Clinical Research Opportunities

NIMH Clinical Research Studies in Arkansas

Clinical Trial of Riluzole in Pediatric Bipolar Disorder
 
This study is testing the effectiveness of riluzole versus placebo for decreasing anxiety in children with pediatric bipolar disorder. 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 bipolar disorder 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 During Phase I, participants are gradually withdrawn from all current psychotropic medications.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 more information, please call (301) 496-8381 or email bipolarkids@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.
 

Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy, such as vincristine, cisplatin, lomustine, and cyclophosphamide, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving radiation therapy with chemotherapy after surgery may kill any remaining tumor cells. It is not yet known whether standard-dose radiation therapy combined with chemotherapy after surgery is more effective than reduced-dose craniospinal (head and spine) radiation therapy plus either posterior fossa (back of the brain) boost or tumor bed (site of the tumor) boost radiation therapy combined with chemotherapy in treating medulloblastoma.

This randomized phase III trial is studying standard-dose radiation therapy to see how well it works compared to reduced-dose craniospinal radiation therapy AND posterior fossa boost radiation therapy to see how well it works compared to tumor bed boost radiation therapy when given together with chemotherapy in treating young patients who have undergone surgery for newly diagnosed standard-risk medulloblastoma.

 

 

This is a randomised, open label multi-centre phase III study comparing the activity of lapatinib alone versus trastuzumab alone versus trastuzumab followed by lapatinib versus lapatinib concomitantly with trastuzumab in the adjuvant treatment of patients with ErbB2 overexpressing and/or amplified breast cancer. Patients will be enrolled according to one of two design schemas, with Design 2 having two chemotherapy options (Design 2 and 2B), and will be randomised to one of four treatment regimens within each design schema.

The primary objective of this study is to compare disease-free survival (DFS) in patients with HER2 overexpressing and/or amplified breast cancer randomised to trastuzumab for one year versus lapatinib for one year versus trastuzumab (12 or 18 weeks, according to assigned design) followed by a six-week treatment-free interval followed by lapatinib (28 or 34 weeks, according to assigned design) versus trastuzumab in combination with lapatinib for one year (52 weeks). Secondary objectives include treatment comparisons with respect to overall survival, time to recurrence, time to distant recurrence, safety and tolerability, incidence of brain metastasis, and analyses conducted separately for cohorts of patients defined by presence or absence of cMyc oncogene amplification, expression level of PTEN and presence or absence of the p95HER2 receptor.

 

Maintenance of Efficacy of Extended-Release Guanfacine HCl in Children and Adolescents With Attention-deficit/Hyperactivity Disorder (ADHD)

The primary objective of this study is to evaluate the long-term maintenance of efficacy of Extended-Release Guanfacine HCl in children and adolescents (6-17 years) with attention-deficit/hyperactivity disorder (ADHD) who respond to an initial open-label, short term treatment with SPD503.

Internet Obesity Treatment Enhanced With Motivational Interviewing

Internet-based weight control programs have been shown effective in producing weight loss, but in-person delivery of behavioral weight control produces significantly greater weight loss than on-line delivery of the same program. Motivational Interviewing has been shown to increase weight loss when delivered as an adjunct to in-person weight loss programs but has not been examined in conjunction with web-based obesity treatment. Therefore, the overall goal of this project is to determine if the addition of on-line Motivational Interviewing to a web-based group behavioral obesity treatment program will augment weight loss outcomes.
 
Lurasidone - A 24-week Extension Study of Patients With Bipolar I Depression
 
This clinical study is designed to test the hypothesis that lurasidone is effective, tolerable, and safe for the treatment of patients with bipolar I depression.
 
Efficacy and Safety of Methylphenidate HCl ER Capsules in Children and Adolescents With ADHD
 

This multi-center parallel study is designed to study the efficacy and safety of fixed doses of methylphenidate extended release (ER)capsules of three dose levels compared with a placebo group in pediatric patients with Attention Deficit Hyperactivity Disorder (ADHD) who are between 6 and 18 years old.

