Phase 2 Depression and Anxiety Trial, Recruiting NCT06595953 Sponsor: National Institute of Mental Health (NIMH) Condition: Depression and Anxiety
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Phase 2 Depression and Anxiety Trial, Recruiting

NCT06595953
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:

  • Both the child and their parent or guardian must be willing to understand and agree to participate in the study.
  • Children and teenagers between the ages of 8 and 17 (male or female) may be considered.
  • A clinician must have confirmed a diagnosis of separation anxiety disorder, generalized anxiety disorder, or social anxiety disorder, using a specific structured interview tool.
  • The child must be willing to attend 12 weekly in-person therapy sessions based on Cognitive Behavioural Therapy (CBT).
  • The child must already be enrolled in a related study called Protocol 01-M-0192.
  • The child must be able to speak, read, and write in English.
  • The child must have an IQ above 70, as measured by a standard assessment that will have taken place under Protocol 01-M-0192.

Who may not be able to join:

  • Children who are currently taking any psychiatric or psychological medications.
  • Children who are currently taking part in another treatment or intervention research study.
  • Children who are currently receiving mental health treatment from a provider outside of NIH (the National Institutes of Health).
  • Children who have a mental health diagnosis other than an anxiety disorder, as determined by the structured clinical interview used in this study.
  • Children who have any serious medical conditions.
  • Children who have circumstances that would prevent them from attending in-person therapy sessions.

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 14 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
4 December 2024
Est. completion
1 October 2029

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Pediatric Anxiety Rating Scale (PARS)

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: 14 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