Attention Deficit Disorder With Hyperactivity Clinical Trial
Official title:
Pilot Study of the Efficacy of Duloxetine in Treating Adults With Attention Deficit Hyperactivity Disorder: a Randomized, Controlled Trial.
Verified date | December 2010 |
Source | Université de Montréal |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Health Canada |
Study type | Interventional |
The purpose of this study is to determine whether duloxetine is an effective treatment of attention deficit disorder in adults.
Status | Completed |
Enrollment | 40 |
Est. completion date | December 2010 |
Est. primary completion date | December 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 50 Years |
Eligibility |
Inclusion Criteria: - Clinical diagnosis of ADHD of at least moderate intensity - Able to give consent - Able to swallow capsules Exclusion Criteria: - Allergic or do not tolerate duloxetine - Under psychotherapy for ADHD - Taking a medication that interacts with duloxetine, including all psychotropic medication - Treated with medication for ADHD - Unstable medical condition - Severe renal insufficiency - Liver insufficiency - Substance/alcool abuse or dependency in the last 6 months - Pregnancy, nursing or inadequate contraceptive methods - Suicide or homicide risk - Organic brain syndrome - Any diagnosis of lifetime bipolar disorder or psychotic disorder, and any actual diagnosis of anxious disorder or major depressive disorder |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Centre Hospitalier Universitaire de Montréal: Hôpital Notre-Dame | Montreal | Quebec |
Lead Sponsor | Collaborator |
---|---|
Université de Montréal | Centre hospitalier de l'Université de Montréal (CHUM) |
Canada,
Tourjman SV, Bilodeau M. Improvement with duloxetine in an adult ADHD patient. J Atten Disord. 2009 Jul;13(1):95-6. doi: 10.1177/1087054708326109. Epub 2009 Apr 9. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Impact of duloxetine on the Conners' Adult attention-Deficit/Hyperactivity Disorder Rating Scale-Observer Report:Screening Version (CAARS-O:SV) in adult ADHD subjects. | baseline and week 6 | No | |
Secondary | Impact of duloxetine on the Clinical Global Impression Scale in ADHD adults | baseline and week 6 | No | |
Secondary | Impact of duloxetine on the Conners' Adult attention-Deficit/Hyperactivity Disorder Rating Scale-Self Report : Long Version(44) (CAARS-S:L), in adult ADHD subjects. | baseline and week 6 | No | |
Secondary | Impact of duloxetine on anxious and depressive symptoms in adult ADHD subjects. | baseline and week 6 | No | |
Secondary | Impact of duloxetine on Quality of life in adults with ADHD | baseline and week 6 | No | |
Secondary | Impact of duloxetine on executive functions and cognitive performances in adults with ADHD | baseline and week 6 | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT00202605 -
Safety and Efficacy of SPD465 in Adults With ADHD
|
Phase 2 | |
Not yet recruiting |
NCT02677519 -
A 12-Month Open Label Safety Study of Aptensio XR® in Children Ages 4-5 Years Diagnosed With ADHD
|
Phase 4 | |
Completed |
NCT02730572 -
Concerta (Methylphenidate) -To-Generic Switch Study
|
N/A | |
Completed |
NCT01681082 -
Psychological Effects of Tai Chi Training
|
N/A | |
Active, not recruiting |
NCT01330693 -
Cortical Excitability: Phenotype and Biomarker in Attention-deficit, Hyperactivity Disorder (ADHD) Therapy
|
Phase 3 | |
Completed |
NCT00830700 -
Children's Attention Deficit Disorder With Hyperactivity (ADHD) Telemental Health Treatment Study
|
N/A | |
Completed |
NCT00626236 -
Phase 2a Study of Safety and Tolerability of SPN-810 in Children With ADHD and Persistent Serious Conduct Problems
|
Phase 2 | |
Completed |
NCT01012622 -
An Efficacy and Safety Study of Osmotic Release Oral System (OROS) Methylphenidate in Participants With Attention Deficit Hyperactivity Disorder (ADHD)
|
Phase 4 | |
Completed |
NCT00598182 -
Adherence and Long-term Effect of OROS Methylphenidate (CONCERTA): A Follow-up Study
|
N/A | |
Completed |
NCT00381407 -
Organizational Skills Training for Children With Attention Deficit Hyperactivity Disorder
|
N/A | |
Completed |
NCT00178503 -
Methylphenidate for Attention Deficit Hyperactivity Disorder and Autism in Children
|
Phase 2/Phase 3 | |
Completed |
NCT00247572 -
Safety, Tolerability and Abuse Liability Study of Intravenous NRP104 in Adults With Stimulant Abuse Histories
|
Phase 2 | |
Completed |
NCT00557011 -
NRP104, Adderall XR or Placebo in Children Aged 6-12 Years With ADHD
|
Phase 2 | |
Completed |
NCT00118911 -
Cognitive Behavioral Therapy for Treatment of Adult Attention Deficit Hyperactivity Disorder
|
N/A | |
Completed |
NCT00218322 -
Effectiveness of ATMX in Treating Adolescents With ADHD and SUD
|
Phase 4 | |
Completed |
NCT00071656 -
Psychosocial Treatment for Attention Deficit Hyperactivity Disorder (ADHD) Type I
|
N/A | |
Active, not recruiting |
NCT00057668 -
Preventing Behavior Problems in Children With ADHD
|
Phase 2 | |
Completed |
NCT00050622 -
Behavioral Treatment, Drug Treatment, and Combined Treatment for Attention Deficit Hyperactivity Disorder (ADHD)
|
N/A | |
Completed |
NCT00050050 -
Cognitive Behavioral Therapy for Adult Attention Deficit Hyperactivity Disorder
|
Phase 1 | |
Completed |
NCT00031395 -
Clonidine in Attention Deficit Hyperactivity Disorder (ADHD) in Children
|
Phase 3 |