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ADHD clinical trials

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NCT ID: NCT00341029 Completed - Clinical trials for Attention Deficit Hyperactivity Disorder

Genetic Measurements in Blood Cells of Children Taking Adderall or Methylphenidate

Start date: December 7, 2005
Phase: N/A
Study type: Observational

This study, conducted at Duke University in Durham, NC, will determine whether the drugs Adderall and methylphenidate affect the genetic material of children with attention deficit hyperactivity disorder (ADHD). One small study has shown that taking methylphenidate for ADHD may result in higher levels of certain types of changes to the genetic material contained in white blood cells. The changes seen are not directly linked to increased risk of disease, but indicate a possibility that other kinds of damage that may be linked to increased disease may result from taking methylphenidate. The study will also examine whether these types of changes might occur in children treated with Adderall . Children between the ages of 6 and 12 with symptoms of ADHD may be eligible for this study. Candidates are screened with a medical history, psychiatric examination, IQ test, physical examination, and electrocardiogram. Parents and teachers complete questionnaires to rate the severity of the child's ADHD. Qualified children who are diagnosed with ADHD and who are appropriate candidates for treatment with either Adderall or methylphenidate-based drugs (e.g., Concerta, Metadate, Focalin, Ritalin or Ritalin LA) may be selected for this study. At a baseline visit (Visit 0), parents complete questionnaires that rate the severity of their child's ADHD. The children have their vital signs checked (pulse, blood pressure, breathing rate, height, weight and temperature) and have a blood sample drawn. The children are then randomly assigned to treatment with either Adderall or a methylphenidate product. After the baseline visit, participants undergo the following tests and procedures: Dose Optimization Visits (visits 1-4) In the first 4 weeks of the study, the dose of methylphenidate or Adderall is adjusted weekly until doctors determine the dose strength that works best for the individual child. In addition, the following procedures are done at each visit: - Child's vital signs are checked. - Parents complete a questionnaire about the severity of the child's ADHD. - Parent and child describe the impact of symptoms on the child's functioning. - Parents complete forms about common side effects of the study drug. Follow-up Visits (visits 5-6) Children return to the clinic once a month to assess their health and further adjust their medication dose, if needed. The visits are similar to those during the dose optimization period, with the following additional procedures at visit 6: - A blood sample is obtained to measure whether the medication has affected the child's genetic material. - A physical examination is done to check child's health. - Information is provided parents to assist in planning for child's treatment after the study.

NCT ID: NCT00339027 Completed - Obesity Clinical Trials

HealthSpark: Health Access for Children in Federally-Subsidized Child Care

Start date: May 2004
Phase:
Study type: Observational

HealthSpark is a community-based research network of childcare centers designed to improve the health of children in Miami-Dade County. HealthSpark is the health component of SPARK (Supporting Partnerships to Assure Ready Kids), a community coalition led by the Early Childhood Initiative Foundation to improve school readiness in Allapattah/Model City and Homestead/Florida City, two underserved Miami-Dade County communities. The goal of HealthSpark I is to identify the health and healthcare needs of preschool children, then help translate evidence-based intervention into community programs.

NCT ID: NCT00315276 Completed - Clinical trials for Attention Deficit Hyperactivity Disorder

Dose-Finding Study to Evaluate the Efficacy and Safety of Modafinil as Treatment for Adults With ADHD

Start date: May 2006
Phase: Phase 2
Study type: Interventional

The purpose of the study is to evaluate the efficacy and safety of modafinil administered once daily for 9 weeks at doses of 255, 340, 425, and 510 mg as treatment for adults with ADHD.

NCT ID: NCT00264797 Completed - ADHD Clinical Trials

Attention Deficit Hyperactivity Disorder (ADHD) in Adolescents With Substance Use Disorders (SUD)

Start date: February 2006
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine the efficacy of osmotic-release methylphenidate (OROS-MPH) versus placebo for the treatment of ADHD in adolescents with SUD.

NCT ID: NCT00254878 Completed - ADHD Clinical Trials

Placebo-Controlled Comparison of Two Different Brands of Modified-Release Oral Dosage Forms Regarding Safety and Efficacy in Children With Attention Deficit Hyperactivity Disorder (ADHD) Aged 6 - 14

Start date: October 2005
Phase: Phase 3
Study type: Interventional

Currently two different brands of modified-release formulations are providing 50% immediate release beads/pellets and 50% extended release beads/pellets, resulting in a rapid onset and dual peak concentrations of plasma methylphenidate. One is manufactured by Novartis, the other one by Medice (Germany). The objective of the study is to test the hypothesis that the Novartis product is superior to placebo and is clinically not inferior to the formulation manufactured by Medice.

NCT ID: NCT00253747 Completed - Smoking Clinical Trials

Smoking Cessation for Adults With Attention Deficit Hyperactivity Disorder (ADHD)

Start date: November 2005
Phase: Phase 3
Study type: Interventional

The objective of this study is to evaluate whether Osmotic-Release Methylphenidate (OROS MPH), relative to placebo, increases the effectiveness of standard smoking treatment (i.e., nicotine patch and individual smoking cessation counseling) in obtaining prolonged abstinence for smokers with Attention Deficit Hyperactivity Disorder (ADHD).

NCT ID: NCT00228540 Completed - ADHD Clinical Trials

Study to Assess Satisfaction With Modafinil Treatment in Children and Adolescents With ADHD

Start date: September 2005
Phase: Phase 3
Study type: Interventional

An 8-week, Open-Label Study to Characterize the Response to Modafinil (85mg Film-Coated Tablet) Treatment at Dosages up to 425mg/Day in Children and Adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD) (With an Open-Ended Extension Period)

NCT ID: NCT00223561 Completed - ADHD Clinical Trials

Methylphenidate and Driving Ability in Adult Patients With Attention-Deficit Hyperactivity Disorder

Start date: February 2003
Phase: Phase 4
Study type: Interventional

The primary purpose of this study is to determine the effects of methylphenidate versus placebo on driving ability of adult ADHD patients.

NCT ID: NCT00214981 Completed - ADHD Clinical Trials

Evaluate the Safety and Efficacy of Modafinil in Children and Adolescents With ADHD

Start date: September 2003
Phase: Phase 3
Study type: Interventional

Primary objective of this study is to evaluate the safety of treatment with modafinil film-coated tablet.

NCT ID: NCT00190957 Completed - ADHD Clinical Trials

Atomoxetine Treatment of Adults With ADHD and Comorbid Alcohol Abuse

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

Atomoxetine Treatment of Adults with ADHD and Comorbid Alcohol Abuse