Linagliptin in Schizophrenia Patients

Phase 1

Terminated

• Conditions: Schizophrenia
• Interventions: Drug: Linagliptin

• Registration Number: NCT01943019
• Lead Sponsor: Monash University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-08-22
• Study First Submitted QC: 2013-09-11
• Study First Posted: 2013-09-16
• Primary Completion: 2018-07
• Status Verified: 2018-08
• Study Completion: 2018-08
• Last Update Submitted: 2018-08-14
• Last Update Posted: 2018-08-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Linagliptin	Linagliptin	Linagliptin daily

Primary Outcome Measures

Name	Time	Method
PANSS Score	3 months

Secondary Outcome Measures

Name	Time	Method
Drug safety	3 months	No of adverse events recorded per patients

Trial Locations

Locations (1)

Pusat Perubatan Universiti Kebangsaan Malaysia; 🇲🇾 Bandar Tun Razak, Kuala Lumpur, Malaysia