Minnesota Psychiatric Society presents Treatment of Depression in the Primary Care Setting L. Read Sulik, M.D., Medical

1.  Minnesota Psychiatric Society presents Treatment of Depression in the Primary Care Setting L. Read Sulik, M.D., Medical Director Child and Adolescent Psychiatry St. Cloud Hospital CentraCare Health Plaza St. Cloud, MN 56303-5000 320-255-5796 sulikr@centracare.com

3. Outline Depression Antidepressants FDA Black Box Warning What does this mean for providers? Next steps for providers Next steps for patients/parents/families Five levels of Depression Care Review of Proposed Depression Management Protocol Screening Assessment Informed Consent Letter Medication Management Monitoring Visits Communication with therapists Consultation / collaboration between primary care provider and child and adolescent psychiatrists

5. Risk and Reoccurrence

6. Course of Depression in Youth Adults: Comes and goes with periods of normal mood Children and Adolescents: Chronic waxing and waning, with high risk of relapse

7. Depression:Signs and Symptoms

8. Depression A neurochemical illness of the central nervous system that often requires medications to achieve healing and recovery A condition that leads to prominent mood changes, sleep and energy changes and changes in the thinking These changes often lead to interpersonal conflict, academic or work performance problems, and behavior problems. In children and adolescents who are developing in numerous ways but most importantly in the area of self (who am I?), depression has a profound impact on their sense of meaning and their view of their world.

9. Depression: Mood Changes Depressed or sad mood Irritable mood �mood swings� Anhedonia loss of interest social withdrawal, isolating boredom

10. Depression: Physical Symptoms Sleep Difficulty either with too much or too little sleep difficulty with sleep onset awakenings in the middle of the night early morning awakening Increased sleep and sleepiness Fatigue decreased energy

11. Depression: Cognitive Changes Worried, Ruminating thoughts Worthlessness, low self-esteem, guilt Difficulty concentrating Decreased attention, focus Increased distractibility, daydreaming Distortions in thinking Red Colored Glasses Morbid ideation Suicidal ideation

12. Symptoms in Infants and Toddlers Decreased pleasure in activities Sad or flat facial expression Little motor activity Withdrawn from cuddling, being held Too little or too much crying Excessive whining Failure to grow and thrive Verbal expressions of sadness Lack of social interest

13. Symptoms in Preschoolers Frequent, unexplained stomachaches, headaches, and fatigue Overactivity or excessive restlessness Frequent sadness Low tolerance for frustration Irritability Loss of pleasure in previously enjoyable activities Tendency to portray the world as sad or bleak

14. Symptoms in School-Aged Children Frequent and unexplained physical complaints Low self-esteem Excessive worrying Changes in sleep patterns Tearfulness Unprovoked hostility or aggression Refusal or reluctance to attend school Drop in grades Little interest in playing with others Poor communication Thoughts about or efforts to run away Morbid or suicidal thoughts

15. Symptoms in Adolescents Drop in school grades and/or conduct Behavior problems in school Feelings of sadness or hopelessness Low self-esteem Fatigue Changes in sleep patterns Loss of enjoyment of previously enjoyable activities

16. Symptoms in Adolescents Self-destructive behavior Difficulty with relationships Eating-related problems Antisocial or delinquent behavior Social isolation Inattention to appearance Extreme sensitivity to rejection or failure Physical slowness or agitation Morbid or suicidal thoughts or actions

17. Suicidal Thoughts Suicidal thoughts are a symptom of depression. The presence of suicidal thoughts may tell us that the depression is increased in severity or intensity. the presence of wheezing and coughing in a child with asthma is a sign that the asthma is worsening or �flaring up� for whatever reason. When wheezing is occurring the patient needs to let the doctor know so that any further assessment or any changes that need to occur to relieve the symptoms can. Similarly, when an individual begins to experience suicidal thoughts the doctor needs to know this as soon as possible. Children and adolescents don�t always volunteer that they are having suicidal thoughts so asking them these questions is appropriate.

