Neurobiology of Eating Disorders Treatments

Study Overview
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Brief Summary
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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.

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

Conditions
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Anorexia Nervosa, Bulimia Nervosa

Intervention / Treatment
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* Behavioral: CBT (Cognitive Behavioral Therapy)
* Other: IBPP (individual psychology brief psychotherapy)
* Drug: CBT + OLANZAPINE
* Dietary Supplement: nutritional rehabilitation
* Drug: delorazepam


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CBT (Cognitive Behavioral Therapy)<br>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)<br>* It is a worldwide known form of psychotherapy for eating disorders<br>Dietary Supplement: nutritional rehabilitation<br>* all patients were followed-up monthly with nutritionist and dietitian visits<br>Drug: delorazepam<br>* all patients were followed-up with psychiatric visits with symptomatic drug administration (tranquillizer: delorazepam) where necessary<br>|
| Active Comparator: IBPP (IP brief psychotherapy )<br>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. | Other: IBPP (individual psychology brief psychotherapy)<br>* It is a worldwide known form of psychotherapy for eating disorders<br>* Other names: B-APP: brief adlerian psychodynamic psychotherapy;Dietary Supplement: nutritional rehabilitation<br>* all patients were followed-up monthly with nutritionist and dietitian visits<br>Drug: delorazepam<br>* all patients were followed-up with psychiatric visits with symptomatic drug administration (tranquillizer: delorazepam) where necessary<br>|
| Active Comparator: CBT + OLANZAPINE (5 MG)<br>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 | Drug: CBT + OLANZAPINE<br>* It is a worldwide known form of psychotherapy for eating disorders associated with a new antipsychotic with good efficacy on anorexia nervosa<br>Dietary Supplement: nutritional rehabilitation<br>* all patients were followed-up monthly with nutritionist and dietitian visits<br>Drug: delorazepam<br>* all patients were followed-up with psychiatric visits with symptomatic drug administration (tranquillizer: delorazepam) where necessary<br>|

What is the study measuring?
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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 |