A Phase 4 interventional study of Sibutramine and Placebo in Obesity and Binge Eating, sponsored by Yale University. Completed at 3 sites in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-08-18.
Sponsored by Yale University · Phase 4, Interventional, and Treatment
This study will test the effectiveness of two empirically-supported but distinct treatments for recurrent binge eating in obese patients: 1) Cognitive Behavior Therapy, using a pure self-help approach and 2) sibutramine, an anti-obesity medication also found to have efficacy for binge eating. Self-help Cognitive Behavior Therapy and sibutramine will be administered alone and in combination in a primary care setting.
319 studies on the registry are indexed under Bulimia; 53 are open to participants now.
This study's enrollment of 104 is above the median of 61 across 249 interventional studies indexed under Bulimia.
Browse Bulimia studies →Yale University is the lead sponsor of 1,724 studies on the registry; 298 are open to participants now.
Of its 210 completed or terminated interventional studies of FDA-regulated products, 126 (60%) have results posted.
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Exclusion Criteria:
Sibutramine 15 mg daily
Drug: Sibutramine
Placebo Daily
Drug: Placebo
Placebo and Self-help CBT Placebo daily, Cognitive behavioral self-help manual for binge eating
Behavioral: Self-help CBT + Sibutramine
Sibutramine and Self-help CBT 15 mg daily Cognitive behavioral treatment manual for binge eating
Behavioral: Self-help CBT + Placebo
15 mg daily
Also known as: Meridia
Daily
Cognitive behavioral treatment manual for binge eating Sibutramine 15 mg daily
Cognitive behavioral treatment manual for binge eating Placebo daily
Binge Eating (Remission)
Remission from binge eating (zero binge episodes during previous 28 days)
Time frame: 4 months treatment; 6 and 12 month follow up post treatment
BMI
BMI (kg/m\^2) was measured 4 months after treatment.
Time frame: 4 months
| Milestone | Sibutramine | Placebo | Placebo/CBTsh | Sibutramine/CBTsh |
|---|---|---|---|---|
| Started | 26 | 27 | 25 | 26 |
| Completed | 20 | 14 | 21 | 22 |
| Not completed | 6 | 13 | 4 | 4 |
| Withdrew: Withdrawal by subject | 4 | 11 | 4 | 3 |
| Withdrew: Medically withdrawn | 2 | 2 | 0 | 1 |
Remission from binge eating (zero binge episodes during previous 28 days)
| participants | Sibutramine | Placebo | Placebo/CBTsh | Sibutramine/CBTsh |
|---|---|---|---|---|
| Remission at Post-treatment | 10 ± 11.4 | 8 ± 9.9 | 6 ± 7.6 | 6 ± 8.0 |
| Remission at 6 month follow up | 5 | 11 | 10 | 13 |
| Remission at 12 month follow up | 5 | 10 | 10 | 11 |
BMI (kg/m\^2) was measured 4 months after treatment.
| BMI (kg/m^2) | Sibutramine | Placebo | Placebo/CBTsh | Sibutramine/CBTsh |
|---|---|---|---|---|
| BMI | 38.4 ± 7.2 | 39.6 ± 5.7 | 35.9 ± 5.6 | 35.6 ± 4.6 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Sibutramine | — | 0/26 (0%) | 1/26 (3.8%) |
| Placebo | — | 0/27 (0%) | 2/27 (7.4%) |
| Placebo/CBTsh | — | 0/25 (0%) | 0/25 (0%) |
| Sibutramine/CBTsh | — | 0/26 (0%) | 1/26 (3.8%) |
| Event | Sibutramine | Placebo | Placebo/CBTsh | Sibutramine/CBTsh |
|---|---|---|---|---|
| Elevated blood pressureVascular disorders | 1/26 | 2/27 | 0/25 | 1/26 |
| Age, Continuous(years) | Sibutramine | Placebo | Placebo/CBTsh | Sibutramine/CBTsh | Total |
|---|---|---|---|---|---|
| Mean | 41.2 ± 10.3 | 43.2 ± 12.4 | 45.7 ± 12.4 | 45.6 ± 9.4 | 44.2 ± 11.1 |
| Sex: Female, Male(Participants) | Sibutramine | Placebo | Placebo/CBTsh | Sibutramine/CBTsh | Total |
|---|---|---|---|---|---|
| Female | 19 | 18 | 20 | 16 | 73 |
| Male | 7 | 9 | 5 | 10 | 31 |
| Race/Ethnicity, Customized(participants) | Sibutramine | Placebo | Placebo/CBTsh | Sibutramine/CBTsh | Total |
|---|---|---|---|---|---|
| Caucasian | 13 | 12 | 12 | 10 | 47 |
| African-American | 8 | 12 | 6 | 10 | 36 |
| Hispanic-American | 4 | 2 | 4 | 4 | 14 |
| Other | 1 | 1 | 3 | 2 | 7 |
| Age at onset of Binge Eating Disorder (BED)(years) | Sibutramine | Placebo | Placebo/CBTsh | Sibutramine/CBTsh | Total |
|---|---|---|---|---|---|
| Mean | 25.7 ± 11.2 | 25.5 ± 11.1 | 25.7 ± 15.1 | 29.1 ± 13.1 | 26.2 ± 12.5 |
This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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Yale University