18. Treatment for Depression Supportive Therapy and Psychoeducation Pharmacotherapy Individual Psychotherapy Insight Oriented Cognitive Behavioral Interpersonal Play Therapy Group Therapy Family Therapy Hospitalization or Partial Hospitalization

19. Lifestyle Management of Depression Sleep Diet and Nutrition Exercise Relaxation Support System Chemically Free Medications Therapy Fun and Recreation Personal Growth

20. Antidepressants

21. Neurotransmitters andMood, Cognition and Behavior

22. Abnormalities of Neurotransmitter Function lead to:

23. Antidepressants These medications are not only used for depression but also commonly used for anxiety disorders social phobia generalized anxiety disorder obsessive compulsive disorder separation anxiety disorder They are not only prescribed for major depressive disorder but also for dysthymic disorder (a more chronic, intermittent type of depression that comes and goes).

24. Antidepressants The antidepressants and especially the SSRIs have certain characteristics that are very important to consider in their use in children and adolescents: Akathisia Disinhibition Discontinuation Syndrome Fast Rate of Metabolism

25. Akathisia Many of these medications can cause an increased motor restlessness Individuals will describe feeling as if they are �moving inside� or �crawling out of my skin� The restlessness can range from finger tapping and fidgeting to pacing and agitation. As akathisia is increased there can be a feeling of increased irritability and agitation or aggressiveness.

26. Disinhibition Many of these medications can activate or disinhibit children making them more impulsive

27. Discontinuation Syndrome Physical symptoms such as headache dizziness nausea sweating Emotional symptoms may involve increased irritability agitation tension restlessness anxiety

28. Fast Rate of Metabolism The shorter the � life (the faster the metabolism) of the medication, the greater the risk of developing a discontinuation syndrome if the medication is stopped abruptly. Children are often very fast metabolizers of these medicines, so the risk of a discontinuation syndrome may be much higher.

29. SSRI Pharmacokinetic Parameters

31. Common Side Effects Common side effects of antidepressants include dry mouth constipation diarrhea sweating sleep disturbance sexual dysfunction irritability headache appetite changes

32. Adverse Events The patient should notify the prescribing physician if the following occur New thoughts of suicide or a sudden worsening of suicidal thoughts Any attempts to injure or harm self in any way Severely increased motor restlessness Severely increased agitation or irritability Increased rapid and constant talking (mania or hypomania) Increased activity level, extreme hyperactivity Worsening symptoms of depression Increased or new symptoms of anxiety and/or panic attacks Decreased need for sleep

33. FDA Black Box Warning The FDA reviewed data from 24 studies of the use of antidepressants in children and adolescents. These studies involved the treatment of depression or other disorders such as Obsessive Compulsive Disorder or Generalized Anxiety Disorder. There were a total of 4400 children or adolescents in these studies that had been randomly assigned to take the antidepressant or to take a sugar pill (placebo).

34. FDA Black Box Warning The antidepressants included the SSRIs (Celexa, Prozac, Luvox, Paxil and Zoloft) and four "atypical" antidepressants (Wellbutrin, Remeron, Serzone and Effexor XR). The length of time of the studies ranged from 1 to 4 months. About 2 out of every 100 individuals taking the placebo reported an increase of suicidal thoughts. About 4 out of every 100 individuals taking one of the antidepressants in the studies had an increase of suicidal thoughts and behaviors. There were no completed suicides in any of the studies.

35. Call for Close Monitoring The warning does not prohibit the use of antidepressants in children and adolescents. The FDA has recommended that whenever an antidepressant is started or its dose is changed, close attention is needed. Since the warning was first announced, the FDA has been more specific about the recommendation for closer monitoring. After starting an antidepressant, patients should see their doctor Once a week for four weeks Every 2 weeks for the next month At the end of their 12th week taking the drug More often if problems or questions arise

36. TADS Even though this type of follow-up is being recommended for safety reasons, there is evidence that very close monitoring in this manner may lead to improved outcomes in treatment. The National Institute of Mental Health Treatment of Adolescent Depression Study (TADS) was a multi-site study looking at the effect of fluoxetine (Prozac) with or without Cognitive Behavioral Therapy TADS demonstrated that fluoexetine when prescribed and monitored closely (weekly visits) was more effective than cognitive behavioral therapy alone and about equally effective as cognitive behavioral therapy and medication combined.

