Blue Ain’t Your Color: MDD Management in the Primary Care ... · Blue Ain’t Your Color: MDD...

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Blue Ain’t Your Color: MDD Management in the Primary Care Setting

Cole Larsen, PharmD, PhC, BCPSPharmacist ClinicianUniversity of New Mexico HospitalsOctober 8, 2017

Objectives

Describe the incidence and costs associated with depression Discuss screening methods and diagnosis for depression Select an appropriate first-line therapy for a patient with depression

based on reported symptoms and patient comorbidities Provide pharmacologic recommendations for patients with

suboptimal responses to initial therapy Describe opportunities for pharmacists to assist in depression

management

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Where Do You Practice?

A. Ambulatory CareB. Inpatient PharmacyC. Hospital floor pharmacistD. RetailE. Other?

Background

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Epidemiology

Prevalence of ~5% in the general population Other estimates closer to 7% with

lifetime prevalence of 17%

1.5-2.5 time more common in females

Minority groups also disproportionately affected

350 million cases worldwide according to WHO

Pratt LA, Brody DJ. Depression in the United States household population, 2005–2006. NCHS Data Brief. 2008(7):1–8.Kessler R, Berglund P, Demler O, Jin R, Merikangas K, Walters E. Lifetime Prevalence and Age-of-Onset Distributions of DSM-IV Disorders in the National Comorbidity Survey Replication. Archives of General Psychiatry. 2005;62(6):593. doi:10.1001/archpsyc.62.6.593.Depression. World Health Organization. 2016. Available at: http://www.who.int/mediacentre/factsheets/fs369/en/.

Epidemiology

https://www.washingtonpost.com/news/worldviews/wp/2013/11/07/a-stunning-map-of-depression-rates-around-the-world/

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Costs

Poor concentration and decreased functionality Significant economic costs

Lost employment and productivity 23 times greater than direct costs to healthcare system

Those with depression 3X more likely to miss work

Decreased productivity while at work

Feelings of isolation from others Negative effects on relationships Suicide

Risk is quadrupled in Major Depressive Disorder (MDD) population

NCCMH. Depression: the Treatment and Management of Depression in Adults (Update). The British Psychological Society and the Royal College of Psychiatrists. 2010. [Full guideline]

>41,000completed

suicidesper year

9.3 million reported suicidal

thoughts in the past year

10th leading cause of death in

the U.S

3rd leading cause of death for

ages 15-24Males

account for 78% of all suicides

SuicideThe Ultimate Cost of Depression

Centers for Disease Control and Prevention (CDC). Web-based Injury Statistics Query and Reporting System (WISQARS) [Online]. (2013, 2011) National Center for Injury Prevention and Control, CDC (producer). Available from http://www.cdc.gov/injury/wisqars/index.html.

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MDD Risk Factors

Insomnia Alcohol, tobacco, and drug use Family history History of another mental health disorder Chronic disease Lower socioeconomic status

NCCMH. Depression: the Treatment and Management of Depression in Adults (Update). The British Psychological Society and the Royal College of Psychiatrists. 2010. [Full guideline] VA/DoD Clinical Practice Guideline for Management of Major Depressive Disorder. 2009.

Contributing Medications

VA/DoD Clinical Practice Guideline for Management of Major Depressive Disorder. 2009.

Medications Strength of AssociationBeta blockers (propranolol, atenolol,

metoprolol)+/-

Calcium channel blockers +/-ACE-inhibitors +/-

Lipid-lowering agents +/-Reserpine, clonidine, methyldopa +

Corticosteroids +Benzodiazepines, barbiturates +

NSAIDs +Topiramate +Varenicline +

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Common Comorbidities

VA/DoD Clinical Practice Guideline for Management of Major Depressive Disorder. 2009.Almeida S. Arq Neuro-Psiquiatr. 2013;71(9B):689-692.

