Last updated: 11/04/2018 04:36:10
Attention-Deficit Hyperactivity Disorder (ADHD) Study With Adults
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: An 8-week, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Flexible-Dose Comparison of Extended-Release Bupropion Hydrochloride 300-450 mg/day to Assess the Efficacy, Safety, and Effects on Health Outcomes in the Treatment of Adults with Attention-Deficit/Hyperactivity Disorder
Trial description: This is a placebo controlled study evaluating the efficacy and safety of medication in adults with Attention-Deficit Hyperactivity Disorder (ADHD).
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Enrollment:
162
Primary completion date:
2003-30-06
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Kobayashi M, Yoshinaga T, Seki T, et al. In vitro antiretroviral properties of S/GSK1349572, a next-generation HIV integrase inhibitor. [Antimicrob Agents Chemother]. 2011;55(2):813-821.
Wilens TE, Haight BR, Horrigan JP, Hudziak JJ, Rosenthal NE, Connor DF, Hampton KD, Richard NE, Modell JG. Bupropion XL in adults with ADHD: a randomized, placebo-controlled study. Biological Psychiatry, 2005;57:793-801.
Medical condition
Attention Deficit Disorder
Product
bupropion
Collaborators
None
Study date(s)
October 2002 to June 2003
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
18 - 60 Years
Accepts healthy volunteers
no
- Inclusion criteria:
- Patient must be diagnosed with ADHD.
Inclusion and exclusion criteria
Inclusion criteria:
- Inclusion criteria:
- Patient must be diagnosed with ADHD. Exclusion Criteria:
- Patient has a current or past history of seizure disorder, brain injury, anorexia nervosa or bulimia.
- Patient has a current diagnosis of Major Depressive Disorder (MDD).
- Patient has a current primary diagnosis of, or received treatment for, Panic Disorder, Obsessive Compulsive Disorder (OCD), Posttraumatic Stress Disorder (PTSD) or Acute Stress Disorder within the previous 12 months.
- Patient has a lifetime diagnosis of bipolar disorder, schizophrenia or other psychotic disorders.
- Patient has a positive urine test at screening for presence of illicit drugs or alcohol abuse during the past 12 months.
Trial location(s)
Location
GSK Clinical Trials Call Center
Lafayette, CA, United States, 94549
Status
Study Complete
Location
GSK Clinical Trials Call Center
Phoenix, AZ, United States, 85016
Status
Study Complete
Location
GSK Clinical Trials Call Center
Houston, TX, United States, 77007
Status
Study Complete
Location
GSK Clinical Trials Call Center
Paducah, KY, United States, 42003
Status
Study Complete
Location
GSK Clinical Trials Call Center
Worcester, MA, United States, 01655
Status
Study Complete
Location
GSK Clinical Trials Call Center
Chula Vista, CA, United States, 91910
Status
Study Complete
Showing 1 - 6 of 21 Results
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
2003-30-06
Actual study completion date
2003-30-06
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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