Anxiety Disorders (Pediatric) Research Study
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1. Clinical Trial of Fluoxetine in Anxiety and Depression in Children, and Associated Brain Changes
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This study uses functional magnetic resonance imaging (fMRI) to learn how the brain functions in adolescents receiving fluoxetine (Prozac) or cognitive behavioral therapy (CBT) for anxiety or depression in children/adolescents.
All participants will receive interviews to assess how they are doing in general, including his or her general mood, degree of nervousness and behavior. Each participant and one of his or her parents will be interviewed separately and together. All those enrolled in the study will have a physical examination. They will undergo tests involving problem-solving and memory and perform tasks that involve looking at pictures, remembering things, testing reaction times, and making simple choices.
Participants with anxiety or depression will first meet with a psychiatrist or psychologist for two weekly sessions of talk therapy. Those who remain anxious or depressed after these 2 weeks will have the 3 options based on their choice: 1) treatment with fluoxetine daily for 8 weeks 2) cognitive-behavioral therapy (a talk therapy) once a week for 8 weeks 3) a random assignment (50% chance) to either placebo or fluoxetine for 8 weeks. All participants will be seen approximately weekly for 8 weeks by a doctor to talk and complete verbal and written exercises. Blood samples will be drawn for laboratory tests before drug treatment and after it ends.
Those who have not improved by the end of the study will be offered other treatment for 1 to 3 months, and the clinicians will help with finding subsequent aftercare. Those who improve with treatment will continue therapy at NIH until an outside physician is able to assume responsibility for monitoring medication.
To find out if you qualify or for more information, please call (301) 402-8225 or email us at kidswithworries@mail.nih.gov.
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Protocol Information |
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Anxiety Disorders (Pediatric) Research Study
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2. Effect of D-Cycloserine on Treatment in Social Anxiety
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This study examines whether an antibiotic, d-cycloserine (DCS), boosts the effectiveness of cognitive behavior therapy (CBT) for social anxiety. CBT has been shown to be effective for the treatment of social anxiety in children and adults, but even after treatment, approximately 40% may remain diagnosable.
All participants will receive 12 weekly CBT sessions. In addition to receiving the CBT, participants will be randomly assigned (similar to a coin toss) to receive either DCS or a placebo (sugar pill). The pill will be taken 1-2 hours prior to each of the 12 CBT sessions. The pill is taken only on the 12 therapy days. If you are ages 7-55 with a social phobia, you may be eligible for the study.
To find out if you qualify or for more information, please call (301) 402-8225 or email us at kidswithsorries@mail.nih.gov.
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Protocol Information |
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Attention Deficit Hyperactivity Disorder (Pediatric) Research Study
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1. Brain Imaging of Childhood Onset Psychiatric Disorders, Endocrine Disorders and Healthy Controls
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Magnetic Resonance Imaging (MRI) combines a powerful magnet, radio waves, and sophisticated computer technology to provide exquisitely accurate information about the anatomy and physiology of the living, growing human brain - and it does so without the use of harmful radiation. This allows not only for the scanning of children and teens but of repeated scans over the course of development and has launched a new era of adolescent neuroscience. In this study, researchers will use MRIs to assess brain anatomy and function in healthy volunteers and patients with a variety of childhood onset psychiatric disorders. Identical or non-identical twins are of particular interest for the study. Also, because of questions about differences between boy and girl brains people that have atypical hormone levels, such as in congenital adrenal hyperplasia or precocious puberty, or atypical sex chromosome numbers, such as XXY, XXX, XYY, or XXXXY will be included as well. In addition to the brain images, information will be collected about behavior, emotions, and cognition and combined with genetic testing to explore the relationships between genes, brain, and behavior.
To find out if you qualify or for more information, please call (301) 496-5645 or email us at nimhcore@mail.nih.gov.
