SchizophreniaPhase 4NCT02442817
Linagliptin and Mesenchymal Stem Cells: A Pilot Study
A Phase 4 study testing Linagliptin in people with Schizophrenia, run by University of Nevada, Reno at 1 site in United States.
Trial summary
The purpose of the present study is to gather pilot data on the effects of linagliptin on the concentration of the long and short forms of SDF1-α (stromal cell-derived factor alpha) in humans, and to demonstrate the feasibility of such a study in patients with psychosis in our setting. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Linagliptin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Mar 2015to 2 Mar 2018
- Phase
- Phase 4
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Meets DSM (Diagnostic and Statistical Manual) criteria for schizophrenia.
- Considered clinically stable, and on the same dose of antipsychotic for two weeks.
- A score no greater than 3 on the PANSS (Positive and Negative Syndrome Scale) Conceptual Disorganization item.
- Not taking any medications for diabetes, or any anti-inflammatories other than occasional aspirin or acetaminophen. Not taking Clozapine.
- Age 18-45 years.
- Can be available for regular morning appointments from 8:00 am to 10:00 am, preferably on Tuesdays, Wednesdays and Thursdays.
Who cannot join
- Does not meet DSM criteria for substance abuse or dependence.
- No serious current general medical condition, such as cancer, history of stroke or myocardial infarction, tuberculosis, HIV/AIDS, hemophilia, etc.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nevada School of Medicine
Reno, Nevada, 89503
About this study
The purpose of the present study is to gather pilot data on the effects of linagliptin on the concentration of the long and short forms of SDF1-α (stromal cell-derived factor alpha) in humans, and to demonstrate the feasibility of such a study in patients with psychosis in our setting.
Read the detailed description
This study is a 13-week, open-label study of 8 participants with schizophrenia and minimal thought disorder; they will have 12 weeks of treatment and week for assessment. They will receive linagliptin, 5 mg by mouth once per day, while continuing their antipsychotic treatment. The principal outcome measures will be the concentrations of the long and short forms of SDF1-α (stromal cell-derived factor alpha) in blood.
- Conditions
- Schizophrenia
- Being tested
- Linagliptin
- Keywords
- DPP-4 Inhibitor, Linagliptin, SDF1-α
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LinagliptinDrug
Also called Tradjenta
12 weeks of treatment and week for assessment. Linagliptin, 5 mg by mouth once per day for 12 weeks, in combination with continued antipsychotic treatment.
| Study group | Role | What they receive |
|---|---|---|
| Linagliptin patients with schizophrenia | Active comparator | This group will be made up of 8 participants with schizophrenia and minimal thought disorder who have been stable and taking their prescribed antipsychotics; they will have 12 weeks of treatment and week for assessment. They will receive linagliptin, 5 mg by mouth once per day, while continuing their antipsychotic treatment. Receives: Drug: Linagliptin |
| Linagliptin control group | Active comparator | This group will be made up of 10 control participants with no diagnosis of mental disorder; they will have 12 weeks of treatment and week for assessment. They will receive linagliptin, 5 mg by mouth once per day. Receives: Drug: Linagliptin |
What is being measured
The primary outcome is the main question the study is designed to answer.
SDF1-α (stromal cell-derived factor alpha) Concentration
Measured: Blood will be collected on the first week and then biweekly for 12 weeks.
Secondary outcomes (4)
DPP-4 (Dipeptidyl peptidase-4) Activity
Measured: Blood will be collected on the first week and then biweekly for 12 weeks.
Monocyte State
Flow cytometry will be used to examine the state of monocytes to look for cells recently arrived from the bone marrow and to examine the polarization (pro-inflammatory vs. anti-inflammatory) of the monocytes
Measured: Blood will be collected on the first week and then biweekly for 12 weeks.
Absolute/Differential leukocyte count
Flow cytometry will be used.
Measured: Blood will be collected on the first week and then biweekly for 12 weeks.
CD271+ cells
Flow cytometry will be used to detect CD271+ cells.
