Anxiety Disorders (Pediatric) Research Study
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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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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 Research Study
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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 Research Study
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Identical Twin ADHD Study
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ADHD is a highly heritable disorder. We are searching for rare identical twin pairs where one twin has ADHD and the other does not. The purpose of this study is to use brain imaging technology to study the connections between brain regions in identical twins. Participants in this study must be under the age of 21 years. They will be screened with questionnaires, interviews, and psychological testing. Participants' medical and educational records may be reviewed. Participants will undergo an MRI scan of the brain.
Financial compensation and travel assistance is provided.
To find out if you qualify or for more information, please call 301-496-0851 or toll-free at 888-254-3823 or email us at sharpw@mail.nih.gov.
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Protocol Information |
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Attention Deficit Hyperactivity Disorder Research Study
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Young Child ADHD Study (4-8 years)
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Thanks to the participation of over 200 children and teens with ADHD over the past 20 years we already know a great deal about the brain in ADHD. Now we want to work with very young children (between 4 and 8 years) who have ADHD to see if we can uncover the different patterns of brain development that go along with different outcomes.
The research study involves a clinical assessment over a day by our team of child psychiatrists, psychologists, clinical social workers and teachers. It includes an interview with the parents and children, some short psychological tests, and a brain scan (non-invasive; does not involve any radiation).
As we are interested in development, we hope that children will come back every year so we can look at changes in the symptoms of ADHD.
Eligible children will be between the ages of 4 and 8 years, may or may not already be diagnosed with ADHD, and must live within 60 miles of the NIH campus in Bethesda MD.
To find out if your child qualifies or for more information, please call 301-496-0851 or toll-free at 888-254-3823 or email us at sharpw@mail.nih.gov.
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Protocol Information |
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Autism Research Study
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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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Protocol Information |
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Autism Research Study
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Riluzole medication treatment of the repetitive behaviors and compulsions of Autism Spectrum Disorders
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We are enrolling children or adolescents (ages 7-17 years) who have either:
the repetitive behaviors and compulsions associated with an Autism Spectrum Disorder,
or the obsessions and compulsions of Obsessive-Compulsive Disorder (even without an additional disorder on the autism spectrum).
We are looking for young people who have been treated with adequate doses of medication for their obsessions or repetitive behaviors/compulsions, but who have not had adequate response to treatment, or who could not tolerate the treatment.
We are investigating the medication riluzole. Riluzole is FDA-approved for the treatment of ALS (Lou Gehrig disease).
Participants will receive either riluzole or a placebo (a look-alike pill with no active ingredient) for 12 weeks. At the end of those 12 weeks, all study participants will have the option of taking riluzole (no chance of placebo) for the next 12 weeks.
Participants will have a day-long assessment that includes comprehensive psychiatric, physical, and laboratory evaluations. They will then have follow-up evaluations with the NIMH physician about every month for 6 months, and again at 9 and 12 months. Parental consent is required for study participation. There are no costs to participate in the study. Travel assistance may be provided.
Children must also continue to be followed by their own local physicians while in this outpatient study.
To find out if your child qualifies or for more information, please call (301) 435-6652, (301) 496-5323 or email us at OCDNIMH@intra.nimh.nih.gov
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Protocol Information |
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Autism Research Study
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Treatment of Childhood Regressive Autism with Minocycline
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The purpose of this study is to see if administration of minocycline will be helpful to children with regressive autism (diagnosis of autism and history of loss of social and/or language skills). Minocycline, an antibiotic, is FDA-approved for the treatment of a variety of infections. Minocycline also has anti-inflammatory properties, which may be beneficial in autism.
Ten children (ages 3 to 12 years) will be enrolled in a year-long study of minocycline. The children will take minocycline and vitamin B6 daily for 6 months. They will receive a comprehensive medical and psychological assessment as well as laboratory tests prior to starting the study medications. They will be required to return to the NIH clinic for check-ups at 2 weeks, and at 1, 2, 4, 6, and 12 months.
Research evaluations are free of charge and travel expenses to the NIH may be provided. Parents will receive a summary of findings from testing. In order to participate, children should live within a reasonable commuting distance of the NIH campus in Bethesda, MD.
