Linagliptin in Schizophrenia Patients

• Sponsor: Monash University (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01943019
• Collaborator: Universiti Kebangsaan Malaysia Medical Centre (Other)
• Enrollment: 1
• Location: 1
• Arm: 1
• Duration (Months): 60
• Patients Per Site Per Month: 0

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia	Drug: Linagliptin	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 1 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Pilot Study to Assess the Efficacy of Linagliptin as an Adjunct in Schizophrenia Patients
• Study Start Date: Aug 1, 2013
• Actual Primary Completion Date: Jul 1, 2018
• Actual Study Completion Date: Aug 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Linagliptin Linagliptin daily	Drug: Linagliptin

Outcome Measures

Primary Outcome Measures

1. PANSS Score [3 months]

Secondary Outcome Measures

1. Drug safety [3 months]

   No of adverse events recorded per patients

Other Outcome Measures

1. DPP-4 enzyme levels [3 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pusat Perubatan Universiti Kebangsaan Malaysia	Bandar Tun Razak	Kuala Lumpur	Malaysia	56000

Sponsors and Collaborators

• Monash University
• Universiti Kebangsaan Malaysia Medical Centre

Investigators

• Principal Investigator: Maniam Thambu, Pusat Perubatan UKM

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Shaun Lee Wen Huey, Dr, Monash University
• ClinicalTrials.gov Identifier: NCT01943019
• Other Study ID Numbers: Phamon 001
• First Posted: Sep 16, 2013
• Last Update Posted: Aug 16, 2018
• Last Verified: Aug 1, 2018

• Additional relevant MeSH terms: Schizophrenia; Linagliptin

Study Results

No Results Posted as of Aug 16, 2018