Houston, TXNCT03522545Now EnrollingIRB Ready

Treatment-resistant Bipolar Depression Clinical Trial in Houston, TX

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

Sponsored by The University of Texas Health Science Center, Houston

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Expert Care in Houston

Access treatment-resistant bipolar depression specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related treatment-resistant bipolar depression treatment provided free

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Check if you qualify for this treatment-resistant bipolar depression clinical trial in Houston, TX

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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 Houston

    Convenient for TX 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 Houston site if eligible
  4. 4Begin participation

About This Treatment-resistant Bipolar Depression Study in Houston

The overall objective of the investigators is to assess the therapeutic efficacy and tolerability of Allogeneic Bone Marrow Derived Multipotent Mesenchymal Stromal Cells (MSCs) isolated from hematogenous bone marrow for treatment of treatment-resistant bipolar depression patient (TRBD).

Sponsor: The University of Texas Health Science Center, Houston

Who Can Participate

Inclusion Criteria

Diagnosis of DSM-IV-TR of Bipolar I or Bipolar II disorder as verified by the semi-structured diagnostic interviews SCID. The diagnosis may be supported by information from significant others, and from hospital records.
Age: 18-65 years
Severity: meet DSM-IV-TR criteria of depressive episode and MADRS of 25 or above
Treatment resistance: None response to two trials (during lifetime) with mood stabilizers with proven efficacy in bipolar depression (lithium, lamotrigine, quetiapine, olanzapine) and/or antidepressants. a A trial is defined as at least 6 weeks in adequate or tolerated dose as reported by the patient, or patients that have been unable to comply with 6 weeks trials of mood stabilizer or an antidepressant. b None response: Less than 50% reduction in MADRS values or still meet DSM-IV-TR criteria of depressive episode
CRP concentration greater than 5 mg/L
Female subjects whom are not pregnant, not breastfeeding, and not planning on becoming pregnant during the study. Female patients of childbearing potential must be using a reliable method of contraception.
Patient competent to give informed consent according to the judgment of the clinician
Written informed consent
Patient sufficiently fluent in English language to ensure valid responses to psychometric testing (needed for validated neurocognitive outcomes testing)

Exclusion Criteria

MSCs transplant within the last six months
Inability to comply with study protocol
Patient at high suicidal risk according to clinicians' judgement
History of previous brain injury; neurologic impairment and/or deficit; seizure disorder requiring anti-convulsant therapy; renal disease or altered renal function as defined by serum creatinine 2x ULN at admission; hepatic disease or altered liver function as defined by SGPT \> 2 x ULN (non-contusion related), and/or T. Bilirubin 1.5 x ULN at admission; immunosuppression as defined by WBC\<3,000 cells/ml at admission; HIV, splenectomy or cancer
Unstable serious medical conditions, including clinically relevant laboratory abnormalities. Conditions that affect neuropsychological assessment such as Parkinson's Disease, Multiple sclerosis, stroke, alcohol and substance abuse or dependence (according to SCID or DSM-IV-TR). Other serious medical illness that is not adequately controlled and, in the investigator's opinion, would not permit the subject to be managed according to the protocol.
Hemodynamic instability at the time of MSCs infusion.
Positive pregnancy test (at screening or baseline visits).

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 Houston?

Yes, this clinical trial (NCT03522545) has an active research site in Houston, TX 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.

Treatment-resistant Bipolar Depression Treatment Options in Houston, TX

If you're searching for treatment-resistant bipolar depression treatment options in Houston, TX, this clinical trial (NCT03522545) 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 Houston research site is actively enrolling participants for this clinical trial. You'll receive care from experienced treatment-resistant 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 treatment-resistant bipolar depression clinical trials near you to find additional studies recruiting in your area.

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