Medical Conditions Associated with Depression

Cardiovascular diseases Coronary artery diseaseCongestive heart failure

StrokeVascular dementias

Chronic pain syndrome FibromyalgiaReflex sympathetic dystrophy

Low back painDegenerative diseases Hearing loss

Alzheimer’s diseaseParkinson’s disease

Huntington’s diseaseImmune disorders HIV

Multiple sclerosisSystemic lupus erythematosis

Common Comorbidities


Medical Conditions Associated with Depression

Metabolic/endocrine conditions Hypo/hyperthyroidismDiabetes mellitus

Hepatic disease (cirrhosis)Chronic obstructive pulmonary

diseaseKidney disease

Neoplasms Of any kind, especially pancreatic or central nervous system

Trauma Traumatic brain injuryAmputationsBurn injuries

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Diagnosis and Screening

Diagnosis

DSM-5 Depressive symptoms lasting ≥2 weeks with marked clinical impairment

≥5 of 9 symptoms must be present

Must include depressed mood or anhedonia

Not attributed to a substance, alternate medical condition, or alternate psychiatric condition

History negative for manic or hypomanic episodes

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Depressive Symptoms

Sleep InterestGuilt EnergyConcentration Appetite Psychomotor Suicidal ideation

SIG-E-CAPS

Screening

Majority of patients with MDD will be treated by their Primary Care Provider (PCP)

Often underdiagnosed Patients frequently present with somatic complaints

Patient Health Questionnaire-2 (PHQ-2) screening tool Administer annually

Does not assess SI or HI


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Patient Health Questionnaire (PHQ-9) Scored 0 – 27, higher = more severe Completed by patient Score severity

0 – 4 = Minimal depression

5 – 9 = Mild depression

10 – 14 = Moderate depression

15 – 19 = Moderately severe depression

20 – 27 = Severe depression


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Other Rating SystemsScale

Severity of DepressionNone/ Minimal/

Remission Mild Moderate Severe−Very Severe

Hamilton Depression Rating Scale, 17-item (HAM-D17)

0−7 8−13 14−19 20−25 (severe)26-52 (very severe)

Hamilton Depression Rating Scale, 21-item (HAM-D 21)

0−8 9−15 16−22 23−28 (severe)29-64 (very severe)

Hamilton Depression Rating Scale, 24-item (HAM-D 24)

0−9 10−18 19−26 27−34 (severe)35−75 (very severe)

Montgomery-Åsberg Depression Rating Scale (MADRS) 0−6 7−19 20−34 35−60

Beck Depression Inventory (BDI) 0−9 10−18 19−29 30−63

Inventory of Depressive Symptomatology (IDS30)


Quick Inventory of Depressive Symptomatology (QIDS16)


Treatment Selection

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Guideline RecommendationsAPA VA/DoD NICE RANZCP

Release date 2010 2016 2009 (2012 update)

2015

Focus MDD MDD MDD Mood Disorders

First Line Agents

SSRIs, SNRIs, bupropion or mirtazapine

SSRIs, SNRIs, bupropion or mirtazapine

SSRIs SSRIs,bupropion, mirtazapine, others*

Timeline for assessing efficacy

4 weeks 4-6 weeks 3-4 weeks 3 weeks

PHQ-9 score to initiate dual therapy

20 20 15 15

*Venlafaxine first-line in severe depressionSSRI = Selective Serotonin Reuptake Inhibitor, SNRI = Serotonin Norepinephrine Reuptake Inhibitor

Choosing Initial Modality

APA. Practice guideline for the treatment of patients with major depressive disorder. 2010.

Pharmacotherapy Prior positive response Significant sleep or

appetite disturbance Agitation Anticipated chronic

disease course Patient preference

Psychotherapy Prior positive response Provider availability Symptoms attributable to

interpersonal issues, personal loss, etc.

Co-occurring personality disorders

Pregnancy Patient preference

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Agent selection

All antidepressants are considered equally efficacious

Use patient-specific factors to choose agent based on: Side effect profile Medical and psychiatric comorbidities Drug interactions Prior response Response for family members

Monoamine hypothesis

Nutt DJ. J Clin Psychiatry. 2008;69 (suppl E1)

Dopamine

Serotonin

Norepinephrine

ObsessionCompulsions

AttentionInterest

MotivationRewardPleasure

AlertnessEnergy

Mood

Anxiety

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Monoamine Hypothesis

SERT

SerotoninSerotonin receptorSERT: Serotonin Reuptake Transporter

Serotonin is released into the synapse

Post-synaptic neuron

Normal Neurotransmission

Presynaptic neuron

SERT


Serotonin binds to post-synaptic receptors


Signal Transduction

Presynaptic neuron


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SERT


Serotonin then dissociates from the receptors and is taken back up by SERT for recycling


