Medication Enhanced Rapid Therapy

NCT02099825 | Terminated Phase 1

• 1 other identifier: 201306084
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to determine whether taking a one-time dose of a combination of putatively learning-enhancing medications can improve treatment response to a brief learning-based psychotherapy for public speaking anxiety. The two medications are (1) d-cycloserine (DCS), a medication that is an agonist (facilitator) of the NMDA glutamatergic receptor and has been shown in previous studies to facilitate some kinds of learning and memory; and (2) mifepristone, a medication that blocks cortisol, and in preclinical (animal) studies has been shown to reverse certain kinds of stress-related learning impairment or negative learning. Specifically, the investigators goal is to determine if DCS and mifepristone taken together augment the learning that occurs during a brief psychotherapy session---a public speaking exposure exercise. Evidence for this learning effect would be a finding that participants have reduced anxiety at subsequent public speaking exposures.

Conditions

Anxiety Disorders

Keywords

adult male; anxiety; public speaking; healthy controls; exposure therapy; social anxiety; mifepristone; d-cycloserine

Outcome Measures

Primary Outcomes (1)

• Will measure medication tolerability and safety per participant report (i.e. few or no side effects severe enough to stop treatment)

  As measured by a self-reported side effects assessment conducted at this time point entitled: "Spontaneous Reports of Side Effects". This assessment will measure any reports of side effects as well as tolerability.

  End of Session 2--(7-10 days after Session 1)

Secondary Outcomes (4)

• Improvements in Anxiety as measured by several Self Report Assessments

  Session 2- 1st exposure therapy session, occurs 7-10 days after Session 1

• Level of Anxiety as measured by several Self Report Assessments

  Session 1- initial self reports collected;

• Improvements in Anxiety as measured by several Self Report Assessments

  Session 3- 2nd exposure therapy session- occurs 7- 10 days after Session 2

• Improvements in Anxiety as measured by several Self Report Assessments

  Session 4- 3rd exposure therapy- occurs 3 months later

Study Arms (2)

Anxious Adult Males

EXPERIMENTAL

One time dosage of d-cycloserine and mifepristone at Session 2 prior to public speaking exposure sessions.

Drug: d-cycloserine and mifepristone

Non-Anxious Adult Males

ACTIVE COMPARATOR

One time dosage of d-cycloserine and mifepristone at Session 2 prior to public speaking exposure sessions.

Drug: d-cycloserine and mifepristone

Interventions

d-cycloserine and mifepristone DRUG

All participants will receive a one-time only dose of both, d-cycloserine and mifepristone at Session 2

Also known as: mifepristone, Mifeprex, RU-486, one dose of up to 1200 mg, d-cycloserine, Seromycin, one dose of 250 mg

Anxious Adult Males; Non-Anxious Adult Males

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male
• at least 18 years old
• current diagnosis of Social Anxiety Disorder or Social Phobia
• fear of public speaking
• medically stable and in good health
• if currently taking antidepressant treatment, must be on a stable dose for at least 8 weeks
• Liebowitz Social Anxiety Scale score of at least 30

You may not qualify if:

• Female
• inability to provide informed consent
• current or lifetime diagnosis of bipolar disorder, psychotic disorder or eating disorder
• current substance abuse or dependence within the last 6 months
• any cognitive, sensory, or communication problem that would prevent completion of the study
• severe mental health symptoms that require immediate treatment (i.e. active suicidality)
• current use of medication for diagnosis of one or more of the following: seizure disorder, kidney disease, liver disease
• current cancer (or history of metastatic cancer)
• current or recent use (within past 3 months) of systemic corticosteroids
• diabetic individuals
• untreated or unstable endocrinologic disease (i.e. hyperthyroidism)
• lifetime history of Cushing's disease or Addison's disease
• For Control Group:
• Male
• at least 18 years old

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Speech

Interventions

Cycloserine; Mifepristone

Condition Hierarchy (Ancestors)

Mental Disorders; Verbal Behavior; Communication; Behavior

Intervention Hierarchy (Ancestors)

Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Oxazolidinones; Oxazoles; Serine; Amino Acids, Neutral; Amino Acids; Amino Acids, Peptides, and Proteins; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Eric J Lenze, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry

Study Record Dates

• First Submitted: March 19, 2014
• First Posted: March 31, 2014
• Study Start: January 13, 2014
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2022
• Last Updated: April 26, 2023

Record last verified: 2023-04

Locations

US (1)