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Neurobiology of Eating Disorders Treatments (NEDT)

Primary Purpose

Anorexia Nervosa, Bulimia Nervosa

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
CBT (Cognitive Behavioral Therapy)
IBPP (individual psychology brief psychotherapy)
CBT + OLANZAPINE
nutritional rehabilitation
delorazepam
Sponsored by
University of Turin, Italy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anorexia Nervosa

Eligibility Criteria

15 Years - 35 Years (Child, Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Villa Garda

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

CBT (Cognitive Behavioral Therapy)

IBPP (IP brief psychotherapy )

CBT + OLANZAPINE (5 MG)

Arm Description

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

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.

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

Outcomes

Primary Outcome Measures

change in brain secretion of Dopamine at 6 months
plasma homovanillic acid (HVA) measured before and after the therapeutic intervention in each branch.
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
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.

Secondary Outcome Measures

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

Full Information

First Posted
September 24, 2013
Last Updated
November 15, 2013
Sponsor
University of Turin, Italy
Collaborators
University of Milan
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1. Study Identification

Unique Protocol Identification Number
NCT01990755
Brief Title
Neurobiology of Eating Disorders Treatments
Acronym
NEDT
Official Title
Lack of Efficacy of Psychological and Pharmacological Treatments of Eating Disorders: Neurobiological Background
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Turin, Italy
Collaborators
University of Milan

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anorexia Nervosa, Bulimia Nervosa

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
112 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CBT (Cognitive Behavioral Therapy)
Arm Type
Active Comparator
Arm Description
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
Arm Title
IBPP (IP brief psychotherapy )
Arm Type
Active Comparator
Arm Description
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.
Arm Title
CBT + OLANZAPINE (5 MG)
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
CBT (Cognitive Behavioral Therapy)
Intervention Description
It is a worldwide known form of psychotherapy for eating disorders
Intervention Type
Other
Intervention Name(s)
IBPP (individual psychology brief psychotherapy)
Other Intervention Name(s)
B-APP: brief adlerian psychodynamic psychotherapy
Intervention Description
It is a worldwide known form of psychotherapy for eating disorders
Intervention Type
Drug
Intervention Name(s)
CBT + OLANZAPINE
Intervention Description
It is a worldwide known form of psychotherapy for eating disorders associated with a new antipsychotic with good efficacy on anorexia nervosa
Intervention Type
Dietary Supplement
Intervention Name(s)
nutritional rehabilitation
Intervention Description
all patients were followed-up monthly with nutritionist and dietitian visits
Intervention Type
Drug
Intervention Name(s)
delorazepam
Intervention Description
all patients were followed-up with psychiatric visits with symptomatic drug administration (tranquillizer: delorazepam) where necessary
Primary Outcome Measure Information:
Title
change in brain secretion of Dopamine at 6 months
Description
plasma homovanillic acid (HVA) measured before and after the therapeutic intervention in each branch.
Time Frame
6 months
Title
change in brain secretion of Noradrenaline at 6 months
Description
plasma 3-methoxy-4-hydroxyphenylglycol (MHPG) measured before and after the therapeutic intervention in each branch
Time Frame
6 months
Title
change in brain secretion of serotonin at 6 months
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Eating Psychopathology improvement after treatments at 6 months
Description
Eating Disorders Examination-12 (EDE 12)
Time Frame
6 months
Title
Depressive Psychopathology improvement after 6 months
Description
Beck Depression Inventory (BDI)
Time Frame
6 months
Title
Anxiety improvement after 6 months
Description
State-Trait Anxiety Index (STAI) Form-Y-1
Time Frame
6 months
Title
Impulsiveness improvement after 6 months
Description
Barratt Impulsiveness Scale
Time Frame
6 months
Title
Self-rated Biochemical improvement after 6 months
Description
Rosenberg Self-Biochemical Scale
Time Frame
6 months
Title
Personality improvement after 6 months
Description
Temperament and Character Inventory (TCI)
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Federico Amianto, MD, PhD
Organizational Affiliation
University of Torino
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Secondo Fassino, MD
Organizational Affiliation
University of Torino
Official's Role
Study Chair
Facility Information:
Facility Name
Villa Garda
City
Garda
State/Province
Veneto
ZIP/Postal Code
37016
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
25539757
Citation
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.
Results Reference
derived

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Neurobiology of Eating Disorders Treatments

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