Neurobiology of Eating Disorders Treatments

Anorexia Nervosa Clinical Trial

— NEDT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01990755
• Other study ID #: Brambilla trial
• Status: Completed
• Phase: N/A
• First received: September 24, 2013
• Last updated: November 15, 2013
• Start date: May 2010
• Est. completion date: May 2013

Study information

• Verified date: November 2013
• Source: University of Turin, Italy
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 15 Years to 35 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anorexia Nervosa
• Bulimia
• Bulimia Nervosa
• Eating Disorders

Intervention

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

Other:
• IBPP (individual psychology brief psychotherapy)
It is a worldwide known form of psychotherapy for eating disorders

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

Locations

Country	Name	City	State
Italy	Villa Garda	Garda	Veneto

Sponsors (2)

Lead Sponsor	Collaborator
University of Turin, Italy	University of Milan

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	Eating Psychopathology improvement after treatments at 6 months	Eating Disorders Examination-12 (EDE 12)	6 months	No
Secondary	Depressive Psychopathology improvement after 6 months	Beck Depression Inventory (BDI)	6 months	No
Secondary	Anxiety improvement after 6 months	State-Trait Anxiety Index (STAI) Form-Y-1	6 months	No
Secondary	Impulsiveness improvement after 6 months	Barratt Impulsiveness Scale	6 months	No
Secondary	Self-rated Biochemical improvement after 6 months	Rosenberg Self-Biochemical Scale	6 months	No
Secondary	Personality improvement after 6 months	Temperament and Character Inventory (TCI)	6 months	No