Neurobiology of Eating Disorders Treatments (NEDT)

November 15, 2013 updated by: Federico Amianto, University of Turin, Italy

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

Study Type

Interventional

Enrollment (Actual)

112

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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

It is a worldwide known form of psychotherapy for eating disorders
all patients were followed-up monthly with nutritionist and dietitian visits
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.

all patients were followed-up monthly with nutritionist and dietitian visits
all patients were followed-up with psychiatric visits with symptomatic drug administration (tranquillizer: delorazepam) where necessary
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

all patients were followed-up monthly with nutritionist and dietitian visits
all patients were followed-up with psychiatric visits with symptomatic drug administration (tranquillizer: delorazepam) where necessary
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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 6 months
Eating Disorders Examination-12 (EDE 12)
6 months
Depressive Psychopathology improvement after 6 months
Time Frame: 6 months
Beck Depression Inventory (BDI)
6 months
Anxiety improvement after 6 months
Time Frame: 6 months
State-Trait Anxiety Index (STAI) Form-Y-1
6 months
Impulsiveness improvement after 6 months
Time Frame: 6 months
Barratt Impulsiveness Scale
6 months
Self-rated Biochemical improvement after 6 months
Time Frame: 6 months
Rosenberg Self-Biochemical Scale
6 months
Personality improvement after 6 months
Time Frame: 6 months
Temperament and Character Inventory (TCI)
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Federico Amianto, MD, PhD, University of Torino
  • Study Chair: Secondo Fassino, MD, University of Torino

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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