Linagliptin in Schizophrenia Patients

NCT01943019 | Terminated Phase 1

• 1 other identifier: Phamon 001
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

• PANSS Score

  3 months

Secondary Outcomes (1)

• Drug safety

  3 months

Other Outcomes (1)

• DPP-4 enzyme levels

  3 months

Study Arms (1)

Linagliptin

EXPERIMENTAL

Linagliptin daily

Drug: Linagliptin

Interventions

Linagliptin DRUG

Linagliptin

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Monash University: lead
• Universiti Kebangsaan Malaysia Medical Centre: collaborator

Study Sites (1)

Pusat Perubatan Universiti Kebangsaan Malaysia

Bandar Tun Razak, Kuala Lumpur, 56000, Malaysia

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Linagliptin

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinazolines

Study Officials

• Maniam Thambu

  Pusat Perubatan UKM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: August 22, 2013
• First Posted: September 16, 2013
• Study Start: August 1, 2013
• Primary Completion: July 1, 2018
• Study Completion: August 1, 2018
• Last Updated: August 16, 2018

Record last verified: 2018-08

Locations

MY (1)