Neurobiology of Eating Disorders Treatments

NCT01990755 | Completed

• 1 other identifier: Brambilla trial
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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.

Conditions

Anorexia Nervosa; Bulimia Nervosa

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• Eating Psychopathology improvement after treatments at 6 months

  6 months

• Depressive Psychopathology improvement after 6 months

  6 months

• Anxiety improvement after 6 months

  6 months

• Impulsiveness improvement after 6 months

  6 months

• Self-rated Biochemical improvement after 6 months

  6 months

Study Arms (3)

CBT (Cognitive Behavioral Therapy)

ACTIVE COMPARATOR

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); Dietary Supplement: nutritional rehabilitation; Drug: delorazepam

IBPP (IP brief psychotherapy )

ACTIVE COMPARATOR

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); Dietary Supplement: nutritional rehabilitation; Drug: delorazepam

CBT + OLANZAPINE (5 MG)

ACTIVE COMPARATOR

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; Dietary Supplement: nutritional rehabilitation; Drug: delorazepam

Interventions

CBT (Cognitive Behavioral Therapy) BEHAVIORAL

It is a worldwide known form of psychotherapy for eating disorders

CBT (Cognitive Behavioral Therapy)

IBPP (individual psychology brief psychotherapy) OTHER

It is a worldwide known form of psychotherapy for eating disorders

Also known as: B-APP: brief adlerian psychodynamic psychotherapy

IBPP (IP brief psychotherapy )

CBT + OLANZAPINE DRUG

It is a worldwide known form of psychotherapy for eating disorders associated with a new antipsychotic with good efficacy on anorexia nervosa

CBT + OLANZAPINE (5 MG)

nutritional rehabilitation DIETARY_SUPPLEMENT

all patients were followed-up monthly with nutritionist and dietitian visits

CBT (Cognitive Behavioral Therapy); CBT + OLANZAPINE (5 MG); IBPP (IP brief psychotherapy )

delorazepam DRUG

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

CBT (Cognitive Behavioral Therapy); CBT + OLANZAPINE (5 MG); IBPP (IP brief psychotherapy )

Eligibility Criteria

• Age: 15 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• associated major psychiatric problems
• mental retardation

Sponsors & Collaborators

• University of Turin, Italy: lead
• University of Milan: collaborator

Study Sites (1)

Villa Garda

Garda, Veneto, 37016, Italy

Location

Related Publications (1)

• 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.

  PMID: 25539757 DERIVED

MeSH Terms

Conditions

Anorexia Nervosa; Bulimia Nervosa

Interventions

Cognitive Behavioral Therapy; Olanzapine; chlordesmethyldiazepam

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Federico Amianto, MD, PhD

  University of Torino

  PRINCIPAL INVESTIGATOR

• Secondo Fassino, MD

  University of Torino

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dottor

Study Record Dates

• First Submitted: September 24, 2013
• First Posted: November 21, 2013
• Study Start: May 1, 2010
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: November 21, 2013

Record last verified: 2013-11

Locations

IT (1)