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Protocol Information |
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Attention Deficit Hyperactivity Disorder (Pediatric) Research Study
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2. ADHD and Brain Development
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Does your child have ADHD symptoms? Does your child get easily distracted, have trouble sitting still, talk excessively, have difficulty focusing, or interrupt often?This research study seeks to understand brain development during childhood and brain changes over time.We are now recruiting children ages 4-14 with ADHD symptoms or an ADHD diagnosis. Your child may be eligible to participate in 1-2 outpatient visits to the NIH Clinical Center in Bethesda, Maryland. Participation includes an interview with parents and child, psychological testing, non-invasive brain scans, and genetic testing (from a saliva or blood sample.).There is no cost to participate. Compensation is provided. Parental permission is required.Contact Wendy Sharp, LCSW-C: 301-496-0851 (TTY: 1-866-411-1010) sharpw@mail.nih.gov
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Disease and Treatment Information |
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Attention Deficit Hyperactivity Disorder (Pediatric) Research Study
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3. Comparing Attention Deficit Hyperactivity Disorder to Bipolar Disorder in Children: Investigations of Brain Function and Irritability
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This research study seeks to learn about how attention deficit hyperactivity disorder (ADHD) and bipolar disorder (BD) are different in children and adolescents. Researchers will describe the moods and behaviors of children and investigate brain function and irritability. Children with ADHD are being invited to participate as a comparison group as part of a larger research protocol on children with bipolar disorder.
Currently recruiting ages 9-17, with an ADHD diagnosis to participate in 2 outpatient day visits. Children must be medically healthy, and free of bipolar disorder or any mood or other psychiatric disorder that requires treatment. Preference may be given to children who are able to be off stimulant medication for up to 3 days. Children with ADHD will not receive treatment in this study.
Participation includes interviews, research testing, and brain imaging scans.
The studies enroll local participants and are conducted at the NIH Clinical Center in Bethesda, Maryland. All clinical evaluations, research procedures and visits are free of cost. Travel expenses are paid by NIMH. Both parent and child must agree to the child's participation in research. Children and parents are compensated for participation.
FOR FURTHER INFORMATION, Call: 301-496-8381, TTY: 1-866-411-1010, or Email: bipolarkids@mail.nih.gov Ellen Leibenluft, M.D. or Kenneth Towbin, M.D.
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Disease and Treatment Information |
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Attention Deficit Hyperactivity Disorder (Pediatric) Research Study
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4. Brain Imaging & Behavior of Children with ADHD
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The National Institute of Mental Health seeks children and adolescent participants ages 10 to 18, to enroll in this ADHD research study. Researchers are examining how emotions, social situations and problem-solving situations are processed in the brains of children with ADHD.
Eligible participants will be medically healthy, with an ADHD diagnosis, or have ADHD symptoms including inattention, hyperactivity and impulsivity. Participation may include behavioral observation, brain imaging, and psychological interviews which include 1 to 3 outpatient visits, of 2-3 hours each, at the NIH Clinical Center in Bethesda, Maryland.
No treatment is offered. Parental permission is required. There is no cost to participate. Financial compensation and transportation assistance will be provided.
For information call: 301-594-8705, Email: kidsbehavior@mail.nih.gov
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Disease and Treatment Information |
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Autism Spectrum Disorders (Pediatric) Research Study
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1. Clinical and Immunological Investigations of Subtypes of Autism
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The purpose of this study is to learn more about autism and its subtypes. We will look at several types of medical issues, including immunologic problems. As a "natural history" study, children will be followed over the course of several years. We aim to capture medical problems that may be related to autism over time, and study outcomes in areas such as behavior and language.
Three groups of children ages 1-4 years (12 months-60 months)will be included: children with autism, children with developmental delay, and typically developing children. Within the autism group, we are specifically interested in both children with a history of early onset of autism, as well as children with a history of regressive autism. An initial comprehensive evaluation will be conducted, and elements of these assessments will be repeated every 6 to 12 months, depending on the child's age. After the screening assessment, participants will have a medical history, physical exam and developmental evaluation. Participants will also have a comprehensive medical workup. Parents of participants will complete questionnaires about family history and their child's development and will be asked to participate in a genetic study.
To find out if you qualify or for more information, please call (301) 435-7962 or email at NIMH-ASD@mail.nih.gov.
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Autism Spectrum Disorders (Pediatric) Research Study
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2. Identification of Characteristics Associated with Symptom Remission in Autism
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We are recruiting children and adolescents (ages 7-17) who, since being diagnosed with autism, have made significant improvements such that they no longer meet criteria for a diagnosis of autism. We are also recruiting children who continue to meet criteria for autism, as well as typically developing children. Our goal is to better understand how children who make remarkable improvement may differ from children who continue to meet criteria for autism.
