SchizophreniaPhase 2NCT03868839
Telmisartan Pilot Study on Treatment Resistant Schizophrenia
A Phase 2 study testing Telmisartan Pill in people with Schizophrenia and Schizo Affective Disorder, run by Xiaoduo Fan at 1 site in United States.
Trial summary
This study is a 4-week pilot study for subjects with Schizophrenia or Schizoaffective Disorder who have not experienced a significant relief of symptoms from current anti-psychotic medication. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia, Schizo Affective Disorder, Treatment-resistant Schizophrenia
- What is being tested?
- Telmisartan Pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2019to 7 Oct 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Age 18-65 years inclusive.
- Primary diagnosis of Schizophrenia or Schizoaffective Disorder established by a structured psychiatric evaluation (MINI) based on Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-V) criteria.
- A Positive and Negative Syndrome Scale (PANSS) (Kay et al 1987) total score ≥ 70 with a score of > 4 on two or more of the following PANSS items: delusions, conceptual disorganization, hallucinatory behavior, suspiciousness, and unusual thought content.
- A score of ≥4 on the Clinical Global Impression-Severity (CGI-S) (Guy, 1976).
- Must have ongoing antipsychotic treatment for at least 8 weeks, with a stable dose for at least 4 weeks. Subjects who have failed to achieve clinically-recognized symptom reduction to at least 1 marketed antipsychotic agent at a therapeutic dose for ≥ 8 weeks during the past 12 months, will be eligible.
- Women of childbearing potential must have a negative pregnancy test performed at screening visit prior to receiving the study medication. Women enrolled in this trial must use single barrier contraception.
Who cannot join
- Psychiatrically unstable.
- Subjects with any clinically significant abnormalities as determined by medical history, physical exam, clinical and lab evaluation suggestive of an underlying disease state that may, in the opinion of the investigator, confound the results of study, increase risk to the subject, or lead to difficulty complying with the study plan.
- Current insulin treatment for diabetes.
- History of immunosuppression.
- Current or recent radiation or chemotherapy treatment for cancer.
- Chronic use of steroids (except local use or inhaler).
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- Pregnancy or breastfeeding.
- Women who are planning to become pregnant.
- Use of diuretics, ACE inhibitors, spironolactone, potassium supplements, digoxin or warfarin because the possible drug-drug interaction with telmisartan.
- Tested positive for the urine drug screen.
- Subjects at imminent risk of suicide or injury to self or others, as per the opinion of the investigator, or history of significant suicide attempt within the last 6 months as per the Columbia Suicide Severity Rating Scale (C-SSRS).
- Subjects that have taken an investigational drug or taken part in a clinical trial within 30 days prior to screening.
- Subjects with a current (within the last 3 months) DSM-V diagnosis of alcohol or substance use disorder (excluding nicotine and caffeine) as established by the clinical assessment (MINI) at the screening visit will be excluded.
- Any other reason that, in the opinion of the investigator, would compromise patient safety or integrity of the study.
- Subjects with the lab values defined as exclusionary safety values.
Trial locations and contacts
1 site in 1 country.
United States1 site
UMass Psychotic Disorders Research Program
Worcester, Massachusetts, 01610
About this study
Official title: An Open-label Feasibility Trial of Adjunctive Telmisartan in Patients With Treatment Resistant Schizophrenia
This study is a 4-week pilot study for subjects with Schizophrenia or Schizoaffective Disorder who have not experienced a significant relief of symptoms from current anti-psychotic medication. The Investigators hypothesize that 4 weeks of telmisartan at 80mg daily will alter blood biomarkers for inflammation and oxidative stress after 4 weeks treatment.
- Being tested
- Telmisartan Pill
- Medical subject headings
- Schizophrenia, Psychotic Disorders, Schizophrenia, Treatment-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telmisartan PillDrug
Also called Micardis
telmisartan 40mg once a day during week 1; the dose will be increased to 80mg (target dose) or as tolerated during the remaining three weeks.
