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The REsource for Advancing Children’s Health : 

The REsource for Advancing Children’s Health 2008 www.TheReachInstitute.org …Putting Science to Work Best Practices for Use of Psychiatric Medications: What Psychologists Need to Know Peter S. Jensen, MD

Extent of Mental Disorders InChildren and Adolescents : 

Extent of Mental Disorders InChildren and Adolescents 7.8% 8.0% 5.6% 5.0% 1.0% 0.5% Source: Office of the Surgeon General, andNational Institute of Mental Health, 1999

Myths Surrounding The Causes Of Childhood Psychiatric Disorders : 

Bad parenting They'll grow out of it Myths Surrounding The Causes Of Childhood Psychiatric Disorders food additives cause these disorders bad diet

Medications Should Rarely (if ever) Be Used : 

Medications Should Rarely (if ever) Be Used Common Beliefs: Effective Parenting and Teaching Is the Solution Medications Won’t Help in the Long Run We Doctors Know What to Do One Size Fits All Medications are Over-prescribed

Critical Issues: Use of Psychotropic Agents in Children & Adolescents : 

Problem Overview: Too much new information: Physicians may have hard time keeping up Physicians’ practices and clinical treatment needs are often far out in front of the knowledge base Lack of support for new practices (training,tools, failing to address obstacles, etc.) Old habits die hard: changing physician behavior is very complex Lack of public understanding of role of medications Critical Issues: Use of Psychotropic Agents in Children & Adolescents

Critical Issues: Use of Psychotropic Agents in Children & Adolescents : 

Dramatic, 4-10 fold Increases in Uses of All Medications in last 10 years Stimulants (80% in primary care) SSRIs (40% in primary care) Atypical Antipsychotics (20% in primary care) Mood stabilizers (15% in primary care) 75% of all meds “off-label” across all of pediatrics Off-label does not mean inappropriate FDA mandates to conduct testing in children Abundant new information Critical Issues: Use of Psychotropic Agents in Children & Adolescents

Critical Issues: Use of Psychotropic Agents in Children & Adolescents : 

Critical Issues: Use of Psychotropic Agents in Children & Adolescents Over- vs. under-prescribing? Frequent use of multiple medications – “polypharmacy” Need for evidence-based treatment guidelines for treating SED youth with atypicals, mood stabilizers, and other agents Need for guidance on linking-integrating medication with other treatment modalities

Depression Medications: What Works? : 

Depression Medications: What Works? Depression 12 Studies w/TCAs - probably not efficacious SSRIs - ~30 Studies 56% vs. 33% placebo (fluoxetine, paroxetine) data \support SSRI’s over placebo (3 of 4 studies) possible decreases in suicide rates in adolescents

Medications: Bipolar DIsorder : 

Medications: Bipolar DIsorder Relatively few Studies Geller et al. (1998) DBRT lithium, adolescent BPD/SUD vs. PBO 2 other small underpowered studies, no significant differences Studies in progress (e.g., Findling et al., Stanley Foundation)… Disagreements re: Diagnosis: Bipolar I, II, NOS – more studies needed

Risperidone in Bipolar Disorder:Response Pre- and Post-Treatment : 

Risperidone in Bipolar Disorder:Response Pre- and Post-Treatment Mean CGI Severity P<0.01 P<0.001 P<0.01 P<0.01 Extremely severe Severe Marked Moderate Mild Borderline Normal N=28 N=25 N=13 N=28 Frazier JA, et al. J Am Acad Child Adolesc Psychiatry 1999; 38:960–965.

Placebo-Crossover Trial of DivalproexDBD Children w/ Irritable Mood Swings (n=20) : 

Placebo-Crossover Trial of DivalproexDBD Children w/ Irritable Mood Swings (n=20) % Responders Donovan et al., 2000

DVP + Quetiapine vs DVP + Placebo in Manic Adolescents: YMRS Scores : 

DVP + Quetiapine vs DVP + Placebo in Manic Adolescents: YMRS Scores DVP + Quetiapine DVP + Placebo DelBello MP, et al. J Am Acad Child Adolesc Psychiatry. 2002;41:1216-1223. *P < .01 0 7 14 21 28 35 42 Day 40 35 30 25 20 15 10 5 0 YMRS * * * N = 30

Anxiety Medications: What Works? : 

