Anxiety DisordersPhase 1MERiTNCT02099825
Medication Enhanced Rapid Therapy
A Phase 1 study testing d-cycloserine and mifepristone in people with Anxiety Disorders, run by Washington University School of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Anxiety Disorders
- What is being tested?
- d-cycloserine and mifepristone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jan 2014to Oct 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
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.
Read the 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.
- Conditions
- Anxiety Disorders
- Being tested
- d-cycloserine and mifepristone
- Keywords
- adult male, anxiety, public speaking, healthy controls, exposure therapy, social anxiety, mifepristone, d-cycloserine
- Medical subject headings
- Anxiety Disorders, Speech
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
d-cycloserine and mifepristoneDrug
Also called mifepristone, Mifeprex, RU-486, one dose of up to 1200 mg
All participants will receive a one-time only dose of both, d-cycloserine and mifepristone at Session 2
| Study group | Role | What they receive |
|---|---|---|
| Anxious Adult Males | Experimental | One time dosage of d-cycloserine and mifepristone at Session 2 prior to public speaking exposure sessions. Receives: Drug: d-cycloserine and mifepristone |
| Non-Anxious Adult Males | Active comparator | One time dosage of d-cycloserine and mifepristone at Session 2 prior to public speaking exposure sessions. Receives: Drug: d-cycloserine and mifepristone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: End of Session 2--(7-10 days after Session 1)
Secondary outcomes (4)
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Session 4- 3rd exposure therapy- occurs 3 months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2014 (estimated)
- Study start13 Jan 2014
- Primary completionOct 2022
- Study completionOct 2022
Why it stopped: COVID and staffing issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric Lenze, Washington University School of Medicine
- Investigators
- Eric J Lenze, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02099825
- Sponsor's protocol ID
- 201306084
- Acronym
- MERiT
- Status last verified
- Apr 2023
- First submitted
- 19 Mar 2014
- Last updated
- 26 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medication Enhanced Rapid Therapy
- ClinicalTrials.gov ID
- NCT02099825
- Acronym / sponsor ID
- MERiT / 201306084
- Conditions
- Anxiety Disorders
- Keywords
- adult male, anxiety, public speaking, healthy controls, exposure therapy, social anxiety, mifepristone, d-cycloserine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID and staffing issues
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 13 Jan 2014 (actual)
- Primary completion
- Oct 2022 (actual)
- Study completion
- Oct 2022 (actual)
- First posted
- 31 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anxious Adult Males | Experimental | Drug: d-cycloserine and mifepristoneOne time dosage of d-cycloserine and mifepristone at Session 2 prior to public speaking exposure sessions. |
| Non-Anxious Adult Males | Active comparator | Drug: d-cycloserine and mifepristoneOne time dosage of d-cycloserine and mifepristone at Session 2 prior to public speaking exposure sessions. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (25 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| d-cycloserine and mifepristoneAlso: mifepristone, Mifeprex, RU-486, one dose of up to 1200 mgAll participants will receive a one-time only dose of both, d-cycloserine and mifepristone at Session 2 | Drug | Anxious Adult Males, Non-Anxious Adult Males |
Primary outcome
Will measure medication tolerability and safety per participant report (i.e. few or no side effects severe enough to stop treatment)
Time frame: End of Session 2--(7-10 days after Session 1)
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.
4 secondary outcomes
Improvements in Anxiety as measured by several Self Report Assessments
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
Time frame: Session 1- initial self reports collected;
Improvements in Anxiety as measured by several Self Report Assessments
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
Time frame: Session 4- 3rd exposure therapy- occurs 3 months later
Results and safety
The study was stopped early (reason given: COVID and staffing issues). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric J Lenze, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing d-cycloserine and mifepristone in people with Anxiety Disorders, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: COVID and staffing issues). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Will measure medication tolerability and safety per participant report (i.e. few or no side effects severe enough to stop treatment) (time frame: End of Session 2--(7-10 days after Session 1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2023.