| 1 |
NCT03487770 |
Not yet recruiting
New |
Aripiprazole Oral Solution in the Treatment of Children and Adolescents With Autistic Disorder |
|
- Drug: Aripiprazole Oral Solution
- Drug: Placebo Oral Solution
|
Interventional |
Phase 3 |
- Otsuka Beijing Research Institute
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Changes from Baseline to Week 8 (or endpoint) in the ABC-I score
- Clinician-rated CGI-I score at Week 8 (or endpoint)
- Change in ABC subscale scores from Baseline to Week 8 (or endpoint)
- Response Rate at Week 8 (or endpoint) (or endpoint)
|
100 |
All |
6 Years to 17 Years (Child) |
NCT03487770 |
031-403-00106 |
|
April 18, 2018 |
May 19, 2019 |
May 19, 2019 |
April 4, 2018 |
April 4, 2018 |
|
|
| 2 |
NCT03379662 |
Completed |
An Evaluation of Low Level Laser Light Therapy for Autistic Disorder |
|
- Device: Erchonia EAL Laser
- Device: Placebo Laser
|
Interventional |
Not Applicable |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Mean change from baseline to study endpoint in the Aberrant Behavior Checklist (ABC) Irritability & Agitation Subscale score.
|
40 |
All |
5 Years to 17 Years (Child) |
NCT03379662 |
EC_AUT_001 |
|
July 2, 2017 |
October 28, 2017 |
November 28, 2017 |
December 20, 2017 |
December 22, 2017 |
|
- Institute for Brain and Rehabilitation Sciences
Nazareth, Israel
|
| 3 |
NCT00850070 |
Completed
Has Results |
Sapropterin as a Treatment for Autistic Disorder |
|
- Drug: sapropterin
- Drug: Placebo
|
Interventional |
Phase 2 |
- The Children's Health Council
- BioMarin Pharmaceutical
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Clinical Global Impression -- Improvement (CGI-I) Scale
- Clinical Global Impression -- Severity (CGI-S) Scale
- Preschool Language Scale-Fourth Edition (PLS-4). Assesses Expressive and Receptive Language Skills in Ages Birth Through 6 Years, 11 Months.
- (and 7 more...)
|
46 |
All |
3 Years to 6 Years (Child) |
NCT00850070 |
CHC-0901 |
|
March 2009 |
August 2011 |
October 2011 |
February 24, 2009 |
February 21, 2018 |
February 28, 2014 |
- The Children's Health Council
Palo Alto, California, United States
|
| 4 |
NCT00873509 |
Completed |
Buspirone in the Treatment of 2-6 Year Old Children With Autistic Disorder |
|
- Drug: Buspirone
- Drug: Placebo
|
Interventional |
Phase 2
Phase 3 |
- Chugani, Diane C.
- National Institute of Neurological Disorders and Stroke (NINDS)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- To evaluate the effects of twice-daily oral buspirone on core features of autism in autistic children 2-6 years measuring the change from baseline in ADOS (Autism Diagnostic Observation Schedule) Composite Total scores compared to placebo at 6 months.
- To evaluate the effects of twice-daily oral buspirone on the ADOS Composite calibrated severity score, social behavior, repetitive behavior, language, sensory dysfunction and anxiety.
- To determine whether there are age group differences in the effects of buspirone on social interaction, repetitive behavior, language, sensory dysfunction and anxiety.
- (and 3 more...)
|
166 |
All |
2 Years to 6 Years (Child) |
NCT00873509 |
10888
5U01NS061264 |
B-ACE |
May 2009 |
January 2015 |
January 2015 |
April 1, 2009 |
July 26, 2016 |
|
- University California Davis M.I.N.D. Institute
Sacramento, California, United States - Children's Hospital of Michigan Wayne State University
Detroit, Michigan, United States - New York University Langone Medical Center
New York, New York, United States - (and 3 more...)
|
| 5 |
NCT01333072 |
Completed |
Biomarkers in Autism of Aripiprazole and Risperidone Treatment (BAART) |
|
- Drug: Aripiprazole
- Drug: Risperidone
|
Interventional |
Phase 4 |
- Medical University of South Carolina
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Supportive Care
|
- To identify phenotypic and genetic traits that predict response to aripiprazole and risperidone in Autistic Disorder
|
82 |
All |
6 Years to 17 Years (Child) |
NCT01333072 |
R01HD062550-01A1 |
BAART |
July 2011 |
August 2015 |
August 2015 |
April 11, 2011 |
March 16, 2016 |
|
- Medical University of South Carolina
Charleston, South Carolina, United States
|
| 6 |
NCT02947880 |
Not yet recruiting |
Evaluation of the Efficiency of Treatment by BUMETANIDE on Autistic Children With a Known Ethiology |
|
- Drug: Bumetanide
- Drug: Placebo
|
Interventional |
Phase 2 |
- University Hospital, Limoges
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Change (evolution) between day 0 and day 99 of the result of the scale CARS (Childhood Autism Rating Scale).
