John P. O'Reardon

Proposed Diagnostic Criteria for Night Eating Syndrome

OBJECTIVE To propose criteria for diagnosis of the night eating syndrome (NES). METHOD An international research meeting was held in April 2008, and consensus criteria for NES diagnosis were determined. RESULTS The core criterion is an abnormally increased food intake in the evening and nighttime, manifested by (1) consumption of at least 25% of intake after the evening meal, and/or (2) nocturnal awakenings with ingestions at least twice per week. Awareness of the eating episodes is required, as is distress or impairment in functioning. Three of five modifiers must also be endorsed. These criteria must be met for a minimum duration of 3 months. DISCUSSION These criteria help standardize the definition of NES. Additional aspects of the nosology of NES yet to be fully elaborated include its relationship to other eating and sleep disorders. Assessment and analytic tools are needed to assess these new criteria more accurately.

The Night Eating Questionnaire (NEQ): Psychometric properties of a measure of severity of the Night Eating Syndrome

The purpose of this study was to evaluate the Night Eating Questionnaire (NEQ) as a measure of severity of the Night Eating Syndrome (NES). The 14-item NEQ assesses the behavioral and psychological symptoms of NES. The NEQ was evaluated in three samples: 1980 persons who completed the NEQ on the Internet; 81 persons diagnosed with NES; and 194 bariatric surgery candidates. Study 1, using principal components analysis, generated four factors (nocturnal ingestions, evening hyperphagia, morning anorexia, and mood/sleep) and an acceptable alpha (.70). Confirmatory factor analysis suggested that 99% of covariation among factors is accounted for by a higher-order construct. Study 2 found convergent validity of the NEQ with additional measures of night eating, disordered eating, sleep, mood, and stress. Study 3 compared scores from obese bariatric surgery candidates with and without NES and found appropriate discriminant validity of the NEQ. The NEQ appears to be an efficient, valid measure of severity for NES.

Circadian Rhythm Profiles in Women with Night Eating Syndrome

Night eating syndrome (NES) is characterized by evening hyperphagia and frequent awakenings accompanied by food intake. Patients with NES display a delayed circadian pattern of food intake but retain a normal sleep-wake cycle. These characteristics initiated the current study, in which the phase and amplitude of behavioral and neuroendocrine circadian rhythms in patients with NES were evaluated. Fifteen women with NES (mean age ± SD, 40.8 ± 8.7 y) and 14 control subjects (38.6 ± 9.5 y) were studied in the laboratory for 3 nights, with food intake measured daily. Blood also was collected for 25 h (every 2 h from 0800 to 2000 h, and then hourly from 2100 to 0900 h) and assayed for glucose and 7 hormones (insulin, ghrelin, leptin, melatonin, cortisol, thyroid-stimulating hormone [TSH] and prolactin). Statistical analyses utilized linear mixed-effects cosinor analysis. Control subjects displayed normal phases and amplitudes for all circadian rhythms. In contrast, patients with NES showed a phase delay in the timing of meals, and delayed circadian rhythms for total caloric, fat, and carbohydrate intake. In addition, phase delays of 1.0 to 2.8 h were found in 2 food-regulatory rhythms—leptin and insulin—and in the circadian melatonin rhythm (with a trend for a delay in the circadian cortisol rhythm). In contrast, circulating levels of ghrelin, the primary hormone that stimulates food intake, were phase advanced by 5.2 h. The glucose rhythm showed an inverted circadian pattern. Patients with NES also showed reduced amplitudes in the circadian rhythms of food intake, cortisol, ghrelin, and insulin, but increased TSH amplitude. Thus, patients with NES demonstrated significant changes in the timing and amplitude of various behavioral and physiological circadian markers involved in appetite and neuroendocrine regulation. As such, NES may result from dissociations between central (suprachiasmatic nucleus) timing mechanisms and putative oscillators elsewhere in the central nervous system or periphery, such as the stomach or liver. Considering these results, chronobiologic treatments for NES such as bright light therapy may be useful. Indeed, bright light therapy has shown efficacy in reducing night eating in case studies and should be evaluated in controlled clinical trials.

Durability of clinical benefit with transcranial magnetic stimulation (TMS) in the treatment of pharmacoresistant major depression: assessment of relapse during a 6-month, multisite, open-label study

BACKGROUND Although transcranial magnetic stimulation (TMS) can be an effective acute antidepressant treatment, few studies systematically examine persistence of benefit. OBJECTIVE We assessed the durability of antidepressant effect after acute response to TMS in patients with major depressive disorder (MDD) using protocol-specified maintenance antidepressant monotherapy. METHODS Three hundred one patients were randomly assigned to active or sham TMS in a 6-week, controlled trial. Nonresponders could enroll in a second, 6-week, open-label study. Patients who met criteria for partial response (i.e., >25% decrease from the baseline HAMD 17) during either the sham-controlled or open-label study (n = 142) were tapered off TMS over 3 weeks, while simultaneously starting maintenance antidepressant monotherapy. Patients were then followed for 24 weeks in a naturalistic follow-up study examining the long-term durability of TMS. During this durability study, TMS was readministered if patients met prespecified criteria for symptom worsening (i.e., a change of at least one point on the CGI-S scale for 2 consecutive weeks). Relapse was the primary outcome measure. RESULTS Ten of 99 (10%; Kaplan-Meier survival estimate = 12.9%) patients relapsed. Thirty-eight (38.4%) patients met criteria for symptom worsening and 32/38 (84.2%) reachieved symptomatic benefit with adjunctive TMS. Safety and tolerability were similar to acute TMS monotherapy. CONCLUSIONS These initial data suggest that the therapeutic effects of TMS are durable and that TMS may be successfully used as an intermittent rescue strategy to preclude impending relapse.

Night eating syndrome : Diagnosis, epidemiology and management

Night eating syndrome (NES) is an eating disorder characterised by the clinical features of morning anorexia, evening hyperphagia, and insomnia with awakenings followed by nocturnal food ingestion. The core clinical feature appears to be a delay in the circadian timing of food intake. Energy intake is reduced in the first half of the day and greatly increased in the second half, such that sleep is disrupted in the service of food intake. The syndrome can be distinguished from bulimia nervosa and binge eating disorder by the lack of associated compensatory behaviours, the timing of food intake and the fact that the food ingestions are small, amounting to repeated snacks rather than true binges. NES also differs from sleep-related eating disorder by the presence of full awareness, as opposed to parasomnic nocturnal ingestions.NES is of importance clinically because of its association with obesity. Its prevalence rises with increasing weight, and about half of those diagnosed with it report a normal weight status before the onset of the syndrome. The recognition and effective treatment of NES may be an increasingly important way to treat a subset of the obese population. Treatment of the syndrome, however, is still in its infancy. One clinical trial has reported efficacy with the SSRI sertraline. Other treatments, such as the anticonvulsant topiramate, phototherapy and other SSRIs, may also offer future promise.

A Descriptive Study of Non-obese Persons with Night Eating Syndrome and a Weight-Matched Comparison Group

The purpose of this study was to characterize the Night Eating Syndrome (NES) and its correlates among non-obese persons with NES, and to compare them to non-obese healthy controls. Nineteen non-obese persons with NES were compared to 22 non-obese controls on seven-day, 24-hour prospective food and sleep diaries, the Eating Disorder Examination and the Structured Clinical Interview for DSM-IV Diagnoses interviews, and measures of disordered eating attitudes and behavior, mood, sleep, stress, and quality of life. Compared to controls, persons with NES reported significantly different circadian distribution of food intake, greater depressed mood, sleep disturbance, disordered eating and body image concerns, perceived stress, decreased quality of life, and more frequent Axis I comorbidity, specifically anxiety, mood, and substance use disorders. These findings are the first to describe the clinical significance of night eating syndrome among non-obese individuals in comparison to a non-obese control group, and they suggest that NES has negative health implications beyond that associated with obesity.

Effectiveness and safety of vagus nerve stimulation for severe treatment-resistant major depression in clinical practice after FDA approval: outcomes at 1 year.

OBJECTIVE To describe the outcomes of a consecutive series of depressed patients treated with vagus nerve stimulation (VNS) following US Food and Drug Administration (FDA) approval of this intervention. METHOD We implanted a VNS device in 15 consecutive outpatients with treatment-resistant major depressive episodes, including 10 with major depressive disorder and 5 with bipolar disorder (DSM-IV criteria), between November 2005 and August 2006. Existing antidepressant treatment remained fixed as far as clinically possible. The primary outcome was change from baseline in the Beck Depression Inventory (BDI) score. Outcomes were assessed at 6 and 12 months postimplant and compared to those of the VNS pivotal efficacy trial that led to FDA approval of VNS. RESULTS The BDI score decreased significantly compared to baseline at 6 months (P < .05) and 12 months (P < .01), from a mean of 37.8 (SD = 7.8) before VNS activation to a mean of 24.6 (SD = 11.4) at 12 months. By 1 year, 28.6% (n = 4) of the sample responded to VNS and 7.1% (n = 1) remitted according to the BDI. Secondary outcomes on the Hamilton Depression Rating Scale 24-Item showed similar improvement at 1 year, with a 43% response rate (n = 6) and 14.3% remission rate (n = 2). No obvious predictors of response were detected. Side effects of VNS included hoarseness (73%), dyspnea (47%), nausea (40%), pain (33%), and anxiety (20%); no patient terminated treatment due to intolerable side effects. CONCLUSIONS We found that a substantial minority of patients with extremely difficult-to-treat depressive disorders benefited from VNS in an ambulatory clinical practice, with outcomes comparable to those observed in previous VNS efficacy studies and with a similar side effect profile.

