Telmisartan Pilot Study on Treatment Resistant Schizophrenia

NCT03868839 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: H00015574
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Schizophrenia; Schizo Affective Disorder; Treatment-resistant Schizophrenia

Outcome Measures

Primary Outcomes (4)

• Changes in Blood Levels of Tumor Necrosis Factor Alpha

  Levels at week 4 minus levels at baseline

  Baseline (week 0) to 4 weeks after initial dose

• Changes in Blood Levels of Glutathione

  Levels at week 4 minus levels at baseline

  Baseline (week 0) to 4 weeks after initial dose

• Changes in Blood Levels of Interleukin-6

  Levels at week 4 minus levels at baseline

  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

  Baseline (week 0) to 4 weeks after initial dose

Study Arms (1)

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.

Drug: Telmisartan Pill

Interventions

Telmisartan Pill DRUG

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.

Also known as: Micardis

Telmisartan Pill

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xiaoduo Fan: lead

Study Sites (1)

UMass Psychotic Disorders Research Program

Worcester, Massachusetts, 01610, United States

Location

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders; Schizophrenia, Treatment-Resistant

Interventions

Telmisartan

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

The overall limitations and caveat is that this study is a pilot study with small sample size (6 subjects).

Results Point of Contact

• Title: Xiaoduo Fan
• Organization: University of Massachusetts Medical School

xiaoduo.fan@umassmed.edu

5088563881

Study Officials

• Xiaoduo Fan, MD, MPH

  University of Massachusetts, Worcester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 6, 2019
• First Posted: March 11, 2019
• Study Start: February 1, 2019
• Primary Completion: October 7, 2020
• Study Completion: October 7, 2020
• Last Updated: March 2, 2022
• Results First Posted: March 2, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)