Linagliptin and Mesenchymal Stem Cells: A Pilot Study

Phase 4

Completed

• Conditions: Schizophrenia
• Interventions: Drug: Linagliptin

• Registration Number: NCT02442817
• Lead Sponsor: University of Nevada, Reno

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.

Study Timeline

• Study Start: 2015-03-02
• Study First Submitted: 2015-05-08
• Study First Submitted QC: 2015-05-08
• Study First Posted: 2015-05-13
• Primary Completion: 2018-03-02
• Study Completion: 2018-03-02
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-05
• Last Update Posted: 2020-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Linagliptin patients with schizophrenia	Linagliptin	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	Linagliptin	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.

Primary Outcome Measures

Name	Time	Method
SDF1-α (stromal cell-derived factor alpha) Concentration	Blood will be collected on the first week and then biweekly for 12 weeks.

Secondary Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

University of Nevada School of Medicine; 🇺🇸 Reno, Nevada, United States