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					       Overall Goals of the STEP-BD
     Randomized Clinical Trials Pathway
   Answer the question “What to do next?” when acute
    depression doesn’t respond to monotherapy with a
    mood stabilizer
   See if using an antidepressant or non-antidepressant
    treatment makes a difference in recovery
   Test the efficacy of psychosocial therapy
    as an adjunct

Sachs GS, et al. Biol Psychiatry. 2003;53:1028-1042.
   Overview—Randomized Clinical Trials
                          Interventions           Duration                           Outcomes

 Acute               Mood stabilizer +            26 weeks     No increased risk of TEAS
 depression1         antidepressant:                           Recovery rates:
                     bupropion or                              24% on MS + either antidepressant
                     paroxetine                                27% on MS + placebo
                                                               No benefit seen from adding an
 Refractory          Mood stabilizer +            16 weeks     Recovery rates:
 depression2         nonantidepressant                         24% on lamotrigine, 17% on inositol, 5% on
                     adjunct:                                  risperidone
                     lamotrigine, inositol, or                 No statistical difference in the 3 adjuncts; no
                     risperidone                               additive benefit in treating depression
                                                               Ad hoc analyses: lamotrigine may have some
                                                               modest therapeutic benefit
 Psychosocial        Adjunctive treatment         1 year       Recovery rates:
 therapy3            for acute depression:                     77% in FFT, 64.5% in ISPRT, 60% in CBT,
 (for treating       CBT, FFT, or IPSRT                        51.5 in CC
 depression)         Control: CC                               All 3 intensive psychotherapies were
                                                               statistically superior to CC; all 3 also had
                                                               clear benefits of patients becoming well
                                                               sooner and staying well longer
Abbreviations: CBT, cognitive behavioral therapy; CC, Collaborative Care; FFT, family-focused psychoeducational
treatment; IPSRT, Interpersonal Social Rhythm Therapy; MS, Mood Stabilizer; TEAS, treatment-emergent affective switch.

1. Sachs GS, et al. N Engl J Med. 2007;356:1711-1722. 2. Nierenberg AA, et al. Am J Psychiatry. 2006;163:210-216.
3. Miklowitz DJ, et al. Arch Gen Psychiatry. 2007;64:419-427.
               Advantages of Using Intensive
               Psychotherapy as an Adjunct

                                          Patients were 1.6 times more
                                           likely to be well in any given
                                           study month if they received
                                           intensive psychotherapy

                                          Patients became well an
                                           average of 110 days faster
                                           than those in collaborative
Miklowitz DJ, et al. Arch Gen Psychiatry. 2007;64:419-427.
    Risk Factors that Increase the Chance
        of Recurrence after Recovery
If any of the following happened the year prior to
recovery from an acute episode, the risk of recurrence
   Previous lifetime episodes >20
   Number of residual symptoms
    – For every depressive symptom remaining, risk increases
      by 14%
    – For every manic symptom remaining, risk
      increases by 20%
   Length of time spent in prior episode (longer = worse)
   Length of time with anxiety symptoms (longer = worse)

Miklowitz DJ, et al. Arch Gen Psychiatry. 2007;64:419-427.
  Recovery and Recurrence in STEP-BD
   Entered                                             Only ~1/4 of the cohort
  STEP-BD                                              in this study achieved
 symptomatic                                           recovery without a
                                                       relapse in ≤2 years
                                                          within 2 years

      1469                                  858                416
                                            58%                41%
Perlis RH, et al. Am J Psychiatry. 2006;163:217-224.
      Ancillary Anxiety Study in STEP-BD

    ANY current anxiety disorder increases the risk of an
     earlier acute recurrence1
    Presence of anxiety disorder causes, on average, a loss
     of 39 days being well1
    As the number of anxiety disorders increase,
     it increases the loss of days being well1
    Anxiety disorders also increase suicide risk2
    In the 239 STEP-BD patients who were tracked for
     a year in follow-up, 41% of the patients with at least 1
     anxiety disorder relapsed1

