Neurobiology of Eating Disorders Treatments

NCT ID: NCT01990755

Last Updated: 2013-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2013-05-31

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.

Detailed Description

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Conditions

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Anorexia Nervosa Bulimia Nervosa

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type ACTIVE_COMPARATOR

CBT (Cognitive Behavioral Therapy)

Intervention Type BEHAVIORAL

It is a worldwide known form of psychotherapy for eating disorders

nutritional rehabilitation

Intervention Type DIETARY_SUPPLEMENT

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

delorazepam

Intervention Type DRUG

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

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.

Group Type ACTIVE_COMPARATOR

IBPP (individual psychology brief psychotherapy)

Intervention Type OTHER

It is a worldwide known form of psychotherapy for eating disorders

nutritional rehabilitation

Intervention Type DIETARY_SUPPLEMENT

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

delorazepam

Intervention Type DRUG

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

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

Group Type ACTIVE_COMPARATOR

CBT + OLANZAPINE

Intervention Type DRUG

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

nutritional rehabilitation

Intervention Type DIETARY_SUPPLEMENT

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

delorazepam

Intervention Type DRUG

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

Interventions

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CBT (Cognitive Behavioral Therapy)

It is a worldwide known form of psychotherapy for eating disorders

Intervention Type BEHAVIORAL

IBPP (individual psychology brief psychotherapy)

It is a worldwide known form of psychotherapy for eating disorders

Intervention Type OTHER

CBT + OLANZAPINE

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

Intervention Type DRUG

nutritional rehabilitation

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

Intervention Type DIETARY_SUPPLEMENT

delorazepam

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

Intervention Type DRUG

Other Intervention Names

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B-APP: brief adlerian psychodynamic psychotherapy

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
Minimum Eligible Age

15 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Milan

OTHER

Sponsor Role collaborator

University of Turin, Italy

OTHER

Sponsor Role lead

Responsible Party

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Federico Amianto

Dottor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Federico Amianto, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Torino

Secondo Fassino, MD

Role: STUDY_CHAIR

University of Torino

Locations

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Villa Garda

Garda, Veneto, Italy

Site Status

Countries

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Italy

References

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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.

Reference Type DERIVED
PMID: 25539757 (View on PubMed)

Other Identifiers

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Brambilla trial

Identifier Type: -

Identifier Source: org_study_id