Phase 3 Bipolar Disorder Trial, Recruiting (NCT03423680)

Phase 3 Bipolar Disorder Trial, Recruiting NCT03423680 Sponsor: Korea Otsuka Pharmaceutical Co., Ltd. Condition: Bipolar Disorder

Printed from Voxsanity (voxsanity.com.au) — NCT03423680 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.

Back to Bipolar Disorder

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 aged 19 or older but under 70 years old at the time you give your consent to join.
You are able to understand the information given to you and agree to take part in the study.
You have been taking a mood stabilizer medication — either lithium or valproic acid.
You have been diagnosed with bipolar I or bipolar II disorder and are currently going through a major depressive episode (a serious period of low mood).
Your depression has been rated as moderately severe or worse on a standard medical rating scale at two separate appointments before the study begins (confirm with trial site).

Who may not be able to join:

You have bipolar I or bipolar II disorder that is currently showing signs of mania, a mixed state, or psychotic features (such as hallucinations or delusions).
The trial doctor believes you may be at high risk of suicide during the study, based on your current symptoms and your past medical history.

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

Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.

Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: 82-2-3287-9238

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.

Voxsanity

Clinical trials and treatments, explained plainly · voxsanity.com.au

Date:

To: My Doctor

Re: Clinical trial enquiry

I am writing to enquire about the following clinical trial which may be relevant to my care:

Trial: NCT03423680

Sponsor: Korea Otsuka Pharmaceutical Co., Ltd.

Phase: Phase 3

Status: Recruiting

Condition: Bipolar Disorder

Trial contact: 82-2-3287-9238

More information: https://clinicaltrials.gov/study/NCT03423680

Eligibility summary (AI generated)

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

You are aged 19 or older but under 70 years old at the time you give your consent to join.
You are able to understand the information given to you and agree to take part in the study.
You have been taking a mood stabilizer medication — either lithium or valproic acid.
You have been diagnosed with bipolar I or bipolar II disorder and are currently going through a major depressive episode (a serious period of low mood).
Your depression has been rated as moderately severe or worse on a standard medical rating scale at two separate appointments before the study begins (confirm with trial site).

Who may not be able to join:

You have bipolar I or bipolar II disorder that is currently showing signs of mania, a mixed state, or psychotic features (such as hallucinations or delusions).
The trial doctor believes you may be at high risk of suicide during the study, based on your current symptoms and your past medical history.

Important: Always verify eligibility with the trial site directly before applying.

Access in Australia: A treatment being studied in a clinical trial is generally not yet listed on the PBS. Where a medicine is not approved or not available through a trial, the TGA Special Access Scheme may allow a doctor to access unapproved therapeutic goods for individual patients. See voxsanity.com.au/sas-navigator/ for a plain English explainer.

This information was sourced from ClinicalTrials.gov via Voxsanity (data last synced 28 July 2026). It is not medical advice. Please verify the trial's current status directly with the trial site before acting.

Trial details

Status

Recruiting

Phase

Phase 3

Sponsor

Korea Otsuka Pharmaceutical Co., Ltd.

Registry

ClinicalTrials.gov

Start date

22 February 2018

Est. completion

1 November 2025

Where this trial is recruiting

🇰🇷 South Korea

Primary endpoints

Mean change in the Montgomery-Åsberg Depression Rating Scale total 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: 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