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. Author manuscript; available in PMC: 2021 Jun 30.
Published in final edited form as: Clin Ther. 2020 Dec 18;43(1):17–39. doi: 10.1016/j.clinthera.2020.10.006

Table 2.

Study characteristics RCTS investigating combined psychotherapy and pharmacotherapy for BED

Study N % F % W Age BMI Wks FUP (mo) Treatment conditions Study Design
Agras et al. (1994)[30] 108 100 NA 45.0 38.6 36 3
  1. BWL-only

  2. CBT/BWL

  3. CBT/BWL + desipramine

  1. 9 mo (30 sessions)

  2. 3 mo (12 sessions) + 6 mo (18 sessions)

  3. 3 mo + 6 mo + drug (mean dose 285mg/day)

Laederach-Hoffman et al. (1999) [31] 31 87 NA
  1. 35.7

  2. 40.7

39.5 8 6
  1. Diet counseling + supportive therapy

  2. Imipramine

  1. Bi-weekly (30 min) diet counseling + bi-weekly (15–25 min) supportive therapy + monthly sessions of group (90 min) behavior therapy

  2. Fixed dosage of 25 mg three times daily

Ricca et al. (2001) [32] 108 59 NA 25.9 32.3 24 12
  1. CBT

  2. CBT + fluoxetine

  3. CBT + fluvoxamine

  4. Fluoxetine-only

  5. Fluvoxamine-only

  1. 22 individual sessions

  2. CBT + 60 mg/day

  3. CBT + 300 mg/day

  4. Drug-only, as “b” above

  5. Drug-only, as “c” above

Devlin et al. (2005, 2007) [34, 42] 116 78 77 43.0 40.9 20 24
  1. Fluoxetine

  2. Placebo

  3. CBT + placebo

  4. CBT + fluoxetine

*All of the above given in combo with group BWL (16 sessions for 5 mo)
  1. Flexible dosage of 60 mg/day

  2. Placebo

  3. 20 individual CBT sessions

  4. As above, “a” + “c”

Maintenance treatment included double blind medication for 18/24 months and monthly BWL groups
Golay et al. (2005) [29] 89 91 97
  1. 41

  2. 41

  1. 35.7

  2. 37.3

24 None
  1. Orlistat + hypo-caloric diet

  2. Placebo + hypo-caloric diet

  1. Fixed dosage of 120 mg three times daily + hypocaloric diet (600 kcal/day subtracted from daily energy expenditure)

  2. Placebo + hypocaloric diet

Grilo et al. (2005) [36] 50 88 88 47 36.0 12 3
  1. Orlistat + CBTgsh

  2. Placebo + CBTgsh

  1. Fixed dosage of 120 mg three times daily + CBTgsh (CBT self-help manual, plus six 15–20 min individual meetings over 12 wks)

  2. Placebo + CBTgsh

Grilo et al. (2005, 2012) [35, 43] 108 78 89 44 36.3 16 6, 12
  1. Fluoxetine –only

  2. Placebo

  3. CBT + placebo

  4. CBT + fluoxetine

  1. Fixed dosage of 60 mg/day

  2. Placebo

  3. 16 individual weekly (60 min) sessions

  4. As above, a + c

Claudino et al. (2007)[28] 73 96 58
  1. 35

  2. 41

  1. 37.4

  2. 37.4

21 None
  1. CBT + placebo

  2. CBT + topiramate

  1. 19 group sessions of CBT

  2. CBT + flexible dosage of 200 mg/day

Ricca et al. (2009) [33] 52 83 NA
  1. 35

  2. 36

  1. 39.2

  2. 38.4

24 12
  1. CBT

  2. CBT + zonisamide

  1. 22 individual sessions of CBT for 24 wks

  2. CBT + zonisamide 25 mg/day for 7 days, increased as tolerated by 50 mg/day every week to a max of 100 mg/day for BMI < 35 kg/m2 or 150 mg/day for BMI > 35 kg/m2

Grilo & White (2013) [37] 40 78 0
  1. 46

  2. 46

  1. 37.2

  2. 39.0

16 6
  1. BWL + placebo

  2. BWL + orlistat

  1. 16 weekly sessions of a culturally-enhanced adaptation of the Diabetes Prevention Program

  2. Fixed dosage of 120 mg three times daily + BWL

Grilo et al. (2014) [39] 104 73 45 44 38.3 16 6,12
  1. Sibutramine

  2. Placebo

  3. shCBT + sibutramine

  4. shCBT + placebo

  1. Fixed dosage of 15 mg/day

  2. Placebo

  3. Self-help CBT + sibutramine (15 mg/day)

  4. Self-help CBT + placebo

Grilo et al. (2020) [38, 44] 191 71.2 78.5 48.4 39.0 24 6,12
  1. Standard treatment

  2. Stepped care

  1. BWL (1 mo) followed by stratification by response:

    Rapid respondersa:
    • 1a)
      BWL + Medb (5 mo)
    • 1b)
      BWL + Placebo (5 mo)
    Non-rapid responders:
    • 2a)
      CBTgsh + Med (5 mo)
    • 2b)
      CBTgsh + Placebo (5 mo)
  2. BWL (6 mos)

Note: BED = binge eating disorder; FUP = follow-up; RCT = randomized controlled trial; BWL = behavioral weight loss; CBT = cognitive-behavior therapy; gsh = guided self-help; LDX = lisdexamphetamine; MDD = major depressive disorder; GAD = generalized anxiety disorder; OCD = obsessive-compulsive disorder; NA = data not available.

a

Rapid response defined as 65% reduction in binge eating after 1 month of treatment;

b

Sibutramine was dosed at 15 mg/day until market withdrawal and replaced by Orlistat 120 mg/3x day.

An additional N=39 obese patients without BED were also randomized to the treatments. The reader is referred to the publication for findings which notably included BED status as a significant predictor and moderator of outcomes [37].