Clinical Trials for Autism

Clinical trials are research studies conducted in an effort to improve overall patient health and care. Each trial involves running supervised tests to determine the effectiveness and safety of new drugs, procedures and/or devices with the aim of answering scientific questions about a disease or condition. Risks and side-effects are also evaluated during these trials with results ranging from being unpleasant, with side effects such as headaches, to more serious or even life-threatening risks. A clinical trial may be separated into phases, or steps, with each step designed to answer a separate research question. This maybe reflected in the trial name.

A brief description of each phase:

• Phase I: Usually designed to evaluate safety, determine a safe dosage range, and identify side effects on a small group of patients.
• Phase II: If Phase I is successful, the trial is then repeated with a larger group to further evaluate its effect and safety.
• Phase III: Trials are conducted on an ever larger group and are compared with the best current treatment while gathering more information on effect and safety.
• Phase IV: These studies monitor long-term side effects after the treatment has been marketed.

Clinical Trials data for Autism is grouped into the following categories:-

• View by trial name
• View by drugs used in Autism clinical trials

Clinical Trials by trial name

The format for each of the following is:

• The name of the trial,
• followed by whether the trial is recruiting patients,
  - The trial may not have started and not yet recruiting, or the trial may have started and do not need any more recruitements, or the trial may be completed.
  - Note**: Please follow the link to determine the current trial status.
• followed by a list of drug/s, if any, used in the trial

ClinicalTrials.gov has listed the following trials for Autism:

