CURRENT & UPCOMING STUDIES

Our current research studies aim to better understand juvenile bipolar disorder, psychotic illnesses, and autistic spectrum disorders. These include neuroimaging studies and clinical (medication) trials.
(Please click on the links below to learn more about these individual studies.)

Study participants have access to state-of-the-art medical care free of charge. This may include evaluations, tests and medications. For some of the studies, it is possible to be evaluated at either McLean Hospital or Cambridge Health Alliance.

For example, our neuroimaging studies use magnetic resonance imaging (MRI) scans. MRI is a safe way to see inside the brain. Unlike X-rays or CT scans, MRI does not involve any radiation. Over the past 10 years, we have scanned over 200 children and adolescents with and without mental illness.

Treatment Studies/ Neuroimaging Studies
Aripiprazole to treat Children with Autism-Spectrum Disorders
Collaborative Lithium Trials in Early-Onset Bipolar Disorder
Study of Fluoxetine in Autism (SOFIA)
Progression to Schizophrenia
Phenotypic Factors in Autism Spectrum Disorders
Diffusion Tensor Imaging MRI Study
Lithium MRS of Children and Adolescents with Bipolar Disorder Being Treated with Lithium.
Ziprasidone to Prevent Psychosis among Individuals at High Risk (ZIP)

Upcoming Studies
Replays Therapy for Children with Williams and Autism Spectrum Disorders
MRI Study of Children and Adolescents with Bipolar Disorder being treated with Risperidone.

Treatment Studies/ Neuroimaging Studies

Studies of Aripiprazole in Autism
We have several ongoing studies measuring the safety and efficacy of aripiprazole (Abilify®) in autism spectrum disorders, in children ages 6-17. These studies offer a thorough initial psychiatric evaluation, ongoing monitoring, and psychiatric and physical assessments.

Study of Fluoxetine in Autism (SOFIA)
This is a multi-site, 14-week, randomized, placebo-controlled, double blind study investigating the effect of fluoxetine (Prozac ®) on repetitive behaviors in children, 5-17 years old, with an autism spectrum disorder. Subjects will receive thorough psychiatric and physical evaluations. There will be a total of 9 visits, occurring every other week after baseline.

Progression to Schizophrenia
This project is part of a large, NIMH grant under the Center for Intervention Development and Applied Research (CIDAR). The aim of this project is to study subjects who are at various stages of progression of the disorder ("prodromal", first episode, and chronic), giving us a broad perspective and database on phenotypic markers and predictors of progression as well as healthy controls. The study aims to link clinical, cognitive, neuroimaging, electrophysiological, hormonal, and genetic markers of schizophrenia disease progression to the understanding of how the underlying neural circuits may be disturbed. We do this by investigating the expression of genes of interest in specific cellular populations in pre-existing post-mortem material and evaluating genetic association of the relevant genes with progression indices from each of the constituent projects.

Phenotypic Factors in Autism Spectrum Disorders
The goal of this Autism Consortium study is to learn more about the relationship between genes and behavior in autism spectrum disorders. Children aged 24 months and older may be eligible to participate, along with their parents and some siblings. Assessments will include IQ tests, questionnaires, behavioral observations, and a blood sample.

Diffusion Tensor Imaging MRI Study
This study is for volunteers 6-13 years old who either have bipolar disorder or who are healthy comparison children. Children receive a thorough psychiatric evaluation and a clinical MRI scan at McLean Hospital. The scan also includes a novel research technique to examine the brain’s white matter tracts.

"We are especially in need of healthy control children right now."

Funding for this study was awarded to Melissa Lopez-Larson, M.D., by the American Academy of Child and Adolescent Psychiatry.

Replays Therapy for Children with Williams and Autism Spectrum Disorders
Several studies will soon be underway to examine the effectiveness of Dr. Levine's Replays program in helping children with behavioral challenges.

Lithium MRS of Children and Adolescents with Bipolar Disorder Being Treated with Lithium.
This NIH-funded study will use magnetic resonance imaging to measure lithium levels in the brain and correlate them with serum values as well as with clinical and behavioral variables. Children enrolled in the COLT study will be eligible for this study.

Upcoming Studies

MRI Study of Children and Adolescents with Bipolar Disorder being treated with Risperidone.
This study, also NIH-funded, will examine brain metabolite changes in children and adolescents (age 10-16) associated with risperidone treatment.

Ziprasidone to Prevent Psychosis among Individuals at High Risk (ZIP)
The goal of this placebo-controlled study is to determine whether the medication ziprasidone can prevent or delay the onset of psychosis in adolescents and young adults with prodromal symptoms.

Collaborative Lithium Trials in Early-Onset Bipolar Disorder
This multiphase, multi-site study is funded by the federal government in order to provide healthy and safety information about the use of lithium in children. The study will include four phases of treatment. The first phase, the Pharmacokinetic Phase, will include 8 weeks of open-label treatment to determine dosing strategies for children and adolescents with bipolar disorder. Once patients complete the Pharmacokinetic Phase, they may be eligible to continue in the Long-Term Effectiveness Phase for up to 16 weeks of lithium treatment. Patients meeting response criteria during the Long-Term Effectiveness Phase will be eligible to continue in the Discontinuation Phase. During the Discontinuation Phase, subjects will be randomized to either placebo or lithium treatment for up to 28 weeks. Finally, those subjects who experience a mood relapse during the Discontinuation Phase can reinitiate lithium treatment for up to 8 weeks in an open-label Restabilization Phase.