Schizophrenia Clinical Trial
Official title:
Linagliptin and Mesenchymal Stem Cells: A Pilot Study
NCT number | NCT02442817 |
Other study ID # | LING-1 |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | March 2, 2015 |
Est. completion date | March 2, 2018 |
Verified date | November 2020 |
Source | University of Nevada, Reno |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of the present study is to gather pilot data on the effects of linagliptin on the concentration of the long and short forms of SDF1-α (stromal cell-derived factor alpha) in humans, and to demonstrate the feasibility of such a study in patients with psychosis in our setting.
Status | Completed |
Enrollment | 10 |
Est. completion date | March 2, 2018 |
Est. primary completion date | March 2, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 45 Years |
Eligibility | Inclusion Criteria: - Meets DSM (Diagnostic and Statistical Manual) criteria for schizophrenia. - Considered clinically stable, and on the same dose of antipsychotic for two weeks. - A score no greater than 3 on the PANSS (Positive and Negative Syndrome Scale) Conceptual Disorganization item. - Not taking any medications for diabetes, or any anti-inflammatories other than occasional aspirin or acetaminophen. Not taking Clozapine. - Age 18-45 years. - Can be available for regular morning appointments from 8:00 am to 10:00 am, preferably on Tuesdays, Wednesdays and Thursdays. Exclusion Criteria: - Does not meet DSM criteria for substance abuse or dependence. - No serious current general medical condition, such as cancer, history of stroke or myocardial infarction, tuberculosis, HIV/AIDS, hemophilia, etc. |
Country | Name | City | State |
---|---|---|---|
United States | University of Nevada School of Medicine | Reno | Nevada |
Lead Sponsor | Collaborator |
---|---|
University of Nevada, Reno | Augusta University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | SDF1-a (stromal cell-derived factor alpha) Concentration | Blood will be collected on the first week and then biweekly for 12 weeks. | ||
Secondary | DPP-4 (Dipeptidyl peptidase-4) Activity | Blood will be collected on the first week and then biweekly for 12 weeks. | ||
Secondary | Monocyte State | Flow cytometry will be used to examine the state of monocytes to look for cells recently arrived from the bone marrow and to examine the polarization (pro-inflammatory vs. anti-inflammatory) of the monocytes | Blood will be collected on the first week and then biweekly for 12 weeks. | |
Secondary | Absolute/Differential leukocyte count | Flow cytometry will be used. | Blood will be collected on the first week and then biweekly for 12 weeks. | |
Secondary | CD271+ cells | Flow cytometry will be used to detect CD271+ cells. | Blood will be collected on the first week and then biweekly for 12 weeks. |
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