• Safety and Efficacy Study in the Treatment of Intestinal Problems Associated With Autism - This study is no longer recruiting patients (Current: 23 Nov 2006) - Oralgam (human immunoglobulin)
• Use of Acupuncture In Children With Autistic Spectrum Disorder - This study is currently recruiting patients (Current: 23 Nov 2006)
• Randomized Controlled Trial of Acupuncture Versus Sham Acupuncture in Autistic Spectrum Disorder - This study has been completed (Current: 23 Nov 2006)
• Randomized Control Trial of Using Tongue Acupuncture in Autistic Spectrum Disorder Using PET Scan for Clinical Correlation - This study has been completed (Current: 23 Nov 2006)
• Use of Acupuncture In Children With Autistic Spectrum Disorder - This study has been completed (Current: 23 Nov 2006)
• Early Characteristics of Autism - This study is currently recruiting patients (Current: 23 Nov 2006)
• Diet and Behavior in Young Children With Autism - This study is currently recruiting patients (Current: 23 Nov 2006)
• Galantamine Versus Placebo in Childhood Autism - This study is currently recruiting patients (Current: 23 Nov 2006) - Galantamine
• A Study of the Effectiveness and Safety of Risperidone Versus Placebo in the Treatment of Children With Autistic Disorder and Other Pervasive Developmental Disorders (PDD) - This study is no longer recruiting patients (Current: 23 Nov 2006) - risperidone
• Relationship Training for Children With Autism and Their Peers - This study is currently recruiting patients (Current: 23 Nov 2006)
• School- and Home-Based Early Intervention for Toddlers With Autism - This study is currently recruiting patients (Current: 23 Nov 2006)
• Treatment of Autism in Children and Adolescents - This study is no longer recruiting patients (Current: 23 Nov 2006) - Risperidone
• A Study of Aripiprazole and a Study of the Combined Treatment of Aripiprazole and D-Cycloserine in Children and Adolescents With Autism - This study is currently recruiting patients (Current: 23 Nov 2006) - aripiprazole,D-Cycloserine
• Safety and Effectiveness of D-Cycloserine in Children With Autism - This study is currently recruiting patients (Current: 23 Nov 2006) - D-cycloserine
• Mercury Chelation to Treat Autism - This study is currently recruiting patients (Current: 23 Nov 2006) - DMSA
• Randomized Study of Intensive One-on-One Behavioral Treatment Versus Individualized Parent Training in Preschool Aged Children With Autism - This study has been completed (Current: 23 Nov 2006)
• A Controlled Study of Olanzapine in Children With Autism - This study is currently recruiting patients (Current: 23 Nov 2006) - olanzapine (Zyprexa)
• Citalopram for Children With Autism and Repetitive Behavior (STAART Study 1) - This study is currently recruiting patients (Current: 23 Nov 2006) - citalopram
• Effectiveness of Early Intervention With Fluoxetine in Enhancing Developmental Processes in Children With Autism (STAART Study 2) - This study is currently recruiting patients (Current: 23 Nov 2006) - Fluoxetine,Placebo
• Efficacy Study of Subcutaneous Methyl-B12 in Children With Autism - This study is currently recruiting patients (Current: 23 Nov 2006) - methylcobalamin
• Diffusion Tensor Imaging in Autism - This study is not yet open for patient recruitment (Current: 23 Nov 2006)
• Study of Fluoxetine in Adults With Autistic Disorder - This study is no longer recruiting patients (Current: 23 Nov 2006) - Fluoxetine
• Comparison of Applied Behavioral Analysis Vs ABA and Risperidone - This study has been completed (Current: 23 Nov 2006) - Risperidone
• Longitudinal and Biological Study of Childhood Disintegrative Disorder - This study has been terminated (Current: 23 Nov 2006)
• Randomized Study of Fluoxetine in Children and Adolescents With Autism - This study has been completed (Current: 23 Nov 2006) - fluoxetine
• Effects of CX516 on Functioning in Fragile X Syndrome and Autism - This study has been completed (Current: 23 Nov 2006) - CX516 (Ampalex®)
• Childhood Autism Risks From Genetics and the Environment (The CHARGE Study) - This study is currently recruiting patients (Current: 23 Nov 2006)
• MR Scanning of Very Young Children With Severe Developmental Disorders - This study has been completed (Current: 23 Nov 2006)
• Magnetic Resonance Imaging in Children and Adolescents With Autism and Multiple Complex Developmental Disorders - This study is currently recruiting patients (Current: 23 Nov 2006)
• Early Pharmacotherapy Aimed at Neuroplasticity in Autism : Safety and Efficacy - This study is currently recruiting patients (Current: 23 Nov 2006) - Buspirone
• Aripiprazole in Children With Autism: A Pilot Study - This study is currently recruiting patients (Current: 23 Nov 2006) - Aripiprazole
• Ziprasidone in Children With Autism: A Pilot Study - This study is no longer recruiting patients (Current: 23 Nov 2006) - Ziprasidone
• Divalproex Sodium Vs. Placebo in Childhood/Adolescent Autism - This study has been completed (Current: 23 Nov 2006) - divalproex sodium
• 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. - This study is currently recruiting patients (Current: 23 Nov 2006)
• fMRI for the Study of Response Inhibition, and Face and Linguistic Processing in Autism - This study is currently recruiting patients (Current: 23 Nov 2006)
• Divalproex Sodium ER in Adult Autism - This study is currently recruiting patients (Current: 23 Nov 2006) - Divalproex Sodium ER
• Intestinal Inflammation and Carbohydrate Digestion in Autistic Children - This study is currently recruiting patients (Current: 23 Nov 2006)
