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ADHD clinical trials

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NCT ID: NCT00663442 Completed - ADHD Clinical Trials

Basic and Clinical Research on Attention Deficit Hyperactivity Disorder (ADHD)

Start date: December 1999
Phase: Phase 4
Study type: Interventional

Children between 6-17 are evaluated for ADHD and and a blood sample is obtained for DNA extraction. If eligible, they participate in a 4 week, double blind, placebo controlled trial with weekly switches. In randomized order, children receive 18, 36, 54 mg. OROS methylphenidate and placebo. Each week, parent report measures, clinical interviews, and safety assessments are conducted. Hypothesis: Efficacy and adverse events will be dose dependent. Dopamine Transporter Genotype will predict response

NCT ID: NCT00644566 Recruiting - ADHD Clinical Trials

Pilot Study of Shared Care of ADHD in a Pediatric Clinic:Colocation of a Psychologist as an ADHD Care Manager

shared care
Start date: August 2006
Phase: N/A
Study type: Interventional

Due to the shortage of child psychiatrists and the high prevalence of child mental health disorder, pediatricians and other pediatric primary care providers often assume responsibility for the management of various psychiatric disorders, including ADHD, Attention Deficit Hyperactivity Disorder. However, pediatricians have not been well-trained during residency to deal with the complexities of ADHD management. In addition, the system of care under which pediatricians practice do not afford the time availability that is required to properly manage a child with ADHD. On the other hand, if a pediatrician wishes to refer a patient to a child mental health specialist, many obstacles, including but not limited to stigma, insurance issues, and long waiting lists, often interfere with the patient actually receiving services for his/her ADHD. This research project seeks to examine an innovative model of care in which a child psychologist is located on the premises of a pediatric office and is available to share the care of patients with the pediatrician in order to address ADHD. We hypothesize that parents as well as pediatricians will be more satisfied with this model of care and that patients will ultimately have better outcomes. The beginning of our pilot has shown under-identification to be a barrier to care as well, and thus we propose to implement a quality improvement initiative to screen children for psychosocial issues as well. As we have had trouble with recruitment and unfortunately have had more children randomized to TAU than shared care, we propose in December 2007 a phase 2 of our study where all subjects, instead of randomization, are entered into shared care.

NCT ID: NCT00641329 Completed - ADHD Clinical Trials

CLONICEL (Clonidine Sustained Release) as Add-on to Stimulant Medication in 6 to 17 Yr-olds With ADHD

Start date: February 2008
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine if CLONICEL (clonidine HCl sustained release) is a safe and effective add-on to psychostimulant therapy in children and adolescents with attention deficit hyperactivity disorder (ADHD).

NCT ID: NCT00634439 Completed - ADHD Clinical Trials

Safety Study of Atomoxetine and Cerebrovascular Outcomes

Start date: January 2008
Phase: N/A
Study type: Observational

Using a proprietary insurance health claims database, Eli Lilly and Company has contracted with an external party to conduct a retrospective cohort study of health claims for the time period from 1 January 2003 through 31 December 2006 (with follow-up of patients through 30 June 2007). This study will evaluate the potential association between atomoxetine and cerebrovascular events. In this study, the incidence of selected cerebrovascular outcomes as represented in health claims data among adult patients who initiate therapy with atomoxetine will be estimated. In particular the study will focus on cerebrovascular accident (CVA) and transient ischemic attack (TIA) as the outcomes of interest. The incidence for each outcome among atomoxetine initiators will then be compared to the incidence in a cohort of similar patients who initiate stimulant treatment and an age and gender-matched general population cohort. The atomoxetine and stimulant-initiating cohorts will be matched on a broad variety of variables, including age, gender, diagnoses, medication use, and healthcare utilization through the use of propensity score matching in order to minimize the influence of confounding by indication. The analysis will include the cohorts (atomoxetine and stimulant initiators) from a previous completed study with increased follow-up time (1 January 2003 through 30 June 2007) and accrue new atomoxetine and stimulant ADHD medication initiators over a 2 year period, so that the study will represent initiators between January 1, 2003 and December 31, 2006 with follow-up through June 30, 2007.

