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Case 1:09-md-02067-NMG Document 687-35 Filed 02/28/17 Page 2 of 10 MDL-FORP0017526 lIr;~ _~-. IY1S~ ~"' ~ U. _CrMI CW _ trc."'Ia' _~ ta'fI~_.,. Profes~ l"~_~"'IOIO1t.1l1oc tJgI:t.~ ._IOd_~ ~ o.:k~"'

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SLIDE 1

Case 1:09-md-02067-NMG Document 687-35 Filed 02/28/17 Page 2 of 10

MDL-FORP0017526

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SLIDE 2

Case 1:09-md-02067-NMG Document 687-35 Filed 02/28/17 Page 3 of 10

Explore the Latest Information with Our Distinguished Faculty·

Program Chair

Karen D. Wagner. M.D., Ph.D.

Clilrence RoiS Miller Professor & ViCe (hatfman Departmem 01 Psydu.)try & Behavooral ~.enc~ One(101'. DrvISIOO of Child & Adolescent Psychiatry

lJn;lIt'f\olty 01 Texas M«!tr.l18'illlrh

faculty

Boris Birmaher. M.D.

P :cfessor of ~y(tl .. try Un;verSliyof 1'11tslJ.ur9-'l

James T. McCracken. M.D.

Professor 01 PsydMtry

n.re<:tOt. (l>Ild & AdcWs<ent D

IY1S~

UCLA NeVl'opsydtlatnc InstItute 8. ~lai

Neal D. Ryan. M.D.

I'fofessor of Psychi<HrY

J

  • oqulm Ptug-Anllch PrOfl:">5Of III

(ho.

1d and Adolescent Psydllillry

Universrty of Pittsburgh

Elizabeth B. Weller. M.D.

Profes~

  • f PsydHc1Uy ¥1d Pedi.Jtrn

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MDL-FORP0017531

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Case 1:09-md-02067-NMG Document 687-35 Filed 02/28/17 Page 4 of 10

  • ,

K

Series Chair

A Closer Look at Identifying

Depression in

Children and Adolescents

4 Hours Category 1 Karen O. Wagner, M.D., ph.D. Clarence Ross Miller Professor' & Vice Chairman Department of Psychiatry & Behavioral Sciences Director, Division of Child & Adolescent Psychiatry

Univel"$ity of T ex;:ts Medical Branch, Galveston

Series Faculty-

Boris Birmaher, M.D. James T. McCracken, M.D. Neal O. Ryan. M.D. Elizabeth B. Weller, M.D.

Objective

Professor of Psychiatry, University of Pittsburgh Director, Child Mood Disorders Research Western Psychiatric Institute and Clinic Professor of Psychiatry Director. Child & Adolescent Division

UCLA Neuropsychiatric Institute & Hospital

Joaquim Puig-Antich Professor in Child and Adolescent Psychiatry University of Pittsburgh Professor of Psychiatry and Pediatrics University of Pennsylvania B y actively participating in this course, anendees will understand the prevalen<:e, signs anC: S}~

I;'J t. :,

ms

  • f

pediatridadolescent depression and treatment options.

Agenda

8:00·8:30 a.m.

8:30-10:00 a.m. 10:00-10:20 a.m. 10:20-10:40 a.m. 10:40 a.m.-12:10 p.m. 12:10-12:30 p.m.

Registration/Continental Breakfast

How to Appt'opI'iately Di~noH

t>.pression in Children

Question-and-Answer Session

Break How to »Nt Depression in Otlldren and Maximize

TIM;, QcM/ity of

Life

Question-and-Answer Session FACULTY DISCLOSURE STATEMENTS

Boris Birmaher, M.D., has Irdcated that he has no relationships to disdose relating to the subject matter 01 tis presentation. James T. McCracken, M.D., has received grants ar4'Of research support lrom Sotvay Phatmaceuticals Inc., Shire Richwood, Inc .• Gliatech and Eli Lity and Company. He has also received nonorana !rom Shire Richwood, Inc., and Solvay Pharmaceuticals Inc. Neal D. Ryan, M.D., is a COOGUttant lor Pfizer Inc., Abbott labooltories. Hoffman-La Roche Inc., and AstraZeneca Pharmaceuticals LP. He has received grants and reS&afCh support from GIaxOStnlthKllne and wyeth Ayem Pharmaceutical&. Karoo D. Wagner, 104.0, Ph.D., receives gants and rosearctl support from and is a consultant and a member of !he AlJvisay Board for GlaxoSrMhlOine, PIzer Inc., Forest PhatmaceoticaIs, Inc. and Abbott Labof'atories. She also S6IV8S as a consultant lor Jansseo PharmacetJtica Products, L.P. BristoI-Myers Squibb, (.)benri::s and Eli Lilly and Company and is a member 01 the Advisory Board lot

Novartis PharmaceuticaI& She eIso roceiv8sgrants end researd'l support from Eli Uly and Company, BlisllJl ,tyefs SqulD. Organon Inc. a'Id WyfIitJ ~ She is a memberoflle Speskan Bureau b G1a:ccS i1iitl oKJine, Abbott Labotaloiies, Eli UIIy and~

,

Pfizer Inc. end Janssen PtwmaoeutIca Products, LP:

BiZabeth B. Weier, M.D., has reo&iYed honoraria. grants and research support from and serves as a OOI'ISUtant lor NIMH, GlaxoSmithKtne, 0rgM0n Inc., Abbott laboratories. ~Ayerst PhatmaceuIicaIs, Forest Pharmaceutic:als, Inc., and Jotnson &

...

