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Medication Enhanced Rapid Therapy (MERiT)

Primary Purpose

Anxiety Disorders

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
d-cycloserine and mifepristone
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety Disorders focused on measuring adult male, anxiety, public speaking, healthy controls, exposure therapy, social anxiety, mifepristone, d-cycloserine

Eligibility Criteria

18 Years - 55 Years (Adult)MaleAccepts Healthy Volunteers

For Potential Participants suffering from Social Anxiety Disorder or Social Phobia:

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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:

Inclusion Criteria:

  • Male
  • at least 18 years old
  • no current diagnosis of Social Anxiety Disorder or Social Phobia
  • reports no fear of public speaking
  • Liebowitz Social Anxiety Scale score below or equal to 29

Exclusion Criteria:

  • 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

Sites / Locations

  • Washington University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Anxious Adult Males

Non-Anxious Adult Males

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Improvements in Anxiety as measured by several Self Report Assessments
Will measure CHANGES in anxiety level from 1st session to 2nd session as reported in the following self reports: Liebowitz Social Anxiety Scale (LSAS) Brief Resilient Coping Scale (BRCS) Post Event Processing Measure (PEP)-done at beginning of sessions 1, 3 and 4 (to reflect back on previous social engagements), and after speeches delivered at sessions 2, 3, and 4. Subjective Units of Distress Scale 0-100(SUDS 0-100) Social Interaction Anxiety Scale (SIAS) Social Phobia Scale (SPS) Subtle Avoidance Frequency Examination (SAFE) Positive and Negative Affect Scale (PANAS)
Level of Anxiety as measured by several Self Report Assessments
Will measure initial anxiety level at Session 1 as reported in the following self reports: Liebowitz Social Anxiety Scale (LSAS) Brief Resilient Coping Scale (BRCS) Social Interaction Anxiety Scale (SIAS) Social Phobia Scale (SPS) Subtle Avoidance Frequency Examination (SAFE) Positive and Negative Affect Scale (PANAS)
Improvements in Anxiety as measured by several Self Report Assessments
Will measure CHANGES in anxiety level from 2nd session to 3rd session as reported in the following self reports: Liebowitz Social Anxiety Scale (LSAS) Brief Resilient Coping Scale (BRCS) Post Event Processing Measure (PEP)-done at beginning of sessions 1, 3 and 4 (to reflect back on previous social engagements), and after speeches delivered at sessions 2, 3, and 4. Social Interaction Anxiety Scale (SIAS) Social Phobia Scale (SPS) Subtle Avoidance Frequency Examination (SAFE) Positive and Negative Affect Scale (PANAS) Perception of Speech Performance (PSP)- done at beginning of sessions 3 and 4 (to reflect back on previous speech/ previous session), and after speeches delivered at sessions 2, 3, and 4. Subjective Units of Distress Scale 0-100(SUDS 0-100)
Improvements in Anxiety as measured by several Self Report Assessments
Will measure CHANGES in anxiety level from 3rd session to 4th session as reported in the following self reports: Liebowitz Social Anxiety Scale (LSAS) Brief Resilient Coping Scale (BRCS) Post Event Processing Measure (PEP)-done at beginning of sessions 1, 3 and 4 (to reflect back on previous social engagements), and after speeches delivered at sessions 2, 3, and 4. Social Interaction Anxiety Scale (SIAS) Social Phobia Scale (SPS) Subtle Avoidance Frequency Examination (SAFE) Positive and Negative Affect Scale (PANAS) Perception of Speech Performance (PSP)- done at beginning of sessions 3 and 4 (to reflect back on previous speech/ previous session), and after speeches delivered at sessions 2, 3, and 4. Subjective Units of Distress Scale 0-100(SUDS 0-100)

Full Information

First Posted
March 19, 2014
Last Updated
April 24, 2023
Sponsor
Washington University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT02099825
Brief Title
Medication Enhanced Rapid Therapy
Acronym
MERiT
Official Title
Medication Enhanced Rapid Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Terminated
Why Stopped
COVID and staffing issues
Study Start Date
January 13, 2014 (Actual)
Primary Completion Date
October 2022 (Actual)
Study Completion Date
October 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Washington University School of Medicine