The study involves several inpatient and outpatient visits to Bethesda, MD, that may occur over a few days or several weeks, depending on what works best for the child and his or her parents. The study involves an autism diagnostic evaluation as well as a thorough neuropsychological and medical evaluation. A summary of all clinically relevant study findings including results of the neuropsychological exam will be provided. There is no cost to participate and children are compensated for their time. Travel assistance and lodging may be provided.
For further information please call our study coordinator at 301-435-7962 (TTY 866-411-1010) or email autismoutcomestudy@mail.nih.gov
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Disease and Treatment Information |
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Behavioral Problems (Pediatric) Research Study
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1. Brain Changes in Children and Adolescents with Behavioral Problems
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This study examines differences in social- and emotion-related brain activity in children and adolescents with disruptive behavior and conduct problems. All participants receive a cognitive and psychiatric screening. Those that are considered for further inclusion may participate in a second clinical interview. Participants selected for the study may do computer activities either on a laptop or inside an MRI scanner.
If your child is age 10-18, is medically healthy, has behavioral problems (like disruptiveness, anger, or aggression), and does not feel bad or guilty when they do something wrong, he or she may be eligible for the study.
To find out if your child qualifies or for more information, please call (301) 594-8705.
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Disease and Treatment Information |
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Bipolar Disorder (Pediatric) Research Study
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1. Phenomenology and Neurophysiology of Pediatric Bipolar Disorder
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This study seeks to learn more about bipolar disorder in children and adolescents. The objectives are to describe the course of moods and behaviors of children with bipolar disorder and to learn about changes in the brain that are associated with these symptoms.
There are three separate parts to the study. Patients may participate in one or more parts.
Part A is not a treatment study. In part A participants remain in treatment with their community psychiatrist. They do not receive any experimental treatment, but they do receive extensive testing and brain imaging.
In Part B children receive extensive testing and brain imaging off medications.
Part C (the high risk study) is a study of children and adolescents who have a parent, brother or sister with bipolar disorder. These children receive a clinical assessment and testing.
Families who are interested in participating are interviewed by telephone. Those who are judged to be likely to meet criteria for the study are invited to the NIMH.
In Part A, participants first come for one day of interviews to determine if they meet study criteria. Those patients who are accepted return for a 5-day baseline evaluation, including physiologic tests and procedures, neuropsychological testing, and questionnaires and interviews about mood and behavior. In addition, staff members obtain a medical and psychiatric history of the patient and extended family members, and a physical and neurological evaluation. Participants are asked to perform computer and written tests to assess intelligence, memory, learning, motor skills, reaction time, and planning skills. Psychophysiological measures (such as heart rate, skin conductance, and electroencephalogram) are obtained in response to emotions and while playing computer games. Participants are asked to give blood samples for blood count and thyroid levels, liver and kidney function and to check for other diseases. Structural magnetic resonance imaging (MRI) and functional MRI (fMRI) scans of the brain are obtained.
Participants and parents return to the NIH for repeat evaluations and physiologic tests after 2 months, and then every 3 months until 12 months have passed from the first visit. Thereafter, visits are every 6 months for 4 years, and then every year until the patient turns 25. Some visits will involve only interviews and questionnaires, some will also include a physical exam, behavioral tests, or repeat brain imaging. Patients, their parents and siblings will also be asked to have blood drawn to obtain a DNA sample for genetic studies.
In Part B, participants come into the NIH Clinical Center and are gradually removed from all their medications. While off medication, they receive up to two weeks of research studies, like those described above for Part A. Participants are then given appropriate medication and stabilized before returning home.
In the High Risk Study, children of parents with bipolar disorder, or parents and siblings of children with bipolar disorder come for 1-3 days of clinical interviews and assessment, as well as test procedures performed on computers.
All tests and procedures are provided free of charge, and travel expenses are paid by the NIMH.
To find out if you qualify or for more information, please call (301) 496-8381 or email us at bipolarkids@mail.nih.gov.