37. Provider Next Steps A structured frequent follow-up visit to monitor for changes in symptoms and also for presence of adverse effects of medications will not only meet the recommended guidelines for monitoring but ultimately improve care and outcomes. Collaboration, consultation and ongoing communication between primary care providers, child and adolescent psychiatrists and therapists is another way to assure good monitoring and improved care. Parents and professionals will need to improve their awareness of potential adverse events and improve their communication with the physician prescribing the medication.

38. Parent / Family Next Steps The most important thing that parents can do is to learn as much as they can about depression in children and adolescents. Know the medication that is being prescribed to their child. Be able to ask questions about adverse effects and how to recognize them. If the child begins to experience the following, than the physician should be contacted immediately: New thoughts of suicide or a sudden worsening of suicidal thoughts Any attempts of your child to injure him or herself in any way Increased motor restlessness Increased agitation or irritability Increased rapid and constant talking (mania or hypomania) Increased activity level, extreme hyperactivity Worsening symptoms of depression Increased or new symptoms of anxiety and/or panic attacks Difficulty sleeping

39. Screening

40. Screening Tools Screening tools for depression (self-report or provider administered) Zung Depression Scale Symptom Driven Diagnostic System (SDDS) Hamilton Reference Scale Prime MD, PHQ 9 Others

41. Screening Tools for Adults: PHQ-9 Patient at intake presents with symptoms consistent with a primary diagnosis of Major Depressive Disorder or Depression NOS. MD/APP, nurse or therapist administers the PHQ-9. The PHQ-9 triggers one of the following interventions: A score of 20+ � Medications and therapy strongly recommended. MD/APP Intake �If the patient does not already see a therapist, recommend patient schedule a therapy appointment within one week Therapist Intake �Recommend patient schedule with primary care or behavioral health MD/APP within one week for medication. A score of 10 - 19 � Medications and/or therapy are strongly recommended. Follow up appointment to be made within four to six weeks. A score of <10 or depression not primary diagnosis�Treat as usual. 3. PHQ-9 is reviewed with the patient and the process of patient education is begun. An initial plan of intervention is discussed. The patient will be provided with information from the �Hope and Help for Depression� booklet.

43. Assessment

44. Assessment Interview of Patient and Parent/Caregiver Mood Changes Sleep, Energy, Appetite Changes Cognitive Changes Safety Assessment Comorbid Conditions and Differential Diagnosis Family History Self-Report Instruments Children�s Depression Inventory Beck Depression Inventory

45. Assessment of Mood Changes Sadness Irritability Anhedonia

46. Assessment of Sleep/Energy/Appetite Changes Insomnia Disrupted or Restless sleep Daytime fatigue Decreased appetite and weight loss Increased appetite and weight gain Psychomotor retardation or psychomotor agitation

47. Assessment of Cognitive Changes Inattentiveness Poor concentration Distortions and misinterpretations Guilt or worthlessness

48. Assessment of Safety Suicidal Thoughts History of Suicide Attempts Access to medications, firearms Self-injurious behaviors

49. Comorbid Conditions and Differential Diagnosis Substance Abuse Eating Disorders Anxiety Disorders ADHD Bipolar Disorder Trauma Physical Abuse Sexual Abuse Exposure to Domestic Violence

