Clinical Trials
The NH Dept. of Health & Human Services Committee for the Protection of Human Subjects (CPHS) is the Institutional Review Board (IRB) charged with overseeing research conducted in department-funded programs that serve people with primarily mental illness, developmental disabilities, and substance abuse or dependence disorders. Per NH law, no research shall be conducted in these programs until it has been reviewed and approved by the committee. It is the mission of the CPHS to protect the rights and welfare of research participants.
Anxiety Disorders (Adult) Research Study ~ participants aged 18-65, sought for study of the drug AZD2327 for treatment of major depression with anxiety symptoms
Child & Adolescents with Severe Mood Dysregulation ~ participants, aged 7-17, sought for Brain Imaging, Non-Treatment and Treatment Studies (4/11) Click here for Details
Brain Imaging, Non-Treatment and 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). The non-treatment study involves visits to the NIH campus in Bethesda, MD 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 (i.e., Ritalin®) is helpful for severe irritability. Eligible participants receive optimal doses of methylphenidate, 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. Call: 301-496-8381 (TTY: 1-866-411-1010), or e-mail: irritablekids@mail.nih.gov.
National Institute of Mental Health, National Institutes of Health, Department of Health and Human Services.
For more information on research conducted by the National Institute of Mental Health in Bethesda, MD click here http://patientinfo.nimh.nih.gov.
Bipolar Disorder (Pediatric) Research Study - participants, aged 6-17, sought for for research studies on causes of bipolar disorder or severe irritability (9/22/10)
Clinicaltrials.gov - NIH Clinical Trials
Clinical Trials by State ~ search for clinical trials by state
National Institute on Mental Health ~ listing of clinical trials on the NIMH website
Information
A Participant's Guide to Mental Health Clinical Research
Clinical Trials and Older People ~ tips from the National Institute on Aging
