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Trial record 58 of 447 for:    diphenhydramine

Neural Response to Catecholamine Depletion in Subjects Suffering From Bulimia Nervosa in Their Past and Healthy Controls

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ClinicalTrials.gov Identifier: NCT02179814
Recruitment Status : Suspended (Conduct of the first analyses)
First Posted : July 2, 2014
Last Update Posted : January 24, 2019
Sponsor:
Collaborators:
University Hospital Inselspital, Berne
University of Zurich
Information provided by (Responsible Party):
University of Bern

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Bulimia Nervosa Eating Disorders Dopamine Reward Catechol-O-methyltransferase Drug: AMPT/ Demser Drug: Diphenhydramine Drug: Placebo Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Diagnostic
Official Title: Neuronal Correlates of Catecholamine Depletion in Patients With Bulimia Nervosa Off Medication and Healthy Controls
Actual Study Start Date : February 20, 2012
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2022


Arm Intervention/treatment
Experimental: AMPT

Experimental:

alpha-methyl-paratyrosine (AMPT, trade name: Demser), body-weight adjusted dosage (40 mg/kg body weight, maximum 4000mg) at 4 time points over 24 hours

Drug: AMPT/ Demser
alpha-methyl-paratyrosine (AMPT, trade name: Demser) body-weight adjusted dosage (40 mg/kg body weight, maximum 4000mg) at 4 medication intake time points over 24 hours

Sham Comparator: Diphenhydramine & placebo
Diphenhydramine (25mg, trade name in Switzerland: Benocten) at the first medication intake time point, placebo at the second to fourth intake time point (medication intake over 24 hours)
Drug: Diphenhydramine
Diphenhydramine (25mg) at the first medication intake time point
Other Name: Benocten (trade name in Switzerland)

Drug: Placebo
Placebo at the second, third and fourth medication intake time point




Primary Outcome Measures :
  1. Number of participants with side effects [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Performance differences in behavioral tasks after catecholamine depletion [ Time Frame: 4 years ]
  2. Differences in neural activation assessed during functional magnetic resonance imaging (fMRI) in the different conditions [ Time Frame: 4 years ]
  3. 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 [ Time Frame: 4 years ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02179814


Locations
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Switzerland
University Hospital of Psychiatry, University of Bern
Bern 60, Switzerland, 3000
Sponsors and Collaborators
University of Bern
University Hospital Inselspital, Berne
University of Zurich
Investigators
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Principal Investigator: Gregor Hasler, Prof. Dr. med University Hospital of Psychiatry, University of Bern

Publications:
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Responsible Party: University of Bern
ClinicalTrials.gov Identifier: NCT02179814     History of Changes
Other Study ID Numbers: 132/10
2011DR1011 ( Other Identifier: Swissmedic )
32003B_138264 / 1 ( Other Grant/Funding Number: SNF )
First Posted: July 2, 2014    Key Record Dates
Last Update Posted: January 24, 2019
Last Verified: January 2019
Keywords provided by University of Bern:
bulimia nervosa
dopamine
reward
catechol-O-methyltransferase
gene
catecholamines
alpha-methyl-para-tyrosine
magnetic resonance imaging
Additional relevant MeSH terms:
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Diphenhydramine
Promethazine
Sleep Aids, Pharmaceutical
Bulimia
Feeding and Eating Disorders
Bulimia Nervosa
Mental Disorders
Hyperphagia
Signs and Symptoms, Digestive
Signs and Symptoms
alpha-Methyltyrosine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Anesthetics
Sensory System Agents
Peripheral Nervous System Agents
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Allergic Agents
Antipruritics
Dermatologic Agents
Enzyme Inhibitors