Early Phase 1 Depression and Anxiety Trial, By Invitation NCT04509102 Sponsor: University of California, Los Angeles Condition: Depression and Anxiety
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Early Phase 1 Depression and Anxiety Trial, By Invitation

NCT04509102
By Invitation Early Phase 1

voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice

Who may and may not 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 may be able to join

  • Adults between the ages of 18 and 65 who have been diagnosed with a current episode of major depressive disorder, as defined by standard diagnostic criteria (DSM-V).
  • People whose depression has not responded to at least two different antidepressant medications, each taken at an appropriate dose and for an appropriate length of time.
  • People who are currently taking psychiatric medications (other than stimulants or benzodiazepines) may be able to continue those medications during the study.
  • The person's own psychiatrist must agree that joining the study would be safe and appropriate for them.

Who may not be able to join

Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.

  • People who are not able to give informed consent to participate.
  • People who have ever been diagnosed with bipolar disorder.
  • People who have ever been diagnosed with major depressive disorder with psychotic features, schizophrenia, schizoaffective disorder, or any other psychotic disorder.
  • People who have a history of psychotic symptoms.
  • People who have ever been diagnosed with a substance use disorder.
  • People who have a history of misusing or abusing stimulant medications.
  • People who are currently misusing substances.
  • People whose anxiety, tension, or agitation is severe enough that it may make it hard to tolerate the study treatments (confirm with trial site).
  • People who are currently taking stimulant medications.
  • People who are currently taking benzodiazepines (a type of sedative or anti-anxiety medication).
  • People who are currently taking, or have taken in the past two weeks, a type of antidepressant called a monoamine oxidase inhibitor (MAOI).
  • People who have had an allergic reaction or sensitivity to Adderall XR in the past.
  • People who have not been able to tolerate any stimulant medication in the past.
  • People who are pregnant, breastfeeding, or planning to become pregnant during the study.
  • People who have glaucoma (a condition affecting the eyes).
  • People who have motor tics, or whose close family members have been diagnosed with a tic disorder.
  • People who have heart or cardiovascular conditions, including high blood pressure, coronary artery disease, hardening of the arteries, cardiomyopathy, or irregular heartbeat.
  • People who have an overactive thyroid (hyperthyroidism).
  • People who have structural abnormalities of the heart.
  • People who have a close blood relative (parent, sibling, or child) who died suddenly due to a cardiac cause.
  • People who have a history of epilepsy or seizures.
  • People who have had a stroke.
  • People who have had a brain tumour.
  • People who have any metal present in their head.
  • People who have a pacemaker or any medical device implanted near the area of the head or neck where magnetic stimulation would be applied.

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
Early Phase 1 studies are small, early exploratory studies that come before the main Phase 1 to 3 testing, so a standard phase success rate does not apply.

GP referral letter

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Trial details

Status
By Invitation
Phase
Early Phase 1
Registry
ClinicalTrials.gov
Start date
27 September 2021
Est. completion
1 December 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Mean Percent Change in Self-rated Inventory of Depressive Symptoms

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