Neurobiology of Eating Disorders Treatments (NEDT)

Lack of Efficacy of Psychological and Pharmacological Treatments of Eating Disorders: Neurobiological Background

Background. Treatments of eating disorders result too often in partial psychological and physical remission, chronic course, dropout, relapse and death, with no fully known explanations for this failure. In order to clarify this problem, we conducted a three branches study to identify the biochemical background of cognitive-behavioral psychotherapy (CBT), individual psychology brief psychotherapy (IBPP), and psychotherapy-pharmacotherapy with CBT+olanzapine in anorexics (AN) and bulimics (BN) by measuring the levels of plasma homovanillic acid (HVA) for dopamine secretion, plasma 3-methoxy-4-hydroxy-phenylglycol (MHPG) for noradrenalin secretion, and platelet [3 Hydrogen]-Paroxetine-binding Bmax and Kd for serotonin transporter function. The data were then compared with psychopathological and physical alterations. Methods. Branch 1 investigated the effects of 4 months of CBT on plasma HVA, MHPG and [3 Hydrogen]-Par-binding in 14 AN-restricted, 14 AN-bingeing/purging, and 22 BN inpatients. Branch 2 investigated the effects of 4 months of IBPP on plasma HVA in 15 AN and 17 BN outpatients. Branch 3 investigated the effect of 3 months of CBT+olanzapine (5 mg/day) in 30 AN outpatients. The data are analyzed using one-way ANOVA for repeated measures for the changes between basal and post-treatment biological and psychological parameters, two-way ANOVA for repeated measures for the differences in the psychobiological data in the 3 groups, Spearman's test for the correlations between basal and final changes in the psychological and biological scores.

Study Overview

• Status: Completed
• Conditions: Anorexia Nervosa; Bulimia Nervosa
• Intervention / Treatment: Behavioral: CBT (Cognitive Behavioral Therapy); Dietary supplement: nutritional rehabilitation; Drug: delorazepam; Other: IBPP (individual psychology brief psychotherapy); Drug: CBT + OLANZAPINE

• Study Type: Interventional
• Enrollment (Actual): 112
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Veneto
    • Garda, Veneto, Italy, 37016
      • Villa Garda

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 35 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• eating disorders full diagnosis according to Diagnostic and Statistical Manual (DSM-IV)
• age between 15 and 35
• female gender

Exclusion Criteria:

• associated major psychiatric problems
• mental retardation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: CBT (Cognitive Behavioral Therapy); Investigates the effects of cognitive-behavioral therapy (CBT), on the secretion of brain dopamine (DA), noradrenalin (NE) and serotonin (5-HT) in a group of 50 female inpatients, 14 with AN restricter type (AN-R), 14 with the bingeing-purging type (AN-BP), and 22 with BN. Associated intervention (non of interest): psychiatric management (with tranquillizer: delorazepam), nutritional rehabilitation	Behavioral: CBT (Cognitive Behavioral Therapy); It is a worldwide known form of psychotherapy for eating disorders; Dietary supplement: nutritional rehabilitation; all patients were followed-up monthly with nutritionist and dietitian visits; Drug: delorazepam; all patients were followed-up with psychiatric visits with symptomatic drug administration (tranquillizer: delorazepam) where necessary
Active Comparator: IBPP (IP brief psychotherapy ); Investigates the effects in 15 AN and 17 BN patients of an individual psychology brief psychotherapy (IBPP) on psychological alterations and DA secretion measured as peripheral blood values of HVA before and after treatment. Associated intervention (non of interest): psychiatric management (with tranquillizer: delorazepam), nutritional rehabilitation.	Dietary supplement: nutritional rehabilitation; all patients were followed-up monthly with nutritionist and dietitian visits; Drug: delorazepam; all patients were followed-up with psychiatric visits with symptomatic drug administration (tranquillizer: delorazepam) where necessary; Other: IBPP (individual psychology brief psychotherapy); It is a worldwide known form of psychotherapy for eating disorders; Other Names: B-APP: brief adlerian psychodynamic psychotherapy
Active Comparator: CBT + OLANZAPINE (5 MG); The study evaluated in 18 AN-R and 12 AN-BP patients the effects of CBT and of CBT associated with orally administered 5 mg olanzapine on the psychopathological aspects of the disease and on the secretion of HVA. Associated intervention (non of interest): psychiatric management (with tranquillizer: delorazepam), nutritional rehabilitation	Dietary supplement: nutritional rehabilitation; all patients were followed-up monthly with nutritionist and dietitian visits; Drug: delorazepam; all patients were followed-up with psychiatric visits with symptomatic drug administration (tranquillizer: delorazepam) where necessary; Drug: CBT + OLANZAPINE; It is a worldwide known form of psychotherapy for eating disorders associated with a new antipsychotic with good efficacy on anorexia nervosa

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in brain secretion of Dopamine at 6 months	plasma homovanillic acid (HVA) measured before and after the therapeutic intervention in each branch.	6 months
change in brain secretion of Noradrenaline at 6 months	plasma 3-methoxy-4-hydroxyphenylglycol (MHPG) measured before and after the therapeutic intervention in each branch	6 months
change in brain secretion of serotonin at 6 months	the platelet paroxetine binding ([3 Hydrogen]-Par-binding): Bmax (maximum binding capacity) and Kd (dissociation constant) measured before and after the therapeutic intervention in each branch.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Eating Psychopathology improvement after treatments at 6 months	Eating Disorders Examination-12 (EDE 12)	6 months
Depressive Psychopathology improvement after 6 months	Beck Depression Inventory (BDI)	6 months
Anxiety improvement after 6 months	State-Trait Anxiety Index (STAI) Form-Y-1	6 months
Impulsiveness improvement after 6 months	Barratt Impulsiveness Scale	6 months
Self-rated Biochemical improvement after 6 months	Rosenberg Self-Biochemical Scale	6 months
Personality improvement after 6 months	Temperament and Character Inventory (TCI)	6 months

Collaborators and Investigators

• Sponsor: University of Turin, Italy
• Collaborators: University of Milan
• Investigators: Principal Investigator: Federico Amianto, MD, PhD, University of Torino; Study Chair: Secondo Fassino, MD, University of Torino

Publications and helpful links

General Publications

• Brambilla F, Amianto F, Dalle Grave R, Fassino S. Lack of efficacy of psychological and pharmacological treatments of disorders of eating behavior: neurobiological background. BMC Psychiatry. 2014 Dec 24;14:376. doi: 10.1186/s12888-014-0376-7.

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: September 24, 2013
• First Submitted That Met QC Criteria: November 15, 2013
• First Posted (Estimate): November 21, 2013

Study Record Updates

• Last Update Posted (Estimate): November 21, 2013
• Last Update Submitted That Met QC Criteria: November 15, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Signs and Symptoms, Digestive; Hyperphagia; Anorexia; Anorexia Nervosa; Bulimia; Feeding and Eating Disorders; Bulimia Nervosa; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Anticonvulsants; Olanzapine; Chlordesmethyldiazepam
• Other Study ID Numbers: Brambilla trial