Previous Study Results

Asenapine

Results coming soon. The purpose of this research study is to examine the safety and efficacy of asenapine on improving functioning in adolescents with schizophrenia.

Oxytocin

Results coming soon. A study to evaluate the medication, oxytocin, as a supplemental treatment for improving social difficulties in children and adolescents, ages 3 to 17, with autism. Participants will be randomly (by chance) assigned to take either placebo (fake medicine) or active oxytocin for 2 months. After 2 months all participants will take active oxytocin for 2 months.

BMS

Results coming soon. A trial of an investigational medicine called aripiprazole (Abilify®). The study is looking to see if aripiprazole is effective in treating children and adolescents with irritable behaviors.

ICBT-PI

Results coming soon. A study to examine whether an intensive computerized intervention targeted on improving central auditory and visual processing and executive functioning can be used in youth with psychotic spectrum disorders. This is a 52 week study, which involves visits to the study doctor and daily computer play for five months. We are looking for participants (ages 10-19) with a history of psychosis, schizophrenia, schizophreniform disorder or schizoaffective disorder.

ARIPIPRAZOLE fMRI

Results coming soon. An open-label study of aripiprazole (Abilify®) that includes 8 weeks of treatment. Functional MRI’s will be completed at the beginning and end of treatment period for persons with high functioning autism (ages 10-55).

PAIRS

Results coming soon. A study that is looking for children who are not on any medications for treatment of symptoms associated with autism and who do not expect to start such medications. These children will tell us about the rate of development over the course of one year in children who do not get medication. The children will help us know whether developmental benefits we observe with medications are really due to the medications or would happen even without medications because of the other supports many children with autism receive. Children in this study will NOT receive any medications. Participation would involve being assessed by the study doctor, completing cognitive assessments three times over the course of a year. Blood tests are optional at each of the visits.

LATUDA

Results coming soon.  A study to examine whether lurasidone (Latuda ®) induces weight gain in children and adolescents ages 6-19.  Participants must not have taken certain medications that are similar to Lurasidone (Latuda ®) for more than 4 weeks.  Similar medications include Risperidal®, Abilify®, Zyprexa®, Seroquel®, Geodon® and Invega®.

ConnectMe-91

Results coming soon. A study for children with Autism, Asperger’s Disorder and PDD-NOS to see if an investigational drug is safe and may help with some of the core symptoms of autism. Participants will receive active study drug for up to 48 weeks and may be eligible to participate in follow-up research studies.

IMPACT

Results coming soon.  A study that explores three different ways to try to reduce the weight gain caused by antipsychotic medications. Children and adolescents, ages 8-19, who have gained lots of weight while taking iloperidone (Fanapt®), lurasidone (Latuda®), asenapine (Saphris®), aripiprazole (Abilify®), olanzapine (Zyprexa®), quetiapine (Seroquel®), risperidone (Risperdal®), ziprasidone (Geodon®), paliperidone (Invega®), and/or fluoxetine/olanzapine (Symbyax®) are eligible. The ways we are trying to reduce weight are healthy lifestyle guidance, change of medication and/or addition of metformin, a medication that helps the body use insulin better.

STAART 1: A Double-blind, Placebo-controlled Trial of Citalopram for Repetitive Behaviors in Children with Autism Spectrum Conditions

This National Institute of Health funded study has come to a close. The study was headed by Dr. Linmarie Sikich at UNC and by teams at UCLA, Mount Sinai, Zucker Hillside Hospital in New York, Yale, and Dartmouth. In this study, we looked at what the effects of taking an antidepressant called Celexa® (citalopram) are on children and adolescents diagnosed with autism spectrum disorders who display repetitive behaviors. The study results revealed that Citalopram, the scientific name of the drug Celexa®, did not relieve these symptoms any better than placebo. In fact, the behaviors increased in some children on the drug. Celexa® is a drug that treats approximately 30% of people with autism and was believed to be and effective and safe treatment by many physicians but turns out is actually not effective according to study results. This study shows that we need more placebo comparison trials to find out which are effective treatments and rule out medications that really don’t work. We greatly appreciate all of the families who participated in these studies. Without their help, we could not do the studies that help us know which treatments work and which ones don’t.