- CARS (Childhood Autism Rating Scale) between D0 and D99 and between D99 and D190 which will be describe by etiology
|
88 |
All |
5 Years to 17 Years (Child) |
NCT02947880 |
I14039 |
BUMAUTEP |
December 2016 |
December 2019 |
June 2020 |
October 28, 2016 |
October 28, 2016 |
|
|
| 7 |
NCT01617460 |
Completed
Has Results |
A Long-term, Extended Treatment Study of Aripiprazole in Pediatric Patients With Autistic Disorder |
|
|
Interventional |
Phase 3 |
- Otsuka Pharmaceutical Co., Ltd.
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Mean Change From Baseline at the Final Assessment in Aberrant Behavior Checklist Japanese Version (ABC-J) Irritability Subscale Score
|
86 |
All |
6 Years to 17 Years (Child) |
NCT01617460 |
031-11-003 |
|
September 2012 |
October 2016 |
October 2016 |
June 12, 2012 |
October 20, 2017 |
October 20, 2017 |
- Chubu Region, Japan
- Chugoku Region, Japan
- Kanto Region, Japan
- (and 2 more...)
|
| 8 |
NCT02627131 |
Completed |
Autologous Bone Marrow Stem Cell Therapy for Autism |
|
- Biological: Autologous Bone Marrow Mononuclear Cells
|
Interventional |
Phase 2 |
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Change in Total Score of Childhood Autism Rating Scale (CARS)
- Number of adverse events
|
24 |
All |
3 Years to 16 Years (Child) |
NCT02627131 |
TBG 003 |
|
April 2014 |
December 2015 |
December 2015 |
December 10, 2015 |
December 10, 2015 |
|
- Vinmec International Hospital
Hanoi, Vietnam
|
| 9 |
NCT01881737 |
Completed
Has Results |
A Study of Pregnenolone in the Treatment of Individuals With Autism |
|
|
Interventional |
Phase 2 |
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of Participants With Adverse Events According to Dosage Record and Treatment Emergent Symptom (DOTES) as Assessed at All Follow-up Visits (2, 4, 6, 8, 10, 12, and 16 Weeks)
- Social Responsiveness Scale (SRS) Total Score
- Sensory Profile Questionnaire Total Score
- (and 3 more...)
|
15 |
All |
18 Years to 45 Years (Adult) |
NCT01881737 |
SU-08092011-8246 |
|
July 2011 |
September 2013 |
September 2013 |
June 20, 2013 |
March 29, 2017 |
March 29, 2017 |
- Stanford University School of Medicine
Stanford, California, United States
|
| 10 |
NCT01881750 |
Unknown † |
Pivotal Response Group Treatment for Parents of Young Children With Autism |
|
- Behavioral: Pivotal Response Training
- Behavioral: Parent Education Group
|
Interventional |
Not Applicable |
- Stanford University
- Autism Speaks
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Change from Baseline in communication during parent-child and clinician-child interactions at 6, 12, and 24 weeks
- Parenting Stress Index
- Family Empowerment Scale
- (and 4 more...)
|
50 |
All |
2 Years to 6 Years (Child) |
NCT01881750 |
SU-11022010-7151 |
|
September 2010 |
September 2013 |
September 2013 |
June 20, 2013 |
June 20, 2013 |
|
- Stanford University School of Medicine
Stanford, California, United States
|
| 11 |
NCT01617447 |
Completed
Has Results |
A Short Treatment Study of Aripiprazole in Pediatric Patients With Autistic Disorder |
|
- Drug: Placebo of Aripiprazole
- Drug: Aripiprazole
|
Interventional |
Phase 3 |
- Otsuka Pharmaceutical Co., Ltd.
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Mean Change From Baseline in the Aberrant Behavior Checklist Japanese Version (ABC-J) Irritability Subscale Score
|
92 |
All |
6 Years to 17 Years (Child) |
NCT01617447 |
031-11-002 |
|
July 2012 |
June 2015 |
June 2015 |
June 12, 2012 |
April 11, 2017 |
April 11, 2017 |
- Chubu Region, Japan
- Chugoku Region, Japan
- Kanto Region, Japan
- (and 2 more...)
|
| 12 |
NCT00943579 |
Completed
Has Results |
Open-Label Extension Study of Kuvan for Autism |
|
|
Interventional |
Phase 2
Phase 3 |
- The Children's Health Council
- BioMarin Pharmaceutical
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Clinical Global Impressions Scale
- Vineland Adaptive Behavior Scale, 2nd Edition
- Children's Yale Brown Obsessive Compulsive Scale
- (and 5 more...)
|
41 |
All |
3 Years to 6 Years (Child) |
NCT00943579 |
CHC-0902 |
|
August 2009 |
December 2011 |
March 2012 |
July 22, 2009 |
February 21, 2018 |
July 4, 2013 |
- The Children's Health Council
Palo Alto, California, United States
|
| 13 |
NCT00027404 |
Completed |
Study of Fluoxetine in Adults With Autistic Disorder |
|
|
Interventional |
Not Applicable |
- Icahn School of Medicine at Mount Sinai
- FDA Office of Orphan Products Development
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double
- Primary Purpose: Treatment
|
|
48 |
All |
18 Years to 65 Years (Adult) |
NCT00027404 |
FD-R-2026-01
FD-R-002026-01 |
|
September 2001 |
|
August 2005 |
December 7, 2001 |
March 25, 2015 |
|
- Mount Sinai School of Medicine
New York, New York, United States
|
| 14 |
NCT02358317 |
Recruiting |
Motor Learning and Brain Changes in Autism |
|
- Behavioral: Video Game Motor Training
- Behavioral: Sedentary Video Game Training
|
Interventional |
Not Applicable |
- University of Wisconsin, Madison
- Brain & Behavior Research Foundation
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Supportive Care
|
- Balance Time
- Postural Stability
- White matter microstructure of the Corticospinal tract
- (and 2 more...)