Anxiety Medications: What Works? Anxiety Disorders Multiple small studies indeterminate findings Research Units in Pediatric Psychopharmacology (RUPP) study: SSRI (fluvoxamine) vs. PBO, 76% vs. 29%, RUPP Anxiety Study Group, 2001

NIMH RUPP Study, CGI Change by Week : 

Fluvoxamine, n=63; Placebo, n=65; chi-square=28.3, P<0.0001 NIMH RUPP Study, CGI Change by Week

Autism: What Works? : 

Autism: What Works? Autism Agents Tested Under DBRT haloperidol (4 studies) - well-established, but no agent treats core symptoms of autism 2 multisite studies (risperidone - RUPP Autism Study Group), some modest benefits for core symptoms, dramatic benefits for aggression

Clinical Global Impressions – Improvement : 

Clinical Global Impressions – Improvement RUPP Autism Network. N Engl J Med. 2002;347:314-321. Much Improved or Very Much Improved on CGI-I N = 101

A double blind placebo controlled trial of risperidone in autistic disorder : 

A double blind placebo controlled trial of risperidone in autistic disorder McDougle CJ, Aman M, McCracken JT, et al. ACNP, December 9-13,2001, Waikoloa, Hawaii.

What Works? : 

What Works? Schizophrenia 4 DBRTs - 3 w/haloperidol, 2 w/clozapine some evidence of superiority over placebo studies in progress w/risperidone, clzp, etc. Tourettes 5 DBRTs - haloperidol, pimozide, risperidone some evidence of superiority over placebo

Psychotic Children/Adolescents: Study Results : 

Psychotic Children/Adolescents: Study Results Responders* Psychotic Symptoms *Responder status defined as CGI-I of “1” or “2” and at least 20% reduction in BPRS-C total score. Sikich et al. Annual Meeting of the American College of Neuropsychopharmacology (ACNP), December 9, 2001, #149. –37 –36 –23 68 75 47

Risperidone in Tourette’s Syndrome: YGTSS Total Tic Score : 

Risperidone in Tourette’s Syndrome: YGTSS Total Tic Score Whole Group (N=34) Children (N=26) 32* 36* 7 9 YGTSS=Yale Global Tic Severity Scale. *P=0.004. Scahill L et al. Unpublished results.

OCD Medications: What Works? : 

OCD Medications: What Works? Obsessive Compulsive Disorder clomipramine well-established: 3 DBRTs Recent trials w/ several SSRIs, leading to approval by FDA (paroxetine, fluoxetine, sertraline, etc.) Riddle et al., 1996 Wolkow et al., 1997 Riddle et al, 1992

CD/ODD Medications: What Works? : 

CD/ODD Medications: What Works? Conduct/Oppositional Problems and Conduct Disorder Haloperidol, lithium, better than PBO severely aggressive hospitalized children (Campbell et al.) Dextroamphetamine DBRT (Klein & Abikoff, 1997) Risperidone effective for impulsive aggressive symptoms (Aman et al., Findling et al., Turgay et al., 2001)

EFFICACY: Behavioral symptoms (US study) : 

Data on File Week 1 Week 2 Week 3 Week 4 Week 5 Week 6 Endpoint EFFICACY: Behavioral symptoms (US study)

Results: Overt Aggression Scale : 

Results: Overt Aggression Scale Rating by ward personnel for overall score Buitelaar JK et al. J Clin Psychiatry 2001; 62::239–248. *P<0.05, **P<0.01 within group changes between endpoint and baseline or between end of washout and endpoint †P<0.05 differences in changes between risperidone and placebo. 9.0 11.5 8.1 6.7** 8.0 10.4*†

Slide 29: 

methylphenidated water for schools with a large number of ADHD students

ADHD Medications: What Works? : 

ADHD Medications: What Works? ADHD Psychostimulants (MPH, dextroamphetamine, pemoline) - >200 DBRTs Typical investigations of stimulant efficacy usually quite brief New agents (Concerta, Adderal XR) last longer, more convenient, but not more effective) Controlled studies support efficacy of other medications TCAs (18 trials, e.g., Biederman et al, 1991) neuroleptics, carbamazepine buproprion

Slide 31: 

Assessment Points Baseline Early Treatment (3 m) Mid- treatment (9 m) End Treatment (14 m) Follow-up (24 m) Follow-up (36 m) 14-m Treatment Stage 10-m Follow- up After Treatment 22-m Follow- up After Treatment 0 36 24 14 Month Recruitment Screening Diagnosis Random Assignment 579 ADHD Subjects Medication Only 144 Subjects Psychosocial (Behavioral) Treatment Only 144 Subjects Combined Medication and Psychosocial Treatment 145 Subjects Assessment and Referral (Community Control) No Treatment from Study; Assessed for 24 mo. 146 Subjects Recruitment of LNCG Cohort