Measured: Blood will be collected on the first week and then biweekly for 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2015 (estimated)
- Study start2 Mar 2015
- Primary completion2 Mar 2018
- Study completion2 Mar 2018
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 4
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nevada, Reno
- Sponsor type
- University, hospital or other
- Collaborators
- Augusta University
- Responsible party
- Sponsor
- Investigators
- Brian Kirkpatrick, MD, Principal investigator, University of Nevada School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02442817
- Sponsor's protocol ID
- LING-1
- Status last verified
- Nov 2020
- First submitted
- 8 May 2015
- Last updated
- 9 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Linagliptin and Mesenchymal Stem Cells: A Pilot Study
- ClinicalTrials.gov ID
- NCT02442817
- Acronym / sponsor ID
- LING-1
- Conditions
- Schizophrenia
- Keywords
- DPP-4 Inhibitor, Linagliptin, SDF1-α
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of Nevada, RenoUniversity, hospital or other
- Collaborators
- Augusta University
- Study start
- 2 Mar 2015 (actual)
- Primary completion
- 2 Mar 2018 (actual)
- Study completion
- 2 Mar 2018 (actual)
- First posted
- 13 May 2015 (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.
The purpose of the present study is to gather pilot data on the effects of linagliptin on the concentration of the long and short forms of SDF1-α (stromal cell-derived factor alpha) in humans, and to demonstrate the feasibility of such a study in patients with psychosis in our setting.
Detailed description
This study is a 13-week, open-label study of 8 participants with schizophrenia and minimal thought disorder; they will have 12 weeks of treatment and week for assessment. They will receive linagliptin, 5 mg by mouth once per day, while continuing their antipsychotic treatment. The principal outcome measures will be the concentrations of the long and short forms of SDF1-α (stromal cell-derived factor alpha) in blood.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Linagliptin patients with schizophrenia | Active comparator | Drug: LinagliptinThis group will be made up of 8 participants with schizophrenia and minimal thought disorder who have been stable and taking their prescribed antipsychotics; they will have 12 weeks of treatment and week for assessment. They will receive linagliptin, 5 mg by mouth once per day, while continuing their antipsychotic treatment. |
| Linagliptin control group | Active comparator | Drug: LinagliptinThis group will be made up of 10 control participants with no diagnosis of mental disorder; they will have 12 weeks of treatment and week for assessment. They will receive linagliptin, 5 mg by mouth once per day. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Meets DSM (Diagnostic and Statistical Manual) criteria for schizophrenia.
- Considered clinically stable, and on the same dose of antipsychotic for two weeks.
- A score no greater than 3 on the PANSS (Positive and Negative Syndrome Scale) Conceptual Disorganization item.
- Not taking any medications for diabetes, or any anti-inflammatories other than occasional aspirin or acetaminophen. Not taking Clozapine.
- Age 18-45 years.
Key exclusion criteria (2 listed)
- Does not meet DSM criteria for substance abuse or dependence.
- No serious current general medical condition, such as cancer, history of stroke or myocardial infarction, tuberculosis, HIV/AIDS, hemophilia, etc.
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 |
|---|---|---|
| LinagliptinAlso: Tradjenta12 weeks of treatment and week for assessment. Linagliptin, 5 mg by mouth once per day for 12 weeks, in combination with continued antipsychotic treatment. | Drug | Linagliptin control group, Linagliptin patients with schizophrenia |
Primary outcome
SDF1-α (stromal cell-derived factor alpha) Concentration
Time frame: Blood will be collected on the first week and then biweekly for 12 weeks.
4 secondary outcomes
DPP-4 (Dipeptidyl peptidase-4) Activity
Time frame: Blood will be collected on the first week and then biweekly for 12 weeks.
Monocyte State
Time frame: Blood will be collected on the first week and then biweekly for 12 weeks.
Absolute/Differential leukocyte count
Time frame: Blood will be collected on the first week and then biweekly for 12 weeks.
CD271+ cells
Time frame: Blood will be collected on the first week and then biweekly for 12 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2020.
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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.
Brian Kirkpatrick, MD principal investigator
University of Nevada School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Linagliptin in people with Schizophrenia, run by University of Nevada, Reno at 1 site in United States.
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 6 inclusion and 2 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: finished, as of the sponsor's last update on 9 Nov 2020. 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 United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
SDF1-α (stromal cell-derived factor alpha) Concentration (time frame: Blood will be collected on the first week and then biweekly for 12 weeks.). 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 9 Nov 2020.