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Efficacy Of Bupropion For Attention Deficit Hyperactivity Disorder (ADHD) In Adults

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01270555
First Posted: January 5, 2011
Last Update Posted: March 8, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Timothy Wilens, MD, Massachusetts General Hospital
January 3, 2011
January 5, 2011
January 7, 2011
February 25, 2011
March 8, 2013
May 1999
July 2001   (Final data collection date for primary outcome measure)
  • Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS) Score [ Time Frame: baseline and six weeks ]
    Assesses 18 individual criteria symptoms using a severity grid (0 = not present, 3 = severe; overall minimum score = 0, maximum score = 54)
  • Self-reported Weekly Substance Use [ Time Frame: baseline and six weeks ]
    Number of subjects who self-report using at least one of illegal drugs or alcohol, at least once in a week.
Efficacy as defined by change in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS) Score [ Time Frame: baseline to six weeks ]
Complete list of historical versions of study NCT01270555 on ClinicalTrials.gov Archive Site
  • Clinical Global Impressions (CGI) Scale of Substance Use Disorder (SUD) Severity [ Time Frame: baseline and six weeks ]
    CGI-S 1=not ill, 7=extremely ill
  • Clinical Global Impressions (CGI) Scale of ADHD Severity [ Time Frame: baseline and six weeks ]
    Global Severity (CGI-S) 1=not ill, 7=extremely ill
  • Hamilton Anxiety Scale (HAM-A) [ Time Frame: baseline and six weeks ]
    minimum score (least severe anxiety) = 0, maximum (most severe) = 56
  • Hamilton Depression Scale (HAM-D) [ Time Frame: baseline and six weeks ]
    minimum score (least severe depression) = 0, maximum score (most severe) = 84
  • Beck Depression Inventory (BDI) [ Time Frame: baseline and six weeks ]
    minimum score (least severe depression) = 0, maximum score (most severe) = 63
  • Efficacy as defined as change in Clinical Global Impressions (CGI) Scale of SUD Severity [ Time Frame: baseline to six weeks ]
  • Efficacy as defined as change in Clinical Global Impressions (CGI) Scale of ADHD Severity [ Time Frame: baseline to six weeks ]
Not Provided
Not Provided
 
Efficacy Of Bupropion For Attention Deficit Hyperactivity Disorder (ADHD) In Adults
Efficacy Of Bupropion SR For Attention Deficit Hyperactivity Disorder (ADHD) In Adults With Recent Past or Current Substance Use Disorders
The investigators propose to conduct an open study to evaluate the efficacy and tolerability of Bupropion SR using clinically relevant doses in ADHD adults with a recent history of or current substance use disorders. We hypothesize that Bupropion SR will be effective in treating ADHD in this population.
Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Attention Deficit Hyperactivity Disorder (ADHD)
  • Substance Use Disorder (SUD)
Drug: Bupropion SR
100mg capsules Initial dosing 100mgSR every morning, to be titrated to 200mgSR twice daily maximum
Other Name: Wellbutrin
Experimental: Bupropion
Intervention: Drug: Bupropion SR
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
Not Provided
July 2001   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male and female outpatients 18 years old or older, up to 60 years old.
  • Patients with the diagnosis of Attention Deficit Hyperactivity Disorder (ADHD), by DSM-IV, as manifested in clinical evaluation and confirmed by structured interview.
  • Patients within the past 6 months known to abuse or to be dependent on alcohol or any drug (nicotine addiction not included)

Exclusion Criteria:

  • Any clinically unstable medical condition
  • Clinically significant abnormal baseline laboratory values
  • Mental retardation (I.Q. <75) or Organic brain disorders
  • Seizure disorder
  • Patients with a history or an eating disorder including anorexia or bulimia nervosa
  • Pregnant or nursing females
  • Patients with current bipolar disorder
  • Psychotic disorder of any type
  • Patients on psychotropics known to treat ADHD (i.e. stimulants, tricyclics)
  • Patients receiving psychotherapy known to treat ADHD (i.e. cognitive or cognitive/behavioral psychotherapy)
  • Patients demonstrating active withdrawal from substance abuse
Sexes Eligible for Study: All
18 Years to 60 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT01270555
1999-P-009198
No
Not Provided
Not Provided
Timothy Wilens, MD, Massachusetts General Hospital
Massachusetts General Hospital
Not Provided
Not Provided
Massachusetts General Hospital
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP