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Prospective, randomized, double-blind, placebo-controlled phase IIa clinical trial on the effects of an estrogen-progestin combination as add-on to inpatient psychotherapy in adult female patients suffering from anorexia nervosa.

ABSTRACT: BACKGROUND:There is a need for novel treatment approaches in anorexia nervosa (AN). While there is broad knowledge with regard to altered appetite regulation and neuropsychological deficits in AN patients on the one hand, and the effects of estrogen replacement upon neuropsychological performance in healthy subjects on the other, up to now, no study has implemented estrogen replacement in AN patients, in order to examine its effects upon AN-associated and general psychopathology, neuropsychological performance and concentrations of peptide components of the hypothalamus-pituitary-adrenal (HPA) axis and within appetite-regulating circuits. METHODS:This is a randomized placebo-controlled clinical trial on the effects of a 10-week oral estrogen replacement (combination of ethinyl estradiol 0.03 mg and dienogest 2 mg) in adult female AN patients. The primary target is the assessment of the impact of sex hormone replacement upon neuropsychological performance by means of a neuropsychological test battery consisting of a test for verbal intelligence, the Trail making test A and B, a Go/No-go paradigm with food cues and the Wisconsin Card Sorting Test. Secondary targets include a) the examination of safety and tolerability (as mirrored by the number of adverse events), b) assessments of the impact upon eating disorder-specific psychopathology by means of the Eating Disorder Examination Questionnaire (EDE-Q) and the Eating Disorder Inventory-2 (EDI-2), c) the influence upon anxiety using the State-Trait-Anxiety Inventory (STAI), d) assessments of plasma cortisol levels during a dexamethasone-suppression test and appetite-regulating plasma peptides (ghrelin, leptin, insulin, glucose) during an oral glucose tolerance test and, e) a possible impact upon the prescription of antidepressants. DISCUSSION:This is the first study of its kind. There are no evidence-based psychopharmacological options for the treatment of AN. Thus, the results of this clinical trial may have a relevant impact on future treatment regimens. Novel approaches are necessary to improve rates of AN symptom remission and increase the rapidity of treatment response. Identifying the underlying biological (e.g. neuroendocrinological) factors that maintain AN or may predict patient treatment response represent critical future research directions. Continued efforts to incorporate novel pharmacological aspects into treatments will increase access to evidence-based care and help reduce the burden of AN. TRIAL REGISTRATION:European Clinical Trials Database, EudraCT number 2015-004184-36, registered November 2015; ClinicalTrials.gov Identifier: NCT03172533 , retrospectively registered May 2017.

SUBMITTER: Paslakis G

PROVIDER: S-EPMC5891970 | biostudies-literature | 2018 Apr

REPOSITORIES: biostudies-literature

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Prospective, randomized, double-blind, placebo-controlled phase IIa clinical trial on the effects of an estrogen-progestin combination as add-on to inpatient psychotherapy in adult female patients suffering from anorexia nervosa.

Paslakis Georgios G Maas Stefanie S Gebhardt Bernd B Mayr Andreas A Rauh Manfred M Erim Yesim Y

BMC psychiatry 20180410 1

<h4>Background</h4>There is a need for novel treatment approaches in anorexia nervosa (AN). While there is broad knowledge with regard to altered appetite regulation and neuropsychological deficits in AN patients on the one hand, and the effects of estrogen replacement upon neuropsychological performance in healthy subjects on the other, up to now, no study has implemented estrogen replacement in AN patients, in order to examine its effects upon AN-associated and general psychopathology, neurops ...[more]

PMID: 29631553

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Project description:BackgroundAnorexia nervosa (AN) is a life-threatening psychiatric disorder associated with significant medical and psychosocial impairment. Hospital-based behavioral treatment is an effective intervention in the short-term. However, relapse rates following discharge are high and thus, there is a need to identify predictors of longitudinal outcome. The current study provides information regarding illness course and health maintenance among patients with AN over 5 years following discharge from an eating disorder inpatient unit.MethodsParticipants were individuals with AN who were discharged from a specialized, inpatient behaviorally-based unit. Prior to discharge, height and weight were measured and participants completed self-report measures of eating disorder severity and general psychopathology (depression, anxiety, harm avoidance). Participants were contacted annually for self-report measures of weight, eating disorder severity and clinical impairment. Outcome was defined by illness course (body mass index (BMI) and clinical impairment during the 5 years) and health maintenance (categories of weight and eating disorder symptom severity) across follow-up, using all available data. Linear mixed models were used to examine whether demographic and clinical parameters at discharge predicted BMI and clinical impairment over time. Additional analyses examined whether these variables significantly influenced an individual's likelihood of maintaining inpatient treatment gains.ResultsOne-hundred and sixty-eight individuals contributed data. Higher trait anxiety at discharge was associated with a lower BMI during follow-up (p = 0.012). There was a significant interaction between duration of illness and time, whereby duration of illness was associated with a faster rate of weight loss (p = 0.003) during follow-up. As duration of illness increased, there was a greater increase in self-reported clinical impairment (p = 0.011). Increased eating disorder severity at discharge was also associated with greater clinical impairment at follow-up (p = 0.004). Higher BMI at discharge was significantly associated with maintaining healthy weight across a priori BMI-based definitions of health maintenance.ConclusionsWeight status (higher BMI) and duration of illness are key factors in the prognosis of AN. Higher weight targets in intensive treatments may be of value in improving outcomes.

Dataset Information

Prospective, randomized, double-blind, placebo-controlled phase IIa clinical trial on the effects of an estrogen-progestin combination as add-on to inpatient psychotherapy in adult female patients suffering from anorexia nervosa.

Publications

Prospective, randomized, double-blind, placebo-controlled phase IIa clinical trial on the effects of an estrogen-progestin combination as add-on to inpatient psychotherapy in adult female patients suffering from anorexia nervosa.

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