Transcript ADHD - 2nd International Conference on Hospice and Palliative Care

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
Disclosure
• Dr. Peleikis has nothing to disclose
• Dr. Fredriksen has nothing to disclose
Treatment or‘Palliation’of ADHD
• ADHD is not considered as a life-threatening
disorder, but increased mortality is found
(Dalsgaard, 2015)
• Only symptomatic relief - from distressing symptoms
and impaired functioning - on current medications
– Aspects of a palliative aim
– Improves quality of life
– Support patients and their family in living & coping
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 Text Revision
(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
Melchior Adam Weikard
27.04.1742 - 25.07.1803
Der Philosophische Arzt 1775
http://www.divacenter.eu/DIVA.aspx
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)
Treatment of adult ADHD
Medications
•
Centralstimulants
• Methylfenidate
• Short- or long-acting
• Amphetamines
• Short- or long-acting
•
Non-medicational treatment
Non-stimulants
• Atomoxetine
• Buproprione
• Antidepressives (TCA, MAO)
• Reboxetine
• Antihypertensives (clonidine,
guanfacine)
• Modafinile
• Psychosocial
– Psycho-education
– Structured forms of
psychotherapy
• cognitiv behavioral therapy
• Group therapy
– In addition
• Individual plans
• Solution focused treatment
• Habilitation or fascilitation
• Alternatives?
– Diets?
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 many drop-outs
– Few trials examined more than one drug
– Selection bias
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
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
Study Flowchart
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 ADHDsymptoms 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
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
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)
Primary Outcomes by Adherence to Medication
Weeks
Primary Outcome by Adherence to Medication
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
Thank you all….
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
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
Longitudinal study course
Start of medication
Inclusion
Waiting-list
6 weeks 3 months
6 months
12 months
Baseline
Background variables:
Outcome measures:
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• Adult ADHD symptoms (ASRSv1.1)
• Clinician rated global functioning (GAF)
Age and gender
ADHD-symptoms (DIVA 2.0)
Comorbid disorders (MINI)
IQ (HASI; WAIS)
Symptom severity in childhood (WURS)
Other medication
Educational and vocational attainments
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Clinician rated respons (CGI-I)
Self rated symptoms [SCL-90-R (GSI)]
Ratings of side-effects (CADDRA)
Adverse events and drop-outs
Somatic data (heart beat, BP, ECG, hight,
weight)