• An Autism Study Using Nambudripad's Food Allergy Elimination Treatments - This study has been completed (Current: 23 Nov 2006)
• Effect of Hyperbaric Therapy on Markers of Oxidative Stress in Children With Autism - This study is currently recruiting patients (Current: 23 Nov 2006)
• Clinical and Immunological Investigations of Subtypes of Autism - This study is currently recruiting patients (Current: 23 Nov 2006)
• An Open-Label Trial of Aripiprazole in Autism Spectrum Disorders. - This study is currently recruiting patients (Current: 23 Nov 2006) - Aripiprazole
• EEG Studies of Sensory Processing in Autistic Children - This study is currently recruiting patients (Current: 23 Nov 2006)
• Joint Attention Intervention and Young Children With Autism - This study is currently recruiting patients (Current: 23 Nov 2006)
• Autism in Adult Patients and the Effects on Caregivers - This study is not yet open for patient recruitment (Current: 23 Nov 2006)
• Secretin for the Treatment of Autism - This study has been completed (Current: 23 Nov 2006) - secretin, synthetic porcine,secretin, biologically derived porcine
• Treatment of Autistic Children Using NAET Procedures - This study is currently recruiting patients (Current: 23 Nov 2006)
• Methylphenidate in Children and Adolescents With Pervasive Developmental Disorders - This study has been completed (Current: 23 Nov 2006) - methylphenidate,guanfacine
• Drug Treatment for Autism - This study is currently recruiting patients (Current: 23 Nov 2006) - Donepezil HCl
• fMRI Study of Grasping in Autistic Patients - This study is currently recruiting patients (Current: 23 Nov 2006)
• CBT for Comorbid Anxiety Disorders in Children With Asperger Syndrome or PDD-NOS - This study is currently recruiting patients (Current: 23 Nov 2006)
• Study of Aripiprazole in the Treatment of Children and Adolescents With Autistic Disorder (AD) - This study is currently recruiting patients (Current: 23 Nov 2006) - Aripiprazole
• Study of Aripiprazole in the Treatment of Children and Adolescents With Autistic Disorder (AD) - This study is currently recruiting patients (Current: 23 Nov 2006) - Aripiprazole
• Study of Aripiprazole in the Treatment of Serious Behavioral Problems in Children and Adolescents With Autistic Disorder (AD) - This study is currently recruiting patients (Current: 23 Nov 2006) - Aripiprazole
• Atomoxetine Versus Placebo for Symptoms of ADHD in Children and Adolescents With Autism Spectrum Disorder - This study is currently recruiting patients (Current: 23 Nov 2006) - Atomoxetine,Placebo
• Synthetic Human Secretin in Children With Autism and Gastrointestinal Dysfunction - This study has been terminated (Current: 23 Nov 2006) - RG1068 (Synthetic Human Secretin)
• Synthetic Human Secretin in Children With Autism - This study has been completed (Current: 23 Nov 2006) - RG1068 (Synthetic Human Secretin)
• Valproate Response in Aggressive Autistic Adolescents - This study is currently recruiting patients (Current: 23 Nov 2006) - Valproate
• Improving Attention Skills of Children With Autism - This study is currently recruiting patients (Current: 23 Nov 2006)
• Methylphenidate for Attention Deficit Hyperactivity Disorder and Autism in Children - This study is currently recruiting patients (Current: 23 Nov 2006) - methylphenidate-extended release
• Long-Term Drug Treatment for Autistic Children - This study is currently recruiting patients (Current: 23 Nov 2006) - Olanzapine
• An fMRI Study of the Effect of Intravenous Oxytocin Vs. Placebo on Response Inhibition and Face Processing in Autism - This study is not yet open for patient recruitment (Current: 23 Nov 2006) - Oxytocin
• Effects of Hyperbaric Oxygen Therapy in Autistic Children: A Pilot Study - This study is no longer recruiting patients (Current: 23 Nov 2006) - Hyperbaric Oxygen Therapy
• Evaluation and Treatment of Copper/Zinc Imbalance in Children With Autism - This study is not yet open for patient recruitment (Current: 23 Nov 2006) - oral zinc and vitamin C supplement
• A Placebo Controlled Trial of the Clinical Effects of Hyperbaric Therapy in Autistic Children - This study is currently recruiting patients (Current: 23 Nov 2006)
• Screening for Studies on Autism Spectrum Disorders - This study is currently recruiting patients (Current: 23 Nov 2006)
• RUPP PI PDD: Drug and Behavioral Therapy for Children With Pervasive Developmental Disorders - This study is currently recruiting patients (Current: 23 Nov 2006) - Risperidone,Aripiprazole
• Brain Imaging of Childhood Onset Psychiatric Disorders, Endocrine Disorders and Healthy Children - This study is currently recruiting patients (Current: 23 Nov 2006)
• Risperidone Pharmacokinetics in Children With Pervasive Developmental Disorder (PDD) - This study is currently recruiting patients (Current: 23 Nov 2006) - Risperidone
• Genetics and Psychopathology in the 22q11 Deletion Syndrome - This study is currently recruiting patients (Current: 23 Nov 2006)
• Pharmacogenetics of Risperidone in Children Wtih Pervasive Developmental Disorder (PDD) - This study is currently recruiting patients (Current: 23 Nov 2006) - Risperidone
• Agenesis of the Corpus Callosum & Aicardi Syndrome Research Project - This study is currently recruiting patients (Current: 23 Nov 2006)
• Trial of Low-Dose Naltrexone for Children With Pervasive Developmental Disorder (PDD) - This study is not yet open for patient recruitment (Current: 23 Nov 2006) - low dose naltrexone

