Linagliptin and Mesenchymal Stem Cells: A Pilot Study



Status:Recruiting
Conditions:Schizophrenia
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 45
Updated:5/21/2016
Start Date:April 2015
End Date:May 2017
Contact:Brian Kirkpatrick, MD
Email:bkirkpatrick@medicine.nevada.edu
Phone:775-682-8449

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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.

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.
We found this trial at
1
site
Reno, Nevada 89503
Principal Investigator: Brian Kirkpatrick, MD
Phone: 775-682-8449
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Reno, NV
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