""""

.

Supported by an unrestricted educ..-tionar grant from Forest Pharmaceuticals. Inc. *Not all speakers will appear at each program. Faculty subject to change without notice.

MDL-FORPOO17536

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Case 1:09-md-02067-NMG Document 687-35 Filed 02/28/17 Page 5 of 10

Abstract

How to Treat Depression in Children and Maximize Their Quality of Life

Treatment for depression in children and adolescents includes psychotherapy and

  • pharmacotherapy. The major forms of psychotherapy being studied in adolescents are interpersonal

psychotherapy and cognitive behavior therapy. In an open trial, interpersonal therapy showed

slgn~lcant

reduction In adolescents' symptoms of depression. Cognttive behavior therapy has been shown to be effective in treating depression in adolescents. With regard to medications, the selective

serotonin reuptake inhibitors (SSAls) including citaJopram, fluoxetine, paroxetine and sertraline have shown significant reduction in depression in youths compared to placebo. Side effects experienced by

children and adolescents on SSRls in these trials have been mild, with the most common being nausea, stomachaches and headaches. Other antidepressants, such as nefazodone, venlafaxine,

mirtazapine and bupropion require more controlled study in children and adolescents. Therefore, first- line medication treatment for children and adolescents are SSAls. H a child fails to respond to one SSRI, then an alternate SSAI can be considered. If there continues to be no response, then altemative monotherapy such as bupropion, mirtazapine, nefazodone or venlafaxine can be initiated

  • r augmentation strategies, such as buspirone, lithium or combination antidepressants. There are
  • ngoing NIMH trials comparing SSRI, cognitive behavior therapy and combination treatment (SSRI

plus cognitive behavior therapy) in the treatment of adolescent depression. There is also an ongoing NIMH study for treatment-resistant depression in adolescents-with the aim of determining whether a different SSRI, different class of agent or addition of cognitive behavior therapy improves treatment response in depressed adolescents.

_ Outline_

  • I. Psychotherapy
  • A. Interpersonal psychotherapy
  • B. Cognitive behavior therapy
  • II. Pharmacotherapy
  • A. Selective serotonin reuptake inhibitors (SSRls)
  • 1. Citalopram
  • 2. Fluoxetine
  • 3. Paroxetine
  • 4. Sertraline
  • B. Venlafaxine
  • C. Nefazodone
  • D. Bupropton
  • III. Combination Treatment (Psychotherapy Plus Medication)

20

A Closer Look at Identifying Depression in Children and Adolescents

MDL-FORP0017555

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Case 1:09-md-02067-NMG Document 687-35 Filed 02/28/17 Page 6 of 10

References

Birmaher B, Brent D. KoIko D, el a!. Clinical outcome after short·term psychotherapy fof adolescent with major depressive

  • disorder. Arch Gen Psychiatry. 2000;57:29-36.

Brent DA. Holder D, KoIko D. el at A ctinical psychotherapy trial for adolescent depression comparing cognitive family

  • cogni1iw. family and supportive therapy. Arch Gen Psychiatry. 1997(Sep);54(9):Bn-885.

Brent DA, Koike OJ, Binnaher B, at aI. Predjdors of treatment efficacy in a clinical trial of three psychosocial treatments lor

ado4escent depression. J Am Acad Child Adolesc Psychialry. 1998;37(9):906·914.

Emslie GJ, Heiligenstein JH, Hoog S, et aI. FIuoxetine for acute treatment 01 depression in children and adolescents: a placebo-conlroJ

  • Ied. randomized clinical trial. J Am Acad Child Adolesc Psychiatry. 2000.

Emslie GJ, Heiligenstein JH, Hoog S, et al. Fluoxeline for maintenance of reccNery from depression in children arK! adolescents: a ptacebo-coolrolled, randomized clinical trial. NCDEU. 2001.

