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
  Purpose

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.


Condition Intervention
Attention Deficit Hyperactivity Disorder (ADHD)
Substance Use Disorder (SUD)
Drug: Bupropion SR

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy Of Bupropion SR For Attention Deficit Hyperactivity Disorder (ADHD) In Adults With Recent Past or Current Substance Use Disorders

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 32
Study Start Date: May 1999
Primary Completion Date: July 2001 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bupropion Drug: Bupropion SR
100mg capsules Initial dosing 100mgSR every morning, to be titrated to 200mgSR twice daily maximum
Other Name: Wellbutrin

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Timothy Wilens, MD, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01270555     History of Changes
Obsolete Identifiers: NCT01012024
Other Study ID Numbers: 1999-P-009198
Study First Received: January 3, 2011
Results First Received: January 7, 2011
Last Updated: March 4, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Substance-Related Disorders
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Mental Disorders
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Bupropion
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 22, 2014