Drugs used in Clinical Trials for Autism

The format for each of the following is:

• The drug,
• followed by the name of the trial,
• followed by whether the trial is recruiting patients,
  - The trial may not have started and not yet recruiting, or the trial may have started and do not need any more recruitements, or the trial may be completed.
  - Note**: Please follow the link to determine the current trial status.

ClinicalTrials.gov has listed the following drugs in trials for Autism:

• Aripiprazole - A Study of Aripiprazole and a Study of the Combined Treatment of Aripiprazole and D-Cycloserine in Children and Adolescents With Autism - This study is currently recruiting patients (Current: 23 Nov 2006)
• Aripiprazole - An Open-Label Trial of Aripiprazole in Autism Spectrum Disorders. - This study is currently recruiting patients (Current: 23 Nov 2006)
• Aripiprazole - Aripiprazole in Children With Autism: A Pilot Study - This study is currently recruiting patients (Current: 23 Nov 2006)
• Aripiprazole - RUPP PI PDD: Drug and Behavioral Therapy for Children With Pervasive Developmental Disorders - This study is currently recruiting patients (Current: 23 Nov 2006)
• Aripiprazole - Study of Aripiprazole in the Treatment of Children and Adolescents With Autistic Disorder (AD) - This study is currently recruiting patients (Current: 23 Nov 2006)
• Aripiprazole - Study of Aripiprazole in the Treatment of Children and Adolescents With Autistic Disorder (AD) - This study is currently recruiting patients (Current: 23 Nov 2006)
• Aripiprazole - Study of Aripiprazole in the Treatment of Serious Behavioral Problems in Children and Adolescents With Autistic Disorder (AD) - This study is currently recruiting patients (Current: 23 Nov 2006)
• Atomoxetine - Atomoxetine Versus Placebo for Symptoms of ADHD in Children and Adolescents With Autism Spectrum Disorder - This study is currently recruiting patients (Current: 23 Nov 2006)
• Buspirone - Early Pharmacotherapy Aimed at Neuroplasticity in Autism : Safety and Efficacy - This study is currently recruiting patients (Current: 23 Nov 2006)
• CX516 (Ampalex®) - Effects of CX516 on Functioning in Fragile X Syndrome and Autism - This study has been completed (Current: 23 Nov 2006)
• Citalopram - Citalopram for Children With Autism and Repetitive Behavior (STAART Study 1) - This study is currently recruiting patients (Current: 23 Nov 2006)
• D-Cycloserine - A Study of Aripiprazole and a Study of the Combined Treatment of Aripiprazole and D-Cycloserine in Children and Adolescents With Autism - This study is currently recruiting patients (Current: 23 Nov 2006)
• D-cycloserine - Safety and Effectiveness of D-Cycloserine in Children With Autism - This study is currently recruiting patients (Current: 23 Nov 2006)
• DMSA - Mercury Chelation to Treat Autism - This study is currently recruiting patients (Current: 23 Nov 2006)
• Divalproex Sodium ER - Divalproex Sodium ER in Adult Autism - This study is currently recruiting patients (Current: 23 Nov 2006)
• Divalproex Sodium - Divalproex Sodium Vs. Placebo in Childhood/Adolescent Autism - This study has been completed (Current: 23 Nov 2006)
• Donepezil HCl - Drug Treatment for Autism - This study is currently recruiting patients (Current: 23 Nov 2006)
• Fluoxetine - Effectiveness of Early Intervention With Fluoxetine in Enhancing Developmental Processes in Children With Autism (STAART Study 2) - This study is currently recruiting patients (Current: 23 Nov 2006)
• Fluoxetine - Randomized Study of Fluoxetine in Children and Adolescents With Autism - This study has been completed (Current: 23 Nov 2006)
• Fluoxetine - Study of Fluoxetine in Adults With Autistic Disorder - This study is no longer recruiting patients (Current: 23 Nov 2006)
• Galantamine - Galantamine Versus Placebo in Childhood Autism - This study is currently recruiting patients (Current: 23 Nov 2006)
• Guanfacine - Methylphenidate in Children and Adolescents With Pervasive Developmental Disorders - This study has been completed (Current: 23 Nov 2006)