| Study group | Role | What they receive |
|---|---|---|
| Telmisartan Pill | Experimental | Subjects will start telmisartan 40mg once a day during week 1; the dose will be increased to 80mg (target dose) or as tolerated during the remaining three weeks. Receives: Drug: Telmisartan Pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Blood Levels of Tumor Necrosis Factor Alpha
Levels at week 4 minus levels at baseline
Measured: Baseline (week 0) to 4 weeks after initial dose
Changes in Blood Levels of Glutathione
Levels at week 4 minus levels at baseline
Measured: Baseline (week 0) to 4 weeks after initial dose
Changes in Blood Levels of Interleukin-6
Levels at week 4 minus levels at baseline
Measured: Baseline (week 0) to 4 weeks after initial dose
Changes in Blood Levels of High Sensitivity C-Reactive Protein
Levels at week 4 minus levels at baseline
Measured: Baseline (week 0) to 4 weeks after initial dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2019
- Study start1 Feb 2019
- Primary completion7 Oct 2020
- Study completion7 Oct 2020
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 2
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xiaoduo Fan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xiaoduo Fan, University of Massachusetts, Worcester
- Investigators
- Xiaoduo Fan, MD, MPH, Principal investigator, University of Massachusetts, Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03868839
- Sponsor's protocol ID
- H00015574
- Status last verified
- Feb 2022
- First submitted
- 6 Mar 2019
- Last updated
- 2 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Feasibility Trial of Adjunctive Telmisartan in Patients With Treatment Resistant Schizophrenia
- ClinicalTrials.gov ID
- NCT03868839
- Acronym / sponsor ID
- H00015574
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of funding
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Xiaoduo FanUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 7 Oct 2020 (actual)
- Study completion
- 7 Oct 2020 (actual)
- First posted
- 11 Mar 2019 (actual)
- Results
- Posted 2 Mar 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a 4-week pilot study for subjects with Schizophrenia or Schizoaffective Disorder who have not experienced a significant relief of symptoms from current anti-psychotic medication. The Investigators hypothesize that 4 weeks of telmisartan at 80mg daily will alter blood biomarkers for inflammation and oxidative stress after 4 weeks treatment.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Telmisartan Pill | Experimental | Drug: Telmisartan PillSubjects will start telmisartan 40mg once a day during week 1; the dose will be increased to 80mg (target dose) or as tolerated during the remaining three weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18-65 years inclusive.
- Primary diagnosis of Schizophrenia or Schizoaffective Disorder established by a structured psychiatric evaluation (MINI) based on Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-V) criteria.
- A Positive and Negative Syndrome Scale (PANSS) (Kay et al 1987) total score ≥ 70 with a score of > 4 on two or more of the following PANSS items: delusions, conceptual disorganization, hallucinatory behavior, suspiciousness, and unusual thought content.
- A score of ≥4 on the Clinical Global Impression-Severity (CGI-S) (Guy, 1976).
- Must have ongoing antipsychotic treatment for at least 8 weeks, with a stable dose for at least 4 weeks. Subjects who have failed to achieve clinically-recognized symptom reduction to at least 1 marketed antipsychotic agent at a therapeutic dose for ≥ 8 weeks during the past 12 months, will be eligible.
Key exclusion criteria (15 listed)
- Psychiatrically unstable.
- Subjects with any clinically significant abnormalities as determined by medical history, physical exam, clinical and lab evaluation suggestive of an underlying disease state that may, in the opinion of the investigator, confound the results of study, increase risk to the subject, or lead to difficulty complying with the study plan.
- Current insulin treatment for diabetes.
- History of immunosuppression.
- Current or recent radiation or chemotherapy treatment for cancer.
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 |
|---|---|---|
| Telmisartan PillAlso: Micardistelmisartan 40mg once a day during week 1; the dose will be increased to 80mg (target dose) or as tolerated during the remaining three weeks. | Drug | Telmisartan Pill |
Primary outcome
Changes in Blood Levels of Tumor Necrosis Factor Alpha
Time frame: Baseline (week 0) to 4 weeks after initial dose
Levels at week 4 minus levels at baseline
Changes in Blood Levels of Glutathione
Time frame: Baseline (week 0) to 4 weeks after initial dose
Levels at week 4 minus levels at baseline
Changes in Blood Levels of Interleukin-6
Time frame: Baseline (week 0) to 4 weeks after initial dose
Levels at week 4 minus levels at baseline
Changes in Blood Levels of High Sensitivity C-Reactive Protein
Time frame: Baseline (week 0) to 4 weeks after initial dose
Levels at week 4 minus levels at baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Xiaoduo Fan, MD, MPH principal investigator
University of Massachusetts, Worcester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Telmisartan Pill in people with Schizophrenia and Schizo Affective Disorder, run by Xiaoduo Fan 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 15 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 2 Mar 2022. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Changes in Blood Levels of Tumor Necrosis Factor Alpha (time frame: Baseline (week 0) to 4 weeks after initial dose). The study lists 4 primary outcomes in all. 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 2 Mar 2022; AzTrials last refreshed its copy on 2 Nov 2026.