Presynaptic neuron Post-synaptic neuron


SERT

SSRISerotoninSerotonin receptorSERT: Serotonin Reuptake Transporter

In the presence of an SSRI, SERT is blocked, leading to greater serotonin activity

Neurotransmission w/ SSRIs



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SERT

SSRISerotoninSerotonin receptorSERT: Serotonin Reuptake Transporter

In the presence of an SSRI, SERT is blocked, leading to greater serotonin activity

Signal Transduction

Neurotransmission w/ SSRIs



Pharmacotherapy Options

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SSRIs

Stahl S. Stahl's Essential Psychopharmacology. Cambridge: Cambridge University Press; 2008.

•Concern for QTc prolongation•More sedating due to antihistaminergic activity

Citalopram (Celexa)Citalopram (Celexa)

•“Purest” SSRI •Less cardiotoxicity•Fewest drug interactions

Escitalopram (Lexapro)Escitalopram (Lexapro)

QTc Prolongation Recommendations Concern for Torsades de pointes if QTc >500 milliseconds Ensure potassium and magnesium levels are within the normal range Perform ECG prior to initiating citalopram if any of the following present:

Congestive heart failure

Bradyarrhythmias

Concomitant QTc-prolonging agentsCrediblemeds.org

VHA PBM Bulletin. Updated Guidance: Citalopram hydrobromide and dose-dependent QT interval prolongation. September 29, 2011.

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SSRIs


•May be more activating•No tapering required due to long half-life

Fluoxetine (Prozac)Fluoxetine (Prozac)

•Not officially labeled for MDD•Only approved for OCD, off-label use in

eating disorders•Multiple drug interactions

Fluvoxamine (Luvox)Fluvoxamine (Luvox)

SSRIs


•Anticholinergic activity•Only SSRI that requires renal dose adjustments•Worst discontinuation symptoms

Paroxetine (Paxil) Paroxetine (Paxil)

•Weak dopamine reuptake inhibition believed to enhance activity

Sertraline (Zoloft)Sertraline (Zoloft)

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SSRI Dosing Starting dose

(mg/day)Dosing range

(mg/day)Dose

AdjustmentsDrug Interactions

Citalopram 20 20 – 40 Hepatic & age >60, max 20mg

Max 20 mg with omeprazole, cimetidine

Escitalopram 5 – 10 10 – 20 Hepatic & age >60, max 10mg

Concern with omeprazole

Fluoxetine 20 20 – 60(max 80)

Hepatic & geri: “lower dose”

Codeine, tamoxifen,clopidogrel, BBs

Fluvoxamine IR: 50 ER: 100

50 – 300 Hepatic & geri: “titrate slowly”

Strong inhibitor of multiple enzymes

Paroxetine 20 20 – 40(max 60)

Renal & geri: 10-40mg

Codeine, tamoxifen,BBs, digoxin

Sertraline 50 50 – 200 Hepatic: “lower dose”

Macrolides, ritonavir, azoles

Vilazodone 10 20 – 40 Renalelimination,

dose after HD

Substrate of CYP-3A4

In Micromedex Solutions [database online]. Truven Health Analytics, inc. 2015. http://www.micromedexsolutions.com. Spina E. CNS Drugs. 2012;26(1):39-67. VA/DoD Clinical Practice Guideline for Management of Major Depressive Disorder. 2009.

SNRIs


•Greater effectiveness for pain•Contraindicated if CrCl <30 mL/min or if

hepatic dysfunction present

Duloxetine (Cymbalta)Duloxetine (Cymbalta)

•Worse discontinuation symptoms due to short half-life

•Used off-label for menopausal flushing

Venlafaxine (Effexor)Venlafaxine (Effexor)

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SNRIs

Stahl S. Stahl's Essential Psychopharmacology. Cambridge: Cambridge University Press; 2008.Asnis GM and Henderson MA. Neuropsychiatr Dis Treat. 2015;11:125-35.

