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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline
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 moreOther outcome measures
Change in breathing pattern
Change in heart rate
EEG (coherence in alpha, beta, theta, delta, gamma frequencies, in Hertz (Hz))
+8 moreSide effects data
From 2015 Phase 2 trial • 131 Patients • NCT030329653%
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
51 Previous Clinical Trials
5,328 Total Patients Enrolled
National Institute of Mental Health (NIMH)NIH
2,798 Previous Clinical Trials
2,660,821 Total Patients Enrolled
Sahib S Khalsa, MD, PhDPrincipal InvestigatorLaureate Institute for Brain Research
2 Previous Clinical Trials
46 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been diagnosed with schizophrenia or other psychotic disorders according to DSM 5.You are currently thinking about harming yourself and have a plan to do so.You currently have a heart rhythm problem.You currently have a respiratory illness.You have a history of seizures.You have metal objects in your body, such as a pacemaker, or have had certain types of surgery, which can interfere with the MRI scan.You have been diagnosed with anorexia nervosa according to the DSM 5 and are between 18 and 40 years old.You have been diagnosed with bipolar and related disorders according to the DSM 5.You have been diagnosed with antisocial personality disorder according to the DSM 5.You have been diagnosed with generalized anxiety disorder according to the DSM 5.You meet the criteria for panic disorder according to the DSM 5.You have been diagnosed with major depressive disorder according to the DSM 5 guidelines.You have a brain injury caused by certain medical conditions.
Research Study Groups:
This trial has the following groups:- Group 1: Brain injury
- Group 2: Anorexia nervosa
- Group 3: Generalized anxiety disorder
- Group 4: Panic disorder
- Group 5: Major depressive disorder
- Group 6: Healthy comparison
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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