Isoproterenol for Anorexia Nervosa

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Laureate Institute for Brain Research, Tulsa, OK
Anorexia Nervosa+1 More
Isoproterenol - Drug
Eligibility
18 - 65
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a new treatment approach might help people with anorexia nervosa.

See full description

Eligible Conditions

  • Anorexia Nervosa

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Isoproterenol will improve 2 primary outcomes and 4 secondary outcomes in patients with Anorexia Nervosa. Measurement will happen over the course of Immediately after drug/placebo infusion.

Immediately after drug/placebo infusion
Anxiety
Anxiety sensitivity index
Inventory of Depression and Anxiety
Multidimensional Assessment of Interoceptive Awareness
Positive and Negative Affect
Sensation intensity

Trial Safety

Safety Estimate

1 of 3

Side Effects for

Adenosine and Isoproterenol
Site hematoma
3%
Pericardial Effusion
2%
A V Fistula
2%
Transient phrenic nerve paralysis
0%
This histogram enumerates side effects from a completed 2015 Phase 2 trial (NCT03032965) in the Adenosine and Isoproterenol ARM group. Side effects include: Site hematoma with 3%, Pericardial Effusion with 2%, A V Fistula with 2%, Transient phrenic nerve paralysis with 0%.

Trial Design

2 Treatment Groups

Anorexia nervosa-study drug
1 of 2
Anorexia nervosa-placebo
1 of 2
Experimental Treatment
Non-Treatment Group

This trial requires 25 total participants across 2 different treatment groups

This trial involves 2 different treatments. Isoproterenol is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are not being studied for commercial purposes.

Anorexia nervosa-study drug
Drug
Drug: Isoproterenol Intravenous infusions of isoproterenol, delivered in a randomized double blinded order, in each participant. The isoproterenol dose will range from 0.1 micrograms to 4.0 micrograms and exposure during each visit will not exceed 25.0 micrograms. Participants will rate the experience of heartbeat and breathing sensations as well as anxiety induced by the infusion. Other Names: Isuprel
Anorexia nervosa-placebo
Other
Drug: Normal Saline Intravenous infusions of normal saline, delivered in a randomized double blinded order, in each participant. Participants will rate the experience of heartbeat and breathing sensations as well as anxiety induced by the infusion. Other Names: Saline
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Isoprenaline
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: immediately after drug/placebo infusion
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly immediately after drug/placebo infusion for reporting.

Closest Location

Laureate Institute for Brain Research - Tulsa, OK

Eligibility Criteria

This trial is for patients born any sex between 18 and 65 years old. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
The participant must be able to read, write and understand English in order to complete the study procedures. show original
People aged 18 to 40 who have Anorexia Nervosa, or have an Eating Disorder Screen (SCOFF) score ≥ 2 and a current BMI of 17 or greater, may participate in the study show original
The subject must be able to complete all tasks during each session of the experiment. show original
People who want to use the machine must have a body mass index between 17 and 35 kg/m². show original

Patient Q&A Section

What causes anorexia nervosa?

"The lack of a strong biological cause for AN is consistent with the existence of other psychiatric disorders, including BN, with more biological explanations of the etiology of anorexia nervosa." - Anonymous Online Contributor

Unverified Answer

Can anorexia nervosa be cured?

"The degree to which anorexia is associated with bulimic symptoms is a significant predictor of remission of depressive symptoms among women. However, many women who report bulimic and anorexic symptomatology have never experienced either full-blown anorexia nervosa or bulimia nervosa. It appears, therefore, that at least part of the symptomatology of anorexia nervosa is independent of the full-blown form. Further research is required to evaluate whether these findings are due to sampling bias or whether they apply to women with full-blown or subthreshold anorexia nervosa." - Anonymous Online Contributor

Unverified Answer

How many people get anorexia nervosa a year in the United States?

"About 25,000 cases of anorexia nervosa are diagnosed a year in the United States. Eating disorders remain highly comorbid in both inpatient and outpatient populations." - Anonymous Online Contributor

Unverified Answer

What are common treatments for anorexia nervosa?

"The treatments for AN are largely based on the assumption that the disorders are related to some underlying abnormality such as disordered eating and interpersonal motivation. Given that anorexia continues to be highly stigmatising in the modern socio-cultural context, future research is needed into the effectiveness of treatments for anorexia that do not assume a 'causative' aetiology in relation to social factors." - Anonymous Online Contributor

Unverified Answer

What are the signs of anorexia nervosa?

"Symptoms of anorexia nervosa typically appear when patients are young, around the age of 15 years. They include weight loss, fatigue, or the feeling that one is too thin. If the symptoms persist, the problem may be more serious, as individuals with anorexia have an increased risk of experiencing some consequences of starvation, such as depression, low birth weight, or death. Patients can therefore be questioned about physical anomalies, such as low body mass index (BMI), hair loss, and/or dental abnormalities. Other signs of the disease are loss of appetite, anxiety, and bulimia, as well as fear of gaining weight or being fat. There is also evidence of binge eating and eating disorders." - Anonymous Online Contributor

Unverified Answer

What is anorexia nervosa?

"The DSM-III was the first diagnosis classification in AN, but there was controversy from the psychiatric society in the inclusion criteria of AN. Most of the people suffering from AN, however, are not recognized by psychiatric health system, and many are not even recognized by medical health system. AN is highly under-recognized disorder, and we need to revise the diagnostic criteria of AN in the future." - Anonymous Online Contributor

Unverified Answer

Does isoproterenol improve quality of life for those with anorexia nervosa?

"Isoproterenol as a first-generation beta-adrenoceptor agonist improved HRQoL in both ANR and ANL, but further research is needed to clarify whether isoproterenol as an additional treatment agent would improve HRQoL in patients with AN." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in isoproterenol for therapeutic use?

"Today, isoproterenol is no longer the drug of choice, but newer drugs are available. It is very important that any future randomized, placebo-controlled trials consider isoproterenol and compare them with the most recent medications." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating anorexia nervosa?

"It seems that patients do fare better if they have their weight normalized as early as possible and the disorder is diagnosed as early as possible. Current psychotherapies are only slightly more effective than the 'no treatment' group, and the benefits are limited to long-term recovery. To date, no drug has been proven effective in treating the disorder; therefore, the use of psychotropic drugs remains the mainstay of treatment against AN." - Anonymous Online Contributor

Unverified Answer

What does isoproterenol usually treat?

"Isoproterenol is useful for the relief of chest pain for patients suffering from anorexia nervosa. It also inhibits the release of epinephrine in the case of the release of increased level of epinephrine in the condition." - Anonymous Online Contributor

Unverified Answer

Is isoproterenol safe for people?

"Although Ioproterenol is widely used in anorexia nervosa due to symptoms similar to the typical symptoms of angina, there are very few, if any, randomized studies regarding its safety. Furthermore, there are very few recorded cases of cardiopulmonary arrest without any other serious illnesses associated with the use of beta blockers. Thus, there is no evidence indicating that the use of isoproterenol is associated with a higher risk of death or serious injury. The benefits should be weighed against the risks of using beta blockers with this population." - Anonymous Online Contributor

Unverified Answer

How serious can anorexia nervosa be?

"We found that about one in every five people with the disease dies from it. If [anorexia nervosa's consequences can be severe] it is time for you and your doctor to know enough about the disease [to manage it properly]." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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