|
30 |
All |
13 Years to 17 Years (Child) |
NCT02358317 |
2014-1499 |
|
March 2015 |
March 2018 |
March 2018 |
February 6, 2015 |
May 17, 2017 |
|
- Waisman Center, University of Wisconsin-Madison
Madison, Wisconsin, United States
|
| 15 |
NCT01366885 |
Completed
Has Results |
Vitamin D to Prevent Autism in Newborn Siblings |
|
|
Interventional |
Phase 2 |
- Oregon Health and Science University
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Number of Children Who Developed Autism
- Number of Mothers Who Developed Side Effects From Vitamin D
|
20 |
Female |
20 Years to 44 Years (Adult) |
NCT01366885 |
OHSU-AS-11-1-11 |
|
February 2008 |
February 2016 |
February 2016 |
June 6, 2011 |
June 14, 2016 |
June 14, 2016 |
- Evergreen Center
Oregon City, Oregon, United States
|
| 16 |
NCT01039792 |
Completed
Has Results |
Trial of Methyl B12 on Behavioral and Metabolic Measures in Children With Autism |
|
- Drug: Methyl B12
- Dietary Supplement: Placebo
|
Interventional |
Phase 2
Phase 3 |
- University of California, San Francisco
- University of California, Davis
- Arkansas Children's Hospital Research Institute
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Clinical Global Impression-Improvement (CGI-I)
|
57 |
All |
3 Years to 7 Years (Child) |
NCT01039792 |
Autism Speaks 3031 |
B12 |
January 2010 |
October 2013 |
November 2013 |
December 25, 2009 |
February 24, 2017 |
February 24, 2017 |
- UCSF
San Francisco, California, United States
|
| 17 |
NCT03374072 |
Recruiting |
Engaging Siblings of Adults With Autism in Future Planning |
|
- Behavioral: Siblings FORWARD program
- Behavioral: Information Only Condition
|
Interventional |
Not Applicable |
- Boston University Charles River Campus
- National Institute of Mental Health (NIMH)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change in Quality of Sibling Plan of Action
- Sibling Future Planning Actions
- Social Problem-Solving Skills Inventory-Revised
- (and 5 more...)
|
36 |
All |
18 Years and older (Adult, Senior) |
NCT03374072 |
4366E
R34MH111489 |
|
February 1, 2017 |
January 31, 2020 |
January 31, 2020 |
December 15, 2017 |
December 15, 2017 |
|
- Boston University
Boston, Massachusetts, United States
|
| 18 |
NCT00515320 |
Completed |
Study of Fluoxetine in Autism |
|
- Drug: Fluoxetine
- Drug: Placebo
|
Interventional |
Phase 3 |
|
Industry / Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- The percentage change from baseline to the endpoint visit for the CYBOCS-PDD score.
- The time and dose related course of therapeutic effects
- The inter-relationship between these effects in the context of global clinical changes.
- (and 2 more...)
|
158 |
All |
5 Years to 17 Years (Child) |
NCT00515320 |
NPL-2008-4-AUTUS-004 |
SOFIA |
August 2007 |
January 2009 |
January 2009 |
August 13, 2007 |
April 27, 2012 |
|
- Southwest Autism Research and Resource Centre
Phoenix, Arizona, United States - University of California Davis
Sacramento, California, United States - University of Florida, Department of Psychiatry
Gainesville, Florida, United States - (and 14 more...)
|
| 19 |
NCT00572741 |
Completed |
Treating Oxidative Stress and the Metabolic Pathology of Autism |
|
- Dietary Supplement: B12
- Dietary Supplement: Placebo
- Dietary Supplement: folate
- (and 5 more...)
