Medication Enhanced Rapid Therapy

• Status: Suspended
• Trial end date: 2022-08-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Washington University School of Medicine
• Treatments: Cycloserine; Mifepristone

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