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The study has a total of 4 visits, and the medications are given as a one-time dose at only one visit (the second visit). During the first visit, a trained clinical interviewer will provide informed consent and conduct a structured clinical interview. Participants will be included if they are adult males diagnosed with social anxiety disorder and express a fear of public speaking, as well as approximately 10 healthy control participants. Eligible participants will be asked to complete self-report ratings of social anxiety and psychological symptoms and a standard interview about anxiety symptoms. The experimenter will conduct neuropsychological tests used to measure the participant's cognitive functioning. At the second visit the participant will be administered a one-time only dosage of both medications. The participant will be asked to prepare a speech within a short period of time, this is an example of exposure therapy. In exposure therapy, people are exposed to a situation they fear, such as public speaking, in a safe and controlled environment. Often when people do exposure therapy, they find that the situations they have been afraid of are not actually as scary as they seem. The exposure exercise in this study will consist of giving a speech while being video-recorded. Before the exposure exercise, participants will be provided with 250mg DCS and up to 1200mg of mifepristone. Participants will rate their anxiety level and negative and positive affect before and after the speech, as well as during the speech. The experimenter will again conduct neuropsychological tests used to measure the participant's cognitive functioning. (3) & (4) During the next two visits, participants will complete a second and third public speaking exposure exercise identical to the first, with the exception that they will NOT receive medication. Participants will complete a similar battery of symptom measures and anxiety ratings. The investigators will look at a change in anxiety ratings and symptomatology between exposure session 1, exposure session 2, and exposure session 3.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorders
Keywords
adult male, anxiety, public speaking, healthy controls, exposure therapy, social anxiety, mifepristone, d-cycloserine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Anxious Adult Males
Arm Type
Experimental
Arm Description
One time dosage of d-cycloserine and mifepristone at Session 2 prior to public speaking exposure sessions.
Arm Title
Non-Anxious Adult Males
Arm Type
Active Comparator
Arm Description
One time dosage of d-cycloserine and mifepristone at Session 2 prior to public speaking exposure sessions.
Intervention Type
Drug
Intervention Name(s)
d-cycloserine and mifepristone
Other Intervention Name(s)
mifepristone, Mifeprex, RU-486, one dose of up to 1200 mg, d-cycloserine, Seromycin, one dose of 250 mg
Intervention Description
All participants will receive a one-time only dose of both, d-cycloserine and mifepristone at Session 2
Primary Outcome Measure Information:
Title
Will measure medication tolerability and safety per participant report (i.e. few or no side effects severe enough to stop treatment)
Description
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.
Time Frame
End of Session 2--(7-10 days after Session 1)
Secondary Outcome Measure Information:
Title
Improvements in Anxiety as measured by several Self Report Assessments
Description
Will measure CHANGES in anxiety level from 1st session to 2nd session as reported in the following self reports: Liebowitz Social Anxiety Scale (LSAS) Brief Resilient Coping Scale (BRCS) Post Event Processing Measure (PEP)-done at beginning of sessions 1, 3 and 4 (to reflect back on previous social engagements), and after speeches delivered at sessions 2, 3, and 4. Subjective Units of Distress Scale 0-100(SUDS 0-100) Social Interaction Anxiety Scale (SIAS) Social Phobia Scale (SPS) Subtle Avoidance Frequency Examination (SAFE) Positive and Negative Affect Scale (PANAS)
Time Frame
Session 2- 1st exposure therapy session, occurs 7-10 days after Session 1
Title
Level of Anxiety as measured by several Self Report Assessments
Description
Will measure initial anxiety level at Session 1 as reported in the following self reports: Liebowitz Social Anxiety Scale (LSAS) Brief Resilient Coping Scale (BRCS) Social Interaction Anxiety Scale (SIAS) Social Phobia Scale (SPS) Subtle Avoidance Frequency Examination (SAFE) Positive and Negative Affect Scale (PANAS)
Time Frame
Session 1- initial self reports collected;
Title
Improvements in Anxiety as measured by several Self Report Assessments
Description
Will measure CHANGES in anxiety level from 2nd session to 3rd session as reported in the following self reports: Liebowitz Social Anxiety Scale (LSAS) Brief Resilient Coping Scale (BRCS) Post Event Processing Measure (PEP)-done at beginning of sessions 1, 3 and 4 (to reflect back on previous social engagements), and after speeches delivered at sessions 2, 3, and 4. Social Interaction Anxiety Scale (SIAS) Social Phobia Scale (SPS) Subtle Avoidance Frequency Examination (SAFE) Positive and Negative Affect Scale (PANAS) Perception of Speech Performance (PSP)- done at beginning of sessions 3 and 4 (to reflect back on previous speech/ previous session), and after speeches delivered at sessions 2, 3, and 4. Subjective Units of Distress Scale 0-100(SUDS 0-100)
Time Frame
Session 3- 2nd exposure therapy session- occurs 7- 10 days after Session 2
Title
Improvements in Anxiety as measured by several Self Report Assessments
Description
Will measure CHANGES in anxiety level from 3rd session to 4th session as reported in the following self reports: Liebowitz Social Anxiety Scale (LSAS) Brief Resilient Coping Scale (BRCS) Post Event Processing Measure (PEP)-done at beginning of sessions 1, 3 and 4 (to reflect back on previous social engagements), and after speeches delivered at sessions 2, 3, and 4. Social Interaction Anxiety Scale (SIAS) Social Phobia Scale (SPS) Subtle Avoidance Frequency Examination (SAFE) Positive and Negative Affect Scale (PANAS) Perception of Speech Performance (PSP)- done at beginning of sessions 3 and 4 (to reflect back on previous speech/ previous session), and after speeches delivered at sessions 2, 3, and 4. Subjective Units of Distress Scale 0-100(SUDS 0-100)
Time Frame
Session 4- 3rd exposure therapy- occurs 3 months later

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
For Potential Participants suffering from Social Anxiety Disorder or Social Phobia: Inclusion Criteria: 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 Exclusion Criteria: 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: Inclusion Criteria: Male at least 18 years old no current diagnosis of Social Anxiety Disorder or Social Phobia reports no fear of public speaking Liebowitz Social Anxiety Scale score below or equal to 29 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric J Lenze, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

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Medication Enhanced Rapid Therapy

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