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Autism clinical trials

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NCT ID: NCT00263796 Completed - Autism Clinical Trials

An fMRI Study of the Effect of Intravenous Oxytocin vs. Placebo on Response Inhibition and Face Processing in Autism

Start date: March 2006
Phase: Phase 1
Study type: Interventional

To study the effect of oxytocin on face processing and response inhibition in autistic adults by fMRI.

NCT ID: NCT00263367 Completed - Autism Clinical Trials

Effect of Hyperbaric Therapy on Markers of Oxidative Stress in Children With Autism

Start date: October 2005
Phase: N/A
Study type: Interventional

This study will look at the changes taking place in the blood levels of key markers of oxidative stress. Oxidative stress is the biological equivalent of rust on a car. It changes vital cell chemistry. It is known to occur at high pressure oxygen, but little is known about changes at pressures slightly greater than normal atmospheric pressure. Hyperbaric therapy is used in a variety of medical conditions. It is being tested in this study only for safety. It is not being assessed for the ability of hyperbaric oxygen to improve the clinical condition of children with autism. This study was felt to be important since autism appears to be associated with oxidative stress and hyperbarics was being used "off-label" for this condition without safety studies.

NCT ID: NCT00252603 Completed - Autism Clinical Trials

Galantamine Versus Placebo in Childhood Autism

Start date: April 2004
Phase: Phase 3
Study type: Interventional

Autism is a severe neurodevelopmental disorder that affects up to 16 in 10,000 individuals. It is a pervasive developmental disorder affecting social, communicative, and compulsive/repetitive behaviors characterized by stereotypic complex hand and body movements, craving for sameness, and narrow repetitive interests. Autism severely impacts both the affected individual and family members. The proposed study is designed to assess the efficacy of treatment with Galantamine vs. placebo in childhood/adolescent autism fulfilling DSM-IV and Autism Diagnostic Interview (ADI) criteria. We therefore hypothesize: 1. Galantamine will be superior to placebo in the acute treatment of global autism. 2. Galantamine will be superior to placebo in improving functional ability. 3. Galantamine will be superior to placebo in improving language function. 4. Galantamine will be superior to placebo improving irritable and hyperactive behavior. 5. Galantamine will be superior to placebo in improving social deficits.

NCT ID: NCT00251303 Completed - Clinical trials for Autism Spectrum Disorder

Riluzole to Treat Child and Adolescent Obsessive-Compulsive Disorder With or Without Autism Spectrum Disorders

Start date: August 2005
Phase: Phase 2
Study type: Interventional

This study will examine the effectiveness of riluzole for treating Obsessive-Compulsive Disorder in Youth, Including those with Autism Spectrum Disorders.

NCT ID: NCT00247156 Completed - Autism Clinical Trials

An Autism Study Using Nambudripad's Food Allergy Elimination Treatments

Start date: November 2004
Phase: Phase 1/Phase 2
Study type: Interventional

1. We hypothesize that children in the experimental group will show a significant improvement over the control group as all food allergens groups and some other relevant allergenic substances are desensitized in a systematic way using the NAET® methodology within the specified period of study.

NCT ID: NCT00227487 Active, not recruiting - Inflammation Clinical Trials

Intestinal Inflammation and Carbohydrate Digestion in Autistic Children

Start date: October 2005
Phase: N/A
Study type: Interventional

The purpose of the study is to find correlations between non-invasive fecal tests of intestinal inflammation and macro- and microscopic evaluation of duodenal and colonic histology, disaccharidase activity, and intestinal permeability in children with autism.

NCT ID: NCT00211796 Completed - Autism Clinical Trials

Divalproex Sodium ER in Adult Autism

Start date: April 2005
Phase: Phase 4
Study type: Interventional

12-week open label treatment trial of divalproex sodium extended release (Depakote ER) in 10 patients with a diagnosis of autism. Our objective is to determine how well these patients can tolerate the prescribed doses and what added benefits can be attributed to divalproex sodium ER.

NCT ID: NCT00211783 Completed - Autism Clinical Trials

Functional Magnetic Resonance Imaging (fMRI) for the Study of Response Inhibition, and Face and Linguistic Processing in Autism

Start date: November 2004
Phase: N/A
Study type: Observational

This study investigates face processing, response inhibition and phoneme processing in autistic adults by fMRI.

NCT ID: NCT00211770 Completed - Autism Clinical Trials

Use of Functional Behavioral Assessments to Evaluate Stereotypy and Repetitive Behaviors in a Double-blind, Placebo Controlled Trials of Various Medications Used to Treat Children With Autism.

Start date: February 2005
Phase: N/A
Study type: Observational

Autism, originally described by Kanner (1943), is among the most severe of neuropsychiatric disorders. It is a pervasive developmental disorder affecting social, communicative, and compulsive/repetitive behaviors characterized by stereotypic complex hand and body movements, craving for sameness, and narrow repetitive interests. Individuals with autism spectrum disorders (ASD) are characteristically heterogeneous and show marked variability in their response to interventions. Studies of behavioral and psychopharmacological interventions document approximately 1/3 of ASD participants fail to respond to targeted treatments. Efforts to evaluate the specificity of treatment effects are important to inform conceptualizations about the disorder, identify behavioral phenotypes, and to aide clinical decision making. The goal of this study is to evaluate the use of clinical behavioral pharmacology methods, functional behavioral assessments (FBA), in assessing the treatment effects of pediatric medications in children with ASD. The present study of FBA procedures in pharmacological treatment will be conducted as a separate, but parallel study within IRB approved, federally funded, double-masked, placebo controlled medication trials of citalopram (GCO # 01-1295 PS*), an SSRI hypothesized to reduce stereotyped and repetitive behaviors in ASD and divalproex sodium (GCO # 01-0294), a medication recently found to reduce repetitive behaviors in ASD (Hollander et al., in press). This study will focus on the use of FBAs in distinguishing responders vs. nonresponders on the basis of behavior function, in evaluating functional patterns for stereotypy, aggression, and impulsivity, and in using descriptive FBAs as outcome measures in clinical trials. FBAs are behavioral assessment methods used to hypothesize about the function of maladaptive behaviors. FBAs are conducted either through experimental manipulations known as functional analyses or through descriptive analyses procedures, which involve structured observations and parent/caregiver interviews. Descriptive analyses will be conducted with all participants (n=24). The more rigorous, functional analyses will be conducted with a sub-set of the sample (n=6) to corroborate the findings of the descriptive analyses. Data from the FBAs will be collected using videotaped recordings of behavior and coded by trained raters for both the descriptive and experimental analyses. Our pilot data and other published data suggest that certain medications such as citalopram (celexa) and divalproex sodium (Depakote) may improve global functioning in autistic patients and repetitive/compulsive behaviors and social deficits. The addition of FBA methods to evaluate outcome are an important step in extending the research and knowledge of the conditions associated with good and poor treatment response to pediatric medications in children with autism.

NCT ID: NCT00211757 Completed - Autism Clinical Trials

Divalproex Sodium vs. Placebo in Childhood/Adolescent Autism

Start date: September 2002
Phase: Phase 2
Study type: Interventional

The study is designed to assess the efficacy of treatment with divalproex sodium (DS) vs. placebo in childhood/adolescent autism fulfilling DSM-IV and Autism Diagnostic Interview (ADI) criteria. Currently, there are no FDA-approved treatments for this disorder, although behavioral and educational therapies and a variety of medications may play a role in the management of some autistic symptoms.