Controversy: Repetitive transcranial magnetic stimulation or transcranial direct current stimulation shows efficacy in treating psychiatric diseases (depression, mania, schizophrenia, obsessive-complusive disorder, panic, posttraumatic stress disorder)

Brain imaging studies performed over the past 20 years have generated new knowledge about the specific brain regions involved in the brain diseases that have been classically labeled as psychiatric. These include the mood and anxiety disorders, and the schizophrenias. As a natural next step, clinical researchers have investigated whether the minimally invasive brain stimulation technologies (transcranial magnetic stimulation [TMS] or transcranial direct current stimulation [tDCS]) might potentially treat these disorders. In this review, we critically review the research studies that have examined TMS or tDCS as putative treatments for depression, mania, obsessive-complusive disorder, posttraumatic stress disorder, panic disorder, or schizophrenia. (Separate controversy articles deal with using TMS or tDCS to treat pain or tinnitus. We will not review here the large number of studies using TMS or tDCS as research probes to understand disease mechanisms of psychiatric disorders.) Although there is an extensive body of randomized controlled trials showing antidepressant effects of daily prefrontal repetitive TMS, the magnitude or durability of this effect remains controversial. US Food and Drug Administration approval of TMS for depression was recently granted. There is much less data in all other diseases, and therapeutic effects in other psychiatric conditions, if any, are still controversial. Several issues and problems extend across all psychiatric TMS studies, including the optimal method for a sham control, appropriate coil location, best device parameters (intensity, frequency, dosage, and dosing schedule) and refining what subjects should be doing during treatment (activating pathologic circuits or not). In general, TMS or tDCS as a treatment for most psychiatric disorders remains exciting but controversial, other than prefrontal TMS for depression.

Evaluation of Diagnostic Criteria for Night Eating Syndrome Using Item Response Theory Analysis

Uniform diagnostic criteria for the night eating syndrome (NES), a disorder characterized by a delay in the circadian pattern of eating, have not been established. Proposed criteria for NES were evaluated using item response theory (IRT) analysis. Six studies yielded 1,481 Night Eating Questionnaires which were coded to reflect the presence/absence of five night eating symptoms. Symptoms were evaluated based on the clinical usefulness of their diagnostic information and on the assumptions of IRT analysis (unidimensionality, monotonicity, local item independence, correct model specification), using a two parameter logistic (2PL) IRT model. Reports of (1) nocturnal eating and/or evening hyperphagia, (2) initial insomnia, and (3) night awakenings showed high precision in discriminating those with night eating problems, while morning anorexia and delayed morning meal provided little additional information. IRT is a useful tool for evaluating the diagnostic criteria of psychiatric disorders and can be used to evaluate potential diagnostic criteria of NES empirically. Behavioral factors were identified as useful discriminators of NES. Future work should also examine psychological factors in conjunction with those identified here.

A survey of patient acceptability of repetitive transcranial magnetic stimulation (TMS) during pregnancy

OBJECTIVE Given the data that depression is common during pregnancy and that pregnant women prefer non-medication treatment options, we hypothesize repetitive transcranial magnetic stimulation (TMS) may be a treatment option. Given the novelty of TMS, we sought to assess whether patient acceptability would be a barrier to enrolling pregnant women in TMS studies. METHODS In Study 1, 500 pregnant women were surveyed in an outpatient, urban obstetrics clinic using the Edinburgh Depression Rating Scale (EPDS) and a treatment acceptability survey. In Study 2, 51 women were surveyed with the EPDS and acceptability survey using an informational video to increase participant knowledge about TMS. RESULTS Approximately 25% of participants had an EPDS score of ≥12 in both studies. Psychotherapy was identified as the most acceptable treatment option. TMS was considered an unacceptable treatment option to virtually all women before the informational video. After the video, 15.7% considered TMS an acceptable treatment option. CONCLUSION Psychotherapy is the most acceptable treatment option for depression to pregnant women. Increasing participant knowledge about TMS increased its acceptability significantly. Large-scale multi-center trials are needed for confirmation of these results.