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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Timothy Wilens, MD, Massachusetts General Hospital

ClinicalTrials.gov Identifier:

NCT01270555

First received: January 3, 2011

Last updated: March 4, 2013

Last verified: March 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	January 3, 2011
Last Updated Date	March 4, 2013
Start Date ^ICMJE	May 1999
Primary Completion Date	July 2001 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: April 15, 2011)	Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS) Score [ Time Frame: baseline and six weeks ] [ Designated as safety issue: No ] 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 ] [ Designated as safety issue: No ] Number of subjects who self-report using at least one of illegal drugs or alcohol, at least once in a week.
Original Primary Outcome Measures ^ICMJE (submitted: January 3, 2011)	Efficacy as defined by change in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS) Score [ Time Frame: baseline to six weeks ] [ Designated as safety issue: No ]
Change History	Complete list of historical versions of study NCT01270555 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: April 15, 2011)	Clinical Global Impressions (CGI) Scale of Substance Use Disorder (SUD) Severity [ Time Frame: baseline and six weeks ] [ Designated as safety issue: No ] CGI-S 1=not ill, 7=extremely ill Clinical Global Impressions (CGI) Scale of ADHD Severity [ Time Frame: baseline and six weeks ] [ Designated as safety issue: No ] Global Severity (CGI-S) 1=not ill, 7=extremely ill Hamilton Anxiety Scale (HAM-A) [ Time Frame: baseline and six weeks ] [ Designated as safety issue: No ] minimum score (least severe anxiety) = 0, maximum (most severe) = 56 Hamilton Depression Scale (HAM-D) [ Time Frame: baseline and six weeks ] [ Designated as safety issue: No ] minimum score (least severe depression) = 0, maximum score (most severe) = 84 Beck Depression Inventory (BDI) [ Time Frame: baseline and six weeks ] [ Designated as safety issue: No ] minimum score (least severe depression) = 0, maximum score (most severe) = 63
Original Secondary Outcome Measures ^ICMJE (submitted: January 3, 2011)	Efficacy as defined as change in Clinical Global Impressions (CGI) Scale of SUD Severity [ Time Frame: baseline to six weeks ] [ Designated as safety issue: Yes ] Efficacy as defined as change in Clinical Global Impressions (CGI) Scale of ADHD Severity [ Time Frame: baseline to six weeks ] [ Designated as safety issue: Yes ]
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Efficacy Of Bupropion For Attention Deficit Hyperactivity Disorder (ADHD) In Adults
Official Title ^ICMJE	Efficacy Of Bupropion SR For Attention Deficit Hyperactivity Disorder (ADHD) In Adults With Recent Past or Current Substance Use Disorders
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Attention Deficit Hyperactivity Disorder (ADHD) Substance Use Disorder (SUD)
Intervention ^ICMJE	Drug: Bupropion SR 100mg capsules Initial dosing 100mgSR every morning, to be titrated to 200mgSR twice daily maximum Other Name: Wellbutrin
Study Arm (s)	Experimental: Bupropion Intervention: Drug: Bupropion SR
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	32
Completion Date	Not Provided
Primary Completion Date	July 2001 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 60 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT01270555
Other Study ID Numbers ^ICMJE	1999-P-009198
Has Data Monitoring Committee	No
Responsible Party	Timothy Wilens, MD, Massachusetts General Hospital
Study Sponsor ^ICMJE	Massachusetts General Hospital
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Massachusetts General Hospital
Verification Date	March 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top