|
Interventional |
Not Applicable |
- Arkansas Children's Hospital Research Institute
|
Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Behavioral test scores
- Plasma metabolic profile
|
39 |
All |
3 Years to 7 Years (Child) |
NCT00572741 |
59538 |
|
June 2008 |
April 2016 |
April 2016 |
December 13, 2007 |
May 5, 2016 |
|
- Arkansas Children's Hospital Research Institute
Little Rock, Arkansas, United States
|
| 20 |
NCT02275455 |
Recruiting |
Design Of WELL Being Monitoring Systems, Application in Autism |
|
- Behavioral: real life situations
|
Interventional |
Not Applicable |
- University Hospital, Clermont-Ferrand
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Investigator, Outcomes Assessor)
- Primary Purpose: Prevention
|
- Heart Rate Variability from holter electrocardiogram
- Heart Rate Variability from the heart rate transmitter belt
|
60 |
All |
12 Years to 25 Years (Child, Adult) |
NCT02275455 |
CHU-0213
2014-A00611-46 |
Do Well B |
October 2014 |
December 2016 |
December 2018 |
October 27, 2014 |
July 26, 2016 |
|
- University Hospital of Clermont-Ferrand (CHU), France
Clermont-Ferrand, France
|
| 21 |
NCT00787111 |
Terminated |
Extended Management and Measurement of Autism |
|
- Drug: Fluoxetine (prozac)
|
Interventional |
Phase 3 |
|
Industry / Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Safety Outcomes: Laboratory determinations, Urine drugs of abuse tests,Vital Signs,Physical Examinations, Adverse Events/Serious Adverse Events, Clinical Global Impression of Severity (CGI-S AD)
|
128 |
All |
5 Years to 18 Years (Child, Adult) |
NCT00787111 |
NPL-2008-4-AUTUS-005 |
EMMA |
November 2008 |
April 2009 |
April 2009 |
November 7, 2008 |
February 23, 2010 |
|
- Southwest Autism Research and Resource Centre
Phoenix, Arizona, United States - University of California Davis
Sacramento, California, United States - Institute for Behavioral Medicine
Smyrna, Georgia, United States - (and 10 more...)
|
| 22 |
NCT02184390 |
Completed |
Parenting Your Young Child With Autism: A Web-Based Tutorial |
|
- Other: On LIne Parent Training Tutorial
|
Interventional |
Not Applicable |
- Center for Psychological Consultation
- National Institute of Mental Health (NIMH)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- System Usability Scale
- Autism Knowledge Test
|
104 |
All |
18 Months to 6 Years (Child) |
NCT02184390 |
5R44MH086936 |
|
May 2013 |
May 2015 |
September 2015 |
July 9, 2014 |
February 3, 2016 |
|
- Center for Psychological Consulation
Madison, Wisconsin, United States
|
| 23 |
NCT01813318 |
Recruiting |
Study of Acamprosate in Autism |
|
- Drug: Acamprosate
- Drug: Placebo
|
Interventional |
Phase 2
Phase 3 |
- Children's Hospital Medical Center, Cincinnati
- Autism Speaks
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change from baseline to week 10 on the Social WIthdrawal subscale of ABC
- Change Clinical Global Impression- Improvement
- Change in ABC subscales: Irritability, Stereotypy, Hyperactivity, and Inappropriate Speech from baseline to week 10
|
36 |
All |
5 Years to 17 Years (Child) |
NCT01813318 |
CIN001-Acamprosate in Autism |
|
April 2013 |
February 2018 |
February 2018 |
March 18, 2013 |
July 21, 2017 |
|
- Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
|
| 24 |
NCT01624675 |
Completed |
A Study to Evaluate the Efficacy and Safety of Risperidone (R064766) in Children and Adolescents With Irritability Associated With Autistic Disorder |
- Autistic Disorder in Children and Adolescents
|
- Drug: Risperidone
- Drug: Placebo
|
Interventional |
Phase 3 |
- Janssen Pharmaceutical K.K.
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- The change from baseline in the Aberrant Behavior Checklist−Japanese Version (ABC-J) Irritability Subscale scores
- The changes from baseline in the subscale scores of Aberrant Behavior Checklist-Japanese Version (ABC-J) at each evaluation of the double-blind phase
- The changes from baseline in the subscale scores of Aberrant Behavior Checklist-Japanese Version (ABC-J) at each evaluation of the open-label phase
- (and 8 more...)
|
39 |
All |
5 Years to 17 Years (Child) |
NCT01624675 |
CR100877
RIS-AUT-JPN-01 |
|
September 2012 |
October 2014 |
October 2014 |
June 21, 2012 |
October 15, 2015 |
|
- Fuchu, Japan
- Fukui, Japan
- Hirakata, Japan
- (and 14 more...)
|
| 25 |
NCT02862340 |
Completed |
Study of the Involvement of 15q11 - q13 Chromosome Region and CYFIP1 Gene in Autism. Attempt a Genotype-phenotype Correlation |
|
|
Interventional |
Not Applicable |
- Centre Hospitalier Universitaire de Nice
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- presence or absence of abnormality in 15q11q13 gene
- phenotype
|
60 |
All |
4 Years to 18 Years (Child, Adult) |
NCT02862340 |
07-PP-01 |
|
January 2008 |
January 2008 |
February 2012 |
August 11, 2016 |
August 11, 2016 |
|
|
| 26 |
NCT00005014 |
Completed |
Treatment of Autism in Children and Adolescents |
|
|
Interventional |
Phase 3 |
- National Institute of Mental Health (NIMH)
|
NIH |
- Allocation: Randomized
- Masking: Double
- Primary Purpose: Treatment
|
|
101 |
All |
5 Years to 17 Years (Child) |
NCT00005014 |
N01 MH70001
N01 MH70009
N01 MH80011
N01 MH70010
DSIR CT |
|
October 1997 |
|
February 2001 |
April 3, 2000 |
April 17, 2014 |
|
- UCLA
Los Angeles, California, United States - Yale Univ
New Haven, Connecticut, United States - Indiana Univ / Riley Hosp for Children
Indianapolis, Indiana, United States - (and 2 more...)