NCT ID: NCT00593112 Completed - ADHD Clinical Trials

Proton Magnetic Spectroscopy in Children and Adolescents With ADHD Before and After Treatment With OROS Methylphenidate

Start date: November 2006
Phase: Phase 4
Study type: Interventional

This will be an open label study using daily does of up to 126mg/day of Concerta in the treatment of children and adolescents, ages 12-17, who meet DSM-IV criteria for ADHD. Specific hypotheses are as follows: Hypothesis 1: Children and adolescents with ADHD will have significantly higher ACC and DLPFC Glutamate/myo-Inositol containing compounds (Glu/Ino) and Glutamate/creatine + phosphocreatine (Glu/Cr) than matched HCS. Hypothesis 2: After six weeks of treatment, OROS methylphenidate will lower ACC and DLPFC Glu/Ino and Glu/Cr levels in children with ADHD who are methylphenidate responders.

NCT ID: NCT00592254 Active, not recruiting - ADHD Clinical Trials

Screening Protocol for Adults With ADHD

Start date: December 2002
Phase:
Study type: Observational

The objective of this protocol is to establish a comprehensive screening process to evaluate the eligibility of potential adult subjects for appropriate ADHD clinical research studies

NCT ID: NCT00586573 Completed - ADHD Clinical Trials

Open-Label Pilot Study of Namenda in Adult Subjects With ADHD and ADHD NOS

Start date: March 2007
Phase: Phase 4
Study type: Interventional

The primary objective of the study is to assess the efficacy and tolerability of a 12-week trial of memantine hydrochloride administered twice daily in 20 adults (ages 18-55) with ADHD and ADHD NOS. Improvement will be defined as: 1) changes from baseline on the investigator-rated DSM-IV based ADHD Rating Scale; 2) changes from baseline in a questionnaire aimed at assessing executive functions (BRIEF); and 3) changes from screening in a computerized neuropsychological battery (CANTAB). We hypothesize that memantine hydrochloride will be associated with improving ADHD symptoms and associated deficits in executive functions. We also expect that memantine will be well-tolerated with predictable adverse events.

NCT ID: NCT00586157 Completed - Clinical trials for Attention Deficit Hyperactivity Disorder

Study of Medication Patch to Treat Children Ages 6-12 With ADHD

Start date: September 2006
Phase: Phase 4
Study type: Interventional

The purpose of this study is to investigate the effectiveness of a medication skin patch called Methylphenidate Transdermal System (MTS). We will compare the MTS medicated patch to a placebo patch. We want to find out how well it treats ADHD during the early morning hours before a child leaves for school or summertime routines.

NCT ID: NCT00585910 Completed - Clinical trials for Attention Deficit Hyperactivity Disorder

Study of Atomoxetine and OROS Methylphenidate to Treat Children and Adolescents Ages 6-17 With ADHD

Start date: January 2004
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate the safety, effectiveness, and tolerability of atomoxetine and OROS methylphenidate, taken together, in the treatment of ADHD in children and adolescents ages 6-17.

NCT ID: NCT00579267 Completed - Anxiety Disorders Clinical Trials

Reliability and Validity of the MINI International Neuropsychiatric Interview for Children and Adolescents (MINI-KID)

Start date: February 2004
Phase: N/A
Study type: Observational

The primary aims of this study are to assess: 1. The inter-rater and test-retest reliability of the MINI-KID 2. The validity of the standard MINI-KID interview in relation to the parent rated pencil/paper version (MINI-KID-P) and th longer clinician rated "Schedule for Affective Disorders and Schizophrenia for School Aged Children-Present and Lifetime Version (K-SADS-PL) and "expert opinion" (when available). Secondary aims will include evaluating the concordance between: The Children's Global Assessment Scale (a required part of the K-SADS) with the clinician-rated Sheehan Disability Scale (to be administered with the MINI-KID) as a measure of illness severity.