Is NCT07121894 recruiting in Rochester, MN?

Yes, NCT07121894 is currently recruiting participants at its Rochester, MN location. This bipolar depression clinical trial is actively enrolling qualified participants.

How do I join the bipolar depression clinical trial in Rochester?

To join this clinical trial in Rochester, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Rochester clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Bipolar Depression Clinical Trial in Rochester, MN

Who Can Participate

Inclusion Criteria

Age 18-50 years

Willingness to change the current diet to a high fat, low carbohydrate diet

Diagnosis of bipolar I or II disorder, or BP schizoaffective Disorder by DSM-IV (SCID- confirmed). If a participant has already completed a structured diagnostic interview within the last 2 years or in any of the Department of Psychiatry and Psychology Mood Unit studies, existing SCID results can be used for this study; thus, they will not be required to repeat the SCID assessment. If a structured diagnostic interview was completed more than 2 years ago, the current mood state sections of the SCID must be repeated to ensure accuracy of current mood state assessment.

Depressive symptom severity of at least mild (MADRS \> 6) with steady and stable (ie, at least 2 weeks) mood stabilization (eg, lithium, valproate, lamotrigine, carbamazepine/oxcarbamazepine, and/or atypical antipsychotic therapy) and non-psychotropic medication.

Urine drug screen is negative except for allowable drugs that they have been prescribed, such as benzodiazepines.

Pregnancy test is negative.

Established birth control practice for sexually active individuals.

Medical comorbidity is stable (hypertension, T2D, gout - uric acid in normal limits).

Exclusion Criteria

No access to smartphone or internet (unless provided by sponsor)

Inability to provide written, voluntary, informed consent and pass (80%) comprehension assessment related to study goals, risks, and benefits.

Structured clinical interview confirmation of schizophrenia or presence of psychotic symptoms (both SCID and YMRS question 8\>5).

Clinical diagnosis of personality disorder that, upon review by the study psychiatrist, of all available information (SCID, electronic health record), is the primary psychiatric diagnosis.

Mixed symptoms of depression defined as a YMRS ≥12 (i.e., hypomania).

Active suicidal ideation as defined by MADRS score \>4 on question #10 or Columbia Suicide Severity Scale (C-SSRS), yes response to Question #4 (ideation, intent, but no plan) or Question #5 (ideation, intent, and plan).

Any current drug and alcohol use disorder (excluding nicotine); complete (not partial) remission ≥3 months.

Positive toxicology screen for cannabis and cannabis use disorder by structured clinical interview. Participants who use cannabis for recreational or medicinal purposes and fail the toxicology screen can potentially be included if the Cannabis Use Disorder Identification Test (CUDIT-R) score is \< 12.

Currently undergoing ECT, transcranial magnetic stimulation, or deep brain stimulation as an acute or maintenance treatment. Maintenance vagal nerve stimulation is allowed if the placement of device is \> 1 year.

Current involuntary psychiatric hospitalization.

Already in ketosis or on a medication that causes acidosis, such as carbonic anhydrase inhibitors (e.g., acetazolamide "Diamox" and topiramate).

BMI \< 18.5; (m) baseline LDL-c \> 190.

Any active or unstable medical condition judged by the principal investigator as conferring significant medical risk to allow inclusion in the study, such as active severe infection.

Acute pancreatitis or history of lipid-associated pancreatitis.

Type I diabetes.

SGLT2 inhibitor use

Rare inborn errors of metabolism affecting fatty acid processing (typically diagnosed in infancy or, rarely, adolescence), such as Pyruvate carboxylase deficiency and Porphyria

Primary carnitine deficiency

Chronic renal failure, significant renal disease defined as creatinine clearance \<30 or in dialysis.

Severe vitamin D deficiency (serum levels of 25-hydroxyvitamin D \[25(OH)D\] \< 12 ng/mL or 30 nMol/L).

A diagnosis of osteopenia, defined as a bone mineral density (BMD) T-score between -1.0 and -2.5 on a dual-energy X-ray absorptiometry (DEXA) scan or with a history of fragility fractures

Clinically significant laboratory test abnormality

Anticipated elective surgical procedure within the next 18 weeks

Family history of premature coronary artery disease defined as atherosclerotic cardiovascular events (e.g., heart attack, stroke) before 55 and 65 years of age in male and female first-degree relatives, respectively.

History of familial hypercholesterolemia (note -current or start of statin or lipid-lowering drug as part of clinical care is not an exclusion provided managed by a primary care provider) or LDL-C\>190 mg/dl (or LDL\>160 mg/dl if on lipid lowering therapy) or triglycerides\>500 mg/dl.

History of coronary disease or coronary calcifications or coronary stenosis found in invasive cardiac catheterization or imaging.

History of ischemic stroke or carotid plaque found on baseline common carotid intima-media thickness (IMT) ultrasound.

History of peripheral atherosclerotic arterial disease or any other form of clinical atherosclerosis.

History or current diagnosis of respiratory failure defined as a PaO₂ \< 60 mmHg or SpO₂ \< 90% on room air or any condition leading to clinically significant respiratory impairment

History or current diagnosis of liver failure or chronic liver disease with significant impairment, defined as ALT or AST \> 5 times the upper limit of normal, or total bilirubin \> 3 mg/dL.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Rochester?

Yes, this clinical trial (NCT07121894) has an active research site in Rochester, MN that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Bipolar Depression Treatment Options in Rochester, MN

If you're searching for bipolar depression treatment options in Rochester, MN, this clinical trial (NCT07121894) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Rochester research site is actively enrolling participants for this clinical trial. You'll receive care from experienced bipolar depression specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all bipolar depression clinical trials near you to find additional studies recruiting in your area.

Bipolar Depression Clinical Trial in Rochester, MN

Expert Care in Rochester

IRB Approved

No-Cost Care

Apply for This Rochester Location

Why Participate?

Simple Process

About This Bipolar Depression Study in Rochester