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New treatment option for Treatment-Refractory Schizophrenia
Official title Deep Brain Stimulation for Psychosis
ClinicalTrials.gov ID: NCT06257056
What this study is testing
- What it's testing
- There are three hypotheses proposed for this study: 1) Participants will report no unanticipated serious adverse events during the eight months of treatment. 2) Investigators will successfully model psychotic versus non-psychotic brain states using support vector machine (SVM) classifiers.
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 to 70
You may be able to join if
- Men and women (non-pregnant) between ages 22 and 70;
- Diagnostic and Statistical Manual of Mental Disorders (DSM) -5 diagnosis (assessed by Structured Clinical Interview for DSM-5 Axis I disorders...
- Medically healthy, without any acute serious medical disorders
- Treatment refractory and previous trials of treatment defined as: Demonstrated non-sustained response to at least two different antipsychotic drugs...
- Suffering from active and ongoing psychotic symptoms of a continuous and aversive nature.
You likely can't join if
- Active alcohol or substance use disorder within 6 months, excluding nicotine; Urine drug test positive for illicit drugs;
- Current substantial suicidal risk as defined by a plan or clear immediate intent for self-harm, or made a suicide attempt within the last year; or as...
- Neurological/Medical condition that makes the participant, in the opinion of the surgeon, a poor surgical candidate (e.g., progressive...
- Any history of seizure disorder, hemorrhagic stroke, or has high risk of seizure (history of congenital brain malformation, history of brain injury...
- Any medical contraindication to surgery such as infection;
- Coagulopathy: Bleeding propensity and/or one of the following: international normalised ratio (INR) \> 1.5; prolonged activated partial...
See the full eligibility criteria
Who can join
- Men and women (non-pregnant) between ages 22 and 70;
- Diagnostic and Statistical Manual of Mental Disorders (DSM) -5 diagnosis (assessed by Structured Clinical Interview for DSM-5 Axis I disorders SCID-5) of schizophrenia as the primary diagnosis.
- Medically healthy, without any acute serious medical disorders
- Treatment refractory and previous trials of treatment defined as: Demonstrated non-sustained response to at least two different antipsychotic drugs from two different chemical families. And demonstrated non-sustained...
- Suffering from active and ongoing psychotic symptoms of a continuous and aversive nature.
- The PANSS must remain greater than or equal to 90 on two separate assessments (at initial screening and 1 week before surgery), over a 1-month period;
- At least one item on the PANSS positive subscale is 5 or greater.
- Normal brain MRI within 3 months of surgery;
- Stable antipsychotic medication regimen for the month preceding surgery;
- Normal thyroid stimulating hormone (TSH) level within 12 months of study entry;
- Other medical conditions must be stable for at least 6 months;
- Able and willing to give informed consent and agree to attend regular clinic visits for at least 12 months following surgery;
- Able to have a treating psychiatrist or close relative present for discussions about the study and co-sign informed consent;
- Willingness to sign Treatment Contract.
- Participants with a family or caregiver support system to aid the participant throughout the study will be preferentially selected for inclusion.
- For women of childbearing potential:
- Required to provide a negative pregnancy blood test during screening phase of the study, and during several additional timepoints throughout study participation.
- Obligated to use highly effective (those that when used alone or in combination, result in a low failure rate [i.e., less than 1 percent per year], when used consistently and correctly) methods of birth control...
- Will be allowed to participate in the study only after a confirmed menstrual period.
- For men: Obligated to use highly effective (those that when used alone or in combination, result in a low failure rate [i.e., less than 1 percent per year], when used consistently and correctly) methods of birth control...
What rules you out
- Active alcohol or substance use disorder within 6 months, excluding nicotine; Urine drug test positive for illicit drugs;
- Current substantial suicidal risk as defined by a plan or clear immediate intent for self-harm, or made a suicide attempt within the last year; or as identified as The Columbia Suicide Severity Rating Scale (C-SSRS),
- Neurological/Medical condition that makes the participant, in the opinion of the surgeon, a poor surgical candidate (e.g., progressive neurodegenerative disorder, significant cardiopulmonary disorder, need for chronic...
- Any history of seizure disorder, hemorrhagic stroke, or has high risk of seizure (history of congenital brain malformation, history of brain injury, neuro-developmental disorder, currently taking medication that is...
- Any medical contraindication to surgery such as infection;
- Coagulopathy: Bleeding propensity and/or one of the following: international normalised ratio (INR) \> 1.5; prolonged activated partial thromboplastin time (aPTT) ≥ 45 sec; platelet count \< 100×103 /uL;
- Uncontrolled hypertension (systolic \> 140mmHg and/or diastolic \> 90 mmHg), demonstrated on each of three repeated measurements taken within one hour regardless of whether or not the participant is taking...
- Patients with a heart-rate corrected QT interval (QTc) of \> 450 msec
- Participation in another drug, device, or biological study within 90 days;
- Current implanted stimulation devices including cardiac pacemakers, defibrillators, and neurostimulators including spinal cord stimulators and deep brain stimulators;
- Need for Diathermy;
- Chronic use of anticoagulant or anti-platelet agents that cannot be safely stopped for a sufficient duration (minimum 2.5 weeks) in the peri-operative period.
- Any Psychiatric/Neurological/Medical condition that makes the participant, in the opinion of the Investigator, a poor candidate.
- A female participant of childbearing potential who is not able or willing to use highly effective (those that when used alone or in combination, result in a low failure rate [i.e., less than 1 percent per year], when...
- A female participant of childbearing potential who is not able or willing to provide a negative pregnancy blood test during the screening phase of the study and during several additional timepoints throughout study...
- A separate cardiac condition that, in the opinion of study physician would present an unacceptable risk of undergoing general anesthesia or ketamine administration.
- Participants with poorly controlled hypertension or persistent tachycardia, at baseline, will be excluded.
- Participants who are taking an anti-depressant medication.
- Any known contraindications for ketamine and/or esketamine (Spravato):
- Patients for whom a significant elevation of blood pressure would constitute a serious hazard, according to the opinion of the study PI.
- Patients with known hypersensitivity to ketamine, esketamine, or to any of the excipients.
- Patients with Aneurysmal vascular disease (including thoracic and abdominal aorta, intracranial, and peripheral arterial vessels) or arteriovenous malformation.
- Patients with a history of intracerebral hemorrhage.
- Patients with resting heart rate over 90 or below 55 beats per minute (BPM)
- Participants taking a medication with a known interaction with ketamine or esketamine (amphetamines, monoamine oxidase (MAO)-Is, aminophylline, theophylline, norepinephrine, epinephrine, vasopressin, dobutamine...
- During the ketamine administration phase in the hospital, patients with a history of benzodiazepine (or other CNS depressant) usage will undergo more frequent documentation of respiratory rate and heart rate (every 10...
- On the day of planned ketamine (or placebo) administration, Dr. McDonagh will review all medicines being administered to the patient to ensure there is no potential interaction. This will be documented on the Ketamine...
- On the day of planned ketamine (or placebo) administration, people will undergo a urine drug screen to avoid the accidental administration of ketamine to a patient who tests positive for any agents that is...
The study team makes the final eligibility decision.
Where it's taking place
- Dallas, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Dallas, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.