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Anorexia Nervosa clinical trials

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NCT ID: NCT01801397 Recruiting - Clinical trials for Low Bone Mass in Anorexia Nervosa Patients

A Pilot Study to Evaluate the Effect of Forsteo (Teriparatide, 1-34-rh-PTH) in Anorexia Nervosa Patients With Low Bone Mineral Density and Increased Bone Fagility (FAN-Trial)

Start date: March 2014
Phase: Phase 3
Study type: Interventional

Study Title: A pilot study to evaluate the effect of Forsteo® (Teriparatide, 1-34 rh-PTH) in Anorexia Nervosa patients with low mineral density and increased bone fragility (FAN-Trial) Short Title/Study ID: FAN-Trial / Psy-Rheu_2011/1 Indication: Low bone mineral density (Z-Score < -1.5 or T-Score < -1.5 if available) and fragility fractures or very low bone mineral density (Z-Score < -2.5 or T-Score <-2.5 if available) without fragility fractures in Anorexia Nervosa patients Trial Design: Open-label, single-centre pilot study with study drug treatment duration of 24 months. Study Center: Single-centre (University Hospital of Zürich) Investigator(s)/Authors: PD Dr. med Gabriella F. Milos (Principle Investigator and author), Dept of Psychiatry, Centre for Eating Disorders, University Hospital Zürich, CH-8091 Zürich Dr. med. Diana P. Frey (Co-Investigator and author), Dept. of Rheumatology, University Hospital Zürich, CH-8091 Zürich PD Dr. med. Daniel Uebelhart (author), SUVA Fribourg, CH-1701 Fribourg Objective(s)/Outcome(s): Primary endpoint: •To assess the efficacy of Teriparatide (Forsteo®) in increasing the bone mineral density in the lumbar spine, total hip and femoral neck in patients with anorexia nervosa and low bone density at months 12 and 24. Secondary endpoints: - To assess the changes in blood biomarkers - To assess changes in whole body composition - To assess the incidence of new fragility fractures - To assess changes in bone structure - To assess the changes in EDE-Q - Longterm safety and tolerability of Teriparatide (Forsteo®) in patients with AN Assessments for primary endpoint: •BMD at lumbar spine, total hip and femoral neck, measured by DXA Assessments for secondary endpoints: - bone resorption and bone formation markers measured in urine and serum - whole body composition measured by DXA - New clinical peripheral and vertebral fractures - HRqCT of tibia and forearm - EDE-Q Score at months 12 and 24 Safety measurements: - Safety lab (blood and urine) - Clinical adverse event monitoring at all visits Number of Subjects: 10 Diagnosis and Main Inclusion Criteria: - Women, aged > 18 to < 35 years - Having severe anorexia nervosa (AN) (DSM-IV-R) for > 12 months before screening - Presenting with very low bone mineral density (defined as Z-Score < -2.5 or T-Score < -2.5 if available) of at least one of the assessed localizations (lumbar spine L1 - L4, total hip, femoral neck) without any previous fragility fracture - or low bone mineral density (defined as Z-Score < -1.5 or T-Score < -1.5 if available) of at least one of the assessed localizations (lumbar spine L1 - L4, total hip, femoral neck) and at least one previous fragility fracture - In- and out-patients of the Centre for Eating Disorders at the Clinic for Psychiatry and Psychotherapy of the University Hospital of Zurich. Main Exclusion Criteria: - Metabolic bone diseases other than primary osteoporosis (including hyperparathyroidism, osteomalacia, Paget's disease of bone), pre-existing hypercalcemia, severe renal impairment (GFR < 30 ml/min), prior external beam or implant radiation therapy to the skeleton, skeletal malignancies or bone metastases, any unknown elevation of serum alkaline phosphatase, severe psychiatric diseases other than AN, drug addiction, HIV positive patients, pregnancy, open epiphyses - Incapacity to understand the aims of the study or patients not willing to collaborate. Study Product, Dose, Route, Regimen: Teriparatide (Forsteo®), 20µg s.c. daily for 24 months. Duration of study: 24 months. Reference therapy, Dose, Route, Regimen: - Trial with medicinal product

