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Dawn E. Peleikis ᵃ, MD, PhD and Mats Fredriksen ᵇ, MD, PhD

An open-label prospective effectiveness-study : Effectiveness of one-year pharmacological treatment of adult attention-deficit/ hyperactivity disorder (ADHD). Dawn E. Peleikis ᵃ, MD, PhD and Mats Fredriksen ᵇ, MD, PhD ᵃ Department of Psychiatry, Akershus University Hospital, Norway

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Dawn E. Peleikis ᵃ, MD, PhD and Mats Fredriksen ᵇ, MD, PhD

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  1. An open-label prospective effectiveness-study:Effectiveness of one-year pharmacological treatment of adult attention-deficit/ hyperactivity disorder (ADHD) Dawn E. Peleikis ᵃ, MD, PhD and Mats Fredriksen ᵇ, MD, PhD ᵃ Department of Psychiatry, Akershus University Hospital, Norway ᵇ Division of Mental Health and Addiction, Vestfold Hospital Trust, Norway International Conference on Hospice and Palliative Care Orlando, Florida, USA August 31-September 02, 2015

  2. Disclosure • Dr. Peleikis has nothing to disclose • Dr. Fredriksen has nothing to disclose

  3. Treatment or‘Palliation’of ADHD • ADHD is not considered as a life-threateningdisorder, butincreasedmortality is found (Dalsgaard, 2015) • Onlysymptomaticrelief - from distressing symptoms and impairedfunctioning - oncurrentmedications • Aspects of a palliative aim • Improvesquality of life • Support patients and theirfamily in living & coping

  4. ADHD - Diagnose and Core Symptoms • DSM-IV (Text Revision): ADHD Attention-Deficit /Hyperactivity Disorder • DSM-IV TR: The Diagnostic and Statistical Manual of Mental Disorder - Fourth Edition TextRevision (American Psychiatric Association, 2000) • Core symptoms: • Inattention • Hyperactivity - Impulsivity • Nevrodevelopmental – and biological pedriatric psychiatric disorder • High heritability - shown in twin and family studies (70-80%) • High prevalence of persistence into adulthood

  5. Melchior Adam Weikard 27.04.1742 - 25.07.1803 Der Philosophische Arzt 1775

  6. http://www.divacenter.eu/DIVA.aspx

  7. Background • Increasing rate of referred and treated adults with ADHD (Hannås, 2012) • Increased consumption of ADHD drugs in Western Europe • Childhood ADHD persists into adult ADHD in 50-65% (Faraone, 2006) • Worldwide prevalence of adult ADHD: 2-5% (Simon, 2009; Barkley, 2010) • Comorbid psychiatric disorders : Common in ADHD (70-80%) (Torgersen, 2006; Sobanski, 2007)

  8. Non-medicational treatment Psychosocial Psycho-education Structured forms of psychotherapy cognitiv behavioral therapy Group therapy In addition Individual plans Solution focused treatment Habilitation or fascilitation Alternatives? Diets? Treatment of adult ADHD • Medications • Centralstimulants • Methylfenidate • Short- or long-acting • Amphetamines • Short- or long-acting • Non-stimulants • Atomoxetine • Buproprione • Antidepressives (TCA, MAO) • Reboxetine • Antihypertensives (clonidine, guanfacine) • Modafinile

  9. Gap of Knowledge • Is there any clinical relevant evidence for long-term efficacy of ADHD-medication? • Randomized controlled trials (RCTs) had documented short-term efficacy (4-10weeks, a few up to 6 months) (Faraone, 2010; Torgersen, 2008; Fredriksen, 2012) • Small groups and manydrop-outs • Few trials examined more thanone drug • Selection bias

  10. Aims of the Study • A prospective observational study of a clinical relevant sample (real life patients with comorbidities, poly pharmacy) without blinded randomization • Long time follow-up: one-year • Treated with medication according to current guidelines • Standardized evaluation to compare with other studies and to be able to generalize the results

  11. Study Sample • Inclusion: • Previously not medicated patients referred to a specialized Out-patient Clinic for diagnostic and treatment of ADHD • Fulfill the diagnostic criteria for ADHD (DSM-IV-TR) assessed by a board certified psychiatrist • Exclusion: • Previously medicated for ADHD • Patients not allowed to use stimulants or atomoxetine due to other medical conditions • Comorbid acute psychosis or current substance use or dependence with immediate need of other treatment • Intelligence quotient below 2 SD (standard deviations) on the Wechsler Adult Intelligence Scale IV • Autism Spectrum Disorder

  12. Study Flowchart

  13. Methods Design: Prospective observational study for 12 months of adults with ADHD who receive ADHD-medication first time Sample: N=250 included, previously unmedicated Outcome measures: Repeated measures of self-rated ADHD-symptoms by the ASRS, clinical rated changes of global symptoms and functioning (GAF), and clinical rated respons (CGI-I), and self-rated general psychological distress or symptoms (SCL-90R, GSI), and side-effects Other variables: comorbide mental disorders by structural clinical interview (MINI), side-effects (CADDRA), dose of ADHD-medication, type of ADHD-medication, time in treatment

  14. Results • At 12 months follow-up: 232 patients (93%) completed evaluation • 163 patients on-medication (70%) • Most patients used Methylphenidate (by 80%) • Improvements on the primary outcomes (ASRS and GAF) were statistically superior for those continuing on-medication • Median reduction of ADHD-symptoms (ASRS) on-medication at one year evaluation: 39% (versus 13% off-medication) • Greatest improvements were observed in the first 6 weeks, but continued until 12 months completion for those adherent to medication

  15. Results • Higher cumulative dose was associated with greater improvements over time • Comorbid psychiatric disorder and side-effects were associated with weakened recovery • Out of those 69 patients who stopped medication (30%), 31 (45%) reported side-effects as the reason for discontinuation • No serious adverse effects were observed during the study, but 9 patients had to stop medication due to elevated blood pressure (above defined levels 150/95 mmHg)

  16. Primary Outcomes by Adherence to Medication Weeks

  17. Primary Outcome by Adherence to Medication

  18. Conclusion • RCTs have shown efficacy of stimulants and atomoxetine in studies up to 6 months duration • In this study we found effectiveness sustained in open-label observational study design in a clinical relevant setting for one year duration • One year treatment of adult ADHD showed clinically significant reduction of symptoms and improved ratings of global functioning • No serious side-effects occurred, and side-effects were for most patients tolerable

  19. Thank you all….

  20. Further Research • Need for more and longer-duration longitudinal studies of medications of adult ADHD • Other outcome measures are relevant; quality of life, different functional measures, cost- benefit analyses • Other pharmacological agents than stimulants or atomexetine

  21. Further Research • Unresolved impact of psychiatric comorbidities • Studies of benefit of early initiation of treatment or treatment programs are sparse • Large scale epidemiological studies on treatment are few • Limited knowledge of effectiveness of medication in age group above 50 years

  22. Longitudinal studycourse Start of medication Inclusion 6 weeks 3 months 6 months 12 months Waiting-list Baseline Background variables: Outcome measures: • Age and gender • ADHD-symptoms (DIVA 2.0) • Comorbiddisorders (MINI) • IQ (HASI; WAIS) • Symptom severity in childhood (WURS) • Othermedication • Educational and vocationalattainments • Adult ADHD symptoms (ASRSv1.1) • Clinicianrated global functioning (GAF) • Clinicianrated respons (CGI-I) • Selfrated symptoms [SCL-90-R (GSI)] • Ratingsof side-effects (CADDRA) • Adverse events and drop-outs • Somatic data (heart beat, BP, ECG, hight, • weight)

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