- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01990755
Neurobiology of Eating Disorders Treatments (NEDT)
Lack of Efficacy of Psychological and Pharmacological Treatments of Eating Disorders: Neurobiological Background
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Veneto
-
Garda, Veneto, Italy, 37016
- Villa Garda
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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 |
It is a worldwide known form of psychotherapy for eating disorders
all patients were followed-up monthly with nutritionist and dietitian visits
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. |
all patients were followed-up monthly with nutritionist and dietitian visits
all patients were followed-up with psychiatric visits with symptomatic drug administration (tranquillizer: delorazepam) where necessary
It is a worldwide known form of psychotherapy for eating disorders
Other Names:
|
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 |
all patients were followed-up monthly with nutritionist and dietitian visits
all patients were followed-up with psychiatric visits with symptomatic drug administration (tranquillizer: delorazepam) where necessary
It is a worldwide known form of psychotherapy for eating disorders associated with a new antipsychotic with good efficacy on anorexia nervosa
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
6 months
|
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
|
6 months
|
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.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Eating Psychopathology improvement after treatments at 6 months
Time Frame: 6 months
|
Eating Disorders Examination-12 (EDE 12)
|
6 months
|
Depressive Psychopathology improvement after 6 months
Time Frame: 6 months
|
Beck Depression Inventory (BDI)
|
6 months
|
Anxiety improvement after 6 months
Time Frame: 6 months
|
State-Trait Anxiety Index (STAI) Form-Y-1
|
6 months
|
Impulsiveness improvement after 6 months
Time Frame: 6 months
|
Barratt Impulsiveness Scale
|
6 months
|
Self-rated Biochemical improvement after 6 months
Time Frame: 6 months
|
Rosenberg Self-Biochemical Scale
|
6 months
|
Personality improvement after 6 months
Time Frame: 6 months
|
Temperament and Character Inventory (TCI)
|
6 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Federico Amianto, MD, PhD, University of Torino
- Study Chair: Secondo Fassino, MD, University of Torino
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Signs and Symptoms, Digestive
- Hyperphagia
- Anorexia
- Anorexia Nervosa
- Bulimia
- Feeding and Eating Disorders
- Bulimia Nervosa
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Antiemetics
- Gastrointestinal Agents
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Serotonin Uptake Inhibitors
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Serotonin Agents
- Anticonvulsants
- Olanzapine
- Chlordesmethyldiazepam
Other Study ID Numbers
- Brambilla trial
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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