4 study that has completed, run by Augusta University. The registered enrollment target is 23 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00352196
The ClinicalTrials.gov registry entry for NCT00352196 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 23 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Augusta University, which has 106 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Risperidone is the first listed.
NCT00352196 reports 0 study locations.
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.
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