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Telmisartan Pilot Study on Treatment Resistant Schizophrenia | Clinical Trials | Clareo Health

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Telmisartan Pilot Study on Treatment Resistant Schizophrenia

An Open-label Feasibility Trial of Adjunctive Telmisartan in Patients With Treatment Resistant Schizophrenia

NCT03868839•Xiaoduo Fan

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. The Investigators hypothesize that 4 weeks of telmisartan at 80mg daily will alter blood biomarkers for inflammation and oxidative stress after 4 weeks treatment.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

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.
+5 more criteria

Locations (1)

UMass Psychotic Disorders Research Program

Worcester, Massachusetts, United States

Key Dates

Start Date

February 1, 2019

Primary Completion Date

October 7, 2020

Completion Date

October 7, 2020

Last Updated

March 2, 2022

Enrollment

ACTUAL participants

Conditions

SchizophreniaSchizo Affective DisorderTreatment-resistant Schizophrenia

Interventions

Telmisartan Pill

DRUG

Feasibility, Acceptability, and Preliminary Efficacy of Yoga-based Group Intervention for Outpatients With Schizophrenia Spectrum Disorders

NCT07455929

Psychotic DisordersSchizophrenia Spectrum Disorders

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RECRUITING

Biomarkers/Biotypes, Course of Early Psychosis and Specialty Services

NCT06740383

Schizophrenia Spectrum and Other Psychotic DisordersSchizophrenia+5 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 2, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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Telmisartan Pilot Study on Treatment Resistant Schizophrenia

Inclusion Criteria

Exclusion Criteria

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