Phase 4 Depression and Anxiety Trial, Not Yet Recruiting NCT07676669 Sponsor: Watim Medical & Dental College Condition: Depression and Anxiety
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Phase 4 Depression and Anxiety Trial, Not Yet Recruiting

NCT07676669
Not Yet Recruiting Phase 4

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 18 and 60 years of age
  • People who have been diagnosed with bipolar I depression, identified using a standard set of psychiatric guidelines called the DSM-5
  • People who have been taking a mood stabiliser (either lithium or valproate) at the same dose for at least 2 weeks
  • People whose depression symptoms are rated as moderate to severe based on a standard assessment tool (confirm with trial site)
  • People who are willing to give their formal agreement to take part in the trial

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 currently experiencing a manic or mixed mood episode
  • People who have been diagnosed with rapid cycling bipolar disorder, where mood episodes change very frequently
  • People who have a current substance use disorder (problems with alcohol or other drugs)
  • People with a serious neurological condition or who are currently experiencing a medical emergency
  • People who are currently pregnant or breastfeeding
  • People whose depression has not responded to standard treatments and who require a procedure called ECT (electroconvulsive therapy)
  • People who are at active risk of suicide and require emergency care

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 8 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

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

Phone: 03315108703

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 4
Sponsor
Watim Medical & Dental College
Registry
ClinicalTrials.gov
Start date
1 December 2026
Est. completion
1 March 2027

Primary endpoints

Change in Montgomery-Åsberg Depression Rating Scale (MADRS) score

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: 8 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