Janssen Asperger's MRS Risperidone Study
This study will be an open-label, 12-week trial of risperidone in subjects with Asperger's Disorder, according to 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:
- decrease ratios of N-acetylaspartate (NAA), creatine, phosphocreatine (Cr + PCr), and choline in the prefrontal lobe, and
- decrease the severity of negative symptoms and overall improve social behavior, and
- that the two will be correlated.
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
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Biological Basis of Therapy for Negative Symptom Spectrum Disorders: Risperdal Effect on Frontal Metabolism in Asperger's Disorder|
- Scale for the Assessment of Negative Symptoms (SANS)
- PANNS - Positive and Negative Symptom Scale
- BPRS - Brief Psychiatric Rating Scale
- MADRS - Montgomery Asberg Rating Scale
- GAS - Global Assessment Scale
- AIMS - Abnormal Involuntary Movement Scale
- Neurocognitive test battery
|Study Start Date:||November 2001|
|Study Completion Date:||September 2008|
|United States, Georgia|
|Medical College of Georgia, Dept. of Psychiatry|
|Augusta, Georgia, United States, 30912-3800|
|Principal Investigator:||Jeffrey L Rausch, MD||Georgia Regents University|
|Study Director:||Donna L Londino, MD||Georgia Regents University|