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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
                                                               antidepressant
 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
                                           care
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
increased:
   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
                                        Achieved
                                        recovery
                                                           Recurrence
                                                          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
    time
   This comorbidity has not been studied at length in
    adults
   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
    symptoms)
   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.
2007;64:419-427.
National Institute of Mental Health. Effectiveness of Lithium Plus Optimized Medication in Treating People With
Bipolar Disorder (LiTMUS). http://clinicaltrials.gov/show/NCT00667745. 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-
224.
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.
www.grandrounds.com/v66n0710.pdf. 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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