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Linagliptin and Mesenchymal Stem Cells: A Pilot Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02442817
Recruitment Status : Unknown
Verified May 2016 by University of Nevada, Reno.
Recruitment status was:  Recruiting
First Posted : May 13, 2015
Last Update Posted : May 20, 2016
Sponsor:
Collaborator:
Augusta University
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Linagliptin 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 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
Study Start Date : April 2015
Estimated Primary Completion Date : April 2017
Estimated Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
Drug Information available for: Linagliptin

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 Name: 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 Name: Tradjenta




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02442817


Contacts
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Contact: Brian Kirkpatrick, MD 775-682-8449 bkirkpatrick@medicine.nevada.edu
Contact: Anne Marie Greenhalgh, BA 775-682-8439 agreenhalgh@medicine.nevada.edu

Locations
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United States, Nevada
University of Nevada School of Medicine Recruiting
Reno, Nevada, United States, 89503
Contact: Brian Kirkpatrick, MD    775-682-8449    bkirkpatrick@medicine.nevada.edu   
Principal Investigator: Brian Kirkpatrick, MD         
Sponsors and Collaborators
University of Nevada, Reno
Augusta University
Investigators
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Principal Investigator: Brian Kirkpatrick, MD University of Nevada School of Medicine

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Responsible Party: University of Nevada, Reno
ClinicalTrials.gov Identifier: NCT02442817    
Other Study ID Numbers: LING-1
First Posted: May 13, 2015    Key Record Dates
Last Update Posted: May 20, 2016
Last Verified: May 2016
Keywords provided by University of Nevada, Reno:
DPP-4 Inhibitor
Linagliptin
SDF1-α
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Linagliptin
Physiological Effects of Drugs
Hypoglycemic Agents
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action