D-Cycloserine and Virtual Reality Exposure Therapy

NCT02933684 | Withdrawn Phase 2

• 1 other identifier: ULTR000454
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The proposed project aims to increase accessibility of exposure therapy, an evidence based treatment for social anxiety disorder, by adapting a therapist-assisted computer-based program to be delivered in a self-guided manner on an iPad. A significant problem with self-guided treatment delivered via computer is compliance. The vast majority of users do not complete treatment, so achieving therapeutic benefit as quickly as possible is essential. D-cycloserine is a drug found to augment response to therapist-guided exposure therapy for anxiety disorders, but has never been tested with self-guided exposure. This study uses a randomized, double-blind methodology to compare D-cycloserine (50 mg; DCS) to placebo in combination with self-guided virtual reality exposure therapy (VRE) delivered via iPad to treat social anxiety disorder. The proposed study tests the hypothesis that patients who receive DCS in combination with the self-guided VRE will show more improvement than those who receive placebo in combination with VRE. Outcome measures include self-reported symptoms of social anxiety, behavioral avoidance, and diagnostic remission. Participants (N=34) are adults with a primary diagnosis of social anxiety disorder. Participants will complete a structured diagnostic interview, standardized self-report measures of social anxiety, and a behavioral avoidance task (i.e., giving a speech) and will be assessed at pre-treatment, at post-treatment and at 3 month follow-up. Hierarchical linear regression and chi-square analyses will be used to test differences between those randomized to DCS versus placebo on the following outcomes: post-treatment scores of self-reported social phobia symptoms, willingness to and anxiety while giving a speech at post-treatment, and diagnostic remission at 3 month follow-up. The proposed project combines technological advances with translational research to develop an innovative and accessible treatment for those with social anxiety disorder. The pilot data generated from this study will be appealing to a variety of funding agencies, including the National Institute of Mental Health's call for exploratory clinical trials of novel interventions for mental illnesses, the Patient-Centered Outcomes Research Institute's call for effectiveness studies aimed to overcome barriers to treatment, and the National Science Foundation's call for innovation-technology translation research.

Conditions

Social Anxiety Disorder

Outcome Measures

Primary Outcomes (3)

• Change in scores on the Liebowitz Social Anxiety Scale-self report version (LSAS-SR)

  Measures fear in and avoidance of 24 social situations.

  Participants will complete this measure once a week for 6 weeks and again at 17 weeks after the first visit.

• Change in behavioral avoidance

  Complete Unstructured Conversation and Impromptu Speech Tasks. The assessments will be video recorded and the amount of eye contact - in seconds - will be rated by blind observers. The number of seconds of eye contact can then be compared across time points.

  Week 1, week 7, and 17 weeks after the first session.

• Change in scores on the Clinical Global Improvement Scale, Patient Report

  Assesses diagnostic remission.

  Week 7

Secondary Outcomes (5)

• Change in scores on the Social Phobia Scale

  Participants will complete this measure once a week for 6 weeks and again at 17 weeks after the first visit.

• Change in scores on the Social Interaction Anxiety Scale

  Participants will complete this measure once a week for 6 weeks and again at 17 weeks after the first visit.

• Change in scores on the Patient Health Questionnaire

  Week 1, week 7.

• Change in scores on the Sheehan Disability Scale

  Week 1, week 7.

• Change in scores on the Quality of Life Inventory

  Week 1, week 7.

Study Arms (2)

DCS

EXPERIMENTAL

Participants will receive 50mg of Seromycin (aka D-cycloserine) in conjunction with virtual reality exposure therapy once a week for 4 weeks.

Drug: Seromycin; Behavioral: Virtual Reality Exposure Therapy

Placebo

PLACEBO COMPARATOR

Participants will receive a placebo in conjunction with virtual reality exposure therapy once a week for 4 weeks.

Behavioral: Virtual Reality Exposure Therapy; Drug: Placebo

Interventions

Seromycin DRUG

Seromycin (aka D-cycloserine) is an analogue of D-alanine and a partial agonist at the NMDA receptor, which facilitates the process of fear extinction.

Also known as: D-cycloserine

DCS

Virtual Reality Exposure Therapy BEHAVIORAL

Allows for delivery of exposure therapy on an iPad. Participants read a speech to a virtual audience. Exposures become increasingly more difficult as the audience becomes more hostile and speeches increase in length and complexity.

DCS; Placebo

Placebo DRUG

Administered in pill form.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Understand and provide written informed consent prior to conduct of any study procedures.
• Be able to communicate in English with study personnel
• Be able to manipulate the computer interface to interact with the program
• If female, must have a negative pregnancy test prior to treatment and be maintained on an acceptable method of birth control during treatment
• If using psychotropic medication, stable on medication and dosage for 3 months

You may not qualify if:

• Participation in clinical trial within the past 12 months or treatment with DCS in a previous study
• History of mania, schizophrenia, or other psychoses
• Any unstable medical condition; Seizure disorders, with the exception of a childhood history of isolated, non-recurrent febrile seizures
• Current or past substance (except nicotine, caffeine) or alcohol dependence based on DSM-V criteria within six months prior to screening
• Liebowitz Social Anxiety Scale (LSAS) score of \< 50 at baseline

Sponsors & Collaborators

• Georgia State University: lead
• Emory University: collaborator

Study Sites (1)

Georgia State University

Atlanta, Georgia, 30303, United States

Location

Related Publications (21)

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  BACKGROUND

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  BACKGROUND

• Deveney CM, McHugh RK, Tolin DF, Pollack MH, Otto MW. Combining D-cycloserine and exposure-based CBT for the anxiety disorders. Clin Neuropsychiatry 6(2):75-82. 2009.

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MeSH Terms

Conditions

Phobia, Social

Interventions

Cycloserine; Virtual Reality Exposure Therapy

Condition Hierarchy (Ancestors)

Phobic Disorders; Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Oxazolidinones; Oxazoles; Serine; Amino Acids, Neutral; Amino Acids; Amino Acids, Peptides, and Proteins; Desensitization, Psychologic; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Page Anderson, PhD

  Georgia State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 5, 2015
• First Posted: October 14, 2016
• Study Start: January 1, 2015
• Primary Completion: December 31, 2016
• Study Completion: December 31, 2016
• Last Updated: April 13, 2018

Record last verified: 2018-04

Locations

US (1)