50. Assessment of Family History Depression Anxiety Bipolar Disorder Suicide

51. Self-Report Measures Beck Depression Inventory Children�s Depression Inventory

53. Three Visit Minimal Intervention Protocol

54. The Three Visit Minimal Intervention Model First Visit Once depression is suspected and determined it is not Major Depressive Disorder Second Visit Avoid tendency to expect improvement or suggest that patient must be better Third Visit Assess problem for resolution to the point of return to reasonable function vs need for more active therapy

55. Minimal Intervention: First Visit Actively invite the patient to describe the problem Disturb the normal tendency to suggest that feeling blue is irrational Touch the patient. Do a focused physical exam, minimal laboratory tests if indicated Establish a contract for follow-up in 2 weeks

56. Minimal Intervention: Second Visit Open the second visit with social comment Begin the discussion in a non-directive manner Review any remaining medical/laboratory issues Disturb the tendency to �cheerleading� or telling patient everything will soon be better - Listen Establish contract for third visit 2 weeks later

57. Minimal Intervention: Third Visit Open with social comment and await spontaneous report by patient regarding improvement or worsening of depressed mood Directly inquire about the depressed mood Evaluate for further treatment or end of limited interview

58. Desired Outcomes for Minimal Intervention Self-directed improvement by the patient Case is flagged for nurse review and follow-up after three months (research options) Minimal increase in �medical problems� If clinical depression is identified as a result of the screening, �higher� levels of care are pursued

59. Psychoeducational Intervention Protocol

60. Psychoeducational Intervention Appropriate for: Subclinical level of symptoms Minimal to moderate psychosocial stress Minimal disruption of daily functioning Acknowledgment of symptoms, concerns, or need for information by the patient

61. Psychoeducational Intervention Depression Class Biblio-therapy Explanation of depression for patient and family by physician or mental health professional

62. Goals of Psychoeducational Intervention Plan is documented in the patient�s medical chart Provider is notified when patient has completed the class Post-class telephone follow-up by nurse/MD Patient has increased knowledge about depression and self care Patient reports increase in self-care Provider maintains focused monitoring of risk factors and depressive symptoms

63. Information for Patients Depression is a medical illness, not a character defect Recovery is the rule, not the exception Treatment is effective for nearly all patients The aim of treatment is complete remission, not just getting better but staying well The risk of recurrence is significant: 50% after one episode 70% after two episodes 90% after three episodes

64. Possible Resources for Management of Mild/Moderate Depression Patient activation tools Books, pamphlets, community groups Screening tools for depression (self-report or provider administered) Zung Depression Scale Symptom Driven Diagnostic System (SDDS) Hamilton Reference Scale Prime MD, PHQ 9 Others

65. Resources for Management of Mild/Moderate Depression Patient educational materials readily available during encounter Provider training, as needed, in differential diagnosis of depression, including use of diagnostic tools, in patient-provider communication regarding psychosocial issues and in use of psychotropic medications Ability to reassess patient progress in 3-6 weeks Psychiatric consultation regarding medication issues Mental Health professional in primary care clinic or available by phone

66. Desired Outcomes Clinical tracking in medical chart (problem list and diagnosis) leading to monitoring and focused care Improved symptoms and daily functioning Medication management by physician and/or psychiatric nurse Increased readiness for mental health collaboration, as needed

67. Primary Care Physician Management of Moderate/Major Depressive Disorders Subclinical or clinical level of symptoms Minimal to moderate psychosocial stress Mild to moderate disruption of daily functioning Acknowledgment of symptoms, concerns, and need for treatment by the patient Patient not ready for mental health collaboration or referral

68. Primary Care Depression Management Protocol

69. Depression Monitoring Visits Clinic Visits: week 1, 2, 3, 4, 6, 8 , 12 Phone Contact Symptom Review Medication Compliance Adverse Effects Safety Assessment Self-Report Scales

70. Symptom Review Sad Mood Irritability Anhedonia Increased motor activity Sleep problems Decreased motor activity Appetite or Weight Change Fatigue

