Boston, MANCT07699445Now EnrollingIRB Ready

Bipolar Depression Depressed Phase Clinical Trial in Boston, MA

Access cutting-edge bipolar depression depressed phase treatment through this phase 4 clinical trial at a research site in Boston. Study-provided care at no cost to qualified participants.

Sponsored by Massachusetts General Hospital

Quick Self-Assessment

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Expert Care in Boston

Access bipolar depression depressed phase specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related bipolar depression depressed phase treatment provided free

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Check if you qualify for this bipolar depression depressed phase clinical trial in Boston, MA

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Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Boston

    Convenient for MA residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Boston site if eligible
  4. 4Begin participation

About This Bipolar Depression Depressed Phase Study in Boston

This research study examines how a medication called lumateperone may affect mood symptoms, and inflammation in adults with bipolar disorder over approximately 6 weeks. An MRI scan to calculate biological age of the brain will also be obtained at the start of the study.

Sponsor: Massachusetts General Hospital

Who Can Participate

Inclusion Criteria

Aged 18 to 65 years.
Meets DSM-V criteria for Bipolar I Disorder -Depressed without psychosis as confirmed by a semi-structured clinical interview that includes the Mini International Neuropsychiatric Interview.
Current episode at least 4 weeks in duration but not longer than 12 months.
Depression score \> 20 on the Montgomery Asberg Depression Rating Scale (MADRS).
Capable of providing informed consent.

Exclusion Criteria

Meets DSM-V criteria for Schizophrenia, Schizoaffective disorder, or has significant mood-incongruent psychotic symptoms.
Young Mania Rating Scale score \>12.
Meets DSM-V criteria for rapid cycling.
Co-Morbid psychiatric illness, other than generalized anxiety and specific phobias, that in the opinion of the investigator is severe enough that it would likely interfere with the interpretation of changes in the subject's mood state.
Meets DSM-V criteria for an active substance use disorder within the past month.
Active medical condition that in the opinion of the investigator would contribute to the subject's depressed mood (e.g. hypothyroidism).
Significant risk of suicide or self -harm as assessed by clinical interview and the Columbia Suicide Severity Rating Scale (C-SSRS).
Significant risk of harm to others as assessed by clinical interview.
Pregnancy, or, in women of child-bearing potential, an unwillingness to use an accepted method of birth control for the duration of the study.
Current or prior treatment with lumateperone.
Moderate or severe hepatic impairment.
Current treatment with strong or moderate CYP3A4 inhibitors or CYP3A4 inducers.
History of seizure disorder.
Significant cardiovascular or cerebrovascular disease that, in the opinion of the investigator, would increase study risk.
Dementia-related psychosis.
Known hypersensitivity or allergy to lumateperone or any of its components.

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 Boston?

Yes, this clinical trial (NCT07699445) has an active research site in Boston, MA 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 Depressed Phase Treatment Options in Boston, MA

If you're searching for bipolar depression depressed phase treatment options in Boston, MA, this clinical trial (NCT07699445) 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 Boston research site is actively enrolling participants for this phase 4 clinical trial. You'll receive care from experienced bipolar depression depressed phase 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 depressed phase clinical trials near you to find additional studies recruiting in your area.

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