deltatrials
Completed PHASE3 INTERVENTIONAL 2-arm NCT00515879

Effect of D-cycloserine Plus Cognitive Behavioral Therapy on People With Social Phobia

D-cycloserine Enhancement of Exposure in Social Phobia

Sponsor: Boston University Charles River Campus

Updated 10 times since 2017 Last updated: Feb 5, 2019 Started: Dec 31, 2007 Primary completion: Dec 31, 2011 Completion: Dec 31, 2011
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT00515879, this PHASE3 trial focuses on Social Anxiety Disorder and remains completed. Sponsored by Boston University Charles River Campus, it has been updated 10 times since 2007, reflecting substantial change activity. Mental health research at this phase helps define safety and dosing parameters for future study.

Study Description(click to expand)

Social anxiety disorder (SAD) is among the most common psychiatric conditions and is associated with significant distress and dysfunction in social situations. Although treatment with cognitive-behavior therapy (CBT) is known to help remedy SAD, many patients do not respond to this treatment and most do not reach full recovery. In CBT, patients undergo repeated and prolonged exposure practices to feared social situations to learn better ways to deal with anxiety in these settings. Exposure therapy is based on animal models of extinction of conditioned fears, and recent animal research has identified some of the core pathways and neurotransmitters involved in fear extinction. D-cycloserine (DCS) is a drug that appears to facilitate learning and the process of extinction of conditioned fear in both animals and humans. This study will assess the effectiveness of DCS combined with CBT in treating people with SAD. Participants in this double-blind study will be randomly assigned to an active or control group. All participants will attend 18 study visits at the Center for Anxiety and Related Disorders over a 9-month period. There will be 12 CBT sessions of 90 minutes each and 6 assessment visits. The CBT sessions will help participants to become more comfortable with...

Social anxiety disorder (SAD) is among the most common psychiatric conditions and is associated with significant distress and dysfunction in social situations. Although treatment with cognitive-behavior therapy (CBT) is known to help remedy SAD, many patients do not respond to this treatment and most do not reach full recovery. In CBT, patients undergo repeated and prolonged exposure practices to feared social situations to learn better ways to deal with anxiety in these settings. Exposure therapy is based on animal models of extinction of conditioned fears, and recent animal research has identified some of the core pathways and neurotransmitters involved in fear extinction. D-cycloserine (DCS) is a drug that appears to facilitate learning and the process of extinction of conditioned fear in both animals and humans. This study will assess the effectiveness of DCS combined with CBT in treating people with SAD.

Participants in this double-blind study will be randomly assigned to an active or control group. All participants will attend 18 study visits at the Center for Anxiety and Related Disorders over a 9-month period. There will be 12 CBT sessions of 90 minutes each and 6 assessment visits. The CBT sessions will help participants to become more comfortable with social situations. During 5 of the CBT sessions, participants will receive a pill containing either DCS or sugar (placebo). Assessment visits will include interviews, self-report questionnaires, and laboratory tests. These visits will occur at Weeks 1, 7, and 12 during treatment and at Months 3, 6, and 9 post-treatment.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotCompleted~Feb 2017 – ~Mar 2018 · 13 months · monthly snapshotCompleted~Mar 2018 – ~Jun 2018 · 3 months · monthly snapshotCompleted~Jun 2018 – ~Mar 2019 · 9 months · monthly snapshotCompleted~Mar 2019 – ~Jan 2021 · 22 months · monthly snapshotCompleted~Jan 2021 – ~Dec 2022 · 23 months · monthly snapshotCompleted~Dec 2022 – ~Jan 2023 · 31 days · monthly snapshotCompleted~Jan 2023 – ~Jul 2024 · 18 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 19 months · monthly snapshotCompleted

Change History

10 versions recorded
  1. Sep 2024 — Present [monthly]

    Completed PHASE3

  2. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE3

  3. Jan 2023 — Jul 2024 [monthly]

    Completed PHASE3

  4. Dec 2022 — Jan 2023 [monthly]

    Completed PHASE3

  5. Jan 2021 — Dec 2022 [monthly]

    Completed PHASE3

Show 5 earlier versions
  1. Mar 2019 — Jan 2021 [monthly]

    Completed PHASE3

  2. Jun 2018 — Mar 2019 [monthly]

    Completed PHASE3

  3. Mar 2018 — Jun 2018 [monthly]

    Completed PHASE3

  4. Feb 2017 — Mar 2018 [monthly]

    Completed PHASE3

  5. Jan 2017 — Feb 2017 [monthly]

    Completed PHASE3

    First recorded

Dec 2007

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Boston University Charles River Campus
  • National Institute of Mental Health (NIMH)
Data source: Boston University Charles River Campus

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations