N/A
N=40
Escitalopram Treatment of Night Eating Syndrome
Night Eating Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT00636649 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
May 2013
Primary outcome: Primary: Night Eating Questionnaire — -13.0; -10.6 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Escitalopram (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Aug 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Night Eating Questionnaire |
-13.0; -10.6 | — |
| SECONDARY Change in Beck Depression Inventory II (BDI-II) Score |
-2.4; -3.5 | — |
| SECONDARY Change in Coping Inventory for Stressful Situations (CISS) |
2.35; 1.75; 1.25; -1.45; 0; 2.60 | 0.993 |
| SECONDARY Change in Perceived Stress Scale (PSS) |
-0.55; -2.11 | 0.579 |
| SECONDARY Change in Three Factor Eating Questionnaire (TFEQ) |
2.95; 1.85; -0.85; -1.50; -1.60; -1.75 | 0.225 |
| SECONDARY Number of Participants With a Clinical Global Impression - Improvement (CGI-I) Score ≤ 2 |
12; 7 | — |
| SECONDARY Change in Lipid Panel |
-2.8; -2.2; -3.9; 2.8; 27.5; -14.0 | — |
| SECONDARY Change in Beck Anxiety Inventory (BAI) Score |
-1.5; -1.8 | — |
| SECONDARY Change in Glucose |
3.9; 7.6 | — |
| SECONDARY Change in Weight |
-0.43; 1.12 | — |
| SECONDARY Number of Participants Who no Longer Meet the NESHI Criteria |
16; 12 | — |
| SECONDARY Number of Participants Who Had a 50% Reduction in NEQ Scores |
7; 6 | — |
Summary
Night-Eating Syndrome (NES) is an eating disorder characterised by excessive eating at night, sleep disturbance and morning anorexia. This 12-week study examines the effect of escitalopram on symptoms of NES.
Eligibility Criteria
Inclusion Criteria
- Age 18-70 years
- Presence of NES
- BMI 25-50
Exclusion Criteria
- History of schizophrenia or other psychoses
- History of bipolar disorder, anorexia nervosa, bulimia, binge eating disorder
- Current major depressive disorder
- Suicidal ideation
- Psychotropic drugs in the past month
- Drugs or herbal remedies that significantly affect body weight, current participation in a weight loss program, currently following a specialized diet (e.g., Atkins, Zone, etc)
- Lack of benefit with SSRI treatment for NES
- Serious or unstable medical illness
- Allergy or hypersensitivity to escitalopram
- Pregnant, breast-feeding, or planning pregnancy in the next six months.
Data sourced from ClinicalTrials.gov (NCT00636649). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.