Attention Deficit Hyperactivity Disorder Clinical Trial
Official title:
Phase IV Placebo-Controlled Study of Atomoxetine Hydrochloride in the Treatment of Adults With ADHD and Comorbid Social Anxiety Disorder
| Verified date | June 2007 |
| Source | Eli Lilly and Company |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
To investigate the effect of atomoxetine hydrochloride in treating adults who have attention deficit hyperactivity disorder with comorbid social anxiety disorder
| Status | Completed |
| Enrollment | 440 |
| Est. completion date | May 2007 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 65 Years |
| Eligibility |
Inclusion Criteria: - You must be 18 to 65 years old. - You must have been diagnosed with attention deficit hyperactivity disorder and social anxiety disorder. - You must be able to visit the doctor's office at least 8 times over a 16 week period. - You must agree to participate with all tests and examinations that are required for this study. Exclusion Criteria: - You are a woman and pregnant or breastfeeding. - You presently have an acute or unstable medical illness. - You have a history of allergic reaction to atomoxetine hydrochloride. - You are taking medications that are not permitted in this study. Your physician will discuss these with you. - You have taken part in another clinical research trial within the last 30 days or have received treatment with a drug in the last 30 days that has not received regulatory approval. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Puerto Rico | 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. | Rio Piedras | |
| 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. | Belmont | 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. | Bradenton | 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. | Burlington | Vermont |
| 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. | Cedarhurst | 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. | Charleston | South 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. | 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. | Cherry Hill | 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. | Gainesville | 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. | 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. | 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. | Lexington | Kentucky |
| 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. | Midlothian | 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. | Nashua | New Hampshire |
| 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. | Rochester Hills | 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. | San Antonio | 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. | St. Charles | Missouri |
| 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. | Wildomar | California |
| Lead Sponsor | Collaborator |
|---|---|
| Eli Lilly and Company |
United States, Puerto Rico,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Reduction in signs and symptoms of ADHD as measured by the mean changes from baseline to endpoint in Conner's adult ADHD rating scale | |||
| Secondary | Reduction in signs and symptoms of social anxiety as measured by the mean changes from baseline to endpoint in Liebowitz social anxiety scale |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT06129396 -
Effects of Aerobic Exercise Intervention in Adolescents With Attention-deficit/Hyperactivity Disorder (ADHD)
|
N/A | |
| Completed |
NCT04779333 -
Lifestyle Enhancement for ADHD Program 2
|
N/A | |
| Recruiting |
NCT05935722 -
Evaluation of a Home-based Parenting Support Program: Parenting Young Children
|
N/A | |
| Completed |
NCT03148782 -
Brain Plasticity Underlying Acquisition of New Organizational Skills in Children-R61 Phase
|
N/A | |
| Completed |
NCT04832737 -
Strength-based Treatment Approach for Adults With ADHD
|
N/A | |
| Recruiting |
NCT04631042 -
Developing Brain, Impulsivity and Compulsivity
|
||
| Recruiting |
NCT05048043 -
Development of a Game-supported Intervention
|
N/A | |
| Completed |
NCT03337646 -
Evaluation of the Effect and Safety of Lisdexamfetamine in Children Aged 6-12 With ADHD and Autism
|
Phase 4 | |
| Not yet recruiting |
NCT06406309 -
Settling Down for Sleep in ADHD: The Impact of Sensory and Arousal Systems on Sleep in ADHD
|
N/A | |
| Not yet recruiting |
NCT06454604 -
Virtual Reality Treatment for Emerging Adults With ADHD
|
Phase 2 | |
| Not yet recruiting |
NCT06080373 -
Formulation-based CBT for Adult Inmates With ADHD: A Randomized Controlled Trial
|
N/A | |
| Completed |
NCT02911194 -
a2 Milk for Autism and Attention-deficit Hyperactivity Disorder (ADHD)
|
N/A | |
| Completed |
NCT02477280 -
Effects of Expectation, Medication and Placebo on Objective and Self-rated Performance
|
Phase 4 | |
| Completed |
NCT02390791 -
New Technologies to Help Manage ADHD
|
N/A | |
| Completed |
NCT02780102 -
Cognitive-Motor Rehabilitation, Stimulant Drugs, and Active Control in the Treatment of ADHD
|
N/A | |
| Completed |
NCT02555150 -
A Comparison of PRC-063 and Lisdexamfetamine in the Driving Performance of Adults With ADHD
|
Phase 3 | |
| Completed |
NCT02829970 -
Helping College Students With ADHD Lead Healthier Lifestyles
|
N/A | |
| Completed |
NCT02473185 -
Effects of Expectation, Medication and Placebo on Objective and Self-rated Performance During the QbTest
|
Phase 4 | |
| Recruiting |
NCT04296604 -
Transcranial Direct Current Stimulation (tDCS) Neuromodulation of Executive Function Across Neuropsychiatric Populations
|
N/A | |
| Recruiting |
NCT04175028 -
Neuromodulation of Executive Function in the ADHD Brain
|
N/A |