Medication Enhanced Rapid Therapy (MERiT)

The Washington University

Status and phase

Terminated

Phase 1

Conditions

Anxiety Disorders

Treatments

Drug: d-cycloserine and mifepristone

Study type

Interventional

Funder types

Other

Identifiers

NCT02099825

201306084

Details and patient eligibility

About

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.

Full 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.

Enrollment

15 patients

Sex

Male

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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