Anorexia NervosaNEDTNCT01990755
Neurobiology of Eating Disorders Treatments
A study testing CBT (Cognitive Behavioral Therapy), IBPP (individual psychology brief psychotherapy) and CBT + OLANZAPINE in people with Anorexia Nervosa and Bulimia Nervosa, run by University of Turin, Italy at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 15 to 35 years, women only
- Conditions the study is for
- Anorexia Nervosa, Bulimia Nervosa
- What is being tested?
- CBT (Cognitive Behavioral Therapy), IBPP (individual psychology brief psychotherapy) and CBT + OLANZAPINE
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteItaly
- Study dates
- May 2010to May 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 35 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- eating disorders full diagnosis according to Diagnostic and Statistical Manual (DSM-IV)
- age between 15 and 35
- female gender
Who cannot join
- associated major psychiatric problems
- mental retardation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lack of Efficacy of Psychological and Pharmacological Treatments of Eating Disorders: Neurobiological Background
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.
- Conditions
- Anorexia Nervosa, Bulimia Nervosa
- Being tested
- CBT (Cognitive Behavioral Therapy), IBPP (individual psychology brief psychotherapy), CBT + OLANZAPINE, nutritional rehabilitation, delorazepam
- Medical subject headings
- Anorexia Nervosa, Bulimia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT (Cognitive Behavioral Therapy)Behavioural
It is a worldwide known form of psychotherapy for eating disorders
IBPP (individual psychology brief psychotherapy)Other
Also called B-APP: brief adlerian psychodynamic psychotherapy
It is a worldwide known form of psychotherapy for eating disorders
CBT + OLANZAPINEDrug
It is a worldwide known form of psychotherapy for eating disorders associated with a new antipsychotic with good efficacy on anorexia nervosa
nutritional rehabilitationDietary supplement
all patients were followed-up monthly with nutritionist and dietitian visits
delorazepamDrug
all patients were followed-up with psychiatric visits with symptomatic drug administration (tranquillizer: delorazepam) where necessary
| Study group | Role | What they receive |
|---|---|---|
| CBT (Cognitive Behavioral Therapy) | Active comparator | 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 Receives: Behavioral: CBT (Cognitive Behavioral Therapy); Dietary Supplement: nutritional rehabilitation; Drug: delorazepam |
| IBPP (IP brief psychotherapy ) | Active comparator | 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. Receives: Other: IBPP (individual psychology brief psychotherapy); Dietary Supplement: nutritional rehabilitation; Drug: delorazepam |
| CBT + OLANZAPINE (5 MG) | Active comparator | 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 Receives: Drug: CBT + OLANZAPINE; Dietary Supplement: nutritional rehabilitation; Drug: delorazepam |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in brain secretion of Dopamine at 6 months
plasma homovanillic acid (HVA) measured before and after the therapeutic intervention in each branch.
Measured: 6 months
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
Measured: 6 months
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.
Measured: 6 months
Secondary outcomes (6)
Eating Psychopathology improvement after treatments at 6 months
Eating Disorders Examination-12 (EDE 12)
Measured: 6 months
Depressive Psychopathology improvement after 6 months
Beck Depression Inventory (BDI)
Measured: 6 months
Anxiety improvement after 6 months
State-Trait Anxiety Index (STAI) Form-Y-1
Measured: 6 months
Impulsiveness improvement after 6 months
Barratt Impulsiveness Scale
Measured: 6 months
Self-rated Biochemical improvement after 6 months
Rosenberg Self-Biochemical Scale
Measured: 6 months
Personality improvement after 6 months
Temperament and Character Inventory (TCI)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2013 (estimated)
- Study startMay 2010
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Turin, Italy
- Sponsor type
- University, hospital or other
- Collaborators
- University of Milan
- Responsible party
- Principal investigator, Federico Amianto, University of Turin, Italy
- Investigators
- Federico Amianto, MD, PhD, Principal investigator, University of TorinoSecondo Fassino, MD, Study chair, University of Torino
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01990755
- Sponsor's protocol ID
- Brambilla trial
- Acronym
- NEDT
- Status last verified
- Nov 2013
- First submitted
- 24 Sep 2013
- Last updated
- 21 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Brambilla F, Amianto F, Dalle Grave R, Fassino S. Lack of efficacy of psychological and pharmacological treatments of disorders of eating behavior: neurobiological background. BMC Psychiatry. 2014 Dec 24;14:376. doi: 10.1186/s12888-014-0376-7.
