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Trial record 79 of 120 for:    Anti-Bacterial | CYCLOSERINE OR SEROMYCIN

Medication Enhanced Rapid Therapy (MERiT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02099825
Recruitment Status : Active, not recruiting
First Posted : March 31, 2014
Last Update Posted : October 11, 2017
Sponsor:
Information provided by (Responsible Party):
Eric Lenze, Washington University School of Medicine

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Anxiety Disorders Drug: d-cycloserine and mifepristone Phase 1

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).

  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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Medication Enhanced Rapid Therapy
Study Start Date : January 2014
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Anxious Adult Males
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
Other Names:
  • mifepristone
  • Mifeprex
  • RU-486
  • one dose of up to 1200 mg
  • d-cycloserine
  • Seromycin
  • one dose of 250 mg

Active Comparator: Non-Anxious Adult Males
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
Other Names:
  • mifepristone
  • Mifeprex
  • RU-486
  • one dose of up to 1200 mg
  • d-cycloserine
  • Seromycin
  • one dose of 250 mg




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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 ]

    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)


  2. Level of Anxiety as measured by several Self Report Assessments [ Time Frame: Session 1- initial self reports collected; ]

    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)


  3. 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 ]

    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)


  4. Improvements in Anxiety as measured by several Self Report Assessments [ Time Frame: Session 4- 3rd exposure therapy- occurs 3 months later ]

    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)




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02099825


Locations
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United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
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Principal Investigator: Eric J Lenze, MD Washington University School of Medicine

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Responsible Party: Eric Lenze, Professor of Psychiatry, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02099825     History of Changes
Other Study ID Numbers: 201306084
First Posted: March 31, 2014    Key Record Dates
Last Update Posted: October 11, 2017
Last Verified: October 2017

Keywords provided by Eric Lenze, Washington University School of Medicine:
adult male
anxiety
public speaking
healthy controls
exposure therapy
social anxiety
mifepristone
d-cycloserine

Additional relevant MeSH terms:
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Cycloserine
Antibiotics, Antitubercular
Anti-Bacterial Agents
Anxiety Disorders
Mental Disorders
Mifepristone
Abortifacient Agents, Steroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Contraceptives, Postcoital, Synthetic
Contraceptives, Postcoital
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Luteolytic Agents
Menstruation-Inducing Agents
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Antitubercular Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action