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Research Studies: Childhood Mood Disorders

DBSA does not endorse nor recommend any particular research study. Patients should discuss all options with their health care providers and family members before beginning any study.

Many people think that participating in a research study means they will get better treatment for their illness. While this may be true, it's important to remember that a research study is conducted for research purposes—it does not ensure better or safer treatment.

Taking part in a study does not guarantee individual benefits to the participant in the form of newer or safer treatment. The contribution made participating in a research study is to science first and to the patient second.

DBSA, its advisors, and consultants do not endorse or recommend the use of any specific treatment or medication. For advice about specific treatment or medication, patients should consult their physicians and/or mental health professionals.


Brain Lithium Treatment Study

Does your child experience rapid mood swings? Do you or your doctor suspect that your child may have bipolar disorder? Need help? The Pediatric Mood Disorders Program at the University of Illinois at Chicago is currently seeking children and adolescents to participate in a research study. Subjects ages 10-16 will be asked to participate in an 8-week trial of lithium in the treatment of pediatric bipolar disorder. We also seek 10-16 year old healthy youths to compare the patients with typically developing youths. The aim of this study is to udnerstand how the brain functions in unmedicated children and adolescents with bipolar disorder relative to their healthy peers. This study will also investigate whether and how lithium treatment can reverse problems in brain function in kids with bipolar.

The study will, therefore, involve examining your child's brain function in an fMRI scanner before and after 8 weeks of treatment with lithium if your child has bipolar disorder, or, if your child is participating as a healthy subject, just two testing sessions 8 weeks apart. This study is being conducted by Dr. Mani Pavuluri.

This study offers:

  • A diagnostic interview to evaluate your child's mood and behavior. All subjects will be seen by Dr. Pavuluri
  • 8 weeks of medication treatment with lithium under Dr. Pavuluri's care, if your child has bipolar disorder, and weekly visits to monitor your child's response to the medication.
  • One testing session at the beginning and one at the end of treatment; this includes a brain scan (fMRI), neuropychological tests (on a computer), academic tests, and eye movement tests. If your child participates as a healthy subject, he/she will be required only to complete one testing session at the beginning and one at the end of 8 weeks.
  • Monetary compensation for each testing session.

Contact:
Stephanie Parnes (Research Coordinator)
312-413-1710

The Pediatric Mood Disorders Program at the University of Illinois at Chicago
Chicago, IL
60612
United States


Children & Adolescents with Severe Mood Dysregulation: Brain Imaging, Non-Treatment & Treatment Studies

The National Institute of Mental Health is seeking boys and girls ages 7 to 17 with severe mood dysregulation to participate in research. Children and adolescents with mood and behavioral dysregulation display chronic anger, sadness, or irritability, as well as hyperarousal symptoms common in ADHD (such as insomnia, distractibility, hyperactivity) and extreme responses to frustration (such as frequent, severe temper tantrums). Sometimes, children with this pattern of severe chronic irritability and outbursts are given the diagnosis of Bipolar Disorder.

The non-treatment study involves visits to the NIH campus in Bethesda Maryland and includes outpatient assessment, computer tasks, and fMRI scanning (a form of brain imaging),

A treatment study is also available for those who are not doing well on their current medication(s). The treatment study includes these outpatient assessments and research tasks plus discontinuation of all current medications and starting new medications or a placebo. The discontinuation of current medication and starting of new medications occurs while the child is hospitalized or in day treatment at the NIH Clinical Center in Bethesda, MD. The remainder of the treatment trial can be completed in those settings or as an outpatient from home with the child coming to NIH only for clinic visits every other week. This study seeks to learn whether citalopram, a selective serotonin reuptake inhibitor (SSRI), added to methylphenidate (e.g. Ritalin®) is helpful for severe irritability. Eligible participants receive optimal doses of methylphenidate (e.g., Ritalin), and then are randomly assigned to receive citalopram or placebo, in addition to methylphenidate. While these medications are used commonly in the treatment of ADHD, depression, and anxiety, their use in very irritable children is experimental. All participants will receive a thorough clinical evaluation. All participants must be able to fill out daily self rating forms and cooperate with study procedures (including genetics study, MRI, neuropsychological and behavioral testing).

Participants in the treatment study also must be:

  • in  treatment with a psychiatrist who agrees that it is appropriate for the child to participate in the study
  • not doing well on current medications

There is no charge for participation in this study. 
Travel and lodging expenses paid for by NIMH.

