Pharmacological & Behavioral Treatment After Bariatric Surgery: Medication

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Clinical Trial Summary

This study will test the effectiveness of lisdexamfetamine medication as a treatment for loss-of-control eating and weight following bariatric surgery. This is a controlled test of whether, amongst non-responders to acute treatments, lisdexamfetamine medication results in superior outcomes compared with placebo.

See also
Status	Clinical Trial	Phase
Completed	`NCT05295875` - Efficacy and Safety of ALT-801 in the Treatment of Obesity	Phase 2
Recruiting	`NCT04599478` - Pharmacological and Behavioral Treatment After Bariatric Surgery: Acute (Stage 1)	Phase 2/Phase 3
Enrolling by invitation	`NCT04605081` - Pharmacological and Behavioral Treatments After Bariatric Surgery: Maintenance Treatment (Stage 2a)	Phase 2/Phase 3

NCT number	NCT04599504
Study type	Interventional
Source	Yale University
Contact
Status	Enrolling by invitation
Phase	Phase 2/Phase 3
Start date	January 2, 2022
Completion date	May 2027

Pharmacological and Behavioral Treatment After Bariatric Surgery: Medication Change for Non-Responders (Stage 2b)

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms