Linagliptin and Mesenchymal Stem Cells: A Pilot Study

University of Nevada, Reno

Status and phase: Completed; Phase 4

Conditions: Schizophrenia

Treatments: Drug: Linagliptin

Study type: Interventional

Funder types: Other

Identifiers

NCT02442817

LING-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No 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.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

Linagliptin patients with schizophrenia

Active Comparator group

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.

Treatment:

Drug: Linagliptin

Linagliptin control group

Active Comparator group

Description:

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.

Treatment:

Drug: Linagliptin