|
| 27 |
NCT00332241 |
Completed
Has Results |
Study of Aripiprazole in the Treatment of Children and Adolescents With Autistic Disorder (AD) |
|
- Drug: Aripiprazole
- Drug: Placebo
|
Interventional |
Phase 3 |
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Otsuka America Pharmaceutical
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Mean Change (Week 8 - Baseline) in the Autistic Behavior Checklist (ABC) Irritability Subscale Score
- Mean Clinical Global Impressions Improvement Scale (CGI-I) Score
- Number of Participants With Response at Week 8
- (and 5 more...)
|
98 |
All |
6 Years to 17 Years (Child) |
NCT00332241 |
CN138-178 |
|
June 2006 |
April 2008 |
April 2008 |
June 1, 2006 |
December 2, 2013 |
July 23, 2009 |
- Marsella, Gregory
Boca Raton, Florida, United States - Child Neurology Associates, Pc
Atlanta, Georgia, United States - University Of Louisville
Louisville, Kentucky, United States - (and 6 more...)
|
| 28 |
NCT01258465 |
Completed |
Research in Autism: Parent Intervention |
|
- Behavioral: Pivotal Response Training
- Behavioral: Picture Exchange Communication System
|
Interventional |
Not Applicable |
- University of California, San Diego
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Mullen Scales of Early Learning
- Vineland Adaptive Behavior Scales
|
39 |
All |
24 Months to 47 Months (Child) |
NCT01258465 |
MH39434 |
|
January 2005 |
December 2009 |
December 2009 |
December 13, 2010 |
December 13, 2010 |
|
- University of California, San Diego Psychology Department
La Jolla, California, United States - University of California, Santa Barbara, School of Education, Department of Clinical, Counseling, and School Psychology
Santa Barbara, California, United States
|
| 29 |
NCT03183674 |
Recruiting |
Oxytocin in Spectrum Autism Disorders |
|
- Drug: Oxytocin
- Other: placebo
|
Interventional |
Phase 1 |
- University of Sao Paulo General Hospital
|
Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Other
|
|
80 |
All |
3 Years to 16 Years (Child) |
NCT03183674 |
10922213.7.0000.0068-2 |
OxytocinASD |
July 15, 2016 |
July 20, 2017 |
July 29, 2017 |
June 12, 2017 |
June 12, 2017 |
|
- Instituto de Psiquiatria
São Paulo, Brazil
|
| 30 |
NCT00382382 |
Withdrawn |
Diffusion Tensor Imaging in Autism |
|
- Other: diffusion tensor imaging (DTI)
|
Interventional |
Not Applicable |
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Health Services Research
|
- RBS-R scores, including both total and subset scores
|
0 |
Male |
8 Years to 12 Years (Child) |
NCT00382382 |
1R03HD051656 |
|
July 2008 |
July 2009 |
July 2009 |
September 29, 2006 |
March 13, 2015 |
|
- McKnight Brain Institute of the University of Florida
Gainesville, Florida, United States
|
| 31 |
NCT01911442 |
Completed
Has Results |
Lurasidone Pediatric Autism Study |
|
- Drug: Lurasidone 20 mg daily
- Drug: Lurasidone
- Drug: Placebo
|
Interventional |
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change in Aberrant Behavior Checklist (ABC) Irritability Subscale Score at Week 6
- Change From Baseline in Clinical Global Impression-Severity (CGI-S) at Week 6
- Change From Baseline in Aberrant Behavior Checklist (ABC) Hyperactivity Subscale Score at Week 6
- (and 4 more...)
|
150 |
All |
6 Years to 17 Years (Child) |
NCT01911442 |
D1050325 |
|
August 2013 |
November 2014 |
November 2014 |
July 30, 2013 |
February 25, 2016 |
February 25, 2016 |
- Harmonex Neuroscience Research
Dothan, Alabama, United States - Southwest Autism Research & Resource Center
Phoenix, Arizona, United States - Newport Beach Clinical Research Associates
Newport Beach, California, United States - (and 38 more...)
|
| 32 |
NCT02708069 |
Completed |
e-Unstuck:Interactive e-Learning Software for Parents to Support Executive Functioning and Behavior Regulation in Children With Autism Spectrum Disorder |
|
- Other: e-Unstuck
- Other: Unstuck and On Target
|
Interventional |
Not Applicable |
- 3-C Institute for Social Development
- Children's National Health System
|
Industry / Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Supportive Care
|
- Change from baseline in parental knowledge of executive function and the Unstuck and On Target (UOT) intervention as measured on the UOT Knowledge Questionnaire.
- Change from baseline in parental stress on the Parenting Stress Index, Fourth Edition, Short Form (PSI-4-SF).
- Change from baseline in parental self-efficacy on the Parenting Sense of Competence Scale.
