Trial results
AI generated results 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
According to the results reported on ClinicalTrials.gov, this trial enrolled 57 people, all of whom received open-label treatment with a medicine called lamotrigine. Of those 57 participants, 38 completed the trial and 19 did not finish. The trial was measuring changes in depressive symptoms (low mood), manic symptoms (elevated or overactive mood), overall clinical condition, and certain side effects over the course of the study. The reported data shows that, on the main measure of depression — a rating scale called the MADRS, which runs from 0 (no symptoms) to 60 (most severe) — participants' average scores dropped by 15.5 points from the start of the study to the end. A drop in score on this scale means lower reported symptom levels at the end compared to the beginning. A second depression scale (the GRID-HAM-D, scored 0–78) showed a reported average drop of 15.2 points. For manic symptoms (the YMRS scale, scored 0–60), the reported average change was a drop of 0.47 points. On an overall clinical condition scale (the CGI-BP, scored 1–7), the reported average drop was 2.06 points. A measure of certain movement-related side effects (the SAS scale, scored 0–4) showed a reported average change of −0.04 points. Regarding other side effects tracked by a separate checklist (the UKU, covering 49 possible effects), the reported data shows the number of participants experiencing various individual side effects ranged from 8 to 14 people, though the specific side effects linked to each of those numbers were not detailed in the data available. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 3 Depression and Anxiety Trial, Completed
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
- You are 60 years of age or older
- You have been diagnosed with Bipolar Disorder (Type I or Type II) and are currently experiencing a depressive episode
- You have scored above 18 on a standard depression rating scale, indicating a significant level of depression symptoms
- Having a close friend or family member who can provide information about you is helpful but not required
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.
- You have a long-term psychotic condition such as schizophrenia, schizoaffective disorder, or delusional disorder
- You have a medical reason why you cannot take the medication lamotrigine (confirm with trial site)
- You have a documented history of not tolerating lamotrigine well
- You have previously tried lamotrigine for at least 12 weeks and it did not help you
- You are currently dependent on alcohol or drugs, or there are safety concerns related to substance use
- Your mood disorder is believed to be caused by another medical condition or a medical treatment
- You experience "rapid cycling," meaning you have had 4 or more mood episodes (depression, mania, or mixed states) within the past 12 months
- You have been diagnosed with dementia or a degenerative brain disease
- You are unable to communicate in English without the help of an interpreter
- You have significant vision or hearing problems that would prevent you from taking part in interviews or reading study materials
- You have a recent history of heart disease, blood vessel problems, or stroke
- You are considered at high risk for suicide, for example if you are having active thoughts of or plans to end your life
- You are currently admitted as an inpatient in a hospital or medical facility
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.
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.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial was run
These are the locations recorded on the registry, and they are a historical record: this trial is not enrolling, so they are not places you can join it.
Primary endpoints
Assessment of Change in Depressive Symptoms From Baseline on the Montgomery Asberg Depression Rating Scale (MADRS)
Other options
Data last synced from ClinicalTrials.gov: 13 August 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.