• Active metabolite of venlafaxine• Theoretically more stable levels• Slightly more NE activity than venlafaxine

Desvenlafaxine (Pristiq)Desvenlafaxine (Pristiq)

• Greater NE than 5-HT activity• Weight neutral and no QTc prolongation• Significantly increased blood pressure• Lacks indications for other conditions

Levomilnacipran (Fetzima)Levomilnacipran (Fetzima)

SNRI DosingSNRI’s Starting dose


(mg/day)Dose adjustments Drug

interactions

Duloxetine 20 60 – 120 CrCl <30: avoidHepatic: avoid

Codeine, tamoxifen,

BBsVenlafaxine IR: 37.5

XR: 75IR: 150 – 375XR: 150 – 225

Hepatic and renal: “lower dose”

Weak 2D6 inhibition

Desvenlafaxine 50 100 Max dose of 25 mg/d if CrCl <30

Weak 2D6 inhibition

Levomilnacipran 20 120 Max 80 mg/d CrCl 30 – 60 and max 40

mg/d for CrCl 15 - 30

Substrate of 3A4 and P-

GP

In Micromedex Solutions [database online]. Truven Health Analytics, inc. 2015. http://www.micromedexsolutions.com.

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Mixed Activity SERTs

Boulenger et al. International Clinical Psychopharmacology. 2014. 29:138-149. Grant JE et al. 2017 May;32(3):121-126.Wang et al. Chonnam Med J. 2016. 52:91-100.Stahl S. Stahl's Essential Psychopharmacology. Cambridge: Cambridge University Press; 2008.

• 5-HT1A agonist, 1B partial agonist, 1D/3A/7 antagonist and reuptake activity

• Fewer discontinuation symptoms compared with duloxetine (boulenger)

Vortioxetine (Trintellix)Vortioxetine (Trintellix)

• 5-HT1A Partial Agonist and Reuptake Inhibitor (SPARI)• Proposed benefits of faster onset, less sexual side

effects and greater efficacy*• Primary side effect of GI upset

Vilazodone (Viibryd)Vilazodone (Viibryd)

Mixed Activity SERTs

Kostrubsky SEet al. Inhibition of hepatobiliary transport as a predictive method for clinical hepatotoxicity of nefazodone. Toxicol Sci 2006; 90: 451-9)Stahl S. Stahl's Essential Psychopharmacology. Cambridge: Cambridge University Press; 2008.

• 5-HT2A antagonist/reuptake inhibitor (SARI)• Less potently inhibits NE reuptake

• Use severely limited due to hepatotoxicity• Less sedating than trazodone

Nefazodone (Serzone)Nefazodone (Serzone)

• Use limited by sedation

TrazodoneTrazodone

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Mixed Activity SERTsStarting dose


(mg/day)Dose

AdjustmentsDrug Interactions

Vortioxetine

Vilazodone 10 20 – 40 Renalelimination,

dose after HD

Substrate of CYP-3A4

Nefazodone

Trazodone

In Micromedex Solutions [database online]. Truven Health Analytics, inc. 2015. http://www.micromedexsolutions.com. Spina E. CNS Drugs. 2012;26(1):39-67. VA/DoD Clinical Practice Guideline for Management of Major Depressive Disorder. 2009.

Comparative Data

Citrome L. Journal of Affective Disorders. 2016. 196:225-233.

4.3 4.6 1.8 1.2 1.4 3.3 5.1

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Tolerability

Common adverse effects include headache, GI upset, dry mouth, agitation, insomnia, sexual dysfunction, diaphoresis, and weight gain

SNRIs also pose risk of hypertension, tremor and tachyarrhythmia's Other risks

Bleeding

Hyponatremia

Osteoporosis (elderly)

Moret C et al. Journal of Psychopharmacology. 2009;23: 967–974.

Serotonin Syndrome

Rare but serious Counsel patients to discontinue medication and seek care if

Diaphoresis, delirium, agitation, muscle rigidity, clonus, or mydriasis

Higher risk in patients with multiple serotonergic agents Linezolid, tramadol, valproate, triptans, dextromethorphan, L-

tryptophan and other antidepressants (especially MAOIs)

Management largely supportive Cyproheptadine considered treatment of choice

Benzodiazepines for agitation/clonus

Boyer E, Shannon M. New England Journal of Medicine. 2005;352(11):1112-1120.

