Medication Enhanced Rapid Therapy

NCT ID: NCT02099825

Last Updated: 2023-04-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-13
• Study Completion Date: 2022-10-31

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).

1. 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.

2. 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. (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.

Conditions

Anxiety Disorders

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Anxious Adult Males

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

Group Type: EXPERIMENTAL

d-cycloserine and mifepristone

Intervention Type: DRUG

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

Non-Anxious Adult Males

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

Group Type: ACTIVE_COMPARATOR

d-cycloserine and mifepristone

Intervention Type: DRUG

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

Interventions

d-cycloserine and mifepristone

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

Intervention Type: DRUG

Other Intervention Names

mifepristone; Mifeprex; RU-486; one dose of up to 1200 mg; d-cycloserine; Seromycin; one dose of 250 mg

Eligibility Criteria

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

• 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

For Control Group:

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Eric Lenze

Professor of Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eric J Lenze, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Washington University School of Medicine

St Louis, Missouri, United States

Countries

United States

Other Identifiers

201306084

Identifier Type: -

Identifier Source: org_study_id