Milnacipran in Autism and the Functional Locus Coeruleus and Noradrenergic Model of Autism
Autism Spectrum DisorderAsperger Syndrome1 moreAutism Spectrum Disorders (ASD) include Autistic disorder, Asperger's syndrome and Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS). These are developmental disorders beginning prior to three years of age. Recent Centers for Disease Control (CDC) estimates suggest that ASD affects up to 1 in 100 individuals and up to 1 in 50 boys. There are very substantial costs associated with caring for patients with ASD, and ASD has the highest Caregiver Burden Scores of any condition. There are three core symptom domains of ASD, including social deficits, repetitive behaviors and language deficits. Patients can also have associated symptoms of attentional deficits, disruptive behaviors and intellectual disability. There is currently no Food and Drug administration (FDA) approved treatment for the core symptoms of autism, but risperidone and aripiprazole have FDA approval for disruptive behaviors associated with autism. This is a 12 week randomized double blind placebo controlled trial of Milnacipran in adults with ASD or Aspergers Syndrome. Milnacipran is said to play a role in the activation and normalization of the locus coeruleus-noradrenergic system, of which is hypothesized to play a role in behavior adaptations and performance.
D-Cycloserine and Social Skills Training in Autism Spectrum Disorders
Autistic DisorderAsperger's Disorder1 moreThe purpose of this study is to determine the effectiveness of D-cycloserine for improving social impairment in child with pervasive developmental disorders (PDD).
A Study of Oral N-Acetylcysteine in Children With Autism Spectrum Disorders
Autistic DisorderAsperger Syndrome2 moreThe purpose of this study is to determine whether treatment with oral N-acetylcysteine (NAC) will improve behavior problems often associated with autism spectrum disorders.
Study of Lurasidone in Treating Antipsychotic Naive or Quasi-Naive Children and Adolescents
SchizophreniaSchizoaffective Disorder12 moreThe overarching purpose of this pilot study is to collect preliminary data regarding the variability of weight gain associated with lurasidone (Latuda©) treatment of antipsychotic naive children and adolescents in order to inform decisions about including a lurasidone arm in a future large scale trial of different approaches to minimize antipsychotic associated weight gain in the pediatric population. In adults, lurasidone appears to cause minimal weight gain. The participants will be 6-19 years old with psychotic spectrum, mood spectrum, or autism spectrum disorders. They will have 4 weeks or less of lifetime antipsychotic exposure.
Psychotherapy for Anxiety in Children With Autism Spectrum Disorder
Autism Spectrum DisordersAutism7 moreAnxiety disorders affect 40 to 50% of children with autism spectrum disorders (ASD), contributing to substantial distress and impairment. The goal of this study is to examine the effectiveness of a personalized type of psychotherapy against standard-care psychotherapy for addressing anxiety in youth with ASD.
Withdrawal Study of Memantine in Pediatric Patients With Autism, Asperger's Disorder, or Pervasive...
Autistic DisorderAutism4 moreThe purpose of this randomized withdrawal study is to evaluate the safety, tolerability, and efficacy of memantine compared with placebo in pediatric patients with autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS).
Cognitive Behavioral Therapy for Anxiety Disorders in Adolescents With Autism
AutismAsperger's Syndrome5 moreDue to the considerable prevalence of anxiety in youth with autism spectrum disorders, this study seeks to establish the efficacy of a modified cognitive behavioral therapy protocol in 50 adolescents versus other available treatment options.
Portable Visual Guidance System Phase II
Asperger SyndromeHigh Functioning AutismAbstract: In Phase I, we designed and tested a Portable Visual Guidance System (PVGS), which combines a PDA - for user guidance - and an Internet website - for linking the user to an educational support team. Use of the PVGS 1) significantly improved the in vivo social pragmatics of students diagnosed with Aspergers Syndrome/Higher Functioning Autism (AS/HFA); 2) revealed additional ways of improving social pragmatics; and 3) improved activity management in scheduling and vocational tasks. In Phase II, we will focus on social pragmatics and two closely related skills: feelings management and assignment management. We aim to: Replicate Phase I success in the most educational setting for AS/HFA high school aged students: mainstream school inclusion classes. Replicate Phase I findings more efficiently, with a less highly trained, on-site coaching staff and with more distant (non-site) expert supervision of that staff. Contrast the outcomes of the curriculum with a diagnosis-matched wait-list control group. Develop and implement software that will enable on-site staff to create and modify individualized guidance and monitoring screens as needs arise. Design a commercially attractive package of software, video training, video-conferenced support, and manuals. Complete the translation of the SymTrend website and all the above tools into Spanish. Significance: Successful completion of Phase II will: Provide a very effective and comprehensive system for teaching social pragmatics and related management skills to AS/HFA persons in an inclusion context. Provide a means of evaluating IEP effectiveness, thereby enabling a better use of special education funds and a reduction of litigation over IEP plan appropriateness and utility. Provide substantial support for our theoretical rationale for curriculum building in Special Education - a rationale that can guide the formulation of IEPs. Provide a theoretical rationale, an intervention framework, and intervention support technology that can be extended to cognitive behavioral treatment of other neuropsychiatric disorders and can be adapted for other forms of healthcare guidance. Provide an investigative system, as well as an intervention system, for tracking behavioral change in studies of frontal lobe and limbic neuroplasticity in neuropsychiatric disorders.
Atomoxetine, Placebo and Parent Management Training in Autism
AutismPervasive Development Disorder2 moreThe study will evaluate the effectiveness of atomoxetine (Strattera) with and without Parent Management Training (PMT) in children with Autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDDNOS) who have symptoms of Attention Deficit Hyperactivity Disorder (ADHD). This is a double-blind placebo, parallel study where the atomoxetine will have a dose titration over a 6 week period. All children will be seen weekly during this titration period, with additional visits at Week 8 and Week 10. Families assigned to the PMT arm will have an additional weekly meeting with a clinician for a total of 9 PMT visits. PMT involves teaching parents to implement behavioral interventions with their children. Subjects who are clinical responders (ADHD Responders and Compliance Responders) from the 10 week study period will be followed every 4 weeks in a 24-week extension study. Subjects who are clinical nonresponders will continue in PMT if they received PMT during the double-blind phase, and they will receive an open trial of atomoxetine if they were on placebo during the double-blind phase. All subjects (responders and nonresponders) will be invited to participate in follow-up assessments every 4 weeks for 24 weeks after the completion of the double-blind phase.
An Open-Label Trial of Aripiprazole in Autism Spectrum Disorders
AutismAsperger's Disorder1 moreThe aim of this study is to evaluate the efficacy, safety and tolerability of aripiprazole monotherapy in the treatment of children and adolescents suffering from Autism Spectrum Disorder (ASD) over a 12-week period. We hypothesize that aripiprazole may be helpful in reducing ASD-associated symptoms of anxiety and aggression, resulting in significant improvements in global outcome.