- Change from baseline in child executive function as measured on the Behavior Rating of Executive Function (BRIEF)
|
97 |
All |
Child, Adult, Senior |
NCT02708069 |
1R44MH109193 |
e-Unstuck |
March 1, 2017 |
February 28, 2018 |
February 28, 2018 |
March 15, 2016 |
March 2, 2018 |
|
- Children's National Health System
Rockville, Maryland, United States - 3C Institute
Durham, North Carolina, United States
|
| 33 |
NCT01400269 |
Completed |
An Evaluation of a Developmentally-Based Parent Training Program for Children With Autism |
|
- Behavioral: Pacific Autism Center for Education (PACE ) developmentally based parent delivered intervention
|
Interventional |
Not Applicable |
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Social Responsiveness Scale
- Repetitive Behavior Scale
- Family Empowerment Scale
- (and 3 more...)
|
48 |
All |
18 Months to 6 Years (Child) |
NCT01400269 |
SU-11022010-7169 |
|
September 2010 |
January 2014 |
January 2014 |
July 22, 2011 |
August 16, 2016 |
|
- Stanford University School of Medicine
Stanford, California, United States
|
| 34 |
NCT01474278 |
Completed |
A Study of RO5028442 in Adult Male High-Functioning Autistic Patients |
|
- Drug: Placebo
- Drug: RO5028442
|
Interventional |
Phase 1 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Double (Participant, Investigator)
|
- Efficacy: Behavior assessments
- Safety: Incidence of adverse events
|
19 |
Male |
18 Years to 45 Years (Adult) |
NCT01474278 |
BP27801 |
|
December 2011 |
March 2013 |
March 2013 |
November 18, 2011 |
November 2, 2016 |
|
- Los Ageles, California, United States
- New Haven, Connecticut, United States
- Bronx, New York, United States
|
| 35 |
NCT02568631 |
Unknown † |
Improving Social Cognition for Adults With ASD by the Serious Game JeStiMulE Versus Controls |
|
- Other: serious game JeStiMulE
- Other: control video game
|
Interventional |
Phase 2
Phase 3 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change of Emotion recognition
- Change of Social cognition
- Change of impact on quality of life
- (and 2 more...)
|
30 |
All |
18 Years to 40 Years (Adult) |
NCT02568631 |
15-HPNCL-01 |
|
September 2015 |
September 2017 |
September 2017 |
October 6, 2015 |
October 6, 2015 |
|
- Fondation Lenval
Nice, France - Hôpital Pasteur - CHU de Nice
Nice, France - Hôpital psychiatrique de Sainte marie
Nice, France
|
| 36 |
NCT00576732 |
Completed
Has Results |
A Study of the Effectiveness and Safety of Two Doses of Risperidone in the Treatment of Children and Adolescents With Autistic Disorder |
|
- Drug: Placebo
- Drug: Risperidone high dose
- Drug: Risperidone low dose
|
Interventional |
Phase 4 |
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Change in Aberrant Behavior Checklist Irritability (ABC-I) Subscale
- Number of Participants Who Had at Least 25% Improvement in ABC-I
- Change in Clinical Global Impression Severity (CGI-S)
- (and 5 more...)
|
96 |
All |
5 Years to 17 Years (Child) |
NCT00576732 |
CR014740
RISAUT4002 |
|
December 2007 |
September 2009 |
March 2010 |
December 19, 2007 |
May 9, 2014 |
September 28, 2010 |
- Dothan, Alabama, United States
- Phoenix, Arizona, United States
- Sacramento, California, United States
- (and 17 more...)
|
| 37 |
NCT00198120 |
Completed |
Safety and Effectiveness of D-Cycloserine in Children With Autism |
|
- Drug: D-cycloserine
- Drug: Placebo
|
Interventional |
Phase 3 |
- Indiana University
- National Institute of Mental Health (NIMH)
- National Alliance for Research on Schizophrenia and Depression
- Indiana University School of Medicine
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change in Clinical Global Impressions (CGI) Global Improvement
- Change in Lethargy Subscale of the Aberrant Behavior Checklist (ABC)
|
80 |
All |
3 Years to 12 Years (Child) |
NCT00198120 |
K23MH068627
0305-30
DDTR BK-TKND |
|
February 2004 |
September 2007 |
August 2010 |
September 20, 2005 |
April 12, 2016 |
|
- Riley Hospital for Children, Christian Sarkine Autism Treatment Center
Indianapolis, Indiana, United States
|
| 38 |
NCT00676195 |
Completed
Has Results |
An Open-Label Study of N-Acetyl Cysteine in Children With Autism |
|
|
Interventional |
Phase 2 |
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of Participants With Adverse Events Reported on the Dosage Record and Treatment Emergent Symptom Scale (DOTES)
- Social Responsiveness Scale (SRS)
- Sensory Profile Questionnaire (SPQ)
- (and 2 more...)
|
24 |
All |
3 Years to 12 Years (Child) |
NCT00676195 |
SU-05062008-1139 |
|
June 2008 |
June 2010 |
June 2010 |
May 12, 2008 |
March 29, 2017 |
March 29, 2017 |
- Stanford University School of Medicine
Stanford, California, United States
|
| 39 |
NCT00273650 |
Completed |
Efficacy Study of Subcutaneous Methyl-B12 in Children With Autism |
|
- Drug: methylcobalamin
- Other: saline placebo
|
Interventional |
Phase 2
Phase 3 |
- University of California, Davis
|
Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Primary measure is the Clinical Global Impression Scale -Improvement supplemented by videos taken at all visits and rated blindly to measure executive function, speech, and language, and socio-economic development.
