Medication Enhanced Rapid Therapy
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Anxiety |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 10/13/2017 |
| Start Date: | January 2014 |
| End Date: | August 2018 |
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.
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).
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.
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.
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
We found this trial at
1
site
660 S Euclid Ave
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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