Linagliptin and Mesenchymal Stem Cells: A Pilot Study

Schizophrenia Clinical Trial

Official title:

Linagliptin and Mesenchymal Stem Cells: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02442817
• Other study ID #: LING-1
• Status: Completed
• Phase: Phase 4
• Start date: March 2, 2015
• Est. completion date: March 2, 2018

Study information

• Verified date: November 2020
• Source: University of Nevada, Reno
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• Linagliptin
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.

Locations

Country	Name	City	State
United States	University of Nevada School of Medicine	Reno	Nevada

Sponsors (2)

Lead Sponsor	Collaborator
University of Nevada, Reno	Augusta University

Country where clinical trial is conducted

United States, 

Outcome

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.