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CPT II

From the American Psychiatric Association’s (2000) Practice Guidelines for Major Depressive Disorder in Adults:. “ Antidepressant medications should be provided for moderate to severe depressive disorders unless ECT is planned. ”

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CPT II

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  1. From the American Psychiatric Association’s (2000)Practice Guidelines for Major Depressive Disorder in Adults: • “Antidepressant medications should be provided for moderate to severe depressive disorders unless ECT is planned.” • “For example, although some data suggest that cognitive behavioral therapy alone may be effective for patients with moderate to severe major depressive disorder, most suchpatients will require medication.”

  2. CPT II Follow-up Phase (12 months) Acute Phase (16 weeks) Continuation Phase (12 months) 3 booster sessions Prior CT (N=34) CT (N= 60) ADM (N=34) ADM (N= 120) PLACEBO (N=34) PLACEBO (N= 60)

  3. Major Entry Criteria • Principal Diagnosis of Major Depressive Disorder • Two consecutive (at least one week apart) scores of 20 or more on a modified 17-item Hamilton Rating Scale for Depression • No Psychosis or Bipolar Disorder • No Borderline, Antisocial, or Schizotypal PD • No marked Substance Abuse or Dependence in previous 6 months

  4. Reasons Interested Patients Were Screened Out of the Trial

  5. Demographic Information

  6. Depressive Subtype and History Information

  7. Comorbidity I

  8. Comorbidity II

  9. CT (N= 60) ADM (N= 120) PLACEBO (N= 60) Acute Phase (Single blind) Not Augmented (59%) R a n d o m i z a t i o n Augmented (41%) (Triple blind) Weeks 0 2 4 6 8 10 12 14 16 Un-blinding for pill patients

  10. Dropouts in First 8 Weeks

  11. Degrees of Response at 8 Weeks

  12. Mean HRSD Scores Over 8 Weeks

  13. Change in Depressive Symptomsfrom Intake to Week 8 (HRSD)

  14. Dropouts in ADM and CTover 16 Weeks

  15. Percent Responders (HRSD < 12) amongAll Assigned, Across Sites

  16. Degrees of Response after 16 Weeks

  17. Percent Response (HRSD < 12) by Site (16 Weeks)

  18. Sample Characteristics on Potential Predictors of Response DemographicsHistory/Subtype Age 40+12 Ever Hospitalized 19% Female 59% Chronic 50% Minority 18% Recurrent 75% Married 33% Melancholic 31% Employed 82%Atypical 15% Axis I Comorbidity (73%)Axis II Comorbidity (47%) PTSD 17% Cluster A 3% GAD 13%Cluster B 4% Panic Dis. 13% Avoidant 18% Eating Dis. 17% OCPD 15% Subs. Use 36% PD NOS 16% Predicts response across ADM and CT (Prognostic) Predicts differential response to ADM vs. CT (Prescriptive)

  19. Chronicity Predicts Poor Response (Prognostic)

  20. Being Unemployed Predicts Poor Response (Prognostic)

  21. Cluster A Predicts Poor Response (Prognostic)

  22. PTSD Predicts Poor Response(Prognostic)

  23. GAD Predicts Differential Response (Prescriptive)

  24. CPT II Follow-up Phase (12 months) Acute Phase (16 weeks) Continuation Phase (12 months) 3 booster sessions Prior CT (N=34) CT (N= 60) ADM (N=34) ADM (N= 120) PLACEBO (N=34) PLACEBO (N= 60)

  25. 75% 60% 19%

  26. Sample Characteristics on Potential Predictors of Relapse DemographicsHistory/Subtype Age: 40+12 Early Onset: 49% Female: 58% Dysthymic: 34% Minority: 13% Recurrent: 75% Married: 37%Melancholic: 34% Employed: 89% Atypical: 24% Axis I Comorbidity (69%)Axis II Comorbidity (49%) PTSD: 10% Cluster A: 1% GAD: 11% Cluster B: 1% Panic Dis. 12% Avoidant: 18% Eating Dis. 18% OCPD: 13% Subs. Use 31% PD NOS: 19% Predicts risk for relapse

  27. Sustained Improvementfor All Assigned to Treatment

  28. Cumulative Direct Costs of ADM and CT

  29. Sustained Improvement Rates by Site

  30. Treatment Response as a Function of Site and Gender

  31. Response to CT as a Function of PTSD by Site

  32. Therapist Competence as a Function of Experience in the Trial (Vandy)

  33. Response to Treatmentas a Function of Time in Trial

  34. Weekly Paxil Dosage By Site

  35. Weekly Paroxetine Dosage by Site and Augmentation

  36. Response to Treatment as a Function of Ordinal Rank within Group (Vandy)

  37. Response to Treatment as a Function of Ordinal Rank within Group (Penn)

  38. Recovery Remission RX Response, Remission, Recovery, Relapse, Recurrence & Chronicityadapted from Kupfer & Frank 2001 Relapse Recurrence Response ‘Normalcy’ Incompleterecovery progressionto disorder Severity Symptoms X Syndrome Chronicity 16 wks 12 mo 12 mo Treatment phases Acute Maintenance Continuation Time

  39. 25% ITT

  40. Continuation Followup

  41. CPT III Maintenance/Follow-up (36 months) Acute Treatment (3-12 months) Continuation (6-18 months) ADM and CT (N=225) ADM (N=90+) (monthly/ quarterly) (twice weekly/weekly) (monthly) No ADM (N=90+) 1st R a n d o m i z a t i o n 2nd R a n d o m i z a t i o n Response Recurrence Relapse ADM (N=225) ADM (N=90+) (monthly/ quarterly) (monthly) (weekly/biweekly) No ADM (N=90+) Remission Recovery

  42. Medication Sequence SNRI TCA MAOI SNRI or SSRI Augment Augment Augment Augment

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