Trial Outcomes & Findings for Efficacy Of Bupropion For Attention Deficit Hyperactivity Disorder (ADHD) In Adults (NCT NCT01270555)

NCT ID: NCT01270555

Last Updated: 2013-03-08

Results Overview

Assesses 18 individual criteria symptoms using a severity grid (0 = not present, 3 = severe; overall minimum score = 0, maximum score = 54)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 32 participants
• Primary outcome timeframe: baseline and six weeks
• Results posted on: 2013-03-08

Participant Flow

Participant milestones

Measure	Bupropion Once daily treatment with Bupropion with intention to treat ADHD and SUD.
Overall Study STARTED	32
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	13

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Bupropion n=32 Participants Once daily treatment with Bupropion with intention to treat ADHD and SUD.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	32 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	32 years STANDARD_DEVIATION 8.5 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	26 Participants n=5 Participants
Region of Enrollment United States	32 participants n=5 Participants
DSM-IV Attention Deficit Hyperactivity Rating Scale (ADHD RS)	34.1 Units on a scale STANDARD_DEVIATION 8.2 • n=5 Participants
Self-reported Weekly substance use	32 Participants n=5 Participants
Clinical Global Impressions (CGI) Score for SUD Severity	4.0 Units on a scale STANDARD_DEVIATION 0.9 • n=5 Participants
Clinical Global Impressions (CGI) Score for ADHD Severity	5.0 Units on a scale STANDARD_DEVIATION 0.7 • n=5 Participants
Hamilton Anxiety Rating Scale (HAM-A)	8.1 Units on a scale STANDARD_DEVIATION 6.5 • n=5 Participants
Hamilton Depression rating Scale (HAM-D)	8.8 Units on a scale STANDARD_DEVIATION 9.1 • n=5 Participants
Beck Depression Inventory (BDI)	8.9 Units on a scale STANDARD_DEVIATION 5.9 • n=5 Participants

PRIMARY outcome

Timeframe: 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)

Outcome measures

Measure	Bupropion n=32 Participants Once daily treatment with Bupropion with intention to treat ADHD and SUD.
Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS) Score	19.4 Units on a scale Standard Deviation 11.4

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Bupropion n=18 Participants Once daily treatment with Bupropion with intention to treat ADHD and SUD.
Self-reported Weekly Substance Use	18 Participants

SECONDARY outcome

Timeframe: baseline and six weeks

CGI-S 1=not ill, 7=extremely ill

Outcome measures

Measure	Bupropion n=32 Participants Once daily treatment with Bupropion with intention to treat ADHD and SUD.
Clinical Global Impressions (CGI) Scale of Substance Use Disorder (SUD) Severity	3.1 Units on a scale Standard Deviation 0.8

SECONDARY outcome

Timeframe: baseline and six weeks

Global Severity (CGI-S) 1=not ill, 7=extremely ill

Outcome measures

Measure	Bupropion n=32 Participants Once daily treatment with Bupropion with intention to treat ADHD and SUD.
Clinical Global Impressions (CGI) Scale of ADHD Severity	3.8 Units on a scale Standard Deviation 1.1

SECONDARY outcome

Timeframe: baseline and six weeks

minimum score (least severe anxiety) = 0, maximum (most severe) = 56

Outcome measures

Measure	Bupropion n=32 Participants Once daily treatment with Bupropion with intention to treat ADHD and SUD.
Hamilton Anxiety Scale (HAM-A)	4.5 Units on a scale Standard Deviation 6.9

SECONDARY outcome

Timeframe: baseline and six weeks

minimum score (least severe depression) = 0, maximum score (most severe) = 84

Outcome measures

Measure	Bupropion n=32 Participants Once daily treatment with Bupropion with intention to treat ADHD and SUD.
Hamilton Depression Scale (HAM-D)	4.5 Units on a scale Standard Deviation 5.7

SECONDARY outcome

Timeframe: baseline and six weeks

minimum score (least severe depression) = 0, maximum score (most severe) = 63

Outcome measures

Measure	Bupropion n=32 Participants Once daily treatment with Bupropion with intention to treat ADHD and SUD.
Beck Depression Inventory (BDI)	3.7 Units on a scale Standard Deviation 5.1

Adverse Events

Bupropion

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Timothy Wilens, MD

Massachusetts General Hospital

Phone: 617-503-1053

Email: twilens@partners.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place