 
Drug Discrimination in Methadone-Maintained Humans Study 3
 
This study involves giving psychoactive drugs intramuscularly (injected into the muscle of the upper arm or the hip) and/or orally, and measuring the participant's ability to tell the difference between one drug and another, as well as measuring the effects of the drugs on mood, physiology (e.g., heart rate, blood pressure, respiration rate) and behavior. Each participant will receive 2-4 of the listed interventions.
 
Effects of Massage Therapy to Induce Sleep in Preterm Infants
 
Premature infants sometimes require sedation to ensure minimal movement during diagnostic procedures such as MRIs. However, sedatives may produce adverse effects. The purpose of this two-day study is to determine whether massage therapy will promote sleep in preterm infants and also help them to stay asleep, providing a safer way to sedate infants for procedures. A small instrument called a sleep watch or actigraph will be placed around the infant's ankle to measure muscle activity and provide an indication of sleep. Infants will receive a 10- minute massage on one morning of the study and no massage on the alternate morning. Recordings from the actigraph will show whether there is difference in sleep pattern with and without massage. Infants will be monitored for any heart rate and oxygen saturation changes on both mornings of the study.
 
Therapeutic Hypothermia to Improve Survival After Cardiac Arrest in Pediatric Patients-THAPCA-OH [Out of Hospital] Trial
 

Cardiac arrest is a sudden, unexpected loss of heart function. Therapeutic hypothermia, in which the body's temperature is lowered and maintained several degrees below normal for a period of time, has been used to successfully treat adults who have experienced cardiac arrest. This study will evaluate the effectiveness of therapeutic hypothermia at increasing survival rates and reducing the risk of brain injury in infants and children who experience a cardiac arrest while out of the hospital.

 

Therapeutic Hypothermia to Improve Survival After Cardiac Arrest in Pediatric Patients-THAPCA-IH [In Hospital] Trial

 

Cardiac arrest is a sudden, unexpected loss of heart function. Therapeutic hypothermia, in which the body's temperature is lowered and maintained several degrees below normal for a period of time, has been used to successfully treat adults who have experienced cardiac arrest. This study will evaluate the effectiveness of therapeutic hypothermia at increasing survival rates and reducing the risk of brain injury in infants and children who experience a cardiac arrest while in the hospital.

 

Emergency Department Safety Assessment and Follow-up Evaluation (ED-SAFE)

 

The NIMH's RFA-Suicide Prevention in Emergency Medicine Departments recognizes the emergency department (ED) as an important setting to increase suicide detection and prevention efforts but observes that evidence-based practice guidelines do not exist. In response, we have designed the ED Safety Assessment and Follow-up Evaluation (EDSAFE) trial. Two inter-related studies will be conducted using a quasi-experimental design appropriate for studying systems-based change. The studies will share three phases of data collection: Treatment as Usual, Screening Alone, and Intervention. During each phase, 472 suicidal patients (1,416 total) will be enrolled and followed using multiple methods for 12 months.

The first study, the Screening Outcome Study, will use data collected during the first two phases (Treatment as Usual and Screening Alone). Primarily, it will focus on testing a practical approach to screen ED patients for suicidal ideation and behavior and will assess its impact on suicide detection, process outcomes, and suicide behaviors. The second study, the Care-chain Evaluation Study, will use data collected during the last two phases (Screening Alone and Intervention). Primarily, it will evaluate the impact of a multi-component intervention on suicide outcomes. The intervention blends conceptual underpinnings from screening, brief intervention, and referral to treatment (SBIRT) models for health behaviors with empirically grounded strategies for suicide prevention. It will involve (1) Question, Refer, Persuade counseling provided by the treating nurse, (2) incorporation of a Comprehensive Suicide Management Protocol into clinical practice, and (3) post-discharge telephone counseling. Our overarching hypotheses will be tested using a combination of both studies. We predict that screening will improve detection of suicidal ideation, and the intervention will enhance the quality of care and reduce suicide outcomes.

