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Neurobiology of Eating Disorders Treatments (NEDT)

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ClinicalTrials.gov Identifier: NCT01990755
Recruitment Status : Completed
First Posted : November 21, 2013
Last Update Posted : November 21, 2013
Sponsor:
Collaborator:
University of Milan
Information provided by (Responsible Party):
Federico Amianto, University of Turin, Italy

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.

Condition or disease Intervention/treatment Phase
Anorexia Nervosa Bulimia Nervosa Behavioral: CBT (Cognitive Behavioral Therapy) Other: IBPP (individual psychology brief psychotherapy) Drug: CBT + OLANZAPINE Dietary Supplement: nutritional rehabilitation Drug: delorazepam Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 112 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Lack of Efficacy of Psychological and Pharmacological Treatments of Eating Disorders: Neurobiological Background
Study Start Date : May 2010
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eating Disorders

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

Behavioral: CBT (Cognitive Behavioral Therapy)
It is a worldwide known form of psychotherapy for eating disorders

Dietary Supplement: nutritional rehabilitation
all patients were followed-up monthly with nutritionist and dietitian visits

Drug: delorazepam
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.

Other: IBPP (individual psychology brief psychotherapy)
It is a worldwide known form of psychotherapy for eating disorders
Other Name: B-APP: brief adlerian psychodynamic psychotherapy

Dietary Supplement: nutritional rehabilitation
all patients were followed-up monthly with nutritionist and dietitian visits

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

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

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

Dietary Supplement: nutritional rehabilitation
all patients were followed-up monthly with nutritionist and dietitian visits

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




Primary Outcome Measures :
  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 Outcome Measures :
  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)



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Ages Eligible for Study:   15 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01990755


Locations
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Italy
Villa Garda
Garda, Veneto, Italy, 37016
Sponsors and Collaborators
University of Turin, Italy
University of Milan
Investigators
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Principal Investigator: Federico Amianto, MD, PhD University of Torino
Study Chair: Secondo Fassino, MD University of Torino

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Federico Amianto, Dottor, University of Turin, Italy
ClinicalTrials.gov Identifier: NCT01990755     History of Changes
Other Study ID Numbers: Brambilla trial
First Posted: November 21, 2013    Key Record Dates
Last Update Posted: November 21, 2013
Last Verified: November 2013

Additional relevant MeSH terms:
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Feeding and Eating Disorders
Anorexia
Anorexia Nervosa
Bulimia
Bulimia Nervosa
Mental Disorders
Signs and Symptoms, Digestive
Signs and Symptoms
Hyperphagia
Olanzapine
Nordazepam
Chlordesmethyldiazepam
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Anticonvulsants
Anti-Anxiety Agents
GABA Modulators