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Protocol Information |
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Bipolar Disorder (Pediatric) Research Study
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2. Clinical Trial of Citalopram and Methylphenidate in Severe Mood Dysregulation
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This study is testing the effectiveness of methylphenidate plus citalopram vs. methylphenidate plus placebo for decreasing irritability in children with severe mood dysregulation (SMD). Children with SMD display chronic anger, sadness, or irritability, as well as hyperarousal (such as insomnia, distractibility, hyperactivity) and extreme responses to frustration (such as frequent, severe temper tantrums).
Children ages seven to 17 with SMD may be eligible to participate in this 12- to 15-week inpatient or outpatient study. This study has four phases. During Phase I participants are gradually withdrawn from all current psychotropic medications. Phase II is a one-week psychotropic medication-free period. During Phase III, which lasts two weeks, participants are treated with methylphenidate alone. Phase IV lasts for eight weeks. During this time, participants continue methylphenidate treatment and are randomly assigned to also receive either citalopram or placebo.
At the end of the study, those who received methylphenidate plus placebo will have the opportunity to receive methylphenidate plus active citalopram if clinically appropriate.
All procedures and medications associated with the research are provided at no cost to participants, and transportation expenses are reimbursed by NIMH. Schooling will be provided while on the inpatient unit or in day treatment.
To find out if you qualify or for more information, please call (301) 496-8381 or email us at irritablekids@mail.nih.gov.
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Disease and Treatment Information |
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Bipolar Disorder (Pediatric) Research Study
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3. Clinical Trial of Riluzole in Pediatric Bipolar Disorder
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This study is testing the effectiveness of riluzole versus placebo for decreasing anxiety in children with pediatric bipolar disorder (BP). Children and youth with bipolar disorder display episodic elevated mood and associated symptoms of decreased need for sleep, increased goal-directed behavior, and increased self-esteem/grandiosity.
Children ages 9 to 17 with BP may be eligible to participate in this 12- to 15-week inpatient or outpatient study. This study has four phases. During Phase I, participants are gradually withdrawn from all current psychotropic medications. Phase II is a one-week medication-free period. During Phase III, which lasts two weeks, participants are randomly assigned to also receive either riluzole or placebo (a "sugar pill"). Phase IV lasts for 6 weeks. During this time, participants continue riluzole or placebo.
At the end of the study, those who received placebo have the opportunity to receive riluzole.
All procedures and medications associated with the research are provided at no cost to participants, and assistance with transportation and lodging expenses is available. Schooling will be provided while on the inpatient unit or in day treatment.
To find out if you qualify or for more information, please call (301) 496-8381 or email us at bipolarkids@mail.nih.gov .
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Disease and Treatment Information |
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Bipolar Disorder (Pediatric) Research Study
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4. Characterization and Pathophysiology of Severe Mood and Behavioral Dysregulation in Children and Youth
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This study seeks to describe and follow the symptoms of severe mood and behavioral dysregulation in children and adolescents and to understand the brain mechanisms that cause it. This study has two parts, and a child may participate in one or the other part. Part A involves hospitalization or Day Treatment with gradual tapering of medication followed by extensive behavioral testing and brain imaging while medication-free. Part B includes only the testing and brain imaging, without treatment.
Children and adolescents with mood and behavioral dysregulation display chronic anger, sadness, or irritability, as well as hyperarousal (such as insomnia, distractibility, hyperactivity) and extreme responses to frustration (such as frequent, severe temper tantrums). Study participants, ages 7 to 17, will be followed over time and their symptoms compared with those of children with bipolar disorder and healthy volunteers.
Participants in the treatment study will have any current medications gradually withdrawn over 2- to 8-weeks while in-patients at the NIH Clinical Center. Depending on clinical severity and whether they live locally to the NIMH, participants will either remain on the inpatient unit during the study or can attend the Behavioral Pediatrics Day Treatment Center. Structural magnetic resonance imaging (MRI), functional MRI (fMRI) scans will be obtained to learn about brain structure and function. In addition, participants receive extensive behavioral testing.
Following the medication-free period, patients will be offered standard medications that may be helpful based on the clinical judgment of the treatment team, parents, and outside providers. Participants will be asked to return once every 2 years for follow-up visits.
All procedures and medications associated with the research are provided at no cost to participants, and transportation expenses are reimbursed by NIMH. Schooling will be provided while on the inpatient unit or in day treatment.