1. Otto MW, et al. Br J Psychiatry. 2006;189:20-25. 2. Simon NM, et al. J Psychiatr Res. 2007;41:255-264.
      Ancillary ADHD Study in STEP-BD

   In bipolar children, ADHD co-occurs 60%–90% of the
   This comorbidity has not been studied at length in
   STEP-BD showed that bipolar adults with ADHD
    – Have a poorer prognosis with bipolar disorders
    – Are more symptomatic
    – Are less likely to recover from mood episodes
    – Are more likely to have more mania episodes
    – Are more at risk for other psychiatric comorbidities

Nierenberg AA, et al. Biol Psychiatry. 2005;57:1467-1473.
    Functional Impairment After Recovery
   Followed 103 STEP-BD subjects who had been in remission at
    least 4 weeks
   The Work and Social Adjustment Scale (WSAS) was used to
    assess overall functional status
   Findings: bipolar patients still have substantial functional
    deficits even during periods of sustained remission (in this
    cohort, 4 weeks to 13 years)
   Degree of functional impairment correlates with degree
    of residual depressive symptoms (but not panic/mania
   Patients may benefit from comprehensive psychosocial and
    rehabilitative interventions
Nierenberg AA, et al. Biol Psychiatry. 2005;57:1467-1473.
                         Take-Away Messages
   Despite best efforts, recurring illness is still too common in
    bipolar disorders
   The value of antidepressants as adjunctive therapy in acute
    bipolar depression has yet to be established
   Nonantidepressant adjunctive therapy may have modest
    benefits in refractory bipolar depression
   Intensive psychotherapy has value as perhaps the most useful
    adjunct to pharmacotherapy in treating bipolar depression
   Careful evaluations tracking patient symptoms at recovery can
    help alter recurrences
   The most important single independent predictor of risk was
    residual, subthreshold mood elevation symptoms

Thase ME. Curr Psychiatry Rep. 2007;9:497-503.
                          Suggested Readings
Fagiolini A, Kupfer DJ, Masalehdan A, et al. Functional impairment in the remission phase of bipolar disorder.
Bipolar Disord. 2005;7:281-285.
Miklowitz DJ, Otto MW, Frank E, et al. Psychosocial treatments for bipolar depression. Arch Gen Psychiatry.
National Institute of Mental Health. Effectiveness of Lithium Plus Optimized Medication in Treating People With
Bipolar Disorder (LiTMUS). Accessed November 8, 2008.
Nierenberg AA, Ostacher MJ, Calabrese JR, et al. Treatment-resistant bipolar depression: a STEP-BD equipoise
randomized effectiveness trial of antidepressant augmentation with lamotrigine, inositol, or risperidone. Am J
Psychiatry. 2006;163:210-216.
Perlis RH, Brown E, Baker RW, Nierenberg AA. Clinical features of bipolar depression versus major depressive
disorder in large multicenter trials. Am J Psychiatry. 2006;163:225-231.
Perlis RH, Ostacher MJ, Patel JK, et al. Predictors of recurrence in bipolar disorder: primary outcomes from the
Systemic Treatment Enhancement Program for Bipolar Disorder (STEP-BD). Am J Psychiatry. 2006;163:217-
Post RM, Altschuler LL, Leverich GS, et al. Mood switch in bipolar depression: comparison of adjunctive
venlafaxine, bupropion and sertraline. Br J Psychiatry. 2006;189:124-131.
Sachs GS, Nierenberg AA, Calabrese JR. Effectiveness of adjunctive antidepressant treatment for bipolar
depression. N Engl J Med. 2007;356:1711-1722.
Suppes T, Dennehy EB, Hirschfield R, et al. The Texas implementation of medication algorithms: update to the
algorithms for treatment of bipolar I disorder. J Clin Psychiatry. 2005;66:870-886. Accessed November 8, 2008.
Suppes T, Leverich GS, Keck PE, et al. The Stanley Foundation Bipolar Treatment Outcome Network II.
Demographics and illness characteristics of the first 261 patients. J Affect Disord. 2001;67:45-59.

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