Melatonin Treatment for Night-Eating Syndrome (MLT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02500017|
Recruitment Status : Terminated (Difficulty recruiting appropriate participants)
First Posted : July 16, 2015
Last Update Posted : January 23, 2018
|Condition or disease||Intervention/treatment||Phase|
|Night-eating Syndrome||Dietary Supplement: Melatonin Other: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Melatonin Treatment for Night-Eating Syndrome|
|Actual Study Start Date :||September 24, 2015|
|Actual Primary Completion Date :||April 25, 2017|
|Actual Study Completion Date :||April 25, 2017|
A commercially available rapid-release formulation of melatonin (5 mg) capsules to be administered once a day for a total of 8 weeks
Dietary Supplement: Melatonin
5mg rapid release melatonin capsule
Placebo Comparator: Placebo
Matching placebo capsules to be administered once a day for a total of 8 weeks
matching placebo capsule
- Change in Night Eating Syndrome Symptoms - Night Eating Symptom Scale (NESS) Total Score [ Time Frame: 8 weeks ]Change in total score for the Night Eating Symptom Scale (NESS) from baseline to endpoint. Scores range from 0-52. Lower scores are better than higher scores.
- Change in body weight in kilograms during study duration. [ Time Frame: 8 weeks ]Change in body weight in kilograms from baseline to endpoint.
- Change in body mass index (BMI) during study duration [ Time Frame: 8 weeks ]Change in body weight in kilograms from baseline to endpoint.
- Change in waist circumference in centimeters during study duration. [ Time Frame: 8 weeks ]Change in waist circumference in centimeters from baseline to endpoint.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02500017
|United States, Connecticut|
|Connecticut Mental Health Center|
|New Haven, Connecticut, United States, 06519|
|Principal Investigator:||Cenk Tek, MD||Yale University|