Investing in the future...helping kids and families

Investing in the future...helping kids and families Brief Descriptions of CANDI Research for Children and Adolescents Bipolar: Lamotrigine Hormonal Influences COLT II (Lithium) Vitamin D Typically Developing Children & Adolescents: PING Hormonal Influences Vitamin D Autism Spectrum: Work Model Child & Adolescent Psychiatry UMASS Department of Psychiatry UMASS Medical School/UMASS Memorial Medical Center 365 Plantation Street, Suite 100 Worcester, MA 01605-2397 Website: http://umassmed.edu/psychiatry/candi Docket # s: 13058; 13821; 13541; 13447; 13715; November 2, 2010

How do I learn about helping kids and families through research? STEP 1: Call our CANDI Research Phone Line Monday Friday 508. 856. 5896 (8:00 5:00 PM) or Email: ChildResearch@umassmed.edu STEP 2: CANDI Staff will answer your questions and ask you a few questions to see if you (if you are calling for yourself as a candidate) or your child may be an appropriate match to participate in a research project. STEP 3: If it seems that you or your child may be an appropriate match to participate in a research project and YOU DECIDE YOU WANT to proceed; CANDI staff will schedule a ½ hour to an hour phone screen at your convenience. STEP 4: If, after the phone screen, we think you or your child might be an appropriate match to participate in a research project, AND YOU DECIDE YOU WANT TO CONTINUE, a meeting will be scheduled with one of the CANDI Clinicians to review you or your child s records and to ask further questions. Remember, you may stop your participation at any time! Thanks for considering investing in the future helping kids and families!

Investing in the future... helping kids with Bipolar Symptoms Abbreviated Why CANDI is Primary Age Sex Participants Funded by Participant/Caregiver Title participating Diagnosis Time Commitment *Number of compensation participants Lamotrigine The FDA has requested that Bipolar I or age 10-17 M Participants GlaxoSmithKline Reimbursement for travel (Lamictal) GSK investigate the effects suspected F time = up to of Lamictal in children and 60 weeks Compensation for time adolescents to determine if *166-360 participants Lamictal is safe and effective from 26 different Study medication is provided for use as an "add-on" therapy sites in USA to treat symptoms of * CANDI hopes to enroll up to 12 Weekly visits with CANDI Bipolar Disorder participants Clinicians are included Hormonal To better understand Bipolar I age 6-14 F * Participants Anonymous Family Foundation Reimbursement for Influences the biology depressed time = 2 +/- weeks travel that may lead to or mixed * MRI imaging will be *40 girls total in MA: Bipolar Disorder or suspected completed at UMASS 20 with Bipolar symptoms, Compensation for time in children. * Participants blood 20 with out Bipolar samples will be symptoms or diagnosis, mostly Participants will receive a Data will aid in the collected at CANDI. depression picture of their brain. development of targeted *Saliva & urine treatments. samples will be Only 4 onsite visits collected at home. COLT II To determine Bipolar I age 7-17 F Participants Eunice Kennedy Reimbursement for (Lithium) the long-term safety & mixed or M time = Shriver National Institute of travel tolerability of Lithium manic or up to 67 weeks Child Health and Human In children & adolescents suspected Development (NICHD) Compensation for time * 225 participants from 10 Study medication is provided different sites in USA * CANDI hopes to enroll Weekly visits with CANDI 22 participants Clinicians are provided

Investing in the future... Helping Kids with Bipolar Symptoms continued Abbreviated Why CANDI is Primary Age Sex Participants Funded by Participant & Title participating Diagnosis Time * Number of Caregiver Commitment Participants Compensation Vitamin D We wish to learn Bipolar age 8-17 M Participants NIMH Participants will receive whether Vitamin D Disorder & F time = up to 11 visits (National Institute of Mental compensation for their Glutamine and has mood stabilizing Mania to CANDI over an Health) time. Glutamate in effects which Diagnosis or 8 week period Children & may provide Caregiver will receive Adolescents new therapies Moody and Participants urine, saliva, CANDI wishes to enroll compensation for travel. Bipolar Disorder for patients have parent & blood samples will be 90 participants: diagnosed with with Bipolar collected at CANDI * 25 diagnosed with Participants will receive Bipolar Disorder or Bipolar & exhibiting photo copy of their brain Disorders MRI Imaging will be mania scan. Typically completed at UMASS * 20 with sub-threshold Developing* Participants diagnosed *see next page with Bipolar Disorder disorder will take Vitamin D soft gel supplement once/day during the study. symptoms of mania and have parent with bipolar *45 typically developing children & adolescents

Investing in the future... How typically developing children & adolescents can help Abbreviated Why CANDI is Primary Age Sex Participants Funded by Participant & Title participating Diagnosis Time Commitment * Number of Caregiver Participants Compensation Hormonal To better understand Typically ages 6-14 F Participants Anonymous Family Reimbursement for Influences the biologic events developing time = 2 +/- weeks Foundation travel that may lead to girls Bipolar Disorder in MRI Brain imaging will * Total of 40 girls : Only 4 onsite visits children. be completed at UMASS * 20 typically developing girls and Participants will Data will aid in the Participants blood * 20 girls exhibiting receive an image of development of targeted samples will be Bipolar Symptoms, mostly their brain treatments. collected at CANDI. Saliva & depression urine will be collected at home. PING The data collected will Typically ages 3-20 M Participants National Institutes Compensation for time become part of a large- developing F time = 2 visits of Health scale pediatric brain children and to CANDI Compensation for travel imaging data base that young adults will be available to Only two onsite visits the scientific Participants saliva *Total of 1,400 community. samples will be participants from 10 sites Participants will This data will allow us collected at CANDI. in USA receive an image of to determine what their brain typical brain MRI Imaging will *CANDI hopes to enroll development looks like. be completed at UMASS 120 participants Vitamin D We wish to compare the Typically ages 8-17 M Participants National Institutes Compensation for time MRI image of children and developing F time = 2-3 visits of Health Glutamine and adolescents who have children and to CANDI CANDI wishes to enroll Compensation for travel Glutamate in bipolar disorder and are adolescents 90 participants: Children & taking Vitamin D to healthy Participants urine, saliva, * 25 diagnosed with Only 2-3 onsite visits Adolescents typically developing children & blood samples will be Bipolar & exhibiting Bipolar Disorder and adolescents to learn collected at CANDI mania Participants will whether Vitamin D has a * 20 with sub-threshold receive an image of mood stabilizing effect. This MRI Imaging will be symptoms of mania and their brain may provide new therapies completed at UMASS have parent with bipolar for patients diagnosed with disorder bipolar disorders. *45 typically developing children & adolescents

Investing in the future... Helping Adolescents and Adults with Autism Spectrum Disorders Abbreviated Why CANDI is Primary Age Sex Participants time Funded by Participant & Care- Title participating Diagnosis Commitment * Number of giver compensation participants Work Model We wish to support young Aspergers ages 18-28 M Participants will work Life Sciences Moment Participants will (Customized adults with Aspergers to F 20 hours/week at UMASS Fund accumulate work Employment gain work experience site for 6 months experience. & Training Model) and competitive permament employment Total 9 month *CANDI hopes to enroll Participants will time commitment up to 14 participants. receive compensation Financial compensation for work for their work.