Bipolar Disorder DepressionPhase 4NCT07806227
Broadband Near Infrared Spectroscopy to Understand the Role of Brain Cytochrome C Oxidase in Bipolar Disorder
A Phase 4 study testing Lurasidone (Latuda) in people with Bipolar Disorder Depression, run by Martin Lan at 1 site in United States.
Trial summary
People with a diagnosis of bipolar disorder who are depressed will have a light-based imaging of the brain (Near Infrared Spectroscopy) before and after they have treatment for their depression with a standard, approved medication named lurasidone. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Bipolar Disorder Depression
- What is being tested?
- Lurasidone (Latuda)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2026to 30 Jul 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Diagnosis of bipolar disorder
- Having symptoms of depression
- Taking less than three medications for bipolar disorder
Who cannot join
- Taking any medications that cannot be combined with lurasidone
- Any medical problems that are not well treated
- Any drug or alcohol use disorders that are moderate or severe
- Any severe suicidal ideation, or having had a suicide attempt in the last five years
- Any psychotic symptoms that have occurred outside of a mood episode
- Any electroconvulsive therapy (ECT) within the last six months
- Currently pregnant or planning to become pregnant during the time of the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
New York State Psychiatric Institute
New York, New York, 10032
About this study
Official title: Broadband Near Infrared Spectroscopy to Elucidate the of Role Cortical Brain Cytochrome C Oxidase Activity in the Pathophysiology of Bipolar Disorder
People with a diagnosis of bipolar disorder who are depressed will have a light-based imaging of the brain (Near Infrared Spectroscopy) before and after they have treatment for their depression with a standard, approved medication named lurasidone. They will also answer questions about their history, and give blood samples. The goal is to understand the role of mitochondrial activity in bipolar disorder. Healthy volunteers who have never had a psychiatric disorder will have the same procedures, but they will not receive the medication.
- Conditions
- Bipolar Disorder Depression
- Being tested
- Lurasidone (Latuda)
- Keywords
- Bipolar disorder, Antidepressant treatment, Brain Imaging, Depression, Near Infrared Spectroscopy
- Medical subject headings
- Bipolar Disorder, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lurasidone (Latuda)Drug
The medication will be used to understand how the imaging signal changes when symptoms change during treatment.
| Study group | Role | What they receive |
|---|---|---|
| Bipolar Disorder | Experimental | Participants in a major depressive episode will receive standard treatment with lurasidone for six weeks. Doses can be adjusted based on clinical need. Receives: Drug: Lurasidone (Latuda) |
| Healthy Volunteer | No intervention | Healthy Volunteers will have all research procedures, but will not receive medication treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bipolar Depression Rating Scale
A measure of depression severity. Higher numbers indicate more symptoms.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study start1 Nov 2026 (estimated)
- Primary completion30 Jul 2028 (estimated)
- Study completion30 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Bipolar Disorder DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Bipolar participants receive open label treatment with lurasidone (n=30). Healthy volunteers will not receive treatment (n=30).
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Martin Lan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor-investigator, Martin Lan, New York State Psychiatric Institute
- Investigators
- Martin Lan, MD PhD, Principal investigator, Research Foundation for Mental Hygiene, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07806227
- Sponsor's protocol ID
- Pro00094244
- Other IDs
- R21MH142900
- Status last verified
- Sep 2026
- First submitted
- 2 Sep 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data derived from this study will be uploaded to the National Institute of Mental Health Data Archive (NDA) at the National Institutes of Health (NIH). Aggregate, de-identified data from the study will be uploaded to the website, www.clinicaltrials.org. Data may be shared with researchers outside of New York State Psychiatric Institute, but only after the data are de-identified.
Publications
Kato T. Neurobiological basis of bipolar disorder: Mitochondrial dysfunction hypothesis and beyond. Schizophr Res. 2017 Sep;187:62-66. doi: 10.1016/j.schres.2016.10.037. Epub 2016 Nov 10.
PubMed 27839913Picard M, McEwen BS. Psychological Stress and Mitochondria: A Systematic Review. Psychosom Med. 2018 Feb/Mar;80(2):141-153. doi: 10.1097/PSY.0000000000000545.
PubMed 29389736Holper L, Mann JJ. Test-retest reliability of brain mitochondrial cytochrome-c-oxidase assessed by functional near-infrared spectroscopy. J Biomed Opt. 2018 May;23(5):1-9. doi: 10.1117/1.JBO.23.5.056006.