STAART 1 Article

TEOSS: Treatment of Early Onset Schizophrenia Spectrum

In common practice, it has been standard to for physicians to prescribe atypical (second generation) antipsychotics over typical (first generation) antipsychotics. However, second generation antipsychotics (SGAS) have not demonstrated superiority over it’s first generation counterpart. The TEOSS study (Treatment of Early Onset Schizophrenia Spectrum) compared the effectiveness between two commonly prescribed SGAS, olanzapine (Zyprexa®) and risperidone (Risperdal®), and one first generation antipsychotic, molindone (Moban®), on patients between the ages of 8 to 19 with a diagnosis of schizophrenia or schizoaffective disorder in an 8 week trial.

The results showed that Zyprexa® and Risperal® were associated with significant weight gain, where Zyprexa® displayed the greatest weight gain and increased cholesterol. Moban® was associated with more self-reports of akathisia, which is characterized by an inability to sit still or remain motionless. Zyprexa® and Risperdal® did not display superior treatment outcomes over Moban®. The side effects, however, of the first and second generation antipsychotics were different.

This study raises questions in the preference to prescribe second over first generation antipsychotics. The weight gain in child and adolescent populations taking second generation medication raises some important safety concerns. The main take-away message from this study was that both first and second generation medications should be considered when treating patients with schizophrenia or schizoaffective disorders. Physicians should weigh the benefits and side effects to determine which medication would best suit each individual patient. In most cases, patients will have to try many different medications before finding the one or combination that is best for them.

TEOSS Study Article

Seaside Therapeutics: Arbaclofen Studies

This past September, Seaside Therapeutics announced new findings in a clinical study on a novel treatment for autism spectrum disorders (ASD) and for a study for the treatment of fragile X syndrome (FXS). In both studies, the drug STX209 (also called arbaclofen) showed improvements in measures of social responsiveness. The drug also showed improvements in other measures such as anxiety, hyperactivity, and adaptive function in a group of patients with ASD aged 6-17 years. Neurodevelopmental disorders like ASD and FXS are thought to arise from excessive activation of brain receptors, and arbaclofen may act to control and reduce this hyperactivity. Side effects included agitation, irritability, fatigue, hyperactivity, diarrhea, and insomnia, they generally resolved without any changes to drug dosage. Indiana University School of Medicine Assistant Professor of Psychiatry Craig A. Erickson, M.D., an investigator in the study, said, “This work will potentially open up a door to treating disorders that has, until recently, been firmly shut.” The ASPIRE Research Program was a participating site in both the ASD and FXS clinical trials.

Seaside Autism Article

Arbaclofen cross-over FX study 2012

Arbaclofen in fragile X mice

Report from Synapse and NDDzohgi 2012

New York Times Article on the Sudden End of the Arbaclofen Studies

Curemark: A Phase III Randomized Double Blind Placebo Controlled Trial of LUMINENZ-AT™ (CM-AT) In Children with Autism

LUMINENZ-AT™ is a lipid-encapsulated pancreatic enzyme concentrate (PEC) designed to release chymotrypsin and other proteases in the proximal small intestine. The intended indication of LUMINENZ-AT™ is for the treatment of irritability and hyperactivity, which includes abnormal body movements, in children ages 3-8 who have autism. Curemark’s findings indicate that a large subset of children with autism have an endogenous lack of chymotrypsin, as expressed by low fecal chymotrypsin levels. It is hypothesized that if there is an underlying defect in the digestion of dietary proteins, it would contribute to a deficiency in essential and semi-essential amino acids. This would leave the child unable to synthesize new proteins. Proteins such as neurotransmitters and other essential proteins needed for key bodily functions may not be able to be produced by the body due to a lack of essential amino acids. A partial or complete lack of protein digestion could further lead to allergy and/or other digestive dysfunctions.

Curemark Completed Phase Article

STORY

Results coming soon....