NCT01990755: NEDT

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

Completed NA Last updated 15 November 2013

What this trial tests

NA trial testing CBT (Cognitive Behavioral Therapy) in Anorexia Nervosa in 112 participants. Completed in 1 May 2013.

Timeline

1 May 2010

Primary endpoint
1 May 2013

1 May 2013

Quick facts

Lead sponsor	University of Turin, Italy
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	112
Start date	1 May 2010
Primary completion	1 May 2013
Estimated completion	1 May 2013
Sites	1 location across Italy

Drugs / interventions tested

• CBT (Cognitive Behavioral Therapy)
• IBPP (individual psychology brief psychotherapy)
• CBT + OLANZAPINE — full drug profile →
• nutritional rehabilitation
• delorazepam (DELORAZEPAM) — full drug profile →

Conditions studied

• Anorexia Nervosa — all drugs for Anorexia Nervosa →
• Bulimia Nervosa — all drugs for Bulimia Nervosa →

Sponsor

University of Turin, Italy

Who can join

Adults 15 to 35, female only, with Anorexia Nervosa or Bulimia Nervosa. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Lack of efficacy of psychological and pharmacological treatments of disorders of eating behavior: neurobiological background.
   Brambilla F, Amianto F, Dalle Grave R, Fassino S. · · 2014 · cited 11× · PMID 25539757 · DOI 10.1186/s12888-014-0376-7