Participants must be in treatment with a psychiatrist for mood dysregulation. Those in the longitudinal follow-along study are treated exclusively by their own local physicians.
To find out if you qualify or for more information, please call (301) 496-8381 or email us at irritablekids@mail.nih.gov.
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Protocol Information |
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Conduct Disorder (Pediatric) Research Study
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1. Brain Changes in Children and Adolescents with Conduct Disorder
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This study examines differences in social- and emotion-related brain activity in children and adolescents with disruptive behavior and conduct problems. All participants receive a cognitive and psychiatric screening. Those that are considered for further inclusion may participate in a second clinical interview. Participants selected for the study may do computer activities either on a laptop or inside an MRI scanner.
If your child is age 10-18, is medically healthy, has behavioral problems (like disruptiveness, anger, or aggression), and does not feel bad or guilty when they do something wrong, he or she may be eligible for the study.
To find out if your child qualifies or for more information, please call (301) 594-8705.
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Disease and Treatment Information |
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Depression (Pediatric) Research Study
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1. Clinical Trial of Fluoxetine in Anxiety and Depression in Children, and Associated Brain Changes
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This study uses functional magnetic resonance imaging (fMRI) to learn how the brain functions in adolescents receiving fluoxetine (Prozac) or cognitive behavioral therapy (CBT) for anxiety or depression in children/adolescents.
All participants will receive interviews to assess how they are doing in general, including his or her general mood, degree of nervousness and behavior. Each participant and one of his or her parents will be interviewed separately and together. All those enrolled in the study will have a physical examination. They will undergo tests involving problem-solving and memory and perform tasks that involve looking at pictures, remembering things, testing reaction times, and making simple choices.
Participants with anxiety or depression will first meet with a psychiatrist or psychologist for two weekly sessions of talk therapy. Those who remain anxious or depressed after these 2 weeks will have the 3 options based on their choice: 1) treatment with fluoxetine daily for 8 weeks 2) cognitive-behavioral therapy (a talk therapy) once a week for 8 weeks 3) a random assignment (50% chance) to either placebo or fluoxetine for 8 weeks. All participants will be seen approximately weekly for 8 weeks by a doctor to talk and complete verbal and written exercises. Blood samples will be drawn for laboratory tests before drug treatment and after it ends.
Those who have not improved by the end of the study will be offered other treatment for 1 to 3 months, and the clinicians will help with finding subsequent aftercare. Those who improve with treatment will continue therapy at NIH until an outside physician is able to assume responsibility for monitoring medication.
To find out if you qualify or for more information, please call (301) 402-8225 or email us at kidswithworries@mail.nih.gov.
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Protocol Information |
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Down Syndrome (Pediatric) Research Study
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1. Brain Imaging of Childhood Onset Psychiatric Disorders, Endocrine Disorders and Healthy Controls
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The purpose of the study is to examine how the brain develops in youth with Down syndrome. The study aims to increase our understanding of the links between brain differences and the unique pattern of strengths and challenges in learning and memory associated with Down syndrome.
Two groups will be included: youth (ages 3-17) with a confirmed chromosomal diagnosis of Down syndrome and youth with typical development (ages 3-17). Participation will involve brain imaging (utilizing magnetic resonance imaging or MRI, a medical imaging technique that takes a detailed picture of the brain without use of radiation) and learning and memory testing. An optional blood test for genetic analyses is also requested.
All of the evaluation procedures are provided free of charge and will take between 5 and 7 hours to complete on an outpatient basis (during either two or three visits) to the NIH campus in Bethesda, MD. Parents of participants will be asked to complete questionnaires about their child's development as well. Parental consent is required for participation. Compensation will be provided.
