Trial Outcomes & Findings for Escitalopram Treatment of Night Eating Syndrome (NCT NCT00636649)

NCT ID: NCT00636649

Last Updated: 2016-06-29

Results Overview

The Night Eating Questionnaire (NEQ) is a 14-item self-report scale designed to assess the symptoms of NES including nocturnal ingestions, evening hyperphagia, morning anorexia, and mood/sleep. Scores range from 0-56, with higher scores indicative of greater severity. The NEQ has an acceptable internal consistency reliability (.70). A cut-score of 25 has been shown to yield a positive predictive value of .62.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 40 participants
• Primary outcome timeframe: baseline, 12 weeks
• Results posted on: 2016-06-29

Participant Flow

This study was conducted at Duke University Medical Center and Saint Louis University between 2008 and 2010.

Participant milestones

Measure	Escitalopram Escitalopram was started at 10 mg/d and the dose was increased to 20 mg/d after 4 weeks.	Placebo Dosing of matching placebo was identical.
Overall Study STARTED	20	20
Overall Study COMPLETED	20	20
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Escitalopram Treatment of Night Eating Syndrome

Baseline characteristics by cohort

Measure	Escitalopram n=20 Participants	Placebo n=20 Participants	Total n=40 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=5 Participants	20 Participants n=7 Participants	40 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	45.2 years STANDARD_DEVIATION 13.7 • n=5 Participants	44.8 years STANDARD_DEVIATION 12.3 • n=7 Participants	45.0 years STANDARD_DEVIATION 13.0 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	10 Participants n=7 Participants	21 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants	20 participants n=7 Participants	40 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline, 12 weeks

Population: Data were analyzed as intent-to-treat with all 40 patients included in the analysis. Primary endpoint was change in the NEQ total score, i.e., difference between values between Week 12 (study exit) and baseline. Analysis of covariance was the primary statistical procedure with baseline NEQ score and baseline BMI as covariates.

The Night Eating Questionnaire (NEQ) is a 14-item self-report scale designed to assess the symptoms of NES including nocturnal ingestions, evening hyperphagia, morning anorexia, and mood/sleep. Scores range from 0-56, with higher scores indicative of greater severity. The NEQ has an acceptable internal consistency reliability (.70). A cut-score of 25 has been shown to yield a positive predictive value of .62.

Outcome measures

Measure	Escitalopram n=20 Participants	Placebo n=20 Participants
Night Eating Questionnaire	-13.0 units on a scale Standard Error 1.6	-10.6 units on a scale Standard Error 2.2

SECONDARY outcome

Timeframe: Baseline, 12 weeks

The BDI-II is a 21-item self-report questionnaire designed to measure cognitive, somatic, and behavioral aspects of depression. Scores range from 0 to 63, with higher scores indicating a higher level of depressive symptoms.

Outcome measures

Measure	Escitalopram n=20 Participants	Placebo n=20 Participants
Change in Beck Depression Inventory II (BDI-II) Score	-2.4 units on a scale Standard Error 1.2	-3.5 units on a scale Standard Error 1.5

SECONDARY outcome

Timeframe: Baseline, 12 weeks

TASK = task-oriented coping; EMOT = emotion-oriented coping; AVD = avoidance-focused coping; Avoidance-focused coping may be divided into two subtypes: DIS = distraction-oriented coping; SOC = social diversion-oriented coping. CISS is a 48 item self-report measure used to measure responses to stressful situations rated for frequency on a 5 point Likert scales ranging from1, not at all to 5, very much. This measure assesses three coping styles: Task-Oriented, Emotion-Oriented, and two types of Avoidance-Oriented coping (Social Diversion and Distraction). There are 16 items on each of the primary scales (task, emotion, avoidance) and 5 on social diversion and 8 on distraction. Scores are summed for each subscale and then converted to gender-corrected t-scores with a mean of 50 and a standard deviation of 10. T-scores on the CISS range from a low of 25 (1st percentile) to 75 (99th percentile). Higher scores indicate more adaptive levels of coping.

Outcome measures

Measure	Escitalopram n=20 Participants	Placebo n=20 Participants
Change in Coping Inventory for Stressful Situations (CISS) CISS-TASK	2.35 t-scores Standard Error 3.50	1.75 t-scores Standard Error 1.37
Change in Coping Inventory for Stressful Situations (CISS) CISS-EMOT	1.25 t-scores Standard Error 2.82	-1.45 t-scores Standard Error 1.37
Change in Coping Inventory for Stressful Situations (CISS) CISS-AVD	0 t-scores Standard Error 3.31	2.60 t-scores Standard Error 1.10
Change in Coping Inventory for Stressful Situations (CISS) CISS-DIS	3.40 t-scores Standard Error 2.42	1.95 t-scores Standard Error 1.33
Change in Coping Inventory for Stressful Situations (CISS) CISS-SOC	-2.45 t-scores Standard Error 2.08	2.15 t-scores Standard Error 1.62

SECONDARY outcome

Timeframe: 12 weeks

Population: Participants who completed PSS assessment at baseline and week 12.

The Perceived Stress Scale (PSS) measures the overall level of stress. This instrument contains 14 items accessing overall appraisals of stress in the past month. Minimum score (best value)=0. Maximum score (worst value)=56. A higher score indicates greater stress.