- Secondary measures:NEPSY, ABC, PPVT, SB:V, PDRF, MCDI, PIA-CV, and CARS.
|
35 |
All |
3 Years to 8 Years (Child) |
NCT00273650 |
MB12-AUT |
|
July 2005 |
June 2009 |
August 2009 |
January 9, 2006 |
November 1, 2012 |
|
- UC Davis MIND Institute
Sacramento, California, United States
|
| 40 |
NCT00627705 |
Completed
Has Results |
A Study of N-Acetyl Cysteine in Children With Autism |
|
- Drug: N-Acetyl Cysteine
- Other: Placebo - sugar pill
|
Interventional |
Phase 2 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Total Number of Subjects With Reported Side Effects as Assessed by Dosage Record and Treatment Emergent Symptom Scale (DOTES)
- The Clinical Global Rating Scale (CGRS) Improvement Subscale Score
- Glutathione (GSH) Levels in Peripheral Blood, Measured by State-of-the-art High-performance Liquid Chromatography (HPLC)
- (and 5 more...)
|
43 |
All |
3 Years to 12 Years (Child) |
NCT00627705 |
SU-02012008-995
10142 |
|
February 2008 |
September 2010 |
September 2010 |
March 3, 2008 |
May 18, 2017 |
May 18, 2017 |
- Stanford University School of Medicine
Stanford, California, United States
|
| 41 |
NCT00692315 |
Completed |
Treating Oxidative Stress in Children With Autism |
|
- Drug: Methylcobalamin (methylB12)
|
Interventional |
Not Applicable |
- Arkansas Children's Hospital Research Institute
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Glutathione redox status (GSH/GSSG)
- Vineland Adaptive Behavior Scales
|
40 |
All |
3 Years to 7 Years (Child) |
NCT00692315 |
28839 |
|
September 2006 |
June 2007 |
December 2007 |
June 6, 2008 |
April 15, 2016 |
|
- Arkansas Children's Hospital Research Institute
Little Rock, Arkansas, United States
|
| 42 |
NCT02677051 |
Recruiting |
Sulforaphane in a New Jersey (NJ) Population of Individuals With Autism |
|
- Drug: Sulforaphane
- Drug: Placebo
|
Interventional |
Phase 2 |
- Rutgers, The State University of New Jersey
- Rowan University
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change in Aberrant Behavior Checklist (ABC) scores.
- Change in Social Responsiveness Scale (SRS) scores.
- Clinical Global Impression Severity Scale (CGI-S).
- (and 4 more...)
|
40 |
Male |
13 Years to 30 Years (Child, Adult) |
NCT02677051 |
Pro20120001884
CAUT15APL013 |
|
February 2016 |
July 2018 |
January 2022 |
February 9, 2016 |
January 25, 2018 |
|
- Rutgers University - Staged Research Building
Piscataway, New Jersey, United States
|
| 43 |
NCT00670891 |
Completed |
A Clinical Trial of the Clinical Effects of Hyperbaric Oxygen Therapy in Thai Autistic Children |
|
- Procedure: oxygen (Hyperbaric Oxygen Therapy)
|
Interventional |
Phase 1 |
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Developmental and Skill training assessment, Rajanukul Hospital 5th edition
|
7 |
All |
5 Years to 9 Years (Child) |
NCT00670891 |
VP 000001 |
VPH |
July 2007 |
April 2008 |
April 2008 |
May 2, 2008 |
May 29, 2008 |
|
- Vachira Phuket Hospital
Phuket, Thailand
|
| 44 |
NCT00057408 |
Completed |
A Controlled Study of Olanzapine in Children With Autism |
|
- Drug: olanzapine (Zyprexa)
- Drug: Placebo
|
Interventional |
Phase 2 |
- FDA Office of Orphan Products Development
- National Institute of Mental Health (NIMH)
|
U.S. Fed / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Children's Psychiatric Rating Scale
- Clinical Global Impressions
- Aberant Behavior Checklist
- (and 4 more...)
|
78 |
All |
3 Years to 12 Years (Child) |
NCT00057408 |
2190 |
|
May 2003 |
|
September 2005 |
April 2, 2003 |
March 25, 2015 |
|
- Drexel University College of Medicine c/o Friends Hospital
Philadelphia, Pennsylvania, United States
|
| 45 |
NCT01227668 |
Completed
Has Results |
Phase IV Long-term Maintenance Study of Aripiprazole in the Treatment of Irritability Associated With Autistic Disorder |
- Irritability Associated With Autistic Disorder
|
- Drug: Aripiprazole
- Drug: Placebo
|
Interventional |
Phase 4 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Percentage of Patients Relapsing by Week 16
- Adjusted Mean Change From Baseline to Week 16 on the Aberrant Behavior Checklist Irritability (ABC-I) Subscale Score (Last Observation Carried Forward [LOCF])
- Change From Baseline in Mean Clinical Global Impression Improvement (CGI-I) Scale Score at Week 16 (Last Observation Carried Forward [LOCF])
- Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), and Adverse Events (AEs) Leading to Discontinuation During Phase 1
|
215 |
All |
6 Years to 17 Years (Child) |
NCT01227668 |
CN138-603 |
|
March 2011 |
June 2012 |
June 2012 |
October 25, 2010 |
May 2, 2014 |
May 2, 2014 |
- Harmonex Neuroscience Research, Inc
Dothan, Alabama, United States - Southwest Autism Research And Resource Center
Phoenix, Arizona, United States - Clinical Innovations, Inc.