To find out if your child qualifies or to obtain more information, please call Nancy Raitano Lee, Ph.D. at (301) 435-4520 or email lnancy@mail.nih.gov
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Disease and Treatment Information |
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Hallucinations and Thought Disorders (Pediatric) Research Study
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Evaluating Hallucinations & Delusions in Children
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Studies show that hallucinations and delusions can be part of normal childhood development. This research study is investigating brain functioning associated with hallucinations (auditory and visual) and delusions in children as part of a larger research protocol on childhood psychosis. Researchers are currently recruiting children ages 6-13 who hear voices, see things not there, or are overly suspicious. Eligible participants must be medically healthy and free of neurological illness, schizophrenia, bipolar disorder, autism, seizures, and illicit drug use.Study participation includes 2-3 outpatient visits to the NIH Clinical Center in Bethesda, Maryland. Study procedures may include interviews, psychiatric, medical and genetic testing, and an MRI brain scan. Participants may be invited for follow-up visits.There is no cost to participate. Parental permission is required. Contact: Rachel Miller, Ph.D. 301-496-7962, Email: mrachel@mail.nih.gov, TTY: 1-866-411-1010
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Disease and Treatment Information |
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PANDAS (Pediatric) Research Study
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1. Pediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcal Infections (PANDAS) Research Study for Children
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If your child suddenly developed obsessive or repetitive thoughts and behavior after a strep (streptococcal) infection, he or she may have PANDAS (Pediatric Autoimmune Neuropsychiatric Disorder Associated with Streptococcal infection). We are currently accepting children (aged 4 to 12 years old) with PANDAS into a study investigating whether intravenous immunoglobulin (IVIG) improves the symptoms of PANDAS. Intravenous immunoglobulin is FDA-approved for primary immunodeficiency states and idiopathic thrombocytopenic purpura. Its use in this study is experimental.
During the first 5-day inpatient stay, some children will receive IVIG, and some children will receive a placebo (intravenous salt water with no active ingredient). After 6 weeks, children with severe persistent symptoms may receive IVIG during a second 5-day inpatient stay.
Two additional one- or two-day evaluations 3 and 6 months after the first study visit are required. There is no cost to participate in this study, and travel and lodging assistance will be provided. Parental consent is required.
Children will also continue to be followed by their own physician while in this study.
To find out if your child qualifies or for more information, please call Megan Smith at Yale (203-737-5588) or Lorraine Lougee at NIH (301-435-6652)
(TTY# 1-866-411-1010) or email us at meg.smith@yale.edu or lougeel@mail.nih.gov.
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Protocol Information |
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Schizophrenia (Pediatric) Research Study
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1. Brain Imaging of Childhood Onset Psychiatric Disorders, Endocrine Disorders and Healthy Controls
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Magnetic Resonance Imaging (MRI) combines a powerful magnet, radio waves, and sophisticated computer technology to provide exquisitely accurate information about the anatomy and physiology of the living, growing human brain - and it does so without the use of harmful radiation. This allows not only for the scanning of children and teens but of repeated scans over the course of development and has launched a new era of adolescent neuroscience. In this study, researchers will use MRIs to assess brain anatomy and function in healthy volunteers and patients with a variety of childhood onset psychiatric disorders. Identical or non-identical twins are of particular interest for the study. Also, because of questions about differences between boy and girl brains people that have atypical hormone levels, such as in congenital adrenal hyperplasia or precocious puberty, or atypical sex chromosome numbers, such as XXY, XXX, XYY, or XXXXY will be included as well. In addition to the brain images, information will be collected about behavior, emotions, and cognition and combined with genetic testing to explore the relationships between genes, brain, and behavior.
To find out if you qualify or for more information, please call (301) 496-5645 or email us at nimhcore@mail.nih.gov.
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Protocol Information |
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Schizophrenia (Pediatric) Research Study
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2. Screening Protocol for Childhood Onset Psychotic Disorders
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If your child is between 6 and 18 years old and a mental health professional thinks your child had schizophrenia before his/her 13th birthday, your child may qualify for a study being conducted by the Child Psychiatry Branch. We are looking for children who, before their 13th birthday, had severe hallucinations (voices/visions) and other psychotic symptoms which made them act very different from other children. There are two inpatient studies being conducted with these children. One study is a three week inpatient evaluation study with no changes in medication; recommendations from doctors, teachers, nurses and other professionals will be provided to the families after the child's discharge. The other study is a 4 to 6 month inpatient study involving a time off medication as well as medications used to treat schizophrenia. Research participation is free of charge; transportation and housing are provided to parents.
To find out if your child qualifies or for more information, please call (301) 496-5645 or email us at nimhcore@mail.nih.gov.
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