Intranasal Oxytocin in the Treatment of Autism
Condition: Autism
MeSH terms: Autistic Disorder
Intervention: Oxytocin; Placebo
Intervention description: Intranasal Oxytocin; Placebo Comparator
Intervention MeSH terms: Oxytocin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 19.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Autism; Treatment; Oxytocin; Adults; Autism Spectrum Disorder

Summary:

      The purpose of this study is to learn whether or not the drug called oxytocin is helpful in
      improving mood and social functioning in adults with autism.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female outpatients 18 to 60 years of age.

          2. Meet Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text
             Revision. The diagnosis will be confirmed with Autism Diagnostic Interview-Revised and
             Autism Diagnostic Observation Schedule .

          3. Have a Clinician's Global Impression-Severity score ≥ 4 (moderately ill) at Screening
             and Baseline.

          4. If already receiving stable nonpharmacologic educational, behavioral, and/or dietary
             interventions, have continuous participation during the preceding 3 months prior to
             Screening and will not electively initiate new or modify ongoing interventions for the
             duration of the study.

          5. Have normal physical examination and laboratory test results at Screening. If
             abnormal, the finding(s) must be deemed clinically insignificant by the Investigators.

          6. The patient must be able to speak and understand English sufficiently to understand
             the nature of the study and to allow for the completion of all study assessments.

          7. Have a normal Intelligence Quotient (>70) supported by the Wechsler Abbreviated Scales
             of Intelligence.

        Exclusion Criteria:

          1. Patients born prior to 35 weeks gestational age.

          2. Patients with any primary psychiatric diagnosis other than autism at Screening: a
             history of attention deficit hyperactivity disorder, bipolar disorder, psychosis,
             posttraumatic stress disorder, schizophrenia, or major depressive disorder.

          3. Patients with a medical history of neurological disease, including, but not limited
             to, epilepsy/seizure disorder (except simple febrile seizures), movement disorder,
             tuberous sclerosis, fragile X, and any other known genetic syndromes, or known
             abnormal magnetic resonance imaging/structural lesion of the brain.

          4. Pregnant female patients.

          5. Patients with a medical condition that might interfere with the conduct of the study,
             confound interpretation of the study results, or endanger their own well-being.
             Patients with evidence or history of malignancy or any significant hematological,
             endocrine, cardiovascular (including any rhythm disorder), respiratory, renal,
             hepatic, or gastrointestinal disease.

          6. Patients taking psychoactive medication(s) (e.g., stimulants, antidepressants,
             antipsychotics, antiepileptics, anxiolytics, clonidine).

          7. Patients who plan to initiate or change nonpharmacologic interventions during the
             course of the study.

          8. Patients unable to tolerate venipuncture procedures for blood sampling.

          9. Patients who, in the Investigator's opinion, might not be suitable for the study.