Clinical Trial: Janssen Asperger's MRS (Magnetic Resonance Spectroscopy Risperidone Study

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Biological Basis of Therapy for Negative Symptom Spectrum Disorders: Risperdal Effect on Frontal Metabolism in Asperger's Disorder

Brief 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 s

    Detailed Summary:

    STUDY DESIGN

    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.

    Subjects will first undergo a screening visit during which safety and diagnostic assessments are completed, and a minimum of 3 days will be allowed to evaluate the screening results. Then, the subjects will complete one or two practice sessions to provide training to achieve the necessary stillness for a duration that is sufficient to complete a MRS session. Upon completion of successful practice sessions, subjects will then be scheduled for a MRS visit. Once the MRS is successfully completed, subjects will be assigned to receive risperidone 0.25 mg at their baseline visit.

    Response to risperidone will be measured at weeks 3, 6, 9, and 12 by the Scale for Assessment of Negative Symptoms (SANS). Additional secondary outcome measures are shown below (figure 1). A post-treatment MRS will be conducted after the Week 12 or early termination visit. Subjects will be given adequate medication supply to cover through the day of the final MRS visit.

    Study Medication. Because Asperger's Disorder is diagnosed in childhood and is considered a childhood disease, our previous phase of the study focused on subjects ages 6 - 18. Published dosages of risperidone
    Sponsor: Augusta University

    Current Primary Outcome: Chang in the Scale for the Assessment of Negative Symptoms (SANS) [ Time Frame: Baseline, Week 3, 6, 9, 12 and up to 7 weeks post treatment ]

    Original Primary Outcome: Scale for the Assessment of Negative Symptoms (SANS)

    Current Secondary Outcome:

    • Change in Positive and Negative Symptom Scale (PANNS) [ Time Frame: Baseline, Week 3, 6, 9, 12 and up to 7 weeks post treatment ]
    • Change in Brief Psychiatric Rating Scale (BPRS) [ Time Frame: Baseline, Week 3, 6, 9, 12 and up to 7 weeks post treatment ]
    • Change in Montgomery Asberg Rating Scale (MADRS) [ Time Frame: Baseline, Week 3, 6, 9, 12 and up to 7 weeks post treatment ]
    • Change in Global Assessment Scale (GAS) [ Time Frame: Baseline, Week 3, 6, 9, 12 and up to 7 weeks post treatment ]
    • Change in Abnormal Involuntary Movement Scale (AIMS) [ Time Frame: Baseline, Week 3, 6, 9, 12 and up to 7 weeks post treatment ]
    • Change in Neurocognitive test battery [ Time Frame: Baseline, 12 weeks ]


    Original Secondary Outcome:

    • 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


    Information By: Augusta University

    Dates:
    Date Received: July 12, 2006
    Date Started: November 2001
    Date Completion:
    Last Updated: January 13, 2015
    Last Verified: January 2015