Eating Disorders Clinical Trial
Official title:
Neuronal Correlates of Catecholamine Depletion in Patients With Bulimia Nervosa Off Medication and Healthy Controls
Verified date | January 2019 |
Source | University of Bern |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Bulimia nervosa is a severe psychiatric disorder characterized by recurrent binge eating
episodes followed by inappropriate compensatory behavior to prevent weight gain such as
self-induced vomiting. With this project, the investigators want to investigate the role of
the neurotransmitter dopamine in bulimia nervosa. Dopamine is reported to have an important
influence on the neural reward system and is involved in the processing of gains and losses.
The reward system is functionally connected to the individual perception of rewards in the
environment. A previous study revealed that under catecholamine depletion including dopamine
depletion women suffering from bulimia nervosa in their past reported mild bulimic symptoms
and their reward processing became dysfunctional: their ability to use rewarding stimuli for
task solving was diminished.
The aim of this study is to investigate the role of reduced dopamine availability in the
development or maintaining of bulimia nervosa and in the dysfunctional processing of
rewarding stimuli and negative visual information. Therefore, the investigators hypothesize
that catecholamine depletion achieved by oral administration of alpha-methyl-paratyrosine
(AMPT) will induce mild bulimic symptoms in females suffering from bulimia nervosa in their
past. In addition, they will reveal dysfunctions in reward and emotional processing under
catecholamine depletion. Using functional magnetic resonance imaging, the investigators
propose that a reduced activation of the nucleus accumbens, a neural structure of the reward
system, will be the neural correlate of this dysfunctional reward processing. Furthermore,
the amygdala, a neural structure that is involved in emotional processing, will show a higher
activation under catecholamine depletion. Genetic factors additionally have an influence on
the dopaminergic system. Therefore, the investigators hypothesize that genetic factors, for
example the COMT val-158-met polymorphism may have an effect on the behavioral and neural
response to catecholamine depletion. In sum, this investigation may help to understand which
changes in reward and emotional processing may lead to a reoccurrence of bulimic symptoms.
In future, the findings of this study may help to develop individual pharmacological and
psychotherapeutical interventions to enhance the outcome of treatment.
Status | Suspended |
Enrollment | 60 |
Est. completion date | May 2022 |
Est. primary completion date | May 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: - female - age: 18-60 - caucasian ethnicity - right handedness - normal or corrected to normal vision and hearing performance - remitted bulimic participants: have met the DSM IV criteria for bulimia nervosa in the past - remitted bulimic participants: have been asymptomatic for at least1 month - signed written informed consent Exclusion Criteria - healthy volunteers: any lifetime psychiatric diagnosis - healthy volunteers: any lifetime psychiatric diagnosis in first-degree relatives - no or impaired understanding of the tasks or the risks of the study - medical or neurological illnesses likely to affect physiology or anatomy - suicidal ideation or suicide attempts within the last 8 weeks - current use of psychotropic drugs - history of drug including alcohol and nicotine (not more than 10 cigarettes per day) abuse within 1 year or a lifetime history of alcohol or drug dependence (DSM IV criteria) longer than 2 years - asthma - glaucoma - pyloroduodenal obstruction (gastrointestinal stenosis) - current pregnancy - current breast feeding - cardiac pacemaker - heart or brain surgery - metallic implants and alien objects in the body - tattoos on head, neck or shoulders as well as permanent make-up - claustrophobia |
