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Clinical Trials/NCT01990755
NCT01990755
Completed
Not Applicable

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

University of Turin, Italy1 site in 1 country112 target enrollmentMay 2010

Overview

Phase
Not Applicable
Intervention
CBT (Cognitive Behavioral Therapy)
Conditions
Anorexia Nervosa
Sponsor
University of Turin, Italy
Enrollment
112
Locations
1
Primary Endpoint
change in brain secretion of Dopamine at 6 months
Status
Completed
Last Updated
12 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2010
End Date
May 2013
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
University of Turin, Italy
Responsible Party
Principal Investigator
Principal Investigator

Federico Amianto

Dottor

University of Turin, Italy

Eligibility 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

Arms & Interventions

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

Intervention: CBT (Cognitive Behavioral Therapy)

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

Intervention: nutritional rehabilitation

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

Intervention: delorazepam

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.

Intervention: IBPP (individual psychology brief psychotherapy)

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.

Intervention: nutritional rehabilitation

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.

Intervention: delorazepam

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

Intervention: CBT + OLANZAPINE

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

Intervention: nutritional rehabilitation

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

Intervention: delorazepam

Outcomes

Primary Outcomes

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.

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

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

  • Depressive Psychopathology improvement after 6 months(6 months)
  • Impulsiveness improvement after 6 months(6 months)
  • Eating Psychopathology improvement after treatments at 6 months(6 months)
  • Anxiety improvement after 6 months(6 months)
  • Self-rated Biochemical improvement after 6 months(6 months)
  • Personality improvement after 6 months(6 months)

Study Sites (1)

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