Costa Mesa, California, United States - (and 35 more...)
|
| 46 |
NCT00004449 |
Completed |
Randomized Study of Intensive One-on-one Behavioral Treatment for Preschool Aged Children With Autism |
|
- Behavioral: intensive one-on-one behavioral treatment
- Behavioral: Individualized in home parent training
|
Interventional |
Not Applicable |
- University of California, Los Angeles
- National Institute of Mental Health (NIMH)
|
Other / NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Wechsler Preschool and Primary Scales of Intelligence, 3rd ed.
- Bayley Scales of Infant Development
- Merrill-Palmer Scale of Mental Tests
- (and 2 more...)
|
102 |
All |
2 Years to 3 Years (Child) |
NCT00004449 |
R01MH048863
UCLA-HSPC-G930506611 |
|
May 1998 |
September 2004 |
April 2006 |
October 19, 1999 |
May 27, 2015 |
|
|
| 47 |
NCT00245778 |
Terminated |
fMRI Study of Grasping in Autistic Patients |
|
|
Observational |
|
- University Hospital, Tours
|
Other |
- Observational Model: Case Control
- Primary Purpose: Screening
- Time Perspective: Cross-Sectional
- Time Perspective: Prospective
|
|
30 |
Male |
18 Years to 35 Years (Adult) |
NCT00245778 |
PHRC-R-2003-INCA |
|
March 2004 |
|
February 2007 |
October 28, 2005 |
May 28, 2007 |
|
- University hospital of Tours
Tours, France
|
| 48 |
NCT00086645 |
Completed |
Citalopram for Children With Autism and Repetitive Behavior (STAART Study 1) |
|
- Drug: citalopram hydrobromide
- Other: placebo
|
Interventional |
Phase 2 |
- Boston University
- National Institute of Mental Health (NIMH)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Clinical Global Improvement
- Safety Monitoring Uniform Research Form (SMURF)
- Children's Yale-Brown Obsessive-Compulsive Scale (CYBOCS)
- (and 7 more...)
|
149 |
All |
5 Years to 17 Years (Child) |
NCT00086645 |
U54MH066398 |
|
April 2004 |
October 2006 |
April 2007 |
July 13, 2004 |
March 10, 2017 |
|
- UCLA Neuropsychiatric Institute
Los Angeles, California, United States - Yale University
New Haven, Connecticut, United States - Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States - (and 3 more...)
|
| 49 |
NCT02649959 |
Active, not recruiting |
An Open Label Study of CM-AT for the Treatment of Children With Autism |
|
|
Interventional |
Phase 3 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Aberrant Behavioral Checklist: Subscale of Irritability / Agitation (ABC-I) at fecal chymotrypsin (FCT) levels less than or equal to 12.6
- Aberrant Behavior Checklist: Subscale of Lethargy / Social Withdrawal (ABC-L) at fecal chymotrypsin (FCT) levels less than or equal to 12.6
|
405 |
All |
3 Years to 17 Years (Child) |
NCT02649959 |
00104/Open Label-Autism |
|
October 2015 |
October 2018 |
December 2018 |
January 8, 2016 |
April 17, 2018 |
|
- Southwest Autism Research & Resource Center (S.A.R.R.C.)
Phoenix, Arizona, United States - University of Arizona, Pediatrics Multidisciplinary Research Unit
Tucson, Arizona, United States - Arkansas Children'S Hosp. Research Institute (A.C.H.R.I.)
Little Rock, Arkansas, United States - (and 28 more...)
|
| 50 |
NCT00198107 |
Completed |
Evaluating the Effectiveness of Aripiprazole and D-Cycloserine to Treat Symptoms Associated With Autism |
|
- Drug: Aripiprazole
- Drug: Placebo
- Drug: D-cycloserine
|
Interventional |
Phase 3 |
- Indiana University
- National Institute of Mental Health (NIMH)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Aberrant Behavior Checklist (ABC) Irritability Subscale
- Clinical Global Impression (CGI) Scale
- ABC Subscales
- (and 4 more...)
|
81 |
All |
5 Years to 17 Years (Child) |
NCT00198107 |
R01MH072961
DSIR 82-SEDR |
|
September 2005 |
September 2011 |
September 2011 |
September 20, 2005 |
April 20, 2017 |
|
- Riley Hospital for Children, Christian Sarkine Autism Treatment Center
Indianapolis, Indiana, United States
|
Create an RSS feed from your search for:
Download the search results for: