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NCT07127913: PReSiDio-BP
Closed-Loop Deep Brain Stimulation for Treatment-Resistant Bipolar Depression
NA trial testing Device: Stimulation-ON in Bipolar II Disorder in 10 participants. Currently enrolling.
28 June 2030
Quick facts
| Lead sponsor | Andrew Krystal |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 10 |
| Start date | 16 July 2025 |
| Primary completion | 28 June 2030 |
| Estimated completion | 28 June 2035 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Device: Stimulation-ON
- Device: Stimulation-OFF
- Device: Stimulation -ON Active Control
Conditions studied
- Bipolar II Disorder — all drugs for Bipolar II Disorder →
- Bipolar II Disorder, Most Recent Episode Major Depressive — all drugs for Bipolar II Disorder, Most Recent Episode Major Depressive →
Sponsor
Andrew Krystal — full company profile →
Who can join
Adults 22 to 70, any sex, with Bipolar II Disorder or Bipolar II Disorder, Most Recent Episode Major Depressive. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Neurons are specialized types of cells that are responsible for carrying out the functions of the brain. Neurons communicate with electrical signals. In diseases such as major depression this electrical communication can go awry. One way to change brain function is using electrical stimulation to help alter the communication between groups of neurons in the brain. The purpose of this study is to test a personalized approach to brain stimulation as an intervention for bipolar depression The study researchers will use a surgically implanted device to measure each individual's brain activity related to his/her depression. The researchers will then use small electrical impulses to alter that brain activity and measure whether these changes help reduce depression symptoms. This study is intended for patients with major depression whose symptoms have not been adequately treated with currently available therapies. The device used in this study is called the NeuroPace Responsive Neurostimulation (RNS) System. It is currently FDA approved to treat patients with epilepsy. The study will test whether personalized responsive neurostimulation can safely and effectively treat bipolar depression.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07127913
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Bipolar II Disorder
Currently open trials in the same condition.
- NCT07213466 — Individualized Pharmacological Approach to Obesity in Patients With Bipolar Disorder · Phase 4 · recruiting
- NCT06184581 — Lithium Versus Lamotrigine in Bipolar Disorder, Type II · Phase 4 · recruiting
- NCT05427123 — Children's Bipolar Network Treatment Trial I · recruiting
- NCT05064319 — Gabapentin for Restoring GABA/Glutamate Homeostasis in Co-occurring Bipolar and Cannabis Use Disorders · Phase 2 · recruiting
- NCT03484494 — Low Field Magnetic Stimulation: Imaging Biomarkers in Geriatric Bipolar Depression · NA · active not recruiting
Other Andrew Krystal trials
Trials by the same sponsor.
- NCT04004169 — Closed-Loop Deep Brain Stimulation for Major Depression · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07127913 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Andrew Krystal
- Last refreshed: 17 August 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07127913.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing