NCT00048360|CompletedPhase 3

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

GlaxoSmithKline ClinicalTrials.gov

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1 other identifier

AK130934

Study Type

interventional

Target

162

Locations

1 country

Sites

Timeline

RegisteredOct 2002

StartedOct 2002

CompletionJun 2003

Brief Summary

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

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

162

participants targeted

Target at P25-P50 for phase_3

Timeline

Completed

Started Oct 2002

Shorter than P25 for phase_3

Geographic Reach

1 country

21 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

8 months study duration

Study Start

First participant enrolled

October 1, 2002

Completed

29 days until next milestone

First Submitted

Initial submission to the registry

October 30, 2002

Completed

1 day until next milestone

First Posted

Study publicly available on registry

October 31, 2002

Completed

7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2003

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2003

Completed

Last Updated

February 12, 2013

Status Verified

February 1, 2013

Enrollment Period

8 months

First QC Date

October 30, 2002

Last Update Submit

February 11, 2013

Conditions

Attention Deficit Disorder

Keywords

ADDADHDattention deficithyperactivity

Outcome Measures

Primary Outcomes (1)

ADHD Rating Scale

Secondary Outcomes (2)

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

Interventions

Extended-release bupropion hydrochlorideDRUG

Eligibility Criteria

Age18 Years - 60 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64)

You may qualify if:

Patient must be diagnosed with ADHD.

You may not qualify if:

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.

Contact the study team to confirm eligibility.