• Hyperbaric Oxygen Therapy - Effects of Hyperbaric Oxygen Therapy in Autistic Children: A Pilot Study - This study is no longer recruiting patients (Current: 23 Nov 2006)
• Low Dose Naltrexone - Trial of Low-Dose Naltrexone for Children With Pervasive Developmental Disorder (PDD) - This study is not yet open for patient recruitment (Current: 23 Nov 2006)
• Methylcobalamin - Efficacy Study of Subcutaneous Methyl-B12 in Children With Autism - This study is currently recruiting patients (Current: 23 Nov 2006)
• Methylphenidate-Extended Release - Methylphenidate for Attention Deficit Hyperactivity Disorder and Autism in Children - This study is currently recruiting patients (Current: 23 Nov 2006)
• Methylphenidate - Methylphenidate in Children and Adolescents With Pervasive Developmental Disorders - This study has been completed (Current: 23 Nov 2006)
• Olanzapine (Zyprexa) - A Controlled Study of Olanzapine in Children With Autism - This study is currently recruiting patients (Current: 23 Nov 2006)
• Olanzapine - Long-Term Drug Treatment for Autistic Children - This study is currently recruiting patients (Current: 23 Nov 2006)
• Oral Zinc And Vitamin C Supplement - Evaluation and Treatment of Copper/Zinc Imbalance in Children With Autism - This study is not yet open for patient recruitment (Current: 23 Nov 2006)
• Oralgam (human immunoglobulin) - Safety and Efficacy Study in the Treatment of Intestinal Problems Associated With Autism - This study is no longer recruiting patients (Current: 23 Nov 2006)
• Oxytocin - An fMRI Study of the Effect of Intravenous Oxytocin Vs. Placebo on Response Inhibition and Face Processing in Autism - This study is not yet open for patient recruitment (Current: 23 Nov 2006)
• Placebo - Atomoxetine Versus Placebo for Symptoms of ADHD in Children and Adolescents With Autism Spectrum Disorder - This study is currently recruiting patients (Current: 23 Nov 2006)
• Placebo - Effectiveness of Early Intervention With Fluoxetine in Enhancing Developmental Processes in Children With Autism (STAART Study 2) - This study is currently recruiting patients (Current: 23 Nov 2006)
• RG1068 (Synthetic Human Secretin) - Synthetic Human Secretin in Children With Autism and Gastrointestinal Dysfunction - This study has been terminated (Current: 23 Nov 2006)
• RG1068 (Synthetic Human Secretin) - Synthetic Human Secretin in Children With Autism - This study has been completed (Current: 23 Nov 2006)
• Risperidone - A Study of the Effectiveness and Safety of Risperidone Versus Placebo in the Treatment of Children With Autistic Disorder and Other Pervasive Developmental Disorders (PDD) - This study is no longer recruiting patients (Current: 23 Nov 2006)
• Risperidone - Comparison of Applied Behavioral Analysis Vs ABA and Risperidone - This study has been completed (Current: 23 Nov 2006)
• Risperidone - Pharmacogenetics of Risperidone in Children Wtih Pervasive Developmental Disorder (PDD) - This study is currently recruiting patients (Current: 23 Nov 2006)
• Risperidone - RUPP PI PDD: Drug and Behavioral Therapy for Children With Pervasive Developmental Disorders - This study is currently recruiting patients (Current: 23 Nov 2006)
• Risperidone - Risperidone Pharmacokinetics in Children With Pervasive Developmental Disorder (PDD) - This study is currently recruiting patients (Current: 23 Nov 2006)
• Risperidone - Treatment of Autism in Children and Adolescents - This study is no longer recruiting patients (Current: 23 Nov 2006)
• Secretin, Biologically Derived Porcine - Secretin for the Treatment of Autism - This study has been completed (Current: 23 Nov 2006)
• Secretin, Synthetic Porcine - Secretin for the Treatment of Autism - This study has been completed (Current: 23 Nov 2006)
• Valproate - Valproate Response in Aggressive Autistic Adolescents - This study is currently recruiting patients (Current: 23 Nov 2006)
• Ziprasidone - Ziprasidone in Children With Autism: A Pilot Study - This study is no longer recruiting patients (Current: 23 Nov 2006)

The trial data on this page has been sourced from

• The U.S. National Library of Medicine (NLM) together with ClinicalTrials.gov