Deep Brain Stimulation of Treatment-Resistant Bipolar Depression

Summary

This study is only enrolling at Baylor College of Medicine. The other research locations listed serve to support data analysis only. This research study is to investigate the use of technology called Deep Brain Stimulation (DBS) to potentially improve Treatment-Resistant Bipolar Depression (TRBD) symptoms in patients with severe cases. DBS involves the surgical implantation of leads and electrodes into specific areas of the brain, which are thought to influence the disease. A pack implanted in the chest, called the neurotransmitter, keeps the electrical current coursing to the brain through a wire that connects the neurotransmitter and electrodes. It is believed DBS may restore balance to dysfunctional brain circuitry implicated in TRBD. The goal of this study is to enhance current approaches to DBS targeting in the brain and to use a novel approach to find a better and more reliable system for TRBD treatment. Its important for participants to understand that this is an investigational study where there could be a lack of effectiveness in improving TRBD symptoms. There may be no directly benefit from taking part in this study. This study is expected to last 20 months and involves 3 main steps. 1. Medical, psychiatric, and cognitive evaluations. 2. Implantation of a brain stimulation system. 3. Follow up after implantation of device, including programming, recording, and psychiatric testing. There are risks and benefits to this study which need to be considered when deciding to participate or not. Some of the risks are from surgery, the DBS device and programming, the tests involved, and potential loss of confidentiality, as well as other unknown risks. Some of the more serious risks involved in this study and the percentage that they occur: 1. Bleeding inside the Brain (1 to 2 percent). 2. Infection from the procedures (3 percent) 3. Seizure caused from the procedures (1.2 percent) However, the benefit of this study is that it may help relieve or decrease TRBD symptoms. This form of treatment has shown to reduce symptom severity in other cases. This could potentially improve quality of life and activities in daily routines. There is also a potential benefit to society in that the data the investigators will obtain from this study may help increase the understanding of the mechanisms underlying TRBD symptoms, as well as enhanced Deep Brain Stimulation techniques. Study participation is expected to last 20 months from the time the DBS device is activated and should include approximately 23 visits. These visits also include 8 separate, 24 hour stays at the Menninger NeuroBehvaioral Monitoring Unit (NBU). These 24-hour sessions will occur at multiple points throughout the study (1 week prior to surgery, the week preceding device activation, the week following activation, then after 2 weeks, 4 weeks, 6 months, 9 months, and 12 months). Participants will need to stay locally for the week of the NBU stay (typically Monday through Friday). Study visits will include clinician administered assessments and questionnaires, subject reported assessments, neuropsychological testing, and mobile behavioral assessments which will occur around 23 visits over the course of 20 months.

Eligibility

Inclusion Criteria:

1. Males and females ages 22-64, inclusive
2. Diagnosis: Bipolar I disorder confirmed by SCID-5, currently in a major depressive episode (MDE).
3. Symptom Severity: MADRS score of ≥27 at Screening and pre-operative baseline visit. CGI-S \> 4 and YMRS \<12 at these visits.
4. Failure to respond or maintain a response to a minimum of four evidence-based interventions for bipolar depression in the patient's lifetime, including at least two FDA-approved medications (olanzapine/fluoxetine, quetiapine, lurasidone, cariprazine, lumateperone), or ECT, administered at adequate doses and duration (adequately defined by the Antidepressant Treatment History Form (ATHF-Short Form). During the current episode, the patient must have failed to respond or maintain a response to a minimum of two FDA-approved interventions for bipolar depression. In addition, the patient is required to be currently taking at least one evidence-based medication for bipolar disorder (e.g., lithium, either alone or in combination with an atypical antipsychotic such as quetiapine), unless no evidence-based medications for bipolar disorder are tolerated.
5. Initial mood episode occurred before the age of 40 - to minimize risk of enrolling patients with so atypical onset of initial mania/depression.
6. Must be on a stable dose of psychotropic medications for a minimum of four weeks prior to surgery.
7. Minimum score on the Montreal Cognitive Assessment (MoCA).
8. Able and willing to give informed consent and sign Treatment Contract that includes identification of a reliable informant.

Exclusion Criteria:

1. Lifetime history of a psychotic disorder (e.g., schizophrenia, schizoaffective disorder, and other psychotic disorders), or any history of psychotic symptoms when not in a bipolar mood episode.
2. Currently meets criteria for a manic or hypomanic episode or rapid cycling (4 or more mood episodes in the previous 12 months).
3. Any psychiatric disorder which is the primary focus of treatment within the past 12 months (with bipolar disorder as the secondary focus of treatment).
4. Alcohol/substance use disorder, moderate or severe, within the previous 12 months \[excluding nicotine\].
5. Intellectual disability or neurocognitive disorder.
6. Current major and/or unstable medical conditions. e.g., liver insufficiency, kidney insufficiency, cardiovascular problems \[unstable arrhythmias, chronic heart failure, myocardial infarction (MI), cardiac pacemaker\], systemic infections, cancer, active upper respiratory infections, endocrinopathies, and any major neurological disorder \[e.g., seizure disorder, stroke, dementia, degenerative neurologic diseases, traumatic brain injury\].
7. Any medical contraindication to surgery or condition that makes the patient, in the opinion of the surgeon, a poor candidate.
8. Female who is pregnant or breastfeeding or has plans to become pregnant in the next 24 months.
9. Any contraindication for MRI.
10. Patients with a clinically significant personality disorder, including risk for homicidal or aggressive behavior, which in the opinion of the investigator has a major impact on the patient's current psychiatric status and/or would preclude safe study participation.
11. Patients at serious and imminent risk of suicide and not suitable for an outpatient study, in the judgment of the investigators.
12. Participation in any investigational clinical trial within the preceding 30 days.
13. Current implanted stimulation devices including cardiac pacemakers, defibrillators, and neurostimulators \[including deep brain and spinal cord stimulators\].
14. Patients with no regular contact with at least one adult. Patients who are undomiciled are excluded.
15. Body mass index (BMI) less than 16 and greater than 40 kg/m2
16. Need for diathermy.
17. Unable to sign the informed consent for any reason.
18. Patients who are not under the care of a psychiatrist at Screening and throughout the duration of the study.

Conditions2

Locations4 sites

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