Country | Name | City | State |
---|---|---|---|
Switzerland | University Hospital of Psychiatry, University of Bern | Bern 60 |
Lead Sponsor | Collaborator |
---|---|
University of Bern | University Hospital Inselspital, Berne, University of Zurich |
Switzerland,
Grob S, Stern J, Gamper L, Moergeli H, Milos G, Schnyder U, Hasler G. Behavioral responses to catecholamine depletion in unmedicated, remitted subjects with bulimia nervosa and healthy subjects. Biol Psychiatry. 2015 Apr 1;77(7):661-7. doi: 10.1016/j.biopsych.2013.09.013. Epub 2013 Oct 25. — View Citation
Hasler G, Fromm S, Carlson PJ, Luckenbaugh DA, Waldeck T, Geraci M, Roiser JP, Neumeister A, Meyers N, Charney DS, Drevets WC. Neural response to catecholamine depletion in unmedicated subjects with major depressive disorder in remission and healthy subjects. Arch Gen Psychiatry. 2008 May;65(5):521-31. doi: 10.1001/archpsyc.65.5.521. — View Citation
Homan P, Grob S, Milos G, Schnyder U, Hasler G. Reduction in total plasma ghrelin levels following catecholamine depletion: relation to bulimic and depressive symptoms. Psychoneuroendocrinology. 2013 Sep;38(9):1545-52. doi: 10.1016/j.psyneuen.2012.12.024. Epub 2013 Jan 16. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of participants with side effects | 1 year | ||
Secondary | Performance differences in behavioral tasks after catecholamine depletion | 4 years | ||
Secondary | Differences in neural activation assessed during functional magnetic resonance imaging (fMRI) in the different conditions | 4 years | ||
Secondary | Differences in neural activation assessed during functional magnetic resonance imaging (fMRI) and in performance in behavioral tasks in the different conditions between the different genotypes | 4 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05656859 -
Prevalence of Eating Disorders Among Patients in the Department of Health Promotion
|
||
Completed |
NCT04085861 -
Mental Health in Dancers; an Intervention Study
|
N/A | |
Recruiting |
NCT05651295 -
A Precision Medicine Approach to Target Engagement for Emotion Regulation
|
N/A | |
Enrolling by invitation |
NCT04174703 -
Preparing for Eating Disorders Treatment Through Compassionate Letter-Writing
|
N/A | |
Terminated |
NCT04278755 -
Binge Eating & Birth Control
|
Phase 2 | |
Withdrawn |
NCT03050632 -
Effects of Cognitive and Emotional Functioning on Treatment Outcomes
|
N/A | |
Completed |
NCT02484794 -
Augmenting Specialty Eating Disorder Clinical Treatment With a Smartphone Application
|
N/A | |
Completed |
NCT02567890 -
Swedish Body Project for Prevention of Eating Disorders
|
N/A | |
Completed |
NCT02252822 -
Improving Treatment Engagement for Adolescents With Bulimia Nervosa
|
N/A | |
Completed |
NCT02021344 -
Mental Health First Aid for College Students
|
N/A | |
Completed |
NCT00601354 -
Adding Guided Self-Help Group Therapy to the Alli Weight Loss Program in Treating Binge Eating Disorder
|
N/A | |
Completed |
NCT00418977 -
Comparing the Effectiveness of Two Therapies to Treat Signs of Anorexia Nervosa in Adolescents
|
N/A | |
Completed |
NCT00304187 -
Effectiveness of Antibiotic Treatment for Reducing Binge Eating and Improving Digestive Function in Bulimia Nervosa
|
Phase 2 | |
Completed |
NCT00733525 -
Effectiveness of Stepped Care Versus Best Available Care for Bulimia Nervosa
|
N/A | |
Active, not recruiting |
NCT04779216 -
Effects of Romosozumab on Bone Density in Women With Anorexia Nervosa
|
Phase 3 | |
Completed |
NCT04433663 -
Eating Disorders, Self Regulation and Mentalization
|
N/A | |
Recruiting |
NCT05509257 -
Naltrexone Neuroimaging in Teens With Eating Disorders
|
Early Phase 1 | |
Completed |
NCT04509531 -
Building Resilience in Cyberbullying Victims
|
N/A | |
Recruiting |
NCT05730348 -
Mealtime Anxiety in Eating Disorders
|
||
Enrolling by invitation |
NCT05814653 -
A Study to Evaluate Primary Care Treatment for Adolescent Eating Disorders
|
N/A |