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Linagliptin and Mesenchymal Stem Cells: A Pilot Study

Sponsor
University of Nevada, Reno (Other)
Overall Status
Completed
CT.gov ID
NCT02442817
Collaborator
Augusta University (Other)
10
Enrollment
1
Location
2
Arms
36
Actual Duration (Months)
0.3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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 Design

Study Type:
Interventional
Actual Enrollment :
10 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Linagliptin and Mesenchymal Stem Cells: A Pilot Study
Actual Study Start Date :
Mar 2, 2015
Actual Primary Completion Date :
Mar 2, 2018
Actual Study Completion Date :
Mar 2, 2018

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. DPP-4 (Dipeptidyl peptidase-4) Activity [Blood will be collected on the first week and then biweekly for 12 weeks.]

    2. 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

    3. Absolute/Differential leukocyte count [Blood will be collected on the first week and then biweekly for 12 weeks.]

      Flow cytometry will be used.

    4. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Nevada School of Medicine Reno Nevada United States 89503

    Sponsors and Collaborators

    • University of Nevada, Reno
    • Augusta University

    Investigators

    • Principal Investigator: Brian Kirkpatrick, MD, University of Nevada School of Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Nevada, Reno
    ClinicalTrials.gov Identifier:
    NCT02442817
    Other Study ID Numbers:
    • LING-1
    First Posted:
    May 13, 2015
    Last Update Posted:
    Nov 9, 2020
    Last Verified:
    Nov 1, 2020
    Keywords provided by University of Nevada, Reno
    DPP-4 Inhibitor
    Linagliptin
    SDF1-α
    Additional relevant MeSH terms:
    Schizophrenia
    Linagliptin

    Study Results

    No Results Posted as of Nov 9, 2020