A Phase 1 interventional study of d-cycloserine and mifepristone in Anxiety Disorders, sponsored by Washington University School of Medicine. Terminated at 1 site in United States. Open to male participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-26.
Sponsored by Washington University School of Medicine · Phase 1, Interventional, and Treatment
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.
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).
4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.
This study's enrollment of 15 is below the median of 80 across 4,174 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →Washington University School of Medicine is the lead sponsor of 1,765 studies on the registry; 271 are open to participants now.
Of its 324 completed or terminated interventional studies of FDA-regulated products, 212 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
For Potential Participants suffering from Social Anxiety Disorder or Social Phobia:
Inclusion Criteria:
Exclusion Criteria:
For Control Group:
Inclusion Criteria:
Exclusion Criteria:
One time dosage of d-cycloserine and mifepristone at Session 2 prior to public speaking exposure sessions.
Drug: d-cycloserine and mifepristone
One time dosage of d-cycloserine and mifepristone at Session 2 prior to public speaking exposure sessions.
Drug: d-cycloserine and mifepristone
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
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.
Time frame: End of Session 2--(7-10 days after Session 1)
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)
Time frame: Session 2- 1st exposure therapy session, occurs 7-10 days after Session 1
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)
Time frame: Session 1- initial self reports collected;
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)
Time frame: Session 3- 2nd exposure therapy session- occurs 7- 10 days after Session 2
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)
Time frame: Session 4- 3rd exposure therapy- occurs 3 months later
This study is terminated, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Washington University School of Medicine