MTA Study - Behavioral Treatment (Beh) : 

MTA Study - Behavioral Treatment (Beh) Parent Training Daily “Report Card” Teacher Consultation Contingency Management Aide Tng STP & counselors Paraprof. Aide (PPA) 2x/month Weekly Spring | Summer | Fall | Winter | Spring 3x/month 2x/month monthly Daily 2x/month By phone, then by parent

% “Normalized” at 14-month EndpointMTA Groups vs. Classroom Controls 88% 68% 56% 34% 25% MTA N = 579 Classroom Cntrls N = 288

14-Month Outcomes Teacher SNAP-Inattention Average Score Assessment Point (Days)

Key Differences, MedMgt vs. CC: Initial Titration Dose Dose Frequency #Visits/year Length of Visits Contact w/schools Teacher-Rated Inattention(CC Children Separated By Med Use)

Would You Recommend Treatment? (parent) : 

Would You Recommend Treatment? (parent) Medmgt Comb Beh Not recommend 9% 3% 5% Neutral 9% 1% 2% Slightly Recommend 4% 2% 2% Recommend 35% 15% 24% Strongly recommend 43% 79% 67%

Comparisons & Combinations: What Works? : 

Comparisons & Combinations: What Works? Multi-site Trials for Testing Combined Treatments - generalizability across settings MTA Study: Combined (Meds+BT) may be slightly better than Meds only; Meds-only generally better than Behavior therapy only TADS Study: Combination modestly better than Meds only; Med alone > therapy alone Studies In Progress OCD: CBT vs. SSRI vs. Combo (Foa & March) ADHD w/Anxiety: SSRI + methylphenidate (RUPP) Bipolar w/Depression: mood stabilizer +/- SSRI Multisystemic Therapy, Therapeutic Foster Care, Functional Family Therapy

Comparisons & Combinations: What Works? : 

Behavioral interventions may lower the dose of medication required. Medication may make it easier to implement a successful behavioral program Behavioral interventions can target areas such as not following rules that may not be addressed as well by medication. Medication may more effectively reduce core symptoms. CBT + SSRI may lower risk of suicidal ideation vs. SSRI only Comparisons & Combinations: What Works?

Slide 41: 

Teacher-Rated Disruptive Behavioramong Children whose Parents Changed Most (top 1/3rd) in Neg-Ineff. Disciplinary Practices

Preferences Re: ADHD Treatments : 

Preferences Re: ADHD Treatments Medication only Counseling or therapy Either meds or counseling Either unlikely Other Not sure If your child were diagnosed with ADHD, which of the following would you be more comfortable with? Parents (n=301) Jensen, 2002

General Considerations: I : 

General Considerations: I Every child with a well-diagnosed psychiatric disorder deserves consideration of adequate trials of appropriate medications Stimulants work in up to 90% of children with ADHD Other agents (SSRIs, AAMs) are effective for specific conditions Medications must be titrated; this requires close follow-up & clarity re: effects you want to see

General Considerations: II : 

General Considerations: II If a child does not respond to a medication, re-examine diagnosis, co-existing conditions, treatment, & adherence Medications should not be used as a substitute for necessary environmental modifications and psychotherapeutic approaches For maximum effect, medications should usually be used in combination with therapy, and may enhance therapy effects

Discussion with Child and Family: I : 

Discussion with Child and Family: I Discuss range of proven therapeutic options Explain positives and negatives of medication and other treatments to the family and youth Address stigma/misconceptions Assist family in arriving at a choice of treatment options. Encourage combined treatment options in severe cases or when one form of treatment has failed

Discussion with Child and Family: II : 

Discussion with Child and Family: II Determine target behaviors of concern to family and child with input from teachers and others Explain to child/youth that meds are not to control behavior, but to help increase self-control Encourage self-management, tracking of symptoms, education, and awareness of side effects

Medication Management: I : 

Medication Management: I “Try it and see” approach unavoidable Ensure adequate dose and duration before changing meds or adding another Less is more. Avoid (but don’t shun) polypharmacy Regular follow-up with physician who is expert in use of the meds

Medication Management: II : 

