ADHD Clinical Trial
Official title:
Efficacy and Safety of Once-Daily Atomoxetine Hydrochloride in Adults With ADHD Over an Extended Period of Time (6 Months); With a Brief Evaluation of Executive Cognition
| Verified date | November 2007 |
| Source | Eli Lilly and Company |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
A study to compare the effect of once-daily atomoxetine versus placebo in treating symptoms of ADHD in adults for up to 6 months.
| Status | Completed |
| Enrollment | 440 |
| Est. completion date | September 2006 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 54 Years |
| Eligibility |
Inclusion Criteria: - Male and Female patients with ADHD ages 18-54. - Patient must have ADHD symptoms that cause problem(s) in the home setting. Exclusion Criteria: - Have failed to respond to an adequate trial of treatment with an ADHD stimulant medication, bupropion, or other nonstimulant medication. - Are taking any antipsychotic medication or mood stabilizers within 8 weeks of Visit 1 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST) or speak with your personal physician. | Boise | Idaho |
| United States | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST) or speak with your personal physician. | Charlotte | North Carolina |
| United States | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST) or speak with your personal physician. | Clementon | New Jersey |
| United States | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST) or speak with your personal physician. | Farmington | Connecticut |
| United States | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST) or speak with your personal physician. | Hamden | Connecticut |
| United States | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST) or speak with your personal physician. | Herndon | Virginia |
| United States | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST) or speak with your personal physician. | Houston | Texas |
| United States | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST) or speak with your personal physician. | Jacksonville | Florida |
| United States | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST) or speak with your personal physician. | Lafayette | California |
| United States | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST) or speak with your personal physician. | Lafayette | Indiana |
| United States | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST) or speak with your personal physician. | Lake Jackson | Texas |
| United States | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST) or speak with your personal physician. | Middleton | Wisconsin |
| United States | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST) or speak with your personal physician. | New York | New York |
| United States | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST) or speak with your personal physician. | Okemos | Michigan |
| United States | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST) or speak with your personal physician. | Piscataway | New Jersey |
| United States | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST) or speak with your personal physician. | Seattle | Washington |
| United States | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST) or speak with your personal physician. | Spring Valley | California |
| United States | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST) or speak with your personal physician. | Springfield | Massachusetts |
| United States | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST) or speak with your personal physician. | Troy | Michigan |
| Lead Sponsor | Collaborator |
|---|---|
| Eli Lilly and Company |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Atomoxetine administered orally, QD in the AM, from 25 mg/day to 100 mg/day for 6 months is superior to placebo in ADHD adults. | |||
| Secondary | Atomoxetine administered QD in the AM, provides superior efficacy in the evenings compared with placebo in ADHD adults. |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03148782 -
Brain Plasticity Underlying Acquisition of New Organizational Skills in Children-R61 Phase
|
N/A | |
| Recruiting |
NCT06038942 -
Formal Versus Informal Mindfulness Among University Students With Self-reported ADHD, Nonsuicidal Self-injury, or Stress
|
N/A | |
| Recruiting |
NCT05518435 -
Managing Young People With ADHD in Primary Care Study
|
||
| Active, not recruiting |
NCT04978792 -
Does Cultivating Self-compassion Improve Resilience to Criticism and Improve Mental Health in Adults With ADHD?
|
N/A | |
| Completed |
NCT03216512 -
Effects of Noise Cancelling Headphones on Neurocognitive and Academic Outcomes in ADHD
|
N/A | |
| Completed |
NCT02900144 -
Modified Comprehensive Behavioral Intervention for Tics (M_CBIT)
|
N/A | |
| Completed |
NCT02829528 -
Little Flower Yoga for Kids: Evaluation of a Yoga and Mindfulness Program for Children With Increased Levels of Emotion Dysregulation and Inattention
|
N/A | |
| Not yet recruiting |
NCT02906501 -
Effect of Risperidone on Cognitive Functions in Adolescents With ADHD and Behavioral Disturbances
|
N/A | |
| Completed |
NCT02562469 -
ACTIVATE: A Computerized Training Program for Children With ADHD
|
N/A | |
| Terminated |
NCT02271880 -
Improving Medication Adherence in ADHD Adolescents
|
N/A | |
| Recruiting |
NCT02255565 -
Dose Response Effects of Quillivant XR in Children With ADHD and Autism: A Pilot Study
|
Phase 4 | |
| Completed |
NCT02463396 -
Mindfulness Training in Adults With ADHD
|
N/A | |
| Completed |
NCT01673594 -
Prevention of Stimulant-Induced Euphoria With an Opioid Receptor Antagonist
|
Phase 4 | |
| Terminated |
NCT01733680 -
Amiloride Hydrochloride as an Effective Treatment for ADHD
|
Early Phase 1 | |
| Completed |
NCT02300597 -
Internet-based Support for Young People With ADHD and Autism - a Controlled Study
|
N/A | |
| Active, not recruiting |
NCT01137318 -
Combined Cognitive Remediation and Behavioral Intervention for Treatment of Attention-deficit/Hyperactivity Disorder (ADHD)
|
Phase 2 | |
| Completed |
NCT01404273 -
Functional MRI of Relaxation Response Training in Adults With Attention-Deficit/Hyperactivity Disorder
|
N/A | |
| Completed |
NCT00586157 -
Study of Medication Patch to Treat Children Ages 6-12 With ADHD
|
Phase 4 | |
| Completed |
NCT00573859 -
The Reinforcing Mechanisms of Smoking in Adult ADHD
|
Phase 1/Phase 2 | |
| Completed |
NCT00228540 -
Study to Assess Satisfaction With Modafinil Treatment in Children and Adolescents With ADHD
|
Phase 3 |