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 looked at a medication called lurasidone (at a flexible dose of 20–80 mg per day) compared to a placebo (an inactive dummy pill) in people with bipolar disorder. The trial had two phases: an initial open-label phase (where everyone knew what was being given) in which 965 people started and 503 completed it, followed by a double-blind phase (where neither participants nor researchers knew who was getting which treatment) in which 246 people received lurasidone and 250 received placebo. The main thing being measured was how long it took before participants experienced a return of a mood episode — such as a manic or depressive episode — during the double-blind phase. The reported data shows that for the primary outcome — time until a mood episode returned — a specific number of days was not reported for the lurasidone group (shown as "NA," meaning the data was not available in the submission), while the placebo group had a reported figure of 207 days. For the percentage of participants who experienced a return of a mood episode, the reported data shows 16.7% in the lurasidone group and 21.6% in the placebo group. The time until participants stopped the trial for any reason was reported as 225 days for the lurasidone group and 207 days for the placebo group. Two clinician-rated illness severity scores (rated on a 1–7 scale, where higher means more severe) were also measured; changes from the start of the double-blind phase to week 28 were reported as small increases in both groups, with the lurasidone group showing a change of 0.40 (overall severity) and 0.10 (mania severity), compared with 0.49 and 0.21 respectively in the placebo group. For the secondary outcome measuring time to recurrence of a specific mood episode type, no figures were reported for either group. 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 Bipolar Disorder Trial, Completed
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:
- You are 18 years of age or older
- You have been diagnosed with Bipolar I Disorder according to standard medical guidelines
- You have had at least one manic, mixed, or depressed episode in the past 2 years
- Your mood symptom scores are at or above a certain level on standard rating scales, depending on whether or not you are currently taking lithium or a medication called divalproex (confirm with trial site)
- For the second phase of the trial: your symptoms must have been stable and well-controlled for at least 12 weeks, with only very minor ups and downs allowed, and none in the final 4 weeks before moving to the next phase
Who may not be able to join:
- You have another mental health condition (besides Bipolar I Disorder) that is currently the main focus of your treatment within the past 3 months
- The study doctors are unable to agree on your diagnosis with an independent reviewing organisation
- You have had 8 or more mood episodes in the past 12 months (sometimes called "ultra-fast rapid cycling")
- You test positive for recreational or illegal drugs at the start of the study (if you test positive for cannabis specifically, the study doctor will assess whether you are able to stop using it during the study)
- You have an unstable or poorly managed physical health condition
- You have had certain serious thoughts of suicide, as measured by a standard safety questionnaire
- For the second phase: you have not been taking your study medication as directed during the first phase of the trial
- For the second phase: your symptoms did not become stable within 20 weeks during the first phase of the trial
- For the second phase: you test positive for recreational or illegal drugs at the start of the second phase (cannabis will again be assessed individually by the study doctor)
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.
Contact this trial
Principal Investigator: Medical Director, MD, Sumitomo Pharma America, Inc.
Australian sites
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
Where this trial is recruiting
4 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Time to Recurrence of Mood Event During the Double Blind Treatment Phase
Can't join this trial?
Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.