NCT ID: NCT01772394 Completed - Young Adult Clinical Trials

Cognitive Remediation Therapy in Anorexia Nervosa

TreCogAM
Start date: October 2012
Phase: N/A
Study type: Interventional

"Clinicians from the Maudsley (IoP, London, UK) have specifically tailored a cognitive remediation therapy (CRT) for treating Anorexia Nervosa (AN). It is an intensive manualised training cognitive therapy which addresses the difficulties in flexibility and holistic processing that have been incriminated in AN. CRT has been found to improve AN's neuropsychological functioning and short term outcome. To our knowledge, no French speaking country has tested its effectiveness. Moreover, the question whether it is efficient for both anorexic restrictive and anorexic binge-purging patients remains unanswered. The aim of the present study is to determine if CRT in AN adolescents and young adults has a favourable impact on cognitive functioning and clinical status. We will also explore whether the impact of CRT is similar in both anorexic restrictive and binge-purging subtypes. There will also be an Historical Control Group of patients, sixty, who received traditional medical interventions in a specialized inpatient unit for eating disorders (i.e., EVHAN study)."

NCT ID: NCT01761942 Unknown status - Anorexia Nervosa Clinical Trials

Fatty Acids Omega -3 Diet Supplementation Efficiency and Safety Evaluation in Anorexia Nervosa

FASAN
Start date: September 2012
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether omega -3 fatty acids are effective and safe in treating anorexia nervosa.

NCT ID: NCT01740752 Completed - Anorexia Nervosa Clinical Trials

UCAN2: Uniting Couples in the Treatment of Anorexia Nervosa

UCAN2
Start date: July 2012
Phase: N/A
Study type: Interventional

Uniting Couples in the treatment of Anorexia Nervosa (UCAN2) is a collaborative treatment research study between the University of North Carolina (UNC) Eating Disorders Program and the UNC Department of Psychology and is funded by the National Institute of Mental Health. The study examines two comprehensive treatments as couples face the challenges of anorexia nervosa (AN). The program helps patients with AN and their partners address AN symptoms and unique stresses that AN places on the romantic relationship.

NCT ID: NCT01717079 Terminated - Anorexia Nervosa Clinical Trials

rTMS and Body Shape Perception

STIMOREX
Start date: May 2013
Phase: N/A
Study type: Interventional

Anorexia nervosa (AN) is a frequent, potentially life-threatening eating disorder characterized by a resistance to maintaining body weight at or above a minimally normal weight for age and height, an intense fear of weight gain or being "fat" even though underweight, a loss of menstrual periods in girls and women post-puberty and a disturbance in the experience of body weight or shape. Body weight and shape dissatisfaction is linked to the development, maintenance and relapse of AN. Neuroimaging studies have shown that the inferior parietal cortex is involved in body image perception and less activated in patients with AN compared with healthy subjects. Repetitive transcranial magnetic stimulation (rTMS) is used to modulate cortical excitability, and particularly to increase excitability with high-frequency rTMS. The aim of this study was to investigate the effect of "excitatory" high-frequency rTMS over the "hypoactive" inferior parietal cortex of 54 patients with AN. This randomized, double-blind, placebo-controlled study will compare effective rTMS (2000 ten-Hz stimulations per session, applied at 90% of the resting motor threshold, with 10 sessions in two weeks) versus placebo rTMS. Assessments will be performed before rTMS and after the last rTMS session (immediately after, at 15 days and three months). The principal criteria for judgement is a body image satisfaction scale (Boby Shape Questionnaire, BSQ-34). The secondary criteria for judgement are eating behaviour scales (Eating Attitude Test, EAT-40; Bulimia test, BULIT and Eating Disorders Inventory, EDI-2), the Hamilton depression rating scale and Hamilton anxiety rating scale, a quality of life scale (Short-Form Health Survey, SF-36), a body composition analysis using a Dual-energy X-ray absorptiometry and the alpha-MSH autoantibodies levels (biomarker for eating disorders recently described). Inferior parietal cortex rTMS could not only improve body image perception, but also help in the treatment of eating disorders, allowing weight gain with a decreased anxiety and improving patients' quality of life. Also positive results could have direct therapeutic implications with the possibility to complete regular rTMS sessions, or to implant extradural electrodes for chronic parietal cortex stimulation.

