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NCT01128764 · ClinicalTrials.gov registry record · Phase 1
Integrated Treatment for Comorbid Depression and Obesity in Adolescents
A Phase 1 study, sponsored by Brown University.
- Completed
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
NCT01128764: Completed Phase 1 study, sponsored by Brown University.
NCT01128764 is a Phase 1 study that has completed, run by Brown University. The registered enrollment target is 36 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01128764, a Phase 1 study, has completed, sponsored by Brown University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
Study Summary
Lifetime prevalence of major depression is estimated at 28% by age 18 (Lewinsohn et al., 1999), with higher cumulative rates in females (35%) than males (19%). Approximately 17% of children and adolescents in the United States are obese as defined by a BMI above the 95th percentile, with more than 30% falling between the 85th and 95th percentiles (Ogden et al., 2008). Overweight children and adolescents are at increased risk for type 2 diabetes (Pinhas-Hamiel et al., 1996) and overwhelming risk for adult obesity (Guo et al., 1994). There is a substantial percentage of adolescents who are both overweight and depressed with estimates from clinical samples averaging 25%. Treatment of teens with comorbid medical and psychiatric conditions such as overweight/obesity and depression has received little to no attention in the psychosocial treatment research literature. Due to the large number of adolescents who are both depressed and overweight, developing a behavioral treatment that addresses both problems simultaneously has important public health significance. The purpose of this proposal is to combine treatments for depression and overweight to address these co-occurring conditions in one intervention. The long-term objectives of this research are to develop efficient and effective treatments for co-occurring physical and emotional disorders. The research program will be divided into 3 major phases: a development phase (Stage 1a), a pilot study phase (Stage 1b), and a revision phase. During the development phase (Stage 1a), a treatment for overweight teens and CBT treatment for depressed teens will be adapted into one integrated protocol that addresses depression using CBT techniques, an exercise component, and advice regarding healthy eating. As part of this phase, we will adapt existing intervention manuals and therapist training materials, and gain some initial clinical experience with the intervention via an open trial with 6 teens. During the randomized pilot study
Interventions
- BEHAVIORAL CBT for depression and healthy lifestyle plus exercise
- BEHAVIORAL CBT for depression
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2009-12 |
| Est. Completion | 2013-12 |
| Phase | Phase 1 |
What the finished NCT01128764 record still lists
NCT01128764 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower).
The record links to 0 conditions, and to 2 interventions - of which CBT for depression and healthy lifestyle plus exercise is the first listed.
NCT01128764 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01128764 about?
NCT01128764 is a clinical study titled "Integrated Treatment for Comorbid Depression and Obesity in Adolescents". Lifetime prevalence of major depression is estimated at 28% by age 18 (Lewinsohn et al., 1999), with higher cumulative rates in females (35%) than males (19%). Approximately 17% of children and adolescents in the United States are obese as defined by a BMI above the 95th percentile, with more than 3...
What is the current status of trial NCT01128764?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2009-12. Estimated completion is 2013-12.
What interventions are being tested in trial NCT01128764?
The interventions under investigation include: CBT for depression and healthy lifestyle plus exercise (BEHAVIORAL), CBT for depression (BEHAVIORAL).
Who is sponsoring clinical trial NCT01128764?
This trial is sponsored by Brown University, which has 231 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01128764's enrollment target sits among peer trials
36 1210th of 2000 higher than 743 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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