Emslie GJ, Rush .6..1, Weirbes'g WA, et al. A double-blind, randomized, placebo-controlled lrial of Muoxetine in children and

adolescents with depression. Arch G9fl Psychiatry. 1997;54( 11 ): 1 031·1 037 . Findling AL, Presi<om SH, Marcus AN, et aJ. Netazodone pharmacokinetics in depressed children and adolescents. J Am Acad Child AdoIe6c Psychiatry. 2000;39(8):1008,1016. Keller MG, Ryan NO, Strober M, et al. Efficacy 01 paroxetine in the treatment 01 adolescent rncijor depression: a randomized, controlled trial. J Am Acad Child Adoiesc Psychiatry. 2001 ;4O(7):762.n 2. Mandoki MW, Tapia MA, Tapia MA, Sumner GS, Parl<er JL Venlafaxine in the treatment of children and adok:scents vlith major depression. Psychopharmacol Bull. 1997;33(

1

): 149-154. Mufson L, Moreau 0 , Weissman NM, et aI. Modification of interpersonal psychotherapy with depressed adolescents (IPT ·A): phase I and II studies. JAm Acad Chid Adotesc Psychiatry. 1994;33(5):695-705. Mufson L, Wiessman MM, Moreau 0 , Garfinkel R. Efficacy of interpersonal psychotherapy for depressed adoles -.ants. Arch Gen Psychiatry. 1999;56:573-579. Rohde P. Clarke GN, Mace DE, et al. Cognitive behavioral treatment for depressed adolescents with comorbid conduct

  • disorder. AACAP. 2001, Hawaii.

Santor OA, Kusumakar V. Open trial of interpersonallherapy in adolescents with moderate to severe major depression: effectiveness of novice IPT therapists. J Am Acad Child Adolesc Psychiatry. 2001 ;40(2):236-240. Wagner KO, Robb AS, Findling R. Tiseo PJ. Citalopram is effective in the treatment of major depressive disorder in children and adolescents: resuHs of a placebo-<:ontrolled trial. ACNP. Waikoloa. Hawaii. 2001, p. 158. (Science abstracts)

A Closer Look at Identifying Depression in Children and Adolescents 21

MDL-FORP0017556

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Case 1:09-md-02067-NMG Document 687-35 Filed 02/28/17 Page 7 of 10 32

Key Slides

Side Effects of Paroxetine and Imipramine in Adolescents (Cont.)

Paroxetine Imipramine

(N0r9l) (N-95) Dizziness

24%

Tremor 11".4

47"

.4 15"/0

Comorbid AOHD and Treatment Response

ADHD

.,,""

ADHD

Present

Placebo (N-87)

  • ParoxMlne
  • Imlptamlne
  • Placltbo

Citalopram Treatment for Depression in Children and Adolescents

  • 174 outpatients, ages 7·17 years, with major

depression

  • Double-blind, p lacebo-controlled 8-week trial
  • Randomized to citalopram, 20-40 mg (mean

23 mg) or placebo

A Closer Look at Identifying Depression in Children and Adolescents

MDL-FORP0017567

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Case 1:09-md-02067-NMG Document 687-35 Filed 02/28/17 Page 8 of 10

Key Slides

Baseline Characteristics

Placebo

Citalopram

(N:85) (N-89) Age (mean years, range)

12.1 (M7) 12.1 (7.17) Gender (% female)

54"

.'"

Race ('I. Caucasian)

''''

.,,'

Duration of illness (ye.rs) >.2 2.3

CDRS-R (mean) 57.8 58.1 CGI-5 (m

  • n)

' .3

...

Cltalopram Dose

Mean at

week 8

Children IN=45)

23.3 mgJday

Adolescents

(N::.47)

24.4 mgIday

Childhood Depression Rating Scale-Revlsed (CDRS-R)

A Closer Look at Identifying Depression in Children and Adolescents

33 MDL-FORP0017568

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Case 1:09-md-02067-NMG Document 687-35 Filed 02/28/17 Page 9 of 10

34

Key Slides

Remission Rate by Age Group

  • Age 1_

11

  • Age 12-17

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Most Frequent Adverse Events

Placebo

Citalop~m

Adverse Event"

(N- aS) (N· S9) Headache

2.%

,,%

t

  • • "l$Oa

. %

13%

Rhinitis

5%

13"/0

Abdominal pain

,%

11%

Influenza-like symptoms

.%

7%

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Discontinuation for Adverse Events

A Closer Look at Identifying Depression in Children and Adolescents

MDL-FORP0017569

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Case 1:09-md-02067-NMG Document 687-35 Filed 02/28/17 Page 10 of 10

Self-Assessment Questions

  • I. The prevalence rate of

depression in children is approximately:

  • A. 5%
  • B. 10%
  • C. 15%
  • D. 20%
  • 2. The relapse rate in childhood depression is approximately:
  • A. 20%
  • B. 50%
  • C. 75%
  • D. 90%
  • J. Which of the following medications has been shown to be more effective than placebo in the

treatment of depression in children and adolescents?

  • A. Venlafaxine
  • 8. Ncfazodonc
  • C. Citalopram
  • O. Bupropion
  • 4. Which (onn of psychotherapy bas been shown to be errective in a controlled trial in treating

depression in adolescents?

  • A. Family therapy
  • B. Supportive therapy
  • C. Cognitive-behavior therapy
  • D. Insight-oriented therapy

Answers

  • I. A

2.

B

  • 3. C
  • 4. C

A Closer Look at Identifying Depression in Children and Adolescents 41

MDL-FORP0017576