Schizophrenia
Conditions
Keywords
DPP-4 Inhibitor, Linagliptin, SDF1-α
Brief summary
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.
Detailed description
This study is a 13-week, open-label study of 8 participants with schizophrenia and minimal thought disorder; they will have 12 weeks of treatment and week for assessment. They will receive linagliptin, 5 mg by mouth once per day, while continuing their antipsychotic treatment. The principal outcome measures will be the concentrations of the long and short forms of SDF1-α (stromal cell-derived factor alpha) in blood.
Interventions
DRUGLinagliptin
12 weeks of treatment and week for assessment. Linagliptin, 5 mg by mouth once per day for 12 weeks, in combination with continued antipsychotic treatment.
Sponsors
Augusta University
University of Nevada, Reno
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SDF1-α (stromal cell-derived factor alpha) Concentration | Blood will be collected on the first week and then biweekly for 12 weeks. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| DPP-4 (Dipeptidyl peptidase-4) Activity | Blood will be collected on the first week and then biweekly for 12 weeks. | — |
| Monocyte State | Blood will be collected on the first week and then biweekly for 12 weeks. | 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 |
| Absolute/Differential leukocyte count | Blood will be collected on the first week and then biweekly for 12 weeks. | Flow cytometry will be used. |
| CD271+ cells | Blood will be collected on the first week and then biweekly for 12 weeks. | Flow cytometry will be used to detect CD271+ cells. |
Countries
United States
Outcome results
None listed