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Attention-Deficit Hyperactivity Disorder (ADHD) Study With Adults

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00048360
Enrollment
162
Registered
2002-10-31
Start date
2002-10-31
Completion date
2003-06-30
Last updated
2013-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Attention Deficit Disorder

Keywords

ADD, ADHD, attention deficit, hyperactivity

Brief summary

This is a placebo controlled study evaluating the efficacy and safety of medication in adults with Attention-Deficit Hyperactivity Disorder (ADHD).

Interventions

Sponsors

GlaxoSmithKline
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
ADHD Rating Scale

Secondary

MeasureTime frame
Clinical Global Impressions -Severity and Improvement.
Quality of Life Enjoyment and Satisfaction Questionnaire.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026