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Clinical Trials/NCT01943019
NCT01943019
Terminated
Phase 1

A Pilot Study to Assess the Efficacy of Linagliptin as an Adjunct in Schizophrenia Patients

Monash University1 site in 1 country1 target enrollmentAugust 2013
ConditionsSchizophrenia
InterventionsLinagliptin

Overview

Phase
Phase 1
Intervention
Linagliptin
Conditions
Schizophrenia
Sponsor
Monash University
Enrollment
1
Locations
1
Primary Endpoint
PANSS Score
Status
Terminated
Last Updated
7 years ago

Overview

Brief Summary

Approximately one third of patients with schizophrenia show a poor response to standard treatment with antipsychotic medications. This treatment resistant group of patients represents a major challenge in everyday psychiatry, and consumes a disproportionate amount of time from the clinicians, resulting in considerable costs to the society and government. Anecdotal evidence suggests that the enzyme dipeptidyl peptidase IV (DPPIV) may be altered in patients with schizophrenia, with a higher level DPPIV enzyme activity being noted. We postulate that this may play a role in the neuropathology of schizophrenia patients and by inhibiting the DPPIV enzyme activity with a DPPIV inhibitor such as linagliptin, we will be able to improve and even ameliorate the symptoms of schizophrenic patients. However, until now there have yet any studies on the potential of these inhibitors in schizophrenia patients. A pilot study is thus proposed to evaluate the potential of the DPPIV inhibitor, linagliptin as an adjunct in schizophrenia patients who are non-responsive to treatment, which will establish the feasibility of a larger trial.

Registry
clinicaltrials.gov
Start Date
August 2013
End Date
August 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Shaun Lee Wen Huey

Dr

Monash University

Eligibility Criteria

Inclusion Criteria

  • 18 years of age and above
  • Diagnosis of schizophrenia.
  • Clinically stable antipsychotic regimen for the last 3 months
  • A total score of 80 or greater at baseline on the Positive and Negative Syndrome Scale
  • Competent and willing to provide written, informed consent

Exclusion Criteria

  • History of substance dependence within the past 2 months
  • Existing relevant physical health problems: such as uncontrolled cardiovascular disease and impaired liver/ renal function
  • History of diabetes
  • History of hepatic or biliary diseases / biliary obstruction
  • A serious suicide/homicide risk in the opinion of the investigator
  • Known allergy to linagliptin

Arms & Interventions

Linagliptin

Linagliptin daily

Intervention: Linagliptin

Outcomes

Primary Outcomes

PANSS Score

Time Frame: 3 months

Secondary Outcomes

  • Drug safety(3 months)

Study Sites (1)

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