Is NCT06555406 recruiting in Berkeley, CA?

Yes, NCT06555406 is currently recruiting participants at its Berkeley, CA location. This bipolar disorder clinical trial is actively enrolling qualified participants.

How do I join the bipolar disorder clinical trial in Berkeley?

To join this clinical trial in Berkeley, 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 Berkeley 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 Disorder Clinical Trial in Berkeley, CA

About This Bipolar Disorder Study in Berkeley

The goal of this clinical trial is to understand how level of adherence with time-restricted eating (TRE) predicts change in diurnal rhythms (as measured using the amplitude of diurnal peripheral clock gene expression), and how those changes predict lower mania and depressive symptoms, and downstream improvements in quality of life. The effects of diurnal amplitude of clock gene expression is expected to remain significant when controlling for change in glucose tolerance and inflammation. Participants will be enrolled who are already receiving medication treatment for bipolar disorder. Participants will complete daily measures of eating, sleep and mood for two weeks, and then will be assigned to follow TRE for eight weeks. Symptoms and Quality of Life will be measured at baseline and during and after the food plan.

Sponsor: University of California, Berkeley

Who Can Participate

Inclusion Criteria

Meets diagnostic criteria for bipolar I disorder or bipolar II disorder (but not cyclothymia, bipolar disorder Not otherwise specified or bipolar disorder due to another medical condition) assessed by the Diagnostic Interview for Anxiety, Mood, and Obsessive-compulsive and Related Neuropsychiatric Disorders \[DIAMOND\])

current sleep (insomnia, hypersomnolence) or circadian sleep-wake (delayed phase, advanced phase, irregular sleep-wake, non-24-hour sleep-wake-type) concerns indicated by endorsement of at least some sleep or circadian-related impairment across the screening self-reports or interview

Living in an English-speaking country (and one that the researchers have expertise in research procedures and diet)

Has been speaking English for at least 10 years, speaks English in the home, or certifies that they are able to understand English well for the study and demonstrates this during the screening interview.

Receiving medical care for bipolar disorder (referrals will be provided for those who would like to begin care)

Mood-stabilizing medication regimens stable for at least one month

\< 5 kg weight change in the past 3 months

Currently eating ≥ 12 hours per day at least twice per week

Able to operate the camera function and respond to web-based surveys by phone (loaner phones will be provided as needed)

Not engaged in current shift work or have other responsibilities such as providing care that would chronically disrupt their sleep (i.e., \> 3 h between 22:00 and 05:00 h for at least 1 day/week)

Able to complete 7 days of dietary logs adequately (e.g., at least 2 entries per day, covering at least a 5-hour eating window) during the baseline period

Able to complete screening and baseline questionnaires adequately (e.g., not failing more than 1 attention check item with instructed responding; responding to standard multiple-choice items in a mean of \< 2 seconds per item). Where individuals respond to more than 14 items in a row with the same response, their answers will be manually reviewed for possible invalidity.

Exclusion Criteria

include the following:

Current episode of depression, hypomania or mania, or psychosis (assessed by the DIAMOND), Participants with acute mood disorder episodes will be encouraged to seek treatment and to consider the study when symptoms have remitted.

Eating disorder diagnosis (by self-report of treatment or diagnosis at any point during their life, Short Eating Disorder Examination Questionnaire (EDE-QS) scores above clinical concern thresholds for eating disorders, or DIAMOND interview of symptoms during adulthood)

Past 3-month alcohol use disorder or substance use disorder (assessed by DIAMOND)

Active suicidal ideation coupled with plan, intent or attempt history as assessed by Columbia Suicide Severity Rating Scale

Conditions that would interfere with ability to take part in the intervention, including pregnancy, breastfeeding, uncorrected hypo or hyperthyroidism, gastrointestinal conditions impairing nutrient absorption

Conditions that would confound immune or other study measures, such as HIV, AIDS, lupus, or multiple sclerosis

Medications contraindicated for fasting: clozapine, glucose-lowering medications, diabetes-related injections, medications requiring food early morning or late evening, corticosteroids; Glucagon-like peptide-1 (GLP-1) agonists will not be an exclusion criteria if weight stabilized

Cognitive deficits as noted during the initial interview or as indicated by low performance on the Orientation Memory Concentration Test- Short Version (weighted score \< 20)

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 Berkeley?

Yes, this clinical trial (NCT06555406) has an active research site in Berkeley, CA 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 Disorder Treatment Options in Berkeley, CA

If you're searching for bipolar disorder treatment options in Berkeley, CA, this clinical trial (NCT06555406) 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 Berkeley research site is actively enrolling participants for this clinical trial. You'll receive care from experienced bipolar disorder 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 disorder clinical trials near you to find additional studies recruiting in your area.

Bipolar Disorder Clinical Trial in Berkeley, CA

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