71. Behavior Symptoms alcohol use illicit drug use angry or violent outbursts

72. Medication Compliance no doses missed one or two doses missed 3 or more doses missed

73. Adverse Events dry mouth insomnia appetite change constipation disrupted sleep weight change diarrhea sexual dysfunction Sweating headache

74. Safety Assessment suicidal thoughts suicide intent self-injurious thoughts suicide plan suicide attempt self-injurious behaviors

75. Depression Self-Care Discussion and Teaching Sleep Diet and Nutrition Exercise Relaxation Support System Chemical Use Medications Therapy Recreation Goals and Growth

76. Communication with Therapists HIPAA-compliant ROI form signed at each visit at front desk as standard protocol Establish communication protocol at same interval as monitoring visits Week 1, 2, 3, 4, 6, 8, 12 + Establish communication documentation form that is used by therapists and by primary care providers

77. Consultation Protocol Establish Collaboration / Consultation Protocol between Child and Adolescent Psychiatrists and Primary Care Provider �Curbside Consult� may occur on average of once per 12 week monitoring interval �Triage� patients at high acuity level to emergency child psychiatric appointments Primary care providers may need to do some of the �monitoring visits� so that child psychiatrists are more available for the emergency appointments Consider Mental Health Professional in Primary Care Clinic for triage assessments, consultation, patient and parent teaching

78. Collaborative Care Depression Protocol

79. Primary Care/Mental Health Professional Collaborative Care for Major Depressive Disorder When is it most helpful? Subclinical to clinical level of symptoms Moderate to severe psychosocial stress Moderate to severe disruption of daily functioning

80. Collaborative Intervention Case sharing within mental health and primary care provider team Clinical focus on improvement in patient coping and problem-solving, including mental health consultation and on-site mental health treatment is ideal Psychotropic medication, as indicated, managed in primary care

81. Desired Outcomes for Collaborative Care of Depression Clinical tracking in medical chart (problem list and diagnosis) Focused care for both patient and provider, leading to clarification in provider roles and change in pattern of medical utilization Clinical effectiveness in treatment of depression Improved patient and provider satisfaction

82. Additional Resources Needed for Collaborative Care Appropriately trained mental health provider within primary care team Appropriately trained primary care physician with interest and motivation for collaborative efforts with mental health clinicians Space, shared access to medical record Economic system that values collaborative effort

83. Specialty Care

85. Specialty Care of Major Depressive Disorder Clinical level of symptoms Moderate to severe psychosocial stress Moderate to severe disruption of daily functioning Perceived need for mental health services by both patient and provider

86. Specialist Intervention for the Treatment of Depression Referral (hand-off) to mental health by primary care Focused psychosocial interventions, including clinical focus on improvement in patient coping and problem-solving, unpacking of psychosocial issues, or other specialized treatments (outpatient, day-treatment, partial-hospital, inpatient care), as needed Psychotropic medication, as indicated, managed by specialty or primary care provider

87. Desired Outcomes for Specialized Care Clinical tracking in mental health chart (problem list and diagnosis) Clinical effectiveness in treatment of depression

88. Additional Resources Needed for Specialized Care of Depression Full range of specialty mental health providers and programs Access to the mental health team

89. What are the medications that treat depression and how do they work?

90. Antidepressants Selective Serotonin Reuptake Inhibitors Prozac, Zoloft, Paxil, Luvox, Celexa, Lexapro Atypical Antidepressants Effexor Serzone Remeron Welbutrin Cymbalta

91. The �Not So Selective� SSRI�s Fluoxetine serotonin 2C Sertraline dopaminergic sigma Paroxetine anticholinergic NE Fluvoxamine sigma Citalopram selective All SSRIs have serotonin reuptake inhibition All have different secondary pharmacological properties Secondary actions distinguish one from the other

92. Dopamine Transporter Affinity

93. Fluoexetine (Prozac) Causes appetite suppression and weight loss initially Not well tolerated when initiating treatment in panic disorder Better efficacy in bulimia and binge eating Advantageous in those with psychomotor retardation and hypersomnia Poorly tolerated in those with psychomotor agitation/anxiety/insomnia May cause more undesirable activating side effects May worsen psychotic depression Prozac Weekly (90 mg capsule) only extended release SSRI available

