Treatment%20for%20Adolescents%20With%20Depression%20Study%20%20(TADS)

1
Treatment for Adolescents With Depression Study
(TADS)
2

• Fluoxetine, Cognitive Behavioral
• Therapy, and Their Combination for
• Adolescents With Depression
• Treatment for Adolescents With Depression Study
  (TADS) Team
• JAMA 2004 Vol 292, No. 7

3
(No Transcript)
4
TADS

• A randomized controlled trial funded by the
  National Institute of Mental Health
• Conducted at 13 academic and community centers in
  the United States
• To evaluate the effectiveness of treatments for
  adolescents with MDD

5
Participants

• 429 patients
• Age 12 -17 years (mean age 15 years)
• Primary diagnosis of major depressive disorder
  (DSM-IV)

6
Inclusion Criteria

• Outpatient
• CDRS 45
• IQ 80
• Not taking antidepressants
• Depressive mood in at least 2 contexts for at
  least 6 weeks prior to consent

7
Exclusion criteria

• Bipolar disorder
• Severe conduct disorder
• Substance abuse
• PDD
• Thought disorder
• Concurrent psychotropic medications
• Failed 2 SSRIs or CBT

8
Exclusion criteria

• Dangerousness to self or others
• Had been hospitalized for dangerousness within 3
  months
• Suicidal attempt within 6 months
• Active plan of suicide
• Suicidal ideation with disorganized family

9
Participants

• Moderate to severe symptoms
• Average depressive episode duration - 72 weeks
• 27 had at least minimal suicidal ideation at
  baseline

10
Randomization

• To 1 of 4 treatments for 12 weeks
• Fluoxetine alone
• CBT alone
• Fluoxetine with CBT
• Placebo

11
Randomization

• Blinding
• Independent evaluators

12
Fluoxetine

• 6 medication visits x 20-30 minutes
• Dosage adjusted
• Starting dose 10 mg/d
• Optimum 20 mg/d
• Maximum 40 mg/d
• Mean highest dose 30 mg/d

13
CBT

• 15 sessions over 12 weeks x 50-60 minutes
• Psychoeducation
• Mood monitoring
• Increasing pleasant activities
• Social problem solving
• Cognitive restructuring
• Parent and family sessions

14
Outcome Assessment

• Childrens Depression Rating Scale-Revised
  (CDRS-R)
• CGI improvement score (much improved or very much
  improved)
• Assessed at baseline, week 6, and week12

15
Outcome Assessment

• Reynolds Adolescent Depression Scale (RADS)
• Suicidal Ideation Questionnaire-Junior High
  School Version (SIQ-Jr)
• All measures reported acceptable psychometric
  properties

16
Harm-Related Adverse Event

• Harm to self e.g. cutting
• Worsening of suicidal ideation
• Suicidal attempt
• Harm to others

17
Suicide-Related Adverse Event

• Worsening suicidal ideation
• Suicidal attempt

18
Results

• Combination of fluoxetine with CBT was
  significantly superior to
• placebo
• fluoxetine alone
• CBT alone

19
Results

• Fluoxetine alone was superior to placebo
• CBT alone was not superior to placebo
• Fluoxetine alone was significantly better than
  CBT alone

20
Response Rate Based On CGI

• 71 in the fluoxetine with CBT
• 61 in the fluoxetine alone
• 43 in the CBT alone
• 35 in the placebo

21
Results
Effect size (CDRS-R) Effect size (CGI) NNT
Fluoxetine CBT 0.98 0.84 3
Fluoxetine alone 0.68 0.58 4
CBT alone -0.03 0.20 12
22
Results

• Combination of fluoxetine with CBT is better
  than fluoxetine alone, which is better than CBT
  alone, which is equal to placebo

23
Suicidal Behavior in Children Receiving SSRIs

• Suicidal ideation decreased in all of the
  treatment groups
• 6 of the patients experienced a suicide-related
  event with no statistically significant
  difference among the 4 treatment groups
• Seven patients made a suicide attempt and there
  were no completed suicides

24
Suicidal Behavior in Children Receiving SSRIs

• Harm-related adverse events increased risk (odds
  ratio 2.19) for patients receiving fluoxetine
  compared with those who were not
• The odds ratio was higher for fluoxetine alone
  compared with fluoxetine with CBT.
• Protective effect for CBT for suicidal ideation

25
Summary

• Combination treatment with fluoxetine and CBT
  shows highest efficacy
• CBT is a protective factor for suicide in
  adolescents receiving fluoxetine