 

Comparison of Pixantrone + Rituximab With Gemcitabine + Rituximab in Patients With Aggressive B-cell Non-Hodgkin Lymphoma Who Have Relapsed After Therapy and Are Not Eligible for Stem Cell Transplant

 
The purpose of this study is to evaluate the efficacy of Pixantrone + Rituximab compared to Gemcitabine + Rituximab in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).
 
Study to Assess Compliance With Long-Term Mercaptopurine Treatment in Young Patients With Acute Lymphoblastic Leukemia in Remission
 

Assessing why young patients who have acute lymphoblastic leukemia may not take their medications as prescribed may help identify ways to assist them in taking their medications more consistently and may improve long-term treatment outcomes.

This clinical trial is assessing compliance with long-term mercaptopurine treatment in young patients with acute lymphoblastic leukemia in remission.

 

Lurasidone - A 6-week Study of Patients With Bipolar I Depression (Add-on)

 

This clinical study is designed to test the hypothesis that lurasidone is effective, tolerable, and safe when added to treatment with lithium or Divalproex for the treatment of patients with bipolar I depression.

 

Open-label Long Term (52 Weeks) Safety and Tolerability of Agomelatine Sublingual Tablets in Major Depressive Disorder (MDD)

 

The study will assess safety and tolerability of 0.5 mg/day and 1 mg/day of sublingual (under the tongue) formulation of agomelatine in patients with Major Depressive Disorder over a 52-week open-label phase.

Cohort I is restricted to include patients who have completed a previous Novartis agomelatine (178C) Double-blind study.

Cohort II will include de-novo patients (those who did not participate in a previous agomelatine 178C study) and will only be open for a limited time span ranging from approximately June to Sept 2010, at which point this cohort II will be closed to enrollment.

 

Cyclophosphamide and Prednisone With or Without Immunoglobulin in Treating Abnormal Muscle Movement in Children With Neuroblastoma

 

Drugs used in chemotherapy, work in different ways to stop tumor cells from dividing so they stop growing or die. Steroid therapy decreases inflammation. Combining chemotherapy and steroid therapy with immunoglobulin may be effective in treating abnormal muscle movement associated with neuroblastoma.

This randomized phase II trial is studying cyclophosphamide, prednisone, and immunoglobulin to see how well they work compared to cyclophosphamide and prednisone alone in treating patients with abnormal trunk muscle movements associated with neuroblastoma.

 

Efficacy and Safety of Flexibly Dosed BMS-820836 in the Treatment of Patients With Treatment Resistant Major Depression

 
The purpose of the study is to evaluate the efficacy of study drug (BMS-820836) as compared with continued duloxetine in the treatment of patients with treatment resistant depression (TRD).
 
Telemedicine Outreach for Post Traumatic Stress in CBOCs
 
The purpose of this study is improved outcomes for veterans with Post Traumatic Stress Disorder (PTSD) treated in small VA Community Based Outpatient Clinics (CBOCs). Although psychotherapy and pharmacotherapy treatments for PTSD have been proven to be efficacious in controlled trials, geographic barriers often prevent veterans from accessing these evidence-based treatments. Telemedicine technologies will be used to overcome geographic barriers to care. Specifically, we will evaluate the Telemedicine Outreach for PTSD (TOP) intervention which is based on the principals of the Chronic Care Model and Disease Management, and builds on the evidence base of quality improvement for depression in primary care settings. The TOP intervention will employ an off-site PTSD care team (tele-psychiatrist, tele-psychologist, tele-pharmacist, and tele-nurse care manager) and will use telemedicine technologies (telephone, interactive video and electronically shared medical records) to treat CBOC patients with a newly emerging or chronic PTSD. We hypothesize that study participants randomized to the TOP intervention will receive higher quality of care and experience better outcomes compared to study participants randomized to treatment as usual.