Depression and Anxiety Trial, Recruiting NCT05683223 Sponsor: Boston University Charles River Campus Condition: Depression and Anxiety
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Depression and Anxiety Trial, Recruiting

NCT05683223
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People of any gender or race between 18 and 50 years old.

For the "healthy control" group (people without social anxiety):

  • People who score 30 or below on a standard social anxiety questionnaire (the LSAS) and do not currently have a diagnosed psychiatric condition.

For the "social anxiety disorder" group:

  • People whose main source of distress is social anxiety, particularly fear of social interactions, with a score of 60 or above on the LSAS social anxiety questionnaire.
  • People whose social anxiety is rated as at least "mild" on a standard clinical severity scale.
  • People whose general medical history and lab results show no significant health concerns.
  • People who are willing and able to give informed consent and follow the study requirements.

Who may not be able to join:

  • People with a lifetime history of bipolar disorder, schizophrenia, psychosis, delusional disorders, or obsessive-compulsive disorder; an eating disorder in the past 6 months; a brain condition, intellectual disability, or cognitive difficulty that could interfere with participating in therapy; or alcohol or substance misuse (other than nicotine) in the past 6 months, or an inability to avoid alcohol, marijuana, and stimulants during the active study period.
  • People with significant thoughts of suicide, or who have made a suicide attempt in the 6 months before joining.
  • People currently taking psychiatric medications (such as antidepressants or anxiety medications) whose dose has not been stable for at least 2 weeks before the study begins.
  • People with significant personality difficulties likely to interfere with taking part in the study.
  • People with a serious medical illness or treatment that may require hospitalisation within the next year, or that could affect brain scan (fMRI or EEG) results. (People whose serious illness has been in remission and whose treatment has ended for at least 12 months may still be considered — confirm with trial site.)
  • People with a current or past history of seizures.
  • Women who are pregnant, breastfeeding, or of childbearing age who may become pregnant during the study.
  • People who have started any new psychotherapy within the 3 months before the study baseline, or who are currently receiving therapy specifically targeting social anxiety. People with prior experience of Cognitive Behavioural Therapy (CBT) or treatments involving exposure-based or behavioural skills practice are also excluded. (General supportive or insight-oriented therapy started more than 3 months ago may be acceptable — confirm with trial site.)
  • People who have previously gone through a full course of exposure-based therapy without improvement.
  • People with a history of head injury that caused loss of consciousness, seizures, or ongoing cognitive difficulties.
  • People who cannot have an MRI scan, including those with metal implants, surgical clips, possible metal fragments in the body, braces, or claustrophobia.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 9 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: John Gabrieli, PhD, Massachusetts Institute of Technology

Phone: 617-353-9610

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Boston University Charles River Campus
Registry
ClinicalTrials.gov
Start date
26 May 2023
Est. completion
1 April 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Change in Clinical Global Impression-Improvement Scale (CGI-I); Change in Liebowitz Social Anxiety Scale (LSAS)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 9 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov