- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03868839
Telmisartan Pilot Study on Treatment Resistant Schizophrenia
February 7, 2022 updated by: Xiaoduo Fan
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.
Study Overview
Status
Terminated
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
6
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Massachusetts
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Worcester, Massachusetts, United States, 01610
- UMass Psychotic Disorders Research Program
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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:
- 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.
Exclusion Criteria:
- 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).
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Telmisartan Pill
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.
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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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in Blood Levels of Tumor Necrosis Factor Alpha
Time Frame: Baseline (week 0) to 4 weeks after initial dose
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Levels at week 4 minus levels at baseline
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Baseline (week 0) to 4 weeks after initial dose
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Changes in Blood Levels of Glutathione
Time Frame: Baseline (week 0) to 4 weeks after initial dose
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Levels at week 4 minus levels at baseline
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Baseline (week 0) to 4 weeks after initial dose
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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
|
Baseline (week 0) to 4 weeks after initial dose
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Changes in Blood Levels of High Sensitivity C-Reactive Protein
Time Frame: Baseline (week 0) to 4 weeks after initial dose
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Levels at week 4 minus levels at baseline
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Baseline (week 0) to 4 weeks after initial dose
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Xiaoduo Fan, MD, MPH, University of Massachusetts, Worcester
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2019
Primary Completion (Actual)
October 7, 2020
Study Completion (Actual)
October 7, 2020
Study Registration Dates
First Submitted
March 6, 2019
First Submitted That Met QC Criteria
March 6, 2019
First Posted (Actual)
March 11, 2019
Study Record Updates
Last Update Posted (Actual)
March 2, 2022
Last Update Submitted That Met QC Criteria
February 7, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H00015574
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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