PubMed 29766685Holper L, Lan MJ, Brown PJ, Sublette EM, Burke A, Mann JJ. Brain cytochrome-c-oxidase as a marker of mitochondrial function: A pilot study in major depression using NIRS. Depress Anxiety. 2019 Aug;36(8):766-779. doi: 10.1002/da.22913. Epub 2019 May 21.
PubMed 31111623
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Broadband Near Infrared Spectroscopy to Elucidate the of Role Cortical Brain Cytochrome C Oxidase Activity in the Pathophysiology of Bipolar Disorder
- ClinicalTrials.gov ID
- NCT07806227
- Acronym / sponsor ID
- Pro00094244
- Conditions
- Bipolar Disorder Depression
- Keywords
- Bipolar disorder, Antidepressant treatment, Brain Imaging, Depression, Near Infrared Spectroscopy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Martin LanUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 30 Jul 2028 (estimated)
- Study completion
- 30 Jul 2028 (estimated)
- First posted
- 8 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
People with a diagnosis of bipolar disorder who are depressed will have a light-based imaging of the brain (Near Infrared Spectroscopy) before and after they have treatment for their depression with a standard, approved medication named lurasidone. They will also answer questions about their history, and give blood samples. The goal is to understand the role of mitochondrial activity in bipolar disorder. Healthy volunteers who have never had a psychiatric disorder will have the same procedures, but they will not receive the medication.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Bipolar participants receive open label treatment with lurasidone (n=30). Healthy volunteers will not receive treatment (n=30).
| Arm | Type | Receives |
|---|---|---|
| Bipolar Disorder | Experimental | Drug: Lurasidone (Latuda)Participants in a major depressive episode will receive standard treatment with lurasidone for six weeks. Doses can be adjusted based on clinical need. |
| Healthy Volunteer | No intervention | –Healthy Volunteers will have all research procedures, but will not receive medication treatment |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Diagnosis of bipolar disorder
- Having symptoms of depression
- Taking less than three medications for bipolar disorder
Key exclusion criteria (7 listed)
- Taking any medications that cannot be combined with lurasidone
- Any medical problems that are not well treated
- Any drug or alcohol use disorders that are moderate or severe
- Any severe suicidal ideation, or having had a suicide attempt in the last five years
- Any psychotic symptoms that have occurred outside of a mood episode
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lurasidone (Latuda)The medication will be used to understand how the imaging signal changes when symptoms change during treatment. | Drug | Bipolar Disorder |
Primary outcome
Bipolar Depression Rating Scale
Time frame: 6 weeks
A measure of depression severity. Higher numbers indicate more symptoms.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Background: PubMed 27839913Kato T. Neurobiological basis of bipolar disorder: Mitochondrial dysfunction hypothesis and beyond. Schizophr Res. 2017 Sep;187:62-66. doi: 10.1016/j.schres.2016.10.037. Epub 2016 Nov 10.
- Background: PubMed 29389736Picard M, McEwen BS. Psychological Stress and Mitochondria: A Systematic Review. Psychosom Med. 2018 Feb/Mar;80(2):141-153. doi: 10.1097/PSY.0000000000000545.
- Background: PubMed 29766685Holper L, Mann JJ. Test-retest reliability of brain mitochondrial cytochrome-c-oxidase assessed by functional near-infrared spectroscopy. J Biomed Opt. 2018 May;23(5):1-9. doi: 10.1117/1.JBO.23.5.056006.
- Background: PubMed 31111623Holper L, Lan MJ, Brown PJ, Sublette EM, Burke A, Mann JJ. Brain cytochrome-c-oxidase as a marker of mitochondrial function: A pilot study in major depression using NIRS. Depress Anxiety. 2019 Aug;36(8):766-779. doi: 10.1002/da.22913. Epub 2019 May 21.
- Individual participant dataSharing planned: Yes. De-identified data derived from this study will be uploaded to the National Institute of Mental Health Data Archive (NDA) at the National Institutes of Health (NIH). Aggregate, de-identified data from the study will be uploaded to the website, www.clinicaltrials.org. Data may be shared with researchers outside of New York State Psychiatric Institute, but only after the data are de-identified.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Martin Lan, MD PhD principal investigator
Research Foundation for Mental Hygiene, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lurasidone (Latuda) in people with Bipolar Disorder Depression, run by Martin Lan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Martin Lan (646 774 7610, martin.lan@nyspi.columbia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bipolar Depression Rating Scale (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07806227, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.