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Isoproterenol + Normal saline for Anorexia Nervosa

N/A
Waitlist Available
Led By Sahib S Khalsa, MD, PhD
Research Sponsored by Laureate Institute for Brain Research, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline
Awards & highlights

Study Summary

This trial will help doctors understand how different human illnesses affect the same interoceptive sensations, and identify core underlying neural processes.

Eligible Conditions
  • Traumatic Brain Injury
  • Generalized Anxiety Disorder
  • Anorexia Nervosa
  • Depression
  • Panic Disorder

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in cardiorespiratory sensation intensity
Secondary outcome measures
Change in anxiety level
Eating disorder severity (Eating Disorder Examination scale)
Generalized anxiety disorder severity (Generalized Anxiety Disorder 7 scale)
+2 more
Other outcome measures
Change in breathing pattern
Change in heart rate
EEG (coherence in alpha, beta, theta, delta, gamma frequencies, in Hertz (Hz))
+8 more

Side effects data

From 2015 Phase 2 trial • 131 Patients • NCT03032965
3%
Site hematoma
2%
Pericardial Effusion
2%
A V Fistula
100%
80%
60%
40%
20%
0%
Study treatment Arm
Adenosine and Isoproterenol
Isoproterenol

Trial Design

6Treatment groups
Experimental Treatment
Active Control
Group I: Panic disorderExperimental Treatment2 Interventions
Intravenous bolus infusions of isoproterenol (up to 4 micrograms per infusion) and normal saline.
Group II: Major depressive disorderExperimental Treatment2 Interventions
Intravenous bolus infusions of isoproterenol (up to 4 micrograms per infusion) and normal saline.
Group III: Generalized anxiety disorderExperimental Treatment2 Interventions
Intravenous bolus infusions of isoproterenol (up to 4 micrograms per infusion) and normal saline.
Group IV: Brain injuryExperimental Treatment2 Interventions
Intravenous bolus infusions of isoproterenol (up to 4 micrograms per infusion) and normal saline.
Group V: Anorexia nervosaExperimental Treatment2 Interventions
Intravenous bolus infusions of isoproterenol (up to 4 micrograms per infusion) and normal saline.
Group VI: Healthy comparisonActive Control2 Interventions
Intravenous bolus infusions of isoproterenol (up to 4 micrograms per infusion) and normal saline.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Isoproterenol
2015
Completed Phase 3
~22740
Normal saline
2013
Completed Phase 4
~2090

Find a Location

Who is running the clinical trial?

Laureate Institute for Brain Research, Inc.Lead Sponsor
50 Previous Clinical Trials
5,248 Total Patients Enrolled
National Institute of Mental Health (NIMH)NIH
2,784 Previous Clinical Trials
2,689,178 Total Patients Enrolled
Sahib S Khalsa, MD, PhDPrincipal InvestigatorLaureate Institute for Brain Research
2 Previous Clinical Trials
46 Total Patients Enrolled

Media Library

Isoproterenol Clinical Trial Eligibility Overview. Trial Name: NCT02615119 — N/A
Traumatic Brain Injury Research Study Groups: Brain injury, Anorexia nervosa, Generalized anxiety disorder, Panic disorder, Major depressive disorder, Healthy comparison
Traumatic Brain Injury Clinical Trial 2023: Isoproterenol Highlights & Side Effects. Trial Name: NCT02615119 — N/A
Isoproterenol 2023 Treatment Timeline for Medical Study. Trial Name: NCT02615119 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants has the research team recruited for this program?

"At present, this clinical trial is not accepting new participants. Initially posted in October 2015 and last updated April 2022, a search for other trials related to anorexia nervosa yields 2250 prospective studies while 3 trials are actively searching for volunteers to test Isoproterenol's efficacy."

Answered by AI

In what scenarios is Isoproterenol often administered?

"Isoproterenol is traditionally prescribed to treat brusgada syndrome, but has also been seen as a viable treatment for pacemaker dependence, beta blocker overdose and tilt-table test."

Answered by AI

What other scientific investigations have been conducted with Isoproterenol?

"At present, there are 3 investigations utilizing Isoproterenol; none have reached Phase 3. Tulsa, Oklahoma is the primary site for these trials, but other locations around the country are also hosting experiments with this medication."

Answered by AI

Are there still vacancies available for enrolment in this trial?

"Unfortunately, the medical trial is not recruiting any new patients. Initially posted in October of 2015 with its last update on April 4th 2022, this study has since been superseded by over 2 thousand other studies that are still actively seeking volunteers."

Answered by AI

Who is eligible to take part in this experiment?

"To be enrolled in this medical trial, patients must fit the following criteria: between 18 and 55 years of age; meet DSM 5 standards for anorexia nervosa; have a history of major depressive disorder, generalized anxiety disorder, panic attack, or brain injury caused by either Urbach-Wiethe disease or herpes simplex encephalitis. Altogether 302 people will partake in the study."

Answered by AI

Are minors being included in the experiment?

"Patients between the ages of 18 and 55 are eligible to participate in this clinical trial. There exist 488 trials for minors below 18 years old, while 1541 studies accommodate seniors above 65."

Answered by AI
Recent research and studies
JAMA PsychiatryJournal
Association of Generalized Anxiety Disorder with Autonomic Hypersensitivity and Blunted Ventromedial Prefrontal Cortex Activity During Peripheral Adrenergic Stimulation
Teed, Adam R., Justin S. Feinstein, Maria Puhl, Rachel C. Lapidus, Valerie Upshaw, Rayus T. Kuplicki, Jerzy Bodurka, et al.. 2022. “Association of Generalized Anxiety Disorder with Autonomic Hypersensitivity and Blunted Ventromedial Prefrontal Cortex Activity During Peripheral Adrenergic Stimulation”. JAMA Psychiatry. American Medical Association (AMA). doi:10.1001/jamapsychiatry.2021.4225.
JAMA PsychiatryJournal
Association of Generalized Anxiety Disorder with Autonomic Hypersensitivity and Blunted Ventromedial Prefrontal Cortex Activity During Peripheral Adrenergic Stimulation
Teed, Adam R., Justin S. Feinstein, Maria Puhl, Rachel C. Lapidus, Valerie Upshaw, Rayus T. Kuplicki, Jerzy Bodurka, et al.. 2022. “Association of Generalized Anxiety Disorder with Autonomic Hypersensitivity and Blunted Ventromedial Prefrontal Cortex Activity During Peripheral Adrenergic Stimulation”. JAMA Psychiatry. American Medical Association (AMA). doi:10.1001/jamapsychiatry.2021.4225.
clinicaltrials.govStudy
Neural Basis of Meal Related Interoceptive Dysfunction in Anorexia Nervosa
2015. "Neural Basis of Meal Related Interoceptive Dysfunction in Anorexia Nervosa". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02615119.
~10 spots leftby Apr 2025
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