To find out if your child qualifies, or for more information, please call: 301-435-7962 or email: NIMH-ASD@mail.nih.gov
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Protocol Information |
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Bipolar Disorder (Pediatric) Research Study
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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 bipolarkids@mail.nih.gov .
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Protocol Information |
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Bipolar Disorder (Pediatric) Research Study
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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 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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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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Depression (Pediatric) Research Study
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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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Obsessive-Compulsive Disorder (Pediatric) Research Study
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OCD Sibling Study
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We are examining the causes of Obsessive-Compulsive Disorder (OCD) by looking at the relationship between OCD, the brain, and genetic factors. We are enrolling sibling pairs (ages 8-17) where one sibling has the diagnosis of OCD and the other does not. Siblings must be full siblings (same mother and father).
The 1-day study involves a structured psychiatric interview, psychological testing, a Magnetic Resonance Imaging (MRI) scan, and a brief blood draw. Financial compensation and travel assistance is provided.
To find out if your children qualify or for more information, please call 301-496-0851 or toll-free at 888-254-3823 or email us at sharpw@mail.nih.gov.
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Protocol Information |
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Obsessive-Compulsive Disorder (Pediatric) Research Study
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Riluzole medication treatment of the obsessions and compulsions of Obsessive-Compulsive Disorder
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We are enrolling children or adolescents (ages 7-17 years) who have either:
the repetitive behaviors and compulsions associated with an Autism Spectrum Disorder,
or the obsessions and compulsions of Obsessive-Compulsive Disorder (even without an additional disorder on the autism spectrum).
We are looking for young people who have been treated with adequate doses of medication for their obsessions or repetitive behaviors/compulsions, but who have not had adequate response to treatment, or who could not tolerate the treatment.
We are investigating the medication riluzole. Riluzole is FDA-approved for the treatment of ALS (Lou Gehrig disease).
Participants will receive either riluzole or a placebo (a look-alike pill with no active ingredient) for 12 weeks. At the end of those 12 weeks, all study participants will have the option of taking riluzole (no chance of placebo) for the next 12 weeks.
Participants will have a day-long assessment that includes comprehensive psychiatric, physical, and laboratory evaluations. They will then have follow-up evaluations with the NIMH physician about every month for 6 months, and again at 9 and 12 months. Parental consent is required for study participation. There are no costs to participate in the study. Travel assistance may be provided.
Children must also continue to be followed by their own local physicians while in this outpatient study.
To find out if your child qualifies or for more information, please call (301) 435-6652, (301) 496-5323 or email us at OCDNIMH@intra.nimh.nih.gov.
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Protocol Information |
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Post-Traumatic Stress Disorder (Pediatric) Research Study
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Brain Activity in Health and Illness Research Study: fMRI Study of Adolescents
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If you have a child aged 9 to 17 years old with a history of maltreatment (e.g., physical abuse, sexual abuse, emotional abuse, neglect), your child may be able to participate in a study of the effects of a behavioral treatment program for coping with trauma. Participants who show significant psychological impairments will receive talk therapy sessions and may be eligible for pharmacological therapy with fluoxetine (Prozac). Brain imaging technology will also be used before and after treatment. Healthy adults and healthy children (no history of abuse or psychiatric disorders) may also be eligible for the study.
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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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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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, you 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. This inpatient study tries to understand the causes of severe hallucinations (voices/visions) and other psychotic behaviors; the study offers treatment with a comparison of two drugs used to treat psychosis: Clozaril (clozapine) and Zyprexa (olanzapine). This drug trial begins with: 1) 3 weeks of evaluation and extensive testing while the child is on the medications they were on at admission 2) gradual decrease of medications 3) up to 3 weeks without any medication to help the staff be certain of the diagnosis. At the end of this time, if the staff diagnoses your child with childhood onset schizophrenia, then the child is put on 8 weeks of either clozapine or olanzapine and maybe another 8 weeks of whichever medication (clozapine or olanzapine) the child did not receive during the first 8 week period. Research participation and medication 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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Protocol Information |
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Schizophrenia (Pediatric) Research Study
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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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Protocol Information |
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