Nuedexta for the Treatment of Adults With Autism
Condition: Autism
MeSH terms: Autistic Disorder
Intervention: Nuedexta; Placebo
Intervention description: Nuedexta (Dextromethorphan hydrobromide 20 mg and quinidine sulfate 10 mg) will be given once daily for 7 days. If well-tolerated, it will be given every 12 hours for the next 7 weeks.; Placebo will be given once daily for 7 days.
Intervention MeSH terms: Quinidine; Dextromethorphan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 13.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Adults

Summary:

      Primary: Demonstrate reduced frequency and intensity of maladaptive behaviors as measured by
      the Aberrant Behavior Checklist (ABC) Irritability subscale in subjects given Nuedexta 8
      weeks over subjects given placebo.

      Secondary: Demonstrate a trend towards reduced aggressive behavior as measured by Overt
      Aggression Scale (OAS).
    

Eligibility criteria:

        Inclusion Criteria:

          1. 18 to 60 years of age

          2. Have a collateral informant who can attend visit and answer questionnaires pertaining
             to participant behavior

          3. Diagnosis of autistic spectrum disorder based on the Diagnostic and Statistical
             Manual, 4th edition, Text Revised (DSM-IV-TR) criteria, developmental history, and
             Autism Diagnostic Observation Schedule (ADOS); or confirmed diagnosis of autism during
             childhood through similar methods

          4. Capable of giving informed consent, or have a legal guardian capable of giving consent
             on the subject's behalf; patient able to assent to participate

          5. Mood issues and frontal lobe type perseveration issues

          6. No medication changes within 30 days and no use of new medications during the course
             of the study except for non-related conditions approved by the investigators

        Exclusion Criteria:

          1. Clinically uncontrolled epilepsy

          2. Cardiovascular conditions including cardiac or structural malformation heart failure,
             prolonged QT interval, history of torsades de pointes, or atrioventricular (AV) block

          3. Known genetic disorders, fragile x, or known brain structural abnormalities, cerebral
             palsy, head injury, or brain tumor

          4. Known allergy to either dextromethorphan or quinidine

          5. Concurrent or recent use of Monoamine oxidase inhibitor (MAOI) antidepressants pt
             Nuedexta

          6. Concurrent use of lamotrigine or felbamate or other N-Methyl-D-aspartate (NMDA)
             agonists or antagonists

          7. Thrombocytopenia, hepatitis, bone marrow depression or lupus-like syndrome

          8. Pregnancy - sexually active females of childbearing potential must be on a reliable
             form of contraception

          9. Other clinically significant abnormality on physical, neurological, laboratory, vital
             signs, that could compromise the study or be detrimental to the subject