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NDRI


• Not efficacious for anxiety• Does not cause sexual dysfunction• Additional indication for smoking cessation• May be used as in combination with SSRI/SNRI• Caution in patients with eating disorders and

history of seizures• Counsel patients to avoid bedtime dosing• May increase desipramine levels, CI with

ritonavir

BupropionBupropion

Bupropion dosing Immediate release

Dosed 2-4 times daily

Sustained release “Bupropion SA” Dosed twice daily Formulation typically

used for smoking cessation

Extended release “Bupropion SA 24h” Dosed once daily


Initial (mg/day)

150

Maintenance (mg/day)

300-450 (max 400 for 12hr sustained release)

Hepaticdosing

• 75 mg daily for immediate release

• 150 mg every other day for sustained and extended release

Renal dosing

Consider dose reduction if CrCl<90 mL/min

Interactions Codeine, tamoxifen, BBs

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VAST-D

Compared change to bupropion, augmentation with bupropion or augmentation with aripiprazole

Active treatment phase of 12 weeks with total 36 weeks of follow-up 1522 patients with nonpsychotic MDD and failure to an SSRI, SNRI or

mirtazapine were randomized to treatment in a single-blind manner Remission at better in both augmentation groups but aripiprazole

only one to achieve statistically significant improvement from switch group

Higher rates of anxiety with bupropion (22-24% vs 16%) Higher rates of somnolence, akathisia and weight gain with

aripiprazoleMohamed S, Johnson GR, Chen P, et al; VAST-D Investigators. Effect of antidepressant switching vs augmentation on remission among patients with major depressive disorder unresponsive to antidepressant treatment: the VAST-D randomized clinical trial. JAMA.

VAST-D

Mohamed S, Johnson GR, Chen P, et al; VAST-D Investigators. Effect of antidepressant switching vs augmentation on remission among patients with major depressive disorder unresponsive to antidepressant treatment: the VAST-D randomized clinical trial. JAMA.

0

5

10

15

20

25

30

Bupropion Switch Bupropion Augment Aripiprazole Augment

Perc

ent R

emiss

ion

Remission at 12 weeks

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VAST-D

Mohamed S, Johnson GR, Chen P, et al; VAST-D Investigators. Effect of antidepressant switching vs augmentation on remission among patients with major depressive disorder unresponsive to antidepressant treatment: the VAST-D randomized clinical trial. JAMA.

Mirtazapine

Use generally limited by sedation and weight gain Does not cause sexual dysfunction Also beneficial for anxiety and insomnia Dosed 15-45mg HS

Tends to be less sedating at higher doses

Cautious dose titration in geriatric patients, hepatic dysfunction, and CrCl <40 mL/min


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Discontinuation Symptoms

Divided into affective, gastrointestinal, neuromotor, vasomotor, neurosensory, and other neurological symptoms

Onset usually within 5 days of stopping antidepressant Counsel against abrupt cessation More pronounced with short-acting agents (paroxetine and

venlafaxine)

NCCMH. Depression: the Treatment and Management of Depression in Adults (Update). The British Psychological Society and the Royal College of Psychiatrists. 2010. [Full guideline]

A Word About Supplements Some benefit

St. Johns WortMultiple drug interactions

Risk of serotonin syndrome when combined with SSRIs

Omega-3 Recommend dietary modifications first

Consider if other indications for supplementation exist

Other dietary supplements possibly beneficial when used adjunctively

Sarris J. J Clin Psych. 2012;73:81-86.Royal Australian and New Zealand College of Psychiatrists clinical practice guidelines for mood disorders. Australian & New Zealand Journal of Psychiatry. 2015;49(12):1087-1206.

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Monitoring

Setting Expectations

Most side effects should subside after the first 2 weeks Counsel to take with food to avoid GI upset

Not for PRN use Adequate trial of at least 4-6 weeks before adjusting dose

Increased activity, interest, and cognition in first 1-3 weeks

Mood elevation, return of pleasure, decreased hopeless feelings, and fewer suicidal thoughts in 2-4 weeks

60-70% of patients will respond to an initial antidepressant trial 30-40% will achieve remission

Nierenberg AA. A critical overview of the pharmacologic management of treatment-resistant depression. Psychiatric Clinics of North America. 2007;30:13–29.

