Linagliptin and Mesenchymal Stem Cells: A Pilot Study

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: Linagliptin

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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Nevada
    • Reno, Nevada, United States, 89503
      • University of Nevada School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Linagliptin patients with schizophrenia; 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.	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.; Other Names: Tradjenta
Active Comparator: Linagliptin control group; 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.	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.; Other Names: Tradjenta

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	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	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.

Collaborators and Investigators

• Sponsor: University of Nevada, Reno
• Collaborators: Augusta University
• Investigators: Principal Investigator: Brian Kirkpatrick, MD, University of Nevada School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2015
• Primary Completion (Actual): March 2, 2018
• Study Completion (Actual): March 2, 2018

Study Registration Dates

• First Submitted: May 8, 2015
• First Submitted That Met QC Criteria: May 8, 2015
• First Posted (Estimate): May 13, 2015

Study Record Updates

• Last Update Posted (Actual): November 9, 2020
• Last Update Submitted That Met QC Criteria: November 5, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Linagliptin; DPP-4 Inhibitor; SDF1-α
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Protease Inhibitors; Incretins; Dipeptidyl-Peptidase IV Inhibitors; Linagliptin
• Other Study ID Numbers: LING-1