A Pilot Study to Evaluate the Effect of Forsteo (Teriparatide, 1-34-rh-PTH) in Anorexia Nervosa...
Low Bone Mass in Anorexia Nervosa PatientsStudy 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: NA Trial with medicinal product
ARIpiprazole in Anorexia NErvosa
Anorexia NervosaEvidence is lacking on the effects of different psychotropic drugs in the treatment of anorexia nervosa (AR). However, HVA levels seem to be elevated in this disease, therefore suggesting a role for drugs with a partial agonist profile on dopaminergic receptors. This is a pilot study assessing the effects of aripiprazole in teenagers with AR, compared with a placebo.
Project CORE: Disseminating Eating Disorders Treatment
Anorexia Nervosa/BulimiaAnorexia Nervosa Restricting Type1 moreThe goals of this project are to 1) develop training opportunities for master's-level and pre-doctoral psychology students in evidence-based assessment and treatment of adolescent EDs; 2) to provide the healthcare workforce, including licensed health professionals such as primary care physicians and behavioral health interventionists, with knowledge and competence to recognize early symptoms of and intervention strategies for EDs; and 3) to test the efficacy of delivering two evidence-based treatments for adolescent eating disorders, Family Based Treatment (FBT) and Enhanced Cognitive Behavioral Therapy (CBT-E), in the home-based setting.
Individual Schema-mode Therapy for Anorexia Nervosa: a Pilot Case Series
Anorexia NervosaA reliably effective treatment model for anorexia nervosa is yet to emerge. Recent clinical trials of psychological therapies over 20-30 sessions, have shown modest benefits. There is therefore a need to test new treatments to find more effective treatments. Clinical trials of Schema Therapy have shown low rates of dropout, which is often a problem in the treatment of anorexia nervosa. Treatment with Schema Therapy, for significantly longer than 20-30 sessions, has been shown to be effective for other complex mental health problems.This pilot study is therefore designed to pilot the use of individual Schema Therapy for people with Anorexia Nervosa (iST-AN). This study is a case series pilot study. The study will answer the principal research question: Does individual Schema mode Therapy, adapted for eating disorders, have the potential to improve symptoms, quality of life and weight in people with moderate-severe anorexia nervosa? It will also address secondary research questions: Can people with moderate-severe anorexia nervosa be recruited to, and kept engaged in, a study of iST-AN treatment? What is the ideal length of iST-AN treatment? What is the relationship between self-criticism, body shame, or unhelpful psychological 'modes' and clinical outcome? Fifteen people with moderate-severe Anorexia Nervosa will be recruited from referrals to a specialist eating disorders outpatient service. The study will deliver 65 sessions of Schema Therapy for anorexia nervosa (iST-AN), over a 24 month period, alongside any additional medical or dietetic management required. Standard outcome measures will be collected at 6 month intervals. The research team have expertise in eating disorders research, schema therapy for severe anorexia nervosa and are all members of the local clinical service. The study will take place over a 3 year period.
Look at Food and Lose Your Fear - Evaluation of a Computerized Attention Training (CAT) for Anorexia...
Anorexia NervosaThe purpose of this study is to test the therapeutic effects of a computerized attention training for patients with Anorexia Nervosa (AN). The primary aim is to determine if a computerized attention training can modify attention towards food and ameliorate eating disorder symptoms and related difficulties, such as anxiety. The secondary aim is to explore underlying mechanisms that contribute to these improvements. The stability of potentially observed effects over a one-month period will also be determined.
Fatty Acids Omega -3 Diet Supplementation Efficiency and Safety Evaluation in Anorexia Nervosa
Anorexia NervosaThe purpose of this study is to determine whether omega -3 fatty acids are effective and safe in treating anorexia nervosa.
Study to Evaluate the Efficacy and Tolerability of Apevinat BC Compared to Vitamin Complex
Lack of AppetiteAnorexiaThe purpose of this study is to evaluate the efficacy and tolerability of Apevinat BC compared to vitamin complex, in the treatment of lack of appetite and prevention of deficiency of B and C vitamins.
PINS Stimulator System to Treat Severe Anorexia Nervosa
Anorexia NervosaAnorexia Nervosa (AN) has the highest mortality of any psychiatric disorder and a paucity of effective treatments. AN becomes intractable in around 20%, resulting in huge individual and healthcare costs. The study will help patients with severe AN using DBS. Individuals with severe intractable AN will be eligible to take part in the study.
The Efficacy of Readiness and Motivation Therapy in Individuals With Anorexia Nervosa and Bulimia...
Anorexia NervosaBulimia NervosaThis research examines the efficacy of a 5-session individual psychotherapy intervention designed to enhance readiness and motivation for change in individuals with anorexia nervosa, bulimia nervosa, and eating disorder not otherwise specified. It is hypothesized that individuals randomly assigned to receive Readiness and Motivation Therapy (RMT) will have higher readiness and motivation scores and improved eating disorder and psychiatric symptomatology following the intervention than individuals assigned to a no-treatment control condition.
The Safety and Effect Study of Acupuncture for Anorexia in Patients With Gastrointestinal Tract...
AnorexiaCancer CachexiaThis trail will be carried out to evaluated the effect and safety of acupuncture for the anorexia in patients with gastrointestinal tract and lung cancers.