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Linagliptin and Mesenchymal Stem Cells: A Pilot Study

NCT ID: NCT02442817

Last Updated: 2020-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-02

Study Completion Date

2018-03-02

Brief Summary

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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

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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.

Conditions

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Schizophrenia

Keywords

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DPP-4 Inhibitor Linagliptin SDF1-α

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Linagliptin

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

Linagliptin

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Tradjenta

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Augusta University

OTHER

Sponsor Role collaborator

University of Nevada, Reno

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Brian Kirkpatrick, MD

Role: PRINCIPAL_INVESTIGATOR

University of Nevada School of Medicine

Locations

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University of Nevada School of Medicine

Reno, Nevada, United States

Site Status

Countries

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United States

Other Identifiers

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LING-1

Identifier Type: -

Identifier Source: org_study_id