Neurobiology of Eating Disorders Treatments (NEDT)

University of Turin

Status: Completed

Conditions: Bulimia Nervosa; Anorexia Nervosa

Treatments: Other: IBPP (individual psychology brief psychotherapy); Behavioral: CBT (Cognitive Behavioral Therapy); Drug: delorazepam; Drug: CBT + OLANZAPINE; Dietary Supplement: nutritional rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT01990755

Brambilla trial

Details and patient eligibility

About

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.

Enrollment: 112 patients

Sex: Female

Ages: 15 to 35 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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112 participants in 3 patient groups

CBT (Cognitive Behavioral Therapy)

Active Comparator group

Description:

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

Treatment:

Drug: delorazepam

Behavioral: CBT (Cognitive Behavioral Therapy)

Dietary Supplement: nutritional rehabilitation

IBPP (IP brief psychotherapy )

Active Comparator group

Description:

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.

Treatment:

Drug: delorazepam

Dietary Supplement: nutritional rehabilitation

Other: IBPP (individual psychology brief psychotherapy)

CBT + OLANZAPINE (5 MG)

Active Comparator group

Description:

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

Treatment:

Drug: delorazepam

Drug: CBT + OLANZAPINE

Dietary Supplement: nutritional rehabilitation