Is NCT06263660 recruiting in Tulsa, OK?

Yes, NCT06263660 is currently recruiting participants at its Tulsa, OK location. This depression clinical trial is actively enrolling qualified participants.

How do I join the depression clinical trial in Tulsa?

To join this clinical trial in Tulsa, 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 Tulsa 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.

Depression Clinical Trial in Tulsa, OK

About This Depression Study in Tulsa

This study aims to determine whether a keto-like supplement relative to placebo results in functional brain changes during fMRI tasks evaluating positive and negative valence in individuals with moderate to severe depression. In this double-blind randomized placebo-controlled trial, 75 individuals with a Patient Health Questionnaire (PHQ-9) scale score ≥ 10 (MDD) will be enrolled to participate in an 8-week treatment study to obtain 60 completers. Participants will be randomized with a 1-1 ratio to receive the keto-like supplement (n= 30 completers) or placebo (n=30 completers) taken orally three times per day for 8 weeks. Participants will undergo a 10.5-hour screening/baseline evaluation visit split over 2 days at week 0 including questionnaires, neuroimaging before and after supplement or placebo administration and blood draws, office visits at week 2 (1.5 hours), week 4 (3 hours), week 6 (0.5 hours), week 8 (6 hours), a follow-up visit at week 10 (1.5 hours) and two phone calls between visits (weeks 1 and 3) during which a brief clinical assessment will be obtained (10 minutes each). The total time involved in the study is approximately 23.5 hours.

Sponsor: Laureate Institute for Brain Research, Inc.

Who Can Participate

Inclusion Criteria

Meets the Diagnostic and statistical manual - 5 (DSM-5) diagnostic criteria for MDD without psychotic features (past or present), as confirmed by the M.I.N.I v7.0

PHQ-9 score of ≥10

C-Reactive Protein (CRP) value \> 1

Consent ability and written consent

Body Mass Index (BMI) between 19 and 38 kg/m2

Medically stable based on clinical laboratory tests, medical history and vital signs

No intention to become pregnant during the study

A woman of childbearing potential must have a negative serum pregnancy test at screening

Consent that possible random finding is reported (e.g. brain abnormality during imaging)

Exclusion Criteria

Has a current or recent history of clinically significant suicidality

Has a history of moderate or severe substance or alcohol use disorder according to DSM-5 criteria, except nicotine or caffeine, within 12 months before screening

Has positive test result(s) for alcohol or drugs of abuse (including methadone, opiates, cocaine, cannabinoids, amphetamine/methamphetamine and ecstasy)

Has a current diagnosis of a psychotic disorder (e.g. schizophrenia, bipolar disorder), an eating disorder (e.g. anorexia, bulimia), or learning disability or a personality disorder that is considered by the investigator to interfere with the ability of the subject to adhere to the protocol (e.g. narcissistic personality, borderline personality disorder)

Change in medication dose and/or frequency within the last 6 weeks. Participants must be on stable medications for 6 weeks prior to enrollment.

Plans to change medication dose/frequency during the course of the study. Must plan to remain on stable dose for the duration of the study, unless otherwise indicated by their provider during the course of the study.

Plans to take vitamins and/or mineral supplements during the study. Must refrain for the duration of the study

Unable to complete MRI scans

Is a woman who is pregnant or breast feeding

Plans to conceive a child while enrolled in this study or within 3 months after the last dose of the keto-like supplement

Has received an investigational drug/vaccines, used an invasive investigational medical device within 60 days before the planned first dose of the keto-like supplement or has participated in 2 or more interventional clinical studies in the previous 1 year, or is currently enrolled in any drug or non-drug interventional study.

Has had major surgery, (i.e. requiring general anesthesia) within 12 weeks before screening, or will not have fully recovered from surgery, or has surgery planned during the time they are expected to participate in the study.

Intake of Omega 3 fatty acids (DHA, EPA, fish oil supplements)

Significant cognitive impairment, clinically relevant or progressive disease (e.g., liver, kidney, cardiovascular system, respiratory tract, vascular system, brain, metabolism, thyroid) that could affect the course of the study

Known metabolic disorders (e.g., fatty acid oxidation disorders, ketolysis/ketogenesis or glucogenesis disorder, hyperinsulinism (e.g., pancreatic neuroendocrine tumor), pyruvate carboxylase deficiency, Type 1 and Type 2 diabetes

Allergy to Stevia sweetener, malic acid or orange flavoring

Concern for inability to maintain adherence to the keto-like supplement administration protocol

Currently practicing a ketogenic or paleo diet or planning to do so during the study period.

Change in body weight of more than 5 kg within one month before the start of the intervention

Medical, psychiatric or other conditions that restrict the patient's following abilities: to interpret the study information, to give informed consent, to adhere to the rules of the protocol, or to complete the study

Contraindications to MRI examinations \[persons with metallic implants (e.g., intracranial metal clips) and carriers of electronic devices (e.g., pacemaker) or persons with claustrophobia\]

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 Tulsa?

Yes, this clinical trial (NCT06263660) has an active research site in Tulsa, OK 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.

Depression Treatment Options in Tulsa, OK

If you're searching for depression treatment options in Tulsa, OK, this clinical trial (NCT06263660) 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 Tulsa research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced 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 depression clinical trials near you to find additional studies recruiting in your area.

Depression Clinical Trial in Tulsa, OK

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