Janssen Asperger's MRS (Magnetic Resonance Spectroscopy Risperidone Study

NCT00352196 | Completed Phase 4

• 2 other identifiers: RIS-EMR-4026MCG HAC File #01-09-063
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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:

• 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

Conditions

Asperger's Disorder

Keywords

Asperger's Disorder; Risperidone; Magnetic Resonance Spectroscopy; Social Skills

Outcome Measures

Primary Outcomes (1)

• Chang in the Scale for the Assessment of Negative Symptoms (SANS)

  Baseline, Week 3, 6, 9, 12 and up to 7 weeks post treatment

Secondary Outcomes (6)

• Change in Positive and Negative Symptom Scale (PANNS)

  Baseline, Week 3, 6, 9, 12 and up to 7 weeks post treatment

• Change in Brief Psychiatric Rating Scale (BPRS)

  Baseline, Week 3, 6, 9, 12 and up to 7 weeks post treatment

• Change in Montgomery Asberg Rating Scale (MADRS)

  Baseline, Week 3, 6, 9, 12 and up to 7 weeks post treatment

• Change in Global Assessment Scale (GAS)

  Baseline, Week 3, 6, 9, 12 and up to 7 weeks post treatment

• Change in Abnormal Involuntary Movement Scale (AIMS)

  Baseline, Week 3, 6, 9, 12 and up to 7 weeks post treatment

Study Arms (2)

Magnetic Resonance Spectroscopy

EXPERIMENTAL

Subjects will receive a baseline MRS prior to and within 7 day of completing 12 weeks of standard treatment with.

Drug: Risperidone; Other: Magnetic Resonance Spectroscopy

NO-MRS

OTHER

Subjects will receive 12 weeks of standard treatment of risperidone 0.25 to 11 mg per day, or early termination. Dose titration will based on response and tolerability.

Drug: Risperidone

Interventions

Risperidone DRUG

12 weeks of treatment with risperidone 0.25 to 11 mg per day.

Also known as: Risperdal

Magnetic Resonance Spectroscopy; NO-MRS

Magnetic Resonance Spectroscopy OTHER

Subjects will receive a standard MRS to assess the concentrations and ratios of brain metabolites N-acetylaspartate, creatine, phosphocreatine, and choline.

Also known as: MRS

Magnetic Resonance Spectroscopy

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must be age 6 -18 for the Non-MRS arm of the study, and age 6 or above for the MRS arm of the study.
• If applicable, a parent or legal guardian or legal representatives of study subject must provide informed consent and sign an informed consent document.
• Female patients of childbearing age must be either postmenopausal for at least one year, surgically incapable of childbearing, or effectively practicing an acceptable method of contraception (oral or parenteral hormonal contraceptives, intrauterine device; barrier and spermicide. Abstinence is not an acceptable method).
• Female patients of child-bearing potential must have a negative pregnancy test to be performed at screening and baseline.
• Patients must meet DSM-IV criteria for Asperger's Disorder. Other Axis I \& II disorders excluded are listed below.
• Patient must not have other serious, unstable illnesses and must be otherwise physically healthy on the basis of a physical examination, medical history, electrocardiogram and the results of blood biochemistry, hematology tests and a urinalysis.
• Patient must have a negative urine drug screen with the exception of amphetamines if the patient is being treated with stimulants for four months or longer prior to entry.

You may not qualify if:

• Patients who meet DSM-IV criteria for any psychotic disorder including schizophrenia, schizophreniform disorder, schizoaffective disorder, delusional disorder, brief psychotic disorder, shared psychotic disorder, psychotic disorder due to a general medical condition, substance-induced psychotic disorder,psychotic disorder not otherwise specified, major depression with psychotic features, or bipolar disorder.
• Patients who meet DSM-IV criteria for schizoid, schizotypal, or paranoid personality disorder. Patients who meet DSM-IV criteria for autistic disorder or pervasive developmental disorder.
• Claustrophobic patients and those otherwise unable to successfully complete the MRS procedure prior to baseline.
• Patients who meet criteria for substance abuse or dependence within the past three months. (Nicotine and caffeine are exceptions).
• Patients believed by the investigator to be at significant risk for suicidal or violent behavior during the course of the trial.
• Female patients who are pregnant or nursing.
• Patients with a known or suspected seizure disorder.
• If the results of the serum alanine transaminase (ALT) or aspartate aminotransferase (AST) are more than twice the upper limit of the central laboratory's reference range, the patient may not be enrolled. If the results of any other biochemistry, hematology or urinalysis tests are not within the central laboratory's reference ranges, the patient can be enrolled only on condition that the investigator judges that the deviations are not clinically significant. This should be clearly recorded on the laboratory report and in the source documents.
• Patients with a history of neuroleptic malignant syndrome (NMS) or similar encephalopathic syndrome.
• Patients who, by history, have received treatment with Risperdal or another neuroleptic (including olanzapine or quetiapine) within three months of baseline evaluation. Patients who have received a depot antipsychotic within one treatment cycle prior to screening. Patients who have taken an antidepressant, or lithium within 4 weeks of the trial, 6 weeks for fluoxetine. Patients who have taken any psychotropic medication within 1 week of the trial. Patients who require concomitant medications during the trial.
• Patients with a suspected history of hypersensitivity or intolerance to risperidone.
• Patients with a known or suspected history of severe drug allergy or hypersensitivity (e.g., Steven Johnson's syndrome)
• Patients with an anticipated life expectancy of six months or less.

Sponsors & Collaborators

• Augusta University: lead
• Ortho-McNeil Janssen Scientific Affairs, LLC: collaborator

Study Sites (1)

Medical College of Georgia, Dept. of Psychiatry

Augusta, Georgia, 30912-3800, United States

Location

MeSH Terms

Conditions

Asperger Syndrome; Social Skills

Interventions

Risperidone; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Jeffrey L Rausch, MD

  Augusta University

  PRINCIPAL INVESTIGATOR

• Donna L Londino, MD

  Augusta University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 12, 2006
• First Posted: July 14, 2006
• Study Start: November 1, 2001
• Primary Completion: May 1, 2007
• Study Completion: May 1, 2007
• Last Updated: January 14, 2015

Record last verified: 2015-01

Locations

US (1)