Linagliptin in Schizophrenia Patients

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01943019
• Other study ID #: Phamon 001
• Status: Terminated
• Phase: Phase 1
• Start date: August 2013
• Est. completion date: August 2018

Study information

• Verified date: August 2018
• Source: Monash University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: August 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• Linagliptin

Locations

Country	Name	City	State
Malaysia	Pusat Perubatan Universiti Kebangsaan Malaysia	Bandar Tun Razak	Kuala Lumpur

Sponsors (2)

Lead Sponsor	Collaborator
Monash University	Pusat Perubatan Universiti Kebangsaan Malaysia

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	DPP-4 enzyme levels		3 months
Primary	PANSS Score		3 months
Secondary	Drug safety	No of adverse events recorded per patients	3 months