Phase 2 Depression and Anxiety Trial, Recruiting NCT00018057 Sponsor: National Institute of Mental Health (NIMH) Condition: Depression and Anxiety
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Phase 2 Depression and Anxiety Trial, Recruiting

NCT00018057
Recruiting Phase 2

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:

  • Young people aged 8 to 17 years old, or adults aged 18 to 65 years old, are welcome to apply.
  • Young people must have a parent or guardian who agrees to their participation, and the young person themselves must also agree to take part.
  • Adults must be able to give their own agreement to participate.
  • All participants must have an IQ above 70, which will be checked during a screening visit.
  • All participants must be able to speak English, as the study tasks have only been set up in English.
  • People with an anxiety disorder must have a current diagnosis of OCD, Social Phobia, Separation Anxiety, Generalized Anxiety Disorder, or Panic Disorder.
  • People with an anxiety disorder must have ongoing anxiety symptoms that are significant enough to affect their daily life, which will be confirmed by a clinician over at least two visits.

Who may not be able to join:

  • People with a serious medical condition, or any condition that would prevent them from safely having brain scans (MRI or M/EEG), may not be able to take part in those parts of the study.
  • People who are pregnant may not be able to take part in the brain scanning parts of the study.
  • People who are currently using any mind-altering substances (such as recreational drugs or alcohol misuse) are not eligible.
  • People who are currently having thoughts of suicide are not eligible.
  • People who have ADHD severe enough to need medication for it are not eligible.
  • People who currently have a diagnosis of major depression, post-traumatic stress disorder, or conduct disorder are not eligible at the start of the study (though participants who develop these conditions after joining may be allowed to continue).
  • People with a past or current history of mania, psychosis, or a severe developmental disorder are not eligible.
  • People who have recently tried an SSRI medication (a common type of antidepressant also used for anxiety) but did not respond to it or could not tolerate it at an appropriate dose are not eligible.
  • People with a moderate to severe history of substance use disorder (other than nicotine or cannabis-related conditions) are not eligible (confirm with trial site).
  • Healthy adult volunteers who have any current psychiatric diagnosis are not eligible for the healthy volunteer group.

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 20 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Daniel S Pine, M.D., National Institute of Mental Health (NIMH)

Phone: (301) 594-1318

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
Phase 2
Registry
ClinicalTrials.gov
Start date
2 October 2001
Est. completion
1 January 2029

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Pediatric Anxiety Rating Scale (PARS); Clinical Global Improvement (CGI) Scale

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: 20 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