New Treatments. For Bipolar Disorder. Po W. Wang, MD Clinical Associate Professor Bipolar Disorders Clinic Stanford University School of Medicine

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1 New Treatments For Bipolar Disorder Po W. Wang, MD Clinical Associate Professor Bipolar Disorders Clinic Stanford University School of Medicine

2 Abbott Laboratories AstraZeneca Bristol-Myers Squibb Corcept Therapeutics Eisai Inc. Elan Pharmaceuticals Eli Lilly and Company GlaxoSmithKline Janssen Pharmaceutica Novartis Pharmaceuticals Pfizer Repligen Sanofi-Aventis Shire Pharmaceuticals Solvay Pharmaceuticals Wyeth Pharmaceuticals

3 Why understanding pharmacology is important to you Current approved treatments Bipolar Depression - Unmet needs Current Research Additional Areas for Breakouts

4 Own your care and collaborate with your doctor. Target symptoms Potentially useful medications Potential side effects Be hopeful about the possibilities!

5 Brand Name Abilify Equetro, Tegretol Thorazine Depakote Lamictal Eskalith, Lithobid Zyprexa Symbyax Seroquel Risperdal Geodon Saphris. Yellow font indicates generic available Generic Name Aripiprazole Carbamazepine Chlorpromazine Divalproex Lamotrigine Lithium Olanzapine Olanzapine-fluoxetine Quetiapine Risperidone Ziprasidone Asenapine

6 Acute Mania Year Drug Acute Depression Year Drug Longer-Term Year Drug 1970 Lithium 1973 Chlorpromazine 1994 Divalproex, ER (2005) 2000 Olanzapine* 2003 Risperidone* 2004 Quetiapine, XR (2008)* 2004 Ziprasidone 2004 Aripiprazole* 2004 Carbamazepine ERC 2009 Asenapine 2003 Olanzapine+fluoxetine combination 2006 Quetiapine, XR (2008) Unmet Need *Adjunctive and monotherapy; LAI = Long-Acting Injectable formulation 1974 Lithium 2003 Lamotrigine 2004 Olanzapine 2005 Aripiprazole 2008 Quetiapine, XR (adjunct) 2009 Risperidone LAI* 2009 Ziprasidone (adjunct) Unmet Need

7 60 Acute Mania Response Acute Depression Response Maintenance Relapse % 20% 58% 24% 23% 57% % 34% 34% = N Medication Placebo Medication Placebo Medication Placebo

8 16 Monotherapy Studies (N ~ 3750) Improved due to other reasons Improved due to drug Not Improved

9 4 Monotherapy / Combination Therapy Studies (N ~ 1400) Improved due to other reasons Improved due to drug Not Improved

10 6 Monotherapy Studies (N ~ 2500) Still well due to other reasons Well due to drug Relapsed

11 % of Weeks Asymptomatic Depressed Manic/hypomanic/cycling/mixed 3% 15% 32% 53% 50% 47%

12 Lithium Anticonvulsants Valproate (Depakote) Carbamazepine (Equetro, Tegretol) Lamotrigine (Lamictal) Oxcarbazepine (Trileptyl) Topiramate (Topamax) Gabapentin (Neurontin) Zonisamide (Zonegran) New Antipsychotics Olanzapine (Zyprexa) Risperidone (Risperidal) Quetiapine (Seroquel) Ziprasidone (Geodon) Aripiprazole (Abilify) Asenapine (Saphris) Clozapine (Clozaril) Antidepressants Prozac+Zyprexa (Symbyax) Fluoxetine (Prozac) Sertraline (Zoloft) Paroxetine (Paxil) Citalopram (Celexa) Tricyclic Antidepressants Monoamine Oxidase Inhibitors Miscellaneous Benzodiazepines (Klonapin, Ativan, etc.) Typical Antipsychotics (Haldol, Thorazine) Thyroid Hormone Nutriceuticals ECT, TMS, VNS Large yellow font indicates approved treatments Small italic font indicates unapproved treatments

13 Armodafinil (Nuvigil) Background Cephalon Pharma Nuvigil - a right-hand version of Provigil Narcolepsy, excessive daytime sleepiness with sleep apnea Provigil efficacious in Bipolar I or II depression (85 patients) Nuvigil efficacious in Bipolar I depression (257 patients) Study Design Nuvigil added to mood stabilizers for Bipolar I depression Gold-standard designed (randomized, placebo-controlled), 8-week study Beginning September 2010 June 2012

14 Lurasidone Background Dainippon Sumitomo Pharma New antipsychotic medication Blocks Dopamine-2 receptors Blocks Serotonin-2A receptors Study Design Bipolar I Depression Gold-standard designed, 6-week study Evaluate efficacy, safety, and tolerability of Lurasidone Beginning September 2010 September 2011

15 L-Methylfolate (Deplin) Background Pamlab, L.L.C. type of folic acid (a vitamin) that enters brain Folate to L-methylfolate conversion limited with Depression, certain medical disorders, poor nutrition Lithium, anticonvulsants, birth control pills, alcohol, tobacco Controls creation of chemicals involved in depression Can accelerate antidepressant response Study Design Deplin added to other medicines (no antidepressants) in Bipolar I depression Gold-standard designed, 8-week study Evaluate efficacy, safety, and tolerability of Deplin Beginning September September 2011

16 Lithium versus Quetiapine (Seroquel) Background Federally funded Agency for Healthcare Research and Quality (AHRQ) Clinical and Health Outcomes Initiative in Comparative Effectiveness (CHOICE) Lithium classical treatment for bipolar disorder Seroquel major newer treatment for bipolar disorder Combination treatments are often used in bipolar disorder Study Design Bipolar I or II Disorder, with at least mild symptoms 6-month, randomized, single-blind rater study Evaluate effectiveness, safety, tolerability of adding Lithium vs. Seroquel Beginning September September 2013

17 Combination Therapy Duration of Therapy Drug Interactions Managing Adverse Effects

18 Be active in your own treatment Bipolar depression - a current research priority New research is always on the horizon

19 Bipolar Research at Stanford Contact Shelley Hill at (650) or or visit

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