Medication Management: II Careful monitoring of side effects and therapeutic response, use of scales, diaries, and checklists, etc. If multiple drugs in combination have little effect, consider “wash-out” of all meds, starting over. Some meds may cause SEs that mimic psychiatric symptoms Beware over-reliance on previous labels/diagnoses

Medication Side Effects : 

Medication Side Effects Concerta, Adderal, Metadate, Ritalin (stimulants): Appetite, sleep, weight/height effects (temporary) Prozac, Luvox, Paxil, Zoloft, Celexa, Remeron (SSRI’s): agitation, sleep disturbances, drowsiness, headache, GI sx, disinhibition Risperdal, Seroquel, Zyprexa, Geodon, Abilify, Clozaril (AAMs): excessive weight gain, hyperglycemia, ?diabetes, sedation, TD, extrapyramidal sx Clonidine, Guanfacine (alpha 2 agonists): sedation, hypotension Lithium, Tegretol, Depakote (mood stabilizers): tremors, nausea/GI sx, polycystic ovaries, liver abnormalities

Treatment Considerations : 

Treatment Considerations Scientifically Supported Treatments : ADHD: 200+ med studies, 80+ psychotherapy studies Depression: 1 medication (+/-), 2 psychotherapies OCD: 4 medications, 1 psychotherapy Anxiety Disorders: 2 medications, 1 psychotherapy Conduct disorders: 1 medication, 1 psychotherapy Autism: 2 medications, 1 psychotherapy Tourette syndrome: 2 medications Psychosis: 3 medications Bipolar Disorder

Recommendations : 

Recommendations Accurate information re: E-B treatments Culturally specific, community-adapted and implemented, re: role and value of various treatments Training/retraining Federal, professional, and advocacy coalition for E-B curricula in training programs (PhD, MA, MSW, MD) Teacher curricula-certification (understanding and attitudes re: childhood disorders) Policy initiatives Model E-B programs Expand PCP time, incentives, flexibility Investment in quality TA to providers

Effectiveness of Interventions by Intervention Type : 

Effectiveness of Interventions by Intervention Type Davis, 2000 No. of Interventions demonstrating positive or negative/inconclusive change

Recommendations : 

Recommendations Accurate information re: E-B treatments Culturally specific, community-adapted and implemented, re: role and value of various treatments Training/retraining Federal, professional, and advocacy coalition for E-B curricula in training programs (PhD, MA, MSW, MD) Teacher curricula-certification (understanding and attitudes re: childhood disorders) Policy initiatives Model E-B programs Expand PCP time, incentives, flexibility Investment in quality TA to providers

How do we connect systems, families, providers, and the evidence base? What are their respective roles and importance in working with a condition such as ADHD? : 

How do we connect systems, families, providers, and the evidence base? What are their respective roles and importance in working with a condition such as ADHD?

Three Levels: Child & Family Factors: e.g., Access, Ease, Acceptance Provider/Organization Factors: e.g., Training level, Usefulness Systemic and Societal Factors: e.g., Access to services, Ethical Issues/Consent, Costs Barriers vs. “Promoters” to Delivery of Effective Services “Effective” Services Efficacious Services

Child & Family Interventions to Increase Involvement : 

Child & Family Interventions to Increase Involvement Shared problem definition and prioritization, and control over process Tailoring to fit specific needs Respect of mutual expertise Cultural similarity “Non-specific” therapeutic factors Engagement strategies

What Is Needed? Tools to Connecting Home, School, and Providers in Children’s Care : 

What Is Needed? Tools to Connecting Home, School, and Providers in Children’s Care Tools for Providers -Evidence-based treatments: what works in both meds and therapy -Easy to use charts/look-up tables to guide use of treatments -Algorithms/Guidelines Tools for Parents -Parent empowerment strategies -Specific information on disorders and treatments -Info on how to get what you need for your child Tools for Teachers -Information on disorders and treatments, classroom methods, etc. Connecting Tools -Rating Scales -Daily Report Card -Bingo card -Web-based communication systems

Slide 60: 

If you could give a single point of advice to a new parent with a child with ADHD, what would it be? What is it most important for them to do? What should they be on the lookout for, or be careful not to do? And lastly, is there any brief story, encounter, or something that you did or that happened to you that you can tell me, that I could pass on to other parents that might help or inspire them?

Slide 61: 

That’s good, Doctor. Touch the guidelines, the guidelines are your friend. Getting doctors to use guidelines 61

Slide 62: 

62 BREAK

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