Outcome measures

Measure	Escitalopram n=20 Participants	Placebo n=18 Participants
Change in Perceived Stress Scale (PSS)	-0.55 units on a scale Standard Error 1.42	-2.11 units on a scale Standard Error 1.39

SECONDARY outcome

Timeframe: Baseline, 12 weeks

The TFEQ (also known as the Eating Inventory) measures dimensions of eating behavior including cognitive restraint of eating, disinhibition, and hunger using a combination of dichotomous questions, 4-point likert scales, and one 5-point likert scale. Restraint is comprised of the responses to 21 questions with possible scores ranging from 0 to 21 (Low scores for all scales indicate an uninhibited eating behavior.). Disinhibition is comprised of the responses to 16 questions with possible scores ranging from 0 to 16 (High scores indicate an uninhibited eating behavior strongly depending on external cues). Hunger is comprised of the responses to 14 questions with possible scores ranging from 0 to 14 ( Low scores indicate an eating behavior strongly depending on feelings of hunger.).

RES = Restraint Subscale; DIS = Disinhibition Subscale; HUN = Hunger Subscale

Outcome measures

Measure	Escitalopram n=20 Participants	Placebo n=20 Participants
Change in Three Factor Eating Questionnaire (TFEQ) TFEQ-RES	2.95 units on a scale Standard Error 1.12	1.85 units on a scale Standard Error 0.56
Change in Three Factor Eating Questionnaire (TFEQ) TFEQ-DIS	-0.85 units on a scale Standard Error 0.73	-1.50 units on a scale Standard Error 0.61
Change in Three Factor Eating Questionnaire (TFEQ) TFEQ-HUN	-1.60 units on a scale Standard Error 0.76	-1.75 units on a scale Standard Error 0.63

SECONDARY outcome

Timeframe: 12 weeks

The CGI-I scale is a clinician rating of overall therapeutic effect ranging from 1 (very much improved) to 7 (very much worse) since commencing treatment.

Outcome measures

Measure	Escitalopram n=20 Participants	Placebo n=20 Participants
Number of Participants With a Clinical Global Impression - Improvement (CGI-I) Score ≤ 2	12 participants	7 participants

SECONDARY outcome

Timeframe: Baseline,12 weeks

Outcome measures

Measure	Escitalopram n=20 Participants	Placebo n=20 Participants
Change in Lipid Panel HDL	-2.8 mg/dL Standard Error 1.8	-2.2 mg/dL Standard Error 1.8
Change in Lipid Panel LDL	-3.9 mg/dL Standard Error 4.4	2.8 mg/dL Standard Error 4.5
Change in Lipid Panel Triglycerides	27.5 mg/dL Standard Error 26.3	-14.0 mg/dL Standard Error 15.6
Change in Lipid Panel total cholesterol	-4.5 mg/dL Standard Error 5.2	-2.3 mg/dL Standard Error 4.5

SECONDARY outcome

Timeframe: Baseline, 12 weeks

The Beck Anxiety Inventory (BAI) is a 21-item self-report measure of anxiety. Scores range from 0 to 63, with higher scores indicative of higher levels of anxiety.

Outcome measures

Measure	Escitalopram n=20 Participants	Placebo n=20 Participants
Change in Beck Anxiety Inventory (BAI) Score	-1.5 units on a scale Standard Error 0.8	-1.8 units on a scale Standard Error 0.9

SECONDARY outcome

Timeframe: Baseline, 12 Week

Outcome measures

Measure	Escitalopram n=20 Participants	Placebo n=20 Participants
Change in Glucose	3.9 mg/dL Standard Error 6.3	7.6 mg/dL Standard Error 4.6

SECONDARY outcome

Timeframe: Baseline, 12 week

Outcome measures

Measure	Escitalopram n=20 Participants	Placebo n=20 Participants
Change in Weight	-0.43 kg Standard Error 0.7	1.12 kg Standard Error 0.6

SECONDARY outcome

Timeframe: Week 12

The Night Eating Syndrome History and Inventory (NESHI) is an unpublished, semistructured interview used to confirm a diagnosis of NES. It assesses a typical 24-hour food intake, including a recall of all meals and snacks, and sleeping patterns. Based on the recall of all meals and snacks, the interviewer judged whether ≥25% of the daily caloric intake was eaten after the evening meal and how often nocturnal ingestions occurred. The NEQ items were reviewed and informed by the dietary recall during the interview, and a new total score was tallied. A final score of ≥25 for the NEQ items, as reviewed during the NESHI, was used as the criterion for NES.

Outcome measures

Measure	Escitalopram n=20 Participants	Placebo n=20 Participants
Number of Participants Who no Longer Meet the NESHI Criteria	16 participants	12 participants

SECONDARY outcome

Timeframe: Week 12

The Night Eating Questionnaire (NEQ) is a 14 item self-report scale designed to assess the symptoms of NES including nocturnal ingestions, evening hypcrphagia, morning anorexia, and mood/slccp. Scores range from 0 to 56, with higher scores indicative of greater severity.

Outcome measures

Measure	Escitalopram n=20 Participants	Placebo n=20 Participants
Number of Participants Who Had a 50% Reduction in NEQ Scores	7 participants	6 participants

Adverse Events

Escitalopram

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Escitalopram n=20 participants at risk	Placebo n=20 participants at risk
Nervous system disorders headache	25.0% 5/20	10.0% 2/20
Psychiatric disorders drowsiness	20.0% 4/20	0.00% 0/20
Gastrointestinal disorders gastrointestinal symptoms	0.00% 0/20	10.0% 2/20
Immune system disorders upper respiratory infection / seasonal allergies	15.0% 3/20	15.0% 3/20
General disorders fatigue	15.0% 3/20	0.00% 0/20
Reproductive system and breast disorders Sexual Dysfunction	10.0% 2/20	0.00% 0/20
Nervous system disorders cognitive symptoms	10.0% 2/20	0.00% 0/20

Additional Information

Kishore Gadde

Duke University Medical Center

Phone: 919-668-0208

Email: kishore.gadde@duke.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place