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| Name | Class |
|---|---|
| Augusta University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Linagliptin patients with schizophrenia | Active Comparator | This group will be made up of 8 participants with schizophrenia and minimal thought disorder who have been stable and taking their prescribed antipsychotics; 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. |
|
| Linagliptin control group | Active Comparator | This group will be made up of 10 control participants with no diagnosis of mental disorder; they will have 12 weeks of treatment and week for assessment. They will receive linagliptin, 5 mg by mouth once per day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Linagliptin | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| SDF1-α (stromal cell-derived factor alpha) Concentration | Blood will be collected on the first week and then biweekly for 12 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| DPP-4 (Dipeptidyl peptidase-4) Activity | Blood will be collected on the first week and then biweekly for 12 weeks. | |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brian Kirkpatrick, MD | University of Nevada School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Nevada School of Medicine | Reno | Nevada | 89503 | United States |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000069476 | Linagliptin |
| ID | Term |
|---|---|
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Blood will be collected on the first week and then biweekly for 12 weeks. |
| Absolute/Differential leukocyte count | Flow cytometry will be used. | Blood will be collected on the first week and then biweekly for 12 weeks. |
| 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. |
| D011799 | Quinazolines |