SchizophreniaPhase 1NCT01943019
Linagliptin in Schizophrenia Patients
A Phase 1 study testing Linagliptin in people with Schizophrenia, run by Monash University at 1 site in Malaysia.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Linagliptin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteMalaysia
- Study dates
- Aug 2013to Aug 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
Pusat Perubatan Universiti Kebangsaan Malaysia
Bandar Tun Razak, Kuala Lumpur, 56000
About this study
Official title: 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.
- Conditions
- Schizophrenia
- Being tested
- Linagliptin
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LinagliptinDrug
| Study group | Role | What they receive |
|---|---|---|
| Linagliptin | Experimental | Linagliptin daily Receives: Drug: Linagliptin |
What is being measured
The primary outcome is the main question the study is designed to answer.
PANSS Score
Measured: 3 months
Secondary outcomes (1)
Drug safety
No of adverse events recorded per patients
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2013 (estimated)
- Study startAug 2013
- Primary completionJul 2018
- Study completionAug 2018
Why it stopped: Inability to obtain patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Monash University
- Sponsor type
- University, hospital or other
- Collaborators
- Universiti Kebangsaan Malaysia Medical Centre
- Responsible party
- Principal investigator, Shaun Lee Wen Huey, Monash University
- Investigators
- Maniam Thambu, Principal investigator, Pusat Perubatan UKM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01943019
- Sponsor's protocol ID
- Phamon 001
- Status last verified
- Aug 2018
- First submitted
- 22 Aug 2013
- Last updated
- 16 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Assess the Efficacy of Linagliptin as an Adjunct in Schizophrenia Patients
- ClinicalTrials.gov ID
- NCT01943019
- Acronym / sponsor ID
- Phamon 001
- Conditions
- Schizophrenia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inability to obtain patients
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Monash UniversityUniversity, hospital or other
- Collaborators
- Universiti Kebangsaan Malaysia Medical Centre
- Study start
- Aug 2013
- Primary completion
- Jul 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 16 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Linagliptin | Experimental | Drug: LinagliptinLinagliptin daily |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Linagliptin | Drug | Linagliptin |
Primary outcome
PANSS Score
Time frame: 3 months
1 secondary outcome
Drug safety
Time frame: 3 months
Results and safety
The study was stopped early (reason given: Inability to obtain patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maniam Thambu principal investigator
Pusat Perubatan UKM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Linagliptin in people with Schizophrenia, run by Monash University at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Inability to obtain patients). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PANSS Score (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2018.