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Treatment Response

Royal Australian and New Zealand College of Psychiatrists clinical practice guidelines for mood disorders. Australian & New Zealand Journal of Psychiatry. 2015;49(12):1087-1206.

Measuring Progress

PHQ-9 at each visit Assess benefit at 4 weeks

Consider dose increase if partial improvement and good tolerability

Change to alternate medication if no response with adequate dose

Ensure adherence Assess willingness to engage in psychotherapy


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Measuring Progress

Mann J. New England Journal of Medicine. 2005;353(17):1819-1834.

Variable ResponseNonresponse Minimal or < 25% decrease in baseline severity of

symptomsPartial response

Reduction in severity of symptoms but symptoms still evident; 26-49% decrease in baseline severity of symptoms

Response ≥ 50% reduction in baseline severity of symptomsRemission No symptoms, return to normal functioning; PHQ-9

score of ≤ 4, maintained for at least 1 month

Recovery Extended remission, PHQ-9 score of ≤ 4, maintained for at least 6 months

Measuring Progress

Assess tolerability Sexual dysfunction

Lower dose

Adjunct with bupropion, or buspirone

Trial alternative agent

Treat with PDE-5 inhibitor

Sedation/InsomniaMove dose to alternate time of day


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Follow-up StrategiesStep Patient Condition Options Reassess at:1 Initial treatment 2 weeks2 Nonresponse to

initial low dose• Increase dose• Consider longer

duration• Switch

4-6 weeks

3 Failed 2nd trial of antidepressant

• Switch• Augment • Consider referral to

specialty care

8-12 weeks

4 Failed 3 trials including augmentation

• Re-evaluate diagnosis and treatment

• Consider referral to specialty care

12-18 weeks


Special Populations

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Medical Co-Morbidities

Cardiovascular disease Caution with SNRIs

Avoid citalopram due to QTc prolongation

Avoid Tricyclic Antidepressants (TCAs)

Parkinson’s disease Depression present in 40-60% of patients

No evidence to suggest one agent over another

SSRIs/SNRIs may worsen tremor



Seizure disorders Bupropion and TCAs lower seizure threshold No increased risk with SSRIs/SNRIs

Obesity/Diabetes Mirtazapine and TCAs can cause/contribute to weight gain SSRIs/SNRIs associated with weight gain to a lesser extent Bupropion is weight neutral and may promote modest weight loss

Traumatic Brain Injury Paroxetine and TCAs can worsen cognition via anticholinergic activity Population with lowered seizure threshold


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Pain syndromes Neuropathic pain

Recommend SNRI or TCA

Migraine and tension headaches Highest quality evidence with amitryptiline, some evidence supporting SNRIs

Fibromyalgia Duloxetine (FDA approved)

Amitriptyline (off-label use)


Patient-Specific Factors

Elderly patients Consider alternative to paroxetine due to anticholinergic effects

Cautious dose titration

Insomnia Consider augmenting with mirtazapine, trazodone, or hydroxyzine

Suicidality SSRIs generally least toxic in overdose


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Pregnancy/Lactation

Depression rate of 10-16% Consider risk/benefit

Psychotherapy preferred for mild/moderate cases

Untreated depression is not benign (premature birth, low birth weight, postnatal complications, impaired cognitive/emotional development)

Pregnancy/lactation risk now a narrative section in package inserts Consider time of initiation and expected duration of therapy

Royal Australian and New Zealand College of Psychiatrists clinical practice guidelines for mood disorders. Australian & New Zealand Journal of Psychiatry. 2015;49(12):1087-1206.

Pregnancy/Lactation

Paroxetine contraindicated in pregnancy Pulmonary HTN, cardiac defects, neonatal withdrawal

Venlafaxine and bupropion also associated with heart defects All other SSRIs/SNRIs previously category C Lactation

Lowest risk with fluoxetine, paroxetine, and sertraline

If pharmacotherapy selected, use lowest effective dose Sertraline preferred

O’Connor E. Primary Care Screening for and Treatment of Depression in Pregnant and Postpartum Women. JAMA. 2016;315(4):388. TOXNET. Toxnetnlmnihgov. 2016. Available at: http://toxnet.nlm.nih.gov/cgi-bin/sis/search2/d?./temp/

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Questions?

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