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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anxious Adult Males | Experimental | One time dosage of d-cycloserine and mifepristone at Session 2 prior to public speaking exposure sessions. |
|
| Non-Anxious Adult Males | Active Comparator | One time dosage of d-cycloserine and mifepristone at Session 2 prior to public speaking exposure sessions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| d-cycloserine and mifepristone | Drug | All participants will receive a one-time only dose of both, d-cycloserine and mifepristone at Session 2 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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For Potential Participants suffering from Social Anxiety Disorder or Social Phobia:
Inclusion Criteria:
Exclusion Criteria:
For Control Group:
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric J Lenze, MD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D013060 | Speech |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D014705 | Verbal Behavior |
| D003142 | Communication |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D003523 | Cycloserine |
| D015735 | Mifepristone |
| ID | Term |
|---|---|
| D007555 | Isoxazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
| 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) | 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) | 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) | Session 4- 3rd exposure therapy- occurs 3 months later |
| D023303 |
| Oxazolidinones |
| D010080 | Oxazoles |
| D012694 | Serine |
| D021542 | Amino Acids, Neutral |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |