Linagliptin in Schizophrenia Patients

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

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.

Study Overview

• Status: Terminated
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: Linagliptin

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Phase 1

Contacts and Locations

Study Locations

• Malaysia
  • Kuala Lumpur
    • Bandar Tun Razak, Kuala Lumpur, Malaysia, 56000
      • Pusat Perubatan Universiti Kebangsaan Malaysia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Linagliptin; Linagliptin daily	Drug: Linagliptin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
PANSS Score	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Drug safety	No of adverse events recorded per patients	3 months

Other Outcome Measures

Outcome Measure	Time Frame
DPP-4 enzyme levels	3 months

Collaborators and Investigators

• Sponsor: Monash University
• Collaborators: Universiti Kebangsaan Malaysia Medical Centre
• Investigators: Principal Investigator: Maniam Thambu, Pusat Perubatan UKM

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (ACTUAL): July 1, 2018
• Study Completion (ACTUAL): August 1, 2018

Study Registration Dates

• First Submitted: August 22, 2013
• First Submitted That Met QC Criteria: September 11, 2013
• First Posted (ESTIMATE): September 16, 2013

Study Record Updates

• Last Update Posted (ACTUAL): August 16, 2018
• Last Update Submitted That Met QC Criteria: August 14, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Protease Inhibitors; Incretins; Dipeptidyl-Peptidase IV Inhibitors; Linagliptin
• Other Study ID Numbers: Phamon 001