94. Sertraline (Zoloft) Possible improvement in cognitive function/sustained attention in some patients Reduction of fatigue, apathy, and psychomotor retardation Less prolactin elevation & its consequences Might cause more psychomotor agitation, anxiety or insomnia in some patients Might be less well tolerated in patients with anxiety May necessitate more dose titration in anxious patients Short half-life may require dosing twice a day

95. Paroxetine (Paxil) Anxiety (short term) Anxiety disorder subtypes (panic, OCD, social phobia 2D6 concomitant drugs Withdrawal Inhibition of both SERT and NET by paroxetine may underlie its broad therapeutic range high-dose paroxetine treatment may be beneficial for patients who fail to respond to treatment with another SSRI or lower doses of paroxetine Paxil CR Controlled release form now available Less GI side effects

96. Fluvoxamine (Luvox) sertraline, fluvoxamine may have increased GI complaints sertraline,fluvoxamine effective in delusional depression Antipsychotic actions? Anxiolytic actions? Anxiety (short term) OCD Psychotic depression? Shorter half life (bid) Sedation GI side effects/irritable bowel syndrome 1A2, 3A4 drugs

97. Citalopram (Celexa) No significant drug interactions No significant activation/Anxiety/Insomnia ? rapid onset ? less sexual dysfunction Does not have secondary pharmacologic properties which may be desirable in some patients Estalopram (Lexapro) Estalopram (Lexapro) is an isomer of citalopram 10mg/day demonstrated comparable efficacy to 40mg/day of Celexa Shorter half-life in children and adolescents may require twice a day dosing

98. Atypical Antidepressants nefazadone (Serzone) Serotonin 5HT2 blockage Association with liver failure (rare) trazadone (Desyrel) Serotonin 5HT2 blockage venlafaxine (Effexor) Serotonin NE Dopamine (in high doses) buproprion (Welbutrin) Dopamine Norepinephrine mirtazapine (Remeron) Serotonin NE duloxetine (Cymbalta) Serotonin NE

99. Tricylic Antidepresants Use TCAs with caution: sedation weight gain dry mouth constipation risk of sudden death (monitor blood levels with EKGs)

100. Summary of Medications for Depression Begin treatment with SSRI activating SSRI for melancholic depression or vegetative depression activating SSRI may increase anxiety watch for and warn parents about akathisia and disinhibition in children watch for and warn about withdrawal syndromes in short half-life SSRIs be aggressive in regulating sleep

101. Summary Depression consists of a change in mood sadness irritability anhedonia physical symptoms cognitive symptoms Depression is a mood disorder AND a sleep and energy disorder AND a thinking disorder To the patient depression is a severe, debilitating condition leading to severe suffering. . . but treatment is effective and no one should continue to suffer without help Treatment must address the biological, psychological, social and spiritual aspects of the illness

102. How can primary care clinic design support quality psychiatric care? Integrated care Shared Care Consultation-liaison Clinical Nurse Specialists, Physician Assistants, Nurse Practitioners Team Management Telemedicine

103. References

104. References

105. References

106. References Ransom, Donald C., Ph.D.; �Commentary: Mental Healthcare in the Primary Care Setting,� Families, Systems & Health, Vol. 15, No. 1, 1997 Sobel D; Rethinking Medicine: Improving Health Outcome with Cost-Effective Psychosocial Interventions; Psychosomatic Medicine, 57:234-244, 1995. US Department of Health & Human services, Public Health Service, Agency for Health Care Policy & Research; �Depression in Primary Care�, Vol. 2: Treatment of Major Depression, 1993 Weihs, Karen M.D.; �COMMENTARY: Mental Healthcare in the Primary Care Setting,� Families, Systems & Heatlh, Vol. 15., No. 1, 1997

107. References

108. References