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Drug Treatment for Autism Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, trips or professional assistance with a real medical doctor. We aren't docs. Always confer with your doctor about Drug Treatment for Autism conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Drug Treatment for Autism Clinical research trials and Drug Treatment for Autism health trials happen in many of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectualness of new does drugs. The intention of the studies / projects is to figure out particular human healthcare questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to detect cures for all forms of circumstances, like Drug Treatment for Autism. Drug Treatment for Autism Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment options before they are available to the general public. Most times the subjects get treatment for free of charge, and occasionally they are paid for their time. Occasionally there is a cost for a Drug Treatment for Autism clinical trial. Subjects frequently get the best healthcare possible for their Drug Treatment for Autism condition. Hazards are a reality, however, and could include more or frequent mD visits, health risks (possibly life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with exacting guidelines to protect clinical trials patients.
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Home > "D" Clinical Trials Conditions > Drug Treatment for Autism  Drug Treatment for Autism
Drug Treatment for Autism
For Condition: Autistic Disorder
Status: Recruiting
Sponsor(s): National Institute of Mental Health (NIMH) ,
Synopsis: The purpose of this study is to examine the safety and effectiveness of donepezil HCl (Aricept) in children and adolescents with Autism Spectrum Disorder (ASD).
Details: Children with autism spectrum disorder (ASD) often have impaired communication, problems with social interaction, and repetitive and stereotyped patterns of behavior. While most research has attempted to treat the behavioral deficits commonly associated with ASD, few studies have attempted to improve the core features of this disorder. A recent study found that donepezil HCl helped to improve speech production, attention span, and ability to express emotions in a group of children with autism. This study will provide an opportunity to conduct further testing of the effects of donepezil HCl on the cognitive deficits presumed to underlie the core features of ASD. This study begins at Week 1 with a baseline assessment. Participants are then randomly assigned to either donepezil HCl or placebo. Participants will start with either a 5mg/day dose of donezepil HCl or placebo followed by a cognitive assessment after 4 weeks on this dose. Participants will then have their dose increased to 10mg/day. Another cognitive assessment will be given after 4 weeks on this dose.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 8 Years/17 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Autism Spectrum Disorder (ASD) - Asperger's Disorder - IQ of 75 or above - Baseline assessment tests within the acceptable range Exclusion Criteria: - Bipolar disorder, schizophrenia, schizoaffective disorder, or psychotic disorder - Seizure disorder requiring the use of anticonvulsant medications - Congenital rubella, cytomegalovirus, or tuberous sclerosis - Medications that produce CNS effects - Medications/preparations that are known to interact with donepezil HCl - Significant medical illness, endocrinopathies, cardiovascular disease, or severe chronic malnutrition - Pregnancy or sexually active females not using a reliable method of contraception - Medications for sleep. Participants will be allowed to take melatonin for sleep as long as dose has been stable for a minimum of 2 weeks prior to study entry and remains stable throughout the course of the trial.
Total Enrollment: 40
Location and Contact Information:
Overall Study Official:
BenjaminHanden, Principal Investigator, University of Pittsburgh, School of Medicine, Department of Psychiatry
Western Psychiatric Institute & Clinic *Recruiting*
Pittsburgh, Pennsylvania, 15213
United States
Recruiting Benjamin Handen 412-383-2190
Additional Information:
Study ID Numbers: NIMH-65941-01;
Study Start Date: October 2002
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00047697
Other Autistic Disorder Studies:
1. Methylphenidate in Children and Adolescents with Pervasive Developmental Disorders
2. A Controlled Study of Olanzapine in Children with Autism
3. RUPP PI PDD: Drug and Behavioral Therapy for Children with Pervasive Developmental Disorders
4. Treatment of Autism in Children and Adolescents
5. Drug Treatment for Autism
Related Studies:
Other Autistic Disorder Clinical Trials
Other Pennsylvania Clinical Trials
Other Pittsburgh Clinical Trials
Drug Treatment for Autism
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