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Completed

NCT Number: NCT01990755

Neurobiology of Eating Disorders Treatments

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.

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Key information

Age range

15 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Villa Garda

Garda, Veneto, 37016, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CBT (Cognitive Behavioral Therapy)

Behavioral

It is a worldwide known form of psychotherapy for eating disorders

IBPP (individual psychology brief psychotherapy)

Other

It is a worldwide known form of psychotherapy for eating disorders

Other names: B-APP: brief adlerian psychodynamic 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

nutritional rehabilitation

Dietary Supplement

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

delorazepam

Drug

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

Primary outcomes

  1. 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.

  2. 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

  3. 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.

Secondary outcomes

  1. Eating Psychopathology improvement after treatments at 6 months

    Time frame: 6 months

    Eating Disorders Examination-12 (EDE 12)

  2. Depressive Psychopathology improvement after 6 months

    Time frame: 6 months

    Beck Depression Inventory (BDI)

  3. Anxiety improvement after 6 months

    Time frame: 6 months

    State-Trait Anxiety Index (STAI) Form-Y-1

  4. Impulsiveness improvement after 6 months

    Time frame: 6 months

    Barratt Impulsiveness Scale

  5. Self-rated Biochemical improvement after 6 months

    Time frame: 6 months

    Rosenberg Self-Biochemical Scale

  6. Personality improvement after 6 months

    Time frame: 6 months

    Temperament and Character Inventory (TCI)

Sponsors and collaborators

Lead sponsor

University of Turin, Italy

Other

Collaborators

  • University of Milan

Registry information

Official study title

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

Acronym: NEDT

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Nov 21, 2013
Registry last updated
Nov 21, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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