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Completed

NCT Number: NCT02442817

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.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Nevada School of Medicine

Reno, Nevada, 89503, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Linagliptin

Drug

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

Primary outcomes

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

    Time frame: Blood will be collected on the first week and then biweekly for 12 weeks.

Secondary outcomes

  1. DPP-4 (Dipeptidyl peptidase-4) Activity

    Time frame: Blood will be collected on the first week and then biweekly for 12 weeks.

  2. Monocyte State

    Time frame: 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

  3. Absolute/Differential leukocyte count

    Time frame: Blood will be collected on the first week and then biweekly for 12 weeks.

    Flow cytometry will be used.

  4. CD271+ cells

    Time frame: Blood will be collected on the first week and then biweekly for 12 weeks.

    Flow cytometry will be used to detect CD271+ cells.

Sponsors and collaborators

Lead sponsor

University of Nevada, Reno

Other

Collaborators

  • Augusta University

Registry information

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
May 13, 2015
Registry last updated
Nov 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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