NCT ID: NCT01642550 Completed - Anorexia Nervosa Clinical Trials

Phase 2 Pilot Study to Evaluate the Safety and Efficacy of RM-131 Administered to Females With Anorexia Nervosa

Start date: November 2012
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine if administration of RM-131 is effective in improving appetite and gastrointestinal symptoms leading to the recovery of patients with anorexia nervosa in the outpatient setting.

NCT ID: NCT01626833 Completed - Anorexia Nervosa Clinical Trials

Severe Decrease of Growth Velocity in Children With Anorexia Nervosa.Therapeutic Trial of Growth Hormone

OREX
Start date: March 2013
Phase: Phase 2/Phase 3
Study type: Interventional

Anorexia nervosa may be responsible for a catch- down or even an interruption of growth, delayed puberty and osteopenia with failure of acquisition of bone mass. The recovery of normal nutrition usually leads to a resumption of growth and pubertal development. However, despite a therapeutic nutritional and psychotherapeutic satisfactory approach, some patients have a significant short stature with reduced adult final height and a deficit of bone mass. The main objective is to evaluate the effect of growth hormone (hGH) treatment on the growth velocity in prepubertal children or children in early puberty with anorexia nervosa and significant reduction of height velocity. This is a single-center, controlled, randomized and double-blind clinical trial evaluating the efficacy of hGH treatment for 1 year against a placebo, on the growth velocity of prepubertal or children in early puberty with Anorexia nervosa and major catch-down.This period is followed by the evaluation of the hGH treatment in children receiving placebo and continued hGH treatment in the treatment arm for 1 year, in total 2 years of study for each child. This second period corresponds to an ethical consideration giving secondarily access to treatment for patients in the placebo group.

NCT ID: NCT01611220 Completed - Anorexia Nervosa Clinical Trials

Dissonance Inpatient Relapse Prevention Program for Anorexia Nervosa

RePAN
Start date: June 2012
Phase: N/A
Study type: Interventional

Anorexia Nervosa inpatient treatment has often a short-term success as weight is restored to a healthy level, but high percentage of patients relapse during the first year following the discharge. The development of strategies to overcome this problem represents a priority for clinicians. Aim of this trial is to evaluate the effects of a relapse prevention program based on cognitive dissonance theory developed for hospitalized patients.

NCT ID: NCT01579682 Completed - Anorexia Nervosa Clinical Trials

Adaptive Family Treatment for Adolescent Anorexia Nervosa

Start date: September 2011
Phase: N/A
Study type: Interventional

Anorexia Nervosa (AN) has the highest mortality rate compared to any other psychiatric disorder. The most promising treatment for adolescents with AN is family-based treatment (FBT). However, only 50% of patients receiving FBT fully remit at 12-month follow-up. Consequently, providing an alternative therapy early in the treatment course for those not responding to FBT may enhance overall outcome. This study aims to develop a new treatment - Intensive Family-Focused Treatment (IFT) - to improve outcomes in those adolescents, aged 12-18 years, who do not show an early response to FBT.

NCT ID: NCT01544400 Terminated - Anorexia Nervosa Clinical Trials

Description and Evaluation of Eating Disorders in Elite Athletes (TCA SHN)

TCA SHN
Start date: June 2010
Phase: N/A
Study type: Observational

Athletes in particular elite athletes have obsessional food and body concerns, in bond with a worship of the performance more and more invading, which lead to clinical and subclinical eating disorders. These eating disorders differ according to the disciplines and are difficult to diagnose in athletes because there are insufficiently described. Our aim at estimating the frequency of eating disorders in athletes and describing eating disorders by means of somatic, dietetic and psychological evaluations.