Efficacy Of Bupropion For Attention Deficit Hyperactivity Disorder (ADHD) In Adults
This study has been completed.
Sponsor:
Massachusetts General Hospital
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
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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 May 23, 2013