PubMed 25539757
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lack of Efficacy of Psychological and Pharmacological Treatments of Eating Disorders: Neurobiological Background
- ClinicalTrials.gov ID
- NCT01990755
- Acronym / sponsor ID
- NEDT / Brambilla trial
- Conditions
- Anorexia Nervosa, Bulimia Nervosa
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Collaborators
- University of Milan
- Study start
- May 2010
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 21 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CBT (Cognitive Behavioral Therapy) | Active comparator | Behavioral: CBT (Cognitive Behavioral Therapy), Dietary Supplement: nutritional rehabilitation, Drug: delorazepamInvestigates 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 |
| IBPP (IP brief psychotherapy ) | Active comparator | Other: IBPP (individual psychology brief psychotherapy), Dietary Supplement: nutritional rehabilitation, Drug: delorazepamInvestigates 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. |
| CBT + OLANZAPINE (5 MG) | Active comparator | Drug: CBT + OLANZAPINE, Dietary Supplement: nutritional rehabilitation, Drug: delorazepamThe 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 |
Who may qualify
- Ages
- 15 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- eating disorders full diagnosis according to Diagnostic and Statistical Manual (DSM-IV)
- age between 15 and 35
- female gender
Key exclusion criteria (2 listed)
- associated major psychiatric problems
- mental retardation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBT (Cognitive Behavioral Therapy)It is a worldwide known form of psychotherapy for eating disorders | Behavioural | CBT (Cognitive Behavioral Therapy) |
| IBPP (individual psychology brief psychotherapy)Also: B-APP: brief adlerian psychodynamic psychotherapyIt is a worldwide known form of psychotherapy for eating disorders | Other | IBPP (IP brief psychotherapy ) |
| CBT + OLANZAPINEIt is a worldwide known form of psychotherapy for eating disorders associated with a new antipsychotic with good efficacy on anorexia nervosa | Drug | CBT + OLANZAPINE (5 MG) |
| nutritional rehabilitationall patients were followed-up monthly with nutritionist and dietitian visits | Dietary supplement | CBT (Cognitive Behavioral Therapy), CBT + OLANZAPINE (5 MG), IBPP (IP brief psychotherapy ) |
| delorazepamall patients were followed-up with psychiatric visits with symptomatic drug administration (tranquillizer: delorazepam) where necessary | Drug | CBT (Cognitive Behavioral Therapy), CBT + OLANZAPINE (5 MG), IBPP (IP brief psychotherapy ) |
Primary outcome
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.
6 secondary outcomes
Eating Psychopathology improvement after treatments at 6 months
Time frame: 6 months
Depressive Psychopathology improvement after 6 months
Time frame: 6 months
Anxiety improvement after 6 months
Time frame: 6 months
Impulsiveness improvement after 6 months
Time frame: 6 months
Self-rated Biochemical improvement after 6 months
Time frame: 6 months
Personality improvement after 6 months
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2013.
- Derived from this study: PubMed 25539757Brambilla F, Amianto F, Dalle Grave R, Fassino S. Lack of efficacy of psychological and pharmacological treatments of disorders of eating behavior: neurobiological background. BMC Psychiatry. 2014 Dec 24;14:376. doi: 10.1186/s12888-014-0376-7.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Federico Amianto, MD, PhD principal investigator
University of Torino
Secondo Fassino, MD study chair
University of Torino
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBT (Cognitive Behavioral Therapy), IBPP (individual psychology brief psychotherapy) and CBT + OLANZAPINE in people with Anorexia Nervosa and Bulimia Nervosa, run by University of Turin, Italy at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in brain secretion of Dopamine at 6 months (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01990755, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2013.