Phase 2 Depression and Anxiety Trial, Not Yet Recruiting NCT03833206 Sponsor: BioLite, Inc. Condition: Depression and Anxiety
Back to Depression And Anxiety

Phase 2 Depression and Anxiety Trial, Not Yet Recruiting

NCT03833206
Not Yet Recruiting Phase 2

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

  • People aged 21 to 85 years old
  • People who have been diagnosed with Stage I, II, or III cancer, confirmed by laboratory tissue testing
  • People who are currently receiving, or have received within the past year, cancer treatment involving radiation therapy and/or chemotherapy
  • People with moderate to severe depressive symptoms, as measured by a specific depression rating scale (MADRS score of 20 or higher)
  • People who have had depressive symptoms lasting at least 2 weeks, based on their own account
  • People who do not have active or urgent suicidal thoughts that would require immediate care or admission to a psychiatric facility
  • People with enough English language ability to complete all study assessments without help from others
  • People who are able to swallow pills
  • People who do not have severe anaemia (confirm with trial site for specific blood test threshold)
  • People who do not have a history of multiple bad reactions or allergies to the study medications
  • People who are not pregnant
  • People who do not have a history of head injury
  • People who do not have a history of epilepsy
  • People who are not currently taking any other antidepressant medications

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 have a current or past diagnosis of obsessive-compulsive disorder, post-traumatic stress disorder, bipolar disorder (type I or II), manic or hypomanic episodes, schizophrenia, major personality disorders that could affect the study, or severe depression with psychotic symptoms
  • People who have a documented history of an intellectual disability
  • People who have taken any antidepressant medication in the 2 weeks before the first study visit (or 4 weeks before, if the medication was fluoxetine)
  • People who are currently being treated with tamoxifen
  • People whose depression did not respond to two or more adequate courses of antidepressant medication, or who the study doctor considers to have treatment-resistant depression, or who have had electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), or brain surgery within the past year
  • People who have a history of any seizure disorder
  • People with significantly abnormal results on vital signs, heart trace (ECG), or blood/lab tests, as determined by the study doctor
  • People assessed as having a high risk of suicide based on a specific rating scale (C-SSRS), including those who have reported serious thoughts of acting on suicidal urges in the past month, or any suicidal behaviour in the past 3 months
  • People who have had a problem with substance dependence or misuse (not including tobacco) in the past 6 months, or who test positive for drugs during the screening period
  • People who drink alcohol above specified weekly limits (confirm with trial site for exact amounts), or who show signs of alcohol withdrawal
  • People with a history of severe allergies to more than one class of medication, or multiple serious drug reactions

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 28 July 2026

If you need support right now

This page includes language about suicide and self-harm, because that is how the trial's eligibility criteria are written. If reading it has been hard, you do not have to keep going. The services below are free, confidential, and answered by people trained for exactly this.

If you or someone else is in immediate danger, call 000.

  • Lifeline — 24/7 crisis support: 13 11 14
  • Suicide Call Back Service — 24/7 counselling: 1300 659 467
  • 13YARN — 24/7, for Aboriginal and Torres Strait Islander people: 13 92 76
  • Beyond Blue — 24/7 mental health support: 1300 22 4636
  • Emergency: 000

Outside Australia? The numbers above are Australian and will not work from overseas. Find a Helpline is a free directory of crisis lines in over 130 countries, run by ThroughLine with the International Association for Suicide Prevention. If you are in immediate danger, call your local emergency number.

Voxsanity is not a crisis service, and nothing on this page is medical advice. More Australian services are listed on our support lines page.

Contact this trial

Principal Investigator: scott A Irwin, MD/PhD, Cedars-Sinai Health System

Phone: +886-3-657-9631

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
Not Yet Recruiting
Phase
Phase 2
Sponsor
BioLite, Inc.
Registry
ClinicalTrials.gov
Start date
15 January 2027
Est. completion
28 February 2028

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Montgomery-Åsberg Depression Rating Scale (MADRS)

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: 28 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