Contact:
301-496-8381
TTY: 1-866-411-1010
bipolarkids@mail.nih.gov

National Institutes of Health Clinical Center
9000 Rockville Pike
Bethesda, MD
20892
United States
http://patientinfo.nimh.nih.gov

[The principal researcher is Ellen Leibenluft, M.D., Chief, Section on Bipolar Spectrum Disorders, Emotion and Development Branch, National Institute of Mental Health Intramural Research Program


National Institute of Mental Health-Research Into the Causes of Bipolar Disorder

National Institute of Mental Health (NIMH) is conducting a research study with children and adolescents, ages 6-17, with bipolar disorder. This study will take place at the NIH Clinical Center in Bethesda, Maryland. Both parent and child must agree to the child’s participation.

Research into Causes of Bipolar Disorder:

  • Children ages 6-17 with bipolar disorder
  • Research tasks include neuroimaging, computer tasks & neuropsychological testing
  • If stable on current medications, annual outpatient visits

OR

  • If unstable on current medications, day or full hospitalization to discontinue medication, perform research tasks while medication-free for 2 weeks, followed by standard medications

There is no charge for extensive evaluations done as part of the study. Travel expenses incurred by the patient and parent/guardian will be paid by the NIMH. For more details, see the NIMH Web site (below) and contact Dr. Ellen Leibenluft at (301) 496-8381.

Participating families from out of town stay at the Children's Inn in Bethesda, MD (http://www.childrensinn.org/).

Contact:
(301) 496-8381

9000 Rockville Pike
Bethesda, MD
20892
United States
http://patientinfo.nimh.nih.gov/BipolarDisorderPediatric.aspx#118


Omega-3 and Therapy Study (OATS)

Researchers at the Ohio State University Medical Center are currently accepting children who have mood difficulties for a treatment study. This study is testing whether omega-3 dietary supplementation and/or individual-family psychoeducational psychotherapy (IF-PEP) will improve functioning in children with depression or bipolar disorder not otherwise specified.

Child participants will be randomly assigned into one of four groups: 1) omega-3 and IF-PEP, 2) placebo and IF-PEP, 3) omega-3 and active monitoring, or 4) placebo and active monitoring. 

OATS lasts 12 weeks. During those 12 weeks children and their caregivers would participate in a screening visit, 6 study assessments and 15-24 therapy sessions (if in Groups 1 or 2) at The Ohio State Medical Center. Assessments consist of interviews with parent and child and pulse & blood pressure readings. We will also collect a blood sample from the child at the first and last of these assessments to monitor omega-3 and nutritional levels in their blood.  Also, a study physician or nurse practitioner will conduct a physical exam of the child at the screening visit and at the last study assessment. 

To be eligible for the study, children must be:

  • Between the ages of 7 and 14
  • Satisfy criteria for depression or bipolar-NOS (you can simply suspect it, we will test for it)
  • Be able to swallow pills (we provide pill swallowing training)
  • Be willing to have blood drawn
  • NOT have a major medical disorder that interferes with study treatment
  • NOT be diagnosed with intellectual disability or autism
  • NOT have psychotic symptoms or active suicidal concern
  • NOT take psychotropic medication, other than stimulants for ADHD or sleep aids, in the month prior to and throughout the remainder of the study

All evaluations, procedures, and supplements for this study will be provided at no cost to participants. There is some reimbursement for travel (a parking voucher or bus/cab fare) and participation for parent (up to $190.00) and child (up to $45.00). There are some risks, which will be explained prior to participation consent.

Contact:
Kayden Healy
614-293-4908
kayden.healy@osumc.edu

Ohio State University Medical Center at OSU Harding Hospital
1670 Upham Dr., Suite 465
Columbus, OH
43210
United States


Pediatric Bipolar Disorder Therapy Treatment Study

The Pediatric Mood Disorders Program at the University of Illinois at Chicago is currently seeking children ages 7-13 with pediatric bipolar disorder (or suspected pediatric bipolar disorder) to participate in a research study funded by the National Institutes of Mental Health. Families will be asked to participate in a psychotherapy treatment program. The purpose of this study is to help us determine how different types of therapies might be helpful to children suffering from pediatric bipolar disorder and their families.  

The study involves weekly therapy sessions for 3 months and then monthly therapy sessions for 6 months (as needed). Children and their parents must be willing to be seen by a physician in our program for medication treatment and monitoring (although this study does not involve starting or changing any medications). Once in the study, children and families take part in regular research interviews and fill out questionnaires about their individual and family functioning every month for three months, and then at the end of the 6-month follow-up. Families will receive compensation for participating in the study. 

Contact:
Jacquelyn Doxie, M.A. (Research Coordinator)
312-996-9438

The Pediatric Mood Disorders Program at the University of Illinois at Chicago
Chicago, IL
60612
United States