drugset / Trial / NCT07806227
Broadband Near Infrared Spectroscopy to Understand the Role of Brain Cytochrome C Oxidase in Bipolar Disorder
Phase 4
Not yet recruiting
60 enrolled
Martin Lan
National Institute of Mental Health (NIMH) · collab
NaSingle-groupOpen-labelTreatment
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. 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.
Timeline
- Start
- 2026-11-01
- Primary completion
- 2028-07-30
- Completion
- 2028-07-30
Publications
- Background 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.
- Background Picard 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 Holper 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 Holper 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lurasidone | Small molecule | — | — |