MIND Institute Clinical Trials and Research Studies
A Controlled Trial of Sertraline in Young Children with Autism Spectrum Disorder
(February 2015–December 2018)
The purpose of this study is to understand the effects of sertraline (Zoloft) on language development and autism symptoms in young children with autism spectrum disorder. If you participate in this study, you can expect three visits to the MIND Institute over six months (an initial visit, a three-month visit, and a final six-month visit). All visits will include a medical check. The initial and final visit will also include several assessments of language, development, and behaviors. The study medication is in liquid form and would need to be given once per day. There are also phone calls during the six months to see how your child is doing in the study.
We are recruiting males and females, ages 2-5 years 8 months old with autism spectrum disorder (ASD).
A Double Blind Randomized Placebo Controlled Study of CM-AT for the Treatment of Autism in Children with All Levels of Fecal Chymotrypsin
(January 2016–March 2017)
The purpose of this research study is to test the safety, tolerability, and effectiveness of the digestive enzyme CM-AT when used to treat core symptoms of autism spectrum disorder. CM-AT is an enzyme preparation, which is similar to the digestive enzymes produced by the pancreas. In this study, CM-AT will be sprinkled on your child’s food and given three times a day. CM-AT is an investigational drug, which means it has not been approved by the U.S. Food and Drug Administration (FDA) for treatment of autism. The study requires a total of 9 visits to the UC Davis MIND Institute, and these visits occur about every two weeks. Overall, the study will require physical exams, medical history reviews, medications reviews, autism testing, caregiver assessments, and safety assessments. Safety assessments include stool-sample collection that must be performed by a parent or caregiver.
We are recruiting males and females, ages 3-8 years old, with autism spectrum disorder (ASD).
Combining Lovastatin and a Parent-Implemented Language Intervention in a Multi-Modal Treatment of Fragile X Syndrome
(January 2016–November 2017)
The purpose of the study is to test the efficacy of a 20-week multimodal treatment comprised of lovastatin or placebo, and the Parent-implemented Language Intervention (PILI) in children with FXS. If you participate in the study, you can expect behavioral assessments, language assessments, medical history, a medical exam, parent questionnaires, and blood draws over three visits to the MIND Institute. The participant and his or her mother will have weekly video teleconferencing training sessions for the language intervention portion of the study, and each participant will be randomized to either the medication lovastatin or placebo throughout study participation.
We are recruiting children and adolescents with fragile X syndrome, ages 10–17 years old.
Fragile X Clinical and Research Cooperative Consortium Registry and Repository
This study aims to develop standards of care for diagnosis, evaluation, and treatment (medical, psychological, educational, and behavioral) for individuals with fragile X full mutation or premutation by collecting data from individuals who are seen at a Fragile X Clinic and Research Consortium Clinic. The protocol involves registering with the database and completing parent questionnaires.
We are recruiting males and females with the full mutation or premutation.
Genotype-Phenotype Relationships in Fragile X Families
(Summer 2012–Spring 2017)
This study aims to learn more about the fragile X premutation compared with those without. The study focuses on identifying areas of specific deficits. If you participate in this study you can expect two visits to the MIND Institute that include a medical history exam, neuropsychological evaluation, behavioral testing, neurological evaluation, balance and tremor assessment, MRI, blood draw, and skin biopsy.
We are recruiting males and females with and without the premutation (ages 8-85 years).
Longitudinal Study of Brain and Cognition in Fragile X Premutation Carriers
This study examines changes in the brain and cognition associated with aging, in males with and without the fragile X premutation. The study consists of three 2-day visits over the course of five years to observe changes in the brain and cognition occurring over time. The protocol involves a medical history exam, neuropsychological evaluation, behavioral testing, MRI, and blood draw.
We are recruiting males (ages 40–75 years) with and without the premutation.
Cognitive Training Program for Children and Adolescents with Fragile X Syndrome
The purpose of this study is to determine if a computer-based and game-oriented training program will enhance the working memory skills of children and adolescents with fragile X syndrome. If you participate in this study, you can expect: three in-home visits, including cognitive and behavioral assessments with your child, with each visit lasting approximately 2–4 hours; the three home visits will occur within an 18-week period; between these visits, your child will be enrolled in a computerized cognitive training program for 5-6 weeks, 5 days/week, 25–45 minutes/day.
We are recruiting males and females (ages 8–18 years) with the full mutation.
A Cognitive Test Battery for Intellectual Disabilities
The purpose of this research is to explore whether certain types of intellectual or cognitive tests are reliable, valid, and sensitive to improvement in evaluating treatment responses among individuals with intellectual disability. This newer cognitive test has been shown to accurately measure various cognitive skills across a wide age range, but has yet to be adapted and tested among individuals with intellectual disability. Participation in the study involves two to three visits at the UC Davis MIND Institute. The first visit will last approximately 3.5–4 hours and is scheduled over a two-day period. The second visit is scheduled approximately 4 weeks later and will be much shorter, only lasting about an hour. Some participants will be asked to return for a third visit. The schedule for the third visit is the same as the first visit and will take place approximately two years later. These visits will include cognitive testing for your son/daughter, and parents/guardian will be asked to fill out questionnaires. This is a multisite study with teams in Chicago and Denver also seeking participants.
We are recruiting individuals between the ages of 6–25 years old with a confirmed diagnosis of intellectual disability caused by fragile X syndrome, Down syndrome, or another cause.