Bupropion for ADHD in Adults
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METHODS
Design: Double blind placebo controlled, randomized, parallel 6 week trial comparing SR Bupropion (up to 200 gm BID, N=21) to placebo (N=19) in adults with DSM-IV ADHD.
Setting: Massachusetts General Hospital - Clinical Psychopharmacology Unit. Study approved by IRB.
Patient Population: 20-59 yr adults recruited from advertisements and referrals to unit. Mean age 38, SD 11. 38 completed, 2 dropouts because of side effects.
Exclusion Criteria: Clinically significant chronic medical conditions, h/o cardiac arrhythmias or seizures, mental retardation IQ < 75, organic brain syndrome, clinically unstable psychiatric condition, bipolar disorder, drug or alcohol abuse or dependence within 6 months preceding the study, or current use of psychotropics.
Screening: 154 subjects, 40 enrolled. 30 not interested, 27 no FU, 17 subs abuse, 11 psychotropics, 10 no ADHD, 9 BPAD or psychotic d/o, 6 medical CI, 4 previous bupropion use.
Diagnosis: Psych eval, physical and neuro exam, EKG, SGOT. Diagnostic interview – structured clinical interview for DSM- III R and DSM –IV supplemented for childhood disorders by unmodified modules from the SADS for school age children – epidemiological version. For diagnosis – fully meet criteria for ADHD by age 7 and well as current past month, chronic course from child to adult, moderate to severe impairment. Diagnostic reliability was excellent between raters and board certified psychiatrists (kappa 1 with 95% CI of 0.8-1). WAIS-R, Wide Range Achievement Test -3 was used for IQ and SE status by Hollingshead Four Factor Index of social status.
Outcome measures:
Efficacy: Overall severity by CGI – severity and improvement. For ADHD – ADHD Rating Scale, good correlation with ADHD Symptom Check List. Dep by HAM-D & BDI, for anxiety HARS. Inattentive type 23 (58%), Combined 14 (35%), Hyperactive / Impulsive 3(8%). 89% had at least one comorbid psychiatric d/o, 49% had symptoms in the last month. For ADHD 11 had taken meds, 7 had counseling, 7 both. Despite av. intelligence 17 needed tutoring, 11 repeated a grade. Smoking status did not differ. CGI, ADHD at baseline and each FU. Depression and anxiety at baseline and end.
Safety: FU was weekly, adverse events and VS each visit.
Intervention: Up to 200 mg BID Bupropion SR. Started at 100mg QAM and increased by 100 mg weekly in BID doses to a total of 400 mg, unless adverse effects present.
Analysis: Stata (Stata Corp, College Park , Tex. ): Projected group size 20 per treatment arm, a bupropion response rate of 60%, placebo response rate of 10% and alpha 0.05, statistical power 0.89. Probability of type II error was 0.11. Improvement in ADHD was defined as ADHD rating score improvement of 30% or better & CGI score of 1 or 2. Comparing improvement: Fisher’s exact. Ordinal data between 2 time points: Wilcoxon signed-rank test for paired data. Ordinal and continuous data at baseline and end point Wilcoxon rank-sum test for paired data. Study groups on binary outcomes Fishers exact test. For continuous variables, group differences was tested using linear regression and generalized estimation equation used for main effect of the drug and time and any relationship between the variables. p 0.05 was significant.
Randomization Yes; Blinding Yes; Baseline characteristics seem equal on those shown in table 1; Equal Treatment yes; Analyzed in group randomized to seems so, but not specifically mentioned Follow up 57% continued Bupropion, other details not available.
Presented by Vidya Krishnan, MD, 29th Nov 04
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