NCT02442817

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_4 schizophrenia

Timeline
Completed

Started Mar 2015

Typical duration for phase_4 schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 2, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 8, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 13, 2015

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 2, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 2, 2018

Completed
Last Updated

November 9, 2020

Status Verified

November 1, 2020

Enrollment Period

3 years

First QC Date

May 8, 2015

Last Update Submit

November 5, 2020

Conditions

Schizophrenia

Keywords

DPP-4 InhibitorLinagliptinSDF1-α

Outcome Measures

Primary Outcomes (1)

  • SDF1-α (stromal cell-derived factor alpha) Concentration

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

Secondary Outcomes (4)

  • DPP-4 (Dipeptidyl peptidase-4) Activity

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

  • Monocyte State

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

  • Absolute/Differential leukocyte count

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

  • CD271+ cells

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

Study Arms (2)

Linagliptin patients with schizophrenia

ACTIVE COMPARATOR

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

Linagliptin control group

ACTIVE COMPARATOR

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

Interventions

LinagliptinDRUG

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.

Also known as: Tradjenta
Linagliptin control groupLinagliptin patients with schizophrenia

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Nevada School of Medicine

Reno, Nevada, 89503, United States

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Linagliptin

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsQuinazolines

Study Officials

  • Brian Kirkpatrick, MD

    University of Nevada School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 8, 2015

First Posted

May 13, 2015

Study Start

March 2, 2015

Primary Completion

March 2, 2018

Study Completion

March 2, 2018

Last Updated

November 9, 2020

Record last verified: 2020-11

Locations

US(1)