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Linagliptin and Mesenchymal Stem Cells: A Pilot Study

Primary Purpose

Schizophrenia

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Linagliptin

About this trial

This is an interventional basic science trial for Schizophrenia focused on measuring DPP-4 Inhibitor, Linagliptin, SDF1-α

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

University of Nevada School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Linagliptin patients with schizophrenia

Linagliptin control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

SDF1-α (stromal cell-derived factor alpha) Concentration

Secondary Outcome Measures

DPP-4 (Dipeptidyl peptidase-4) Activity

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

Absolute/Differential leukocyte count

Flow cytometry will be used.

CD271+ cells

Flow cytometry will be used to detect CD271+ cells.

Full Information

NCT ID

NCT02442817

First Posted

May 8, 2015

Last Updated

November 5, 2020

Sponsor

University of Nevada, Reno

Collaborators

Augusta University

1. Study Identification

Unique Protocol Identification Number

NCT02442817

Brief Title

Linagliptin and Mesenchymal Stem Cells: A Pilot Study

Official Title

Linagliptin and Mesenchymal Stem Cells: A Pilot Study

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Completed

Study Start Date

March 2, 2015 (Actual)

Primary Completion Date

March 2, 2018 (Actual)

Study Completion Date

March 2, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Nevada, Reno

Collaborators

Augusta University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Schizophrenia

Keywords

DPP-4 Inhibitor, Linagliptin, SDF1-α

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Linagliptin patients with schizophrenia

Arm Type

Active Comparator

Arm Description

Arm Title

Linagliptin control group

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Linagliptin

Other Intervention Name(s)

Tradjenta

Intervention Description

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.

Primary Outcome Measure Information:

Title

SDF1-α (stromal cell-derived factor alpha) Concentration

Time Frame