Night Eating SyndromeNCT00636649
Escitalopram Treatment of Night Eating Syndrome
A study testing Escitalopram in people with Night Eating Syndrome, run by Duke University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Night Eating Syndrome
- What is being tested?
- Escitalopram
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2008to Jul 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-70 years
- Presence of NES
- BMI 25-50
Who cannot join
- 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)
Show all 10Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Duke University Medical Center
Durham, North Carolina, 27710
Saint Louis University
St Louis, Missouri, 63103
About this study
Official title: Escitalopram Treatment of Night Eating Syndrome: a Randomized Controlled Trial
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.
- Conditions
- Night Eating Syndrome
- Being tested
- Escitalopram, Placebo
- Keywords
- Eating disorder
- Medical subject headings
- Night Eating Syndrome, Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EscitalopramDrug
10-20 mg
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Escitalopram Receives: Drug: Escitalopram |
| B | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Night Eating Questionnaire
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.
Measured: baseline, 12 weeks
Secondary outcomes (11)
Change in Beck Depression Inventory II (BDI-II) Score
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.
Measured: Baseline, 12 weeks
Change in Coping Inventory for Stressful Situations (CISS)
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.
Measured: Baseline, 12 weeks
Change in Perceived Stress Scale (PSS)
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.
Measured: 12 weeks
Change in Three Factor Eating Questionnaire (TFEQ)
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
Measured: Baseline, 12 weeks
Number of Participants With a Clinical Global Impression - Improvement (CGI-I) Score ≤ 2
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.
Measured: 12 weeks
Change in Lipid Panel
Measured: Baseline,12 weeks
Change in Beck Anxiety Inventory (BAI) Score
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.
Measured: Baseline, 12 weeks
Change in Glucose
Measured: Baseline, 12 Week
Change in Weight
Measured: Baseline, 12 week
Number of Participants Who no Longer Meet the NESHI Criteria
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.
Measured: Week 12
Number of Participants Who Had a 50% Reduction in NEQ Scores
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.
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2008 (estimated)
- Study startOct 2008
- Primary completionAug 2010
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Night Eating SyndromeStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- St. Louis University
- Responsible party
- Sponsor
- Investigators
- Kishore Gadde, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00636649
- Sponsor's protocol ID
- Pro00007133
- Other IDs
- LXP-MD-128A
- Status last verified
- May 2016
- First submitted
- 3 Feb 2008
- Last updated
- 29 Jun 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Vander Wal JS, Gang CH, Griffing GT, Gadde KM. Escitalopram for treatment of night eating syndrome: a 12-week, randomized, placebo-controlled trial. J Clin Psychopharmacol. 2012 Jun;32(3):341-5. doi: 10.1097/JCP.0b013e318254239b.
PubMed 22544016
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Escitalopram Treatment of Night Eating Syndrome: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00636649
- Acronym / sponsor ID
- Pro00007133
- Conditions
- Night Eating Syndrome
- Keywords
- Eating disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- St. Louis University
- Study start
- Oct 2008
- Primary completion
- Aug 2010 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 14 Mar 2008 (estimated)
- Results
- Posted 6 May 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: EscitalopramEscitalopram |
| B | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-70 years
- Presence of NES
- BMI 25-50
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Escitalopram10-20 mg | Drug | A |
| PlaceboPlacebo | Drug | B |
Primary outcome
Night Eating Questionnaire
Time frame: baseline, 12 weeks
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.
11 secondary outcomes
Change in Beck Depression Inventory II (BDI-II) Score
Time frame: Baseline, 12 weeks
Change in Coping Inventory for Stressful Situations (CISS)
Time frame: Baseline, 12 weeks
Change in Perceived Stress Scale (PSS)
Time frame: 12 weeks
Change in Three Factor Eating Questionnaire (TFEQ)
Time frame: Baseline, 12 weeks
Number of Participants With a Clinical Global Impression - Improvement (CGI-I) Score ≤ 2
Time frame: 12 weeks
Change in Lipid Panel
Time frame: Baseline,12 weeks
Change in Beck Anxiety Inventory (BAI) Score
Time frame: Baseline, 12 weeks
Change in Glucose
Time frame: Baseline, 12 Week
Change in Weight
Time frame: Baseline, 12 week
Number of Participants Who no Longer Meet the NESHI Criteria
Time frame: Week 12
Number of Participants Who Had a 50% Reduction in NEQ Scores
Time frame: Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22544016Vander Wal JS, Gang CH, Griffing GT, Gadde KM. Escitalopram for treatment of night eating syndrome: a 12-week, randomized, placebo-controlled trial. J Clin Psychopharmacol. 2012 Jun;32(3):341-5. doi: 10.1097/JCP.0b013e318254239b.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kishore Gadde, MD principal investigator
Duke University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Escitalopram in people with Night Eating Syndrome, run by Duke University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 May 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Night Eating Questionnaire (time frame: baseline, 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00636649, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2016.