Telmisartan Pilot Study on Treatment Resistant Schizophrenia

Sponsor
Xiaoduo Fan (Other)
Overall Status
Terminated
CT.gov ID
NCT03868839
Collaborator
(none)
6
1
1
20.2
0.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Telmisartan Pill
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
6 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
An Open-label Feasibility Trial of Adjunctive Telmisartan in Patients With Treatment Resistant Schizophrenia
Actual Study Start Date :
Feb 1, 2019
Actual Primary Completion Date :
Oct 7, 2020
Actual Study Completion Date :
Oct 7, 2020

Arms and Interventions

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.

Drug: Telmisartan Pill
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:
  • Micardis
  • Outcome Measures

    Primary Outcome Measures

    1. Changes in Blood Levels of Tumor Necrosis Factor Alpha [Baseline (week 0) to 4 weeks after initial dose]

      Levels at week 4 minus levels at baseline

    2. Changes in Blood Levels of Glutathione [Baseline (week 0) to 4 weeks after initial dose]

      Levels at week 4 minus levels at baseline

    3. Changes in Blood Levels of Interleukin-6 [Baseline (week 0) to 4 weeks after initial dose]

      Levels at week 4 minus levels at baseline

    4. Changes in Blood Levels of High Sensitivity C-Reactive Protein [Baseline (week 0) to 4 weeks after initial dose]

      Levels at week 4 minus levels at baseline

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UMass Psychotic Disorders Research Program Worcester Massachusetts United States 01610

    Sponsors and Collaborators

    • Xiaoduo Fan

    Investigators

    • Principal Investigator: Xiaoduo Fan, MD, MPH, University of Massachusetts, Worcester

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Xiaoduo Fan, Associate Professor, University of Massachusetts, Worcester
    ClinicalTrials.gov Identifier:
    NCT03868839
    Other Study ID Numbers:
    • H00015574
    First Posted:
    Mar 11, 2019
    Last Update Posted:
    Mar 2, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Telmisartan Pill
    Arm/Group Description 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. Telmisartan Pill: 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.
    Period Title: Overall Study
    STARTED 6
    COMPLETED 5
    NOT COMPLETED 1

    Baseline Characteristics

    Arm/Group Title Telmisartan Pill
    Arm/Group Description 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. Telmisartan Pill: 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.
    Overall Participants 6
    Age (Count of Participants)
    <=18 years
    0
    0%
    Between 18 and 65 years
    6
    100%
    >=65 years
    0
    0%
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    33.67
    (11.27)
    Sex: Female, Male (Count of Participants)
    Female
    0
    0%
    Male
    6
    100%
    Race/Ethnicity, Customized (Count of Participants)
    White
    4
    66.7%
    Black
    1
    16.7%
    Two or more races
    1
    16.7%
    Region of Enrollment (participants) [Number]
    United States
    6
    100%

    Outcome Measures

    1. Primary Outcome
    Title Changes in Blood Levels of Tumor Necrosis Factor Alpha
    Description Levels at week 4 minus levels at baseline
    Time Frame Baseline (week 0) to 4 weeks after initial dose

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Telmisartan Pill
    Arm/Group Description 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. Telmisartan Pill: 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.
    Measure Participants 5
    Mean (Standard Deviation) [pg/mL]
    1.10
    (0.2377)
    2. Primary Outcome
    Title Changes in Blood Levels of Glutathione
    Description Levels at week 4 minus levels at baseline
    Time Frame Baseline (week 0) to 4 weeks after initial dose

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Telmisartan Pill
    Arm/Group Description 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. Telmisartan Pill: 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.
    Measure Participants 5
    Mean (Standard Deviation) [uM]
    537.00
    (196.404)
    3. Primary Outcome
    Title Changes in Blood Levels of Interleukin-6
    Description Levels at week 4 minus levels at baseline
    Time Frame Baseline (week 0) to 4 weeks after initial dose

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Telmisartan Pill
    Arm/Group Description 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. Telmisartan Pill: 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.
    Measure Participants 5
    Mean (Standard Deviation) [pg/mL]
    4.61
    (3.4472)
    4. Primary Outcome
    Title Changes in Blood Levels of High Sensitivity C-Reactive Protein
    Description Levels at week 4 minus levels at baseline
    Time Frame Baseline (week 0) to 4 weeks after initial dose

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Telmisartan Pill
    Arm/Group Description 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. Telmisartan Pill: 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.
    Measure Participants 5
    Mean (Standard Deviation) [mg/L]
    2.34
    (1.9642)

    Adverse Events

    Time Frame 4 weeks
    Adverse Event Reporting Description
    Arm/Group Title Telmisartan Pill
    Arm/Group Description 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. Telmisartan Pill: 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.
    All Cause Mortality
    Telmisartan Pill
    Affected / at Risk (%) # Events
    Total 0/6 (0%)
    Serious Adverse Events
    Telmisartan Pill
    Affected / at Risk (%) # Events
    Total 0/6 (0%)
    Other (Not Including Serious) Adverse Events
    Telmisartan Pill
    Affected / at Risk (%) # Events
    Total 1/6 (16.7%)
    Eye disorders
    Blurred vision 1/6 (16.7%) 1

    Limitations/Caveats

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

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Xiaoduo Fan
    Organization University of Massachusetts Medical School
    Phone 5088563881
    Email xiaoduo.fan@umassmed.edu
    Responsible Party:
    Xiaoduo Fan, Associate Professor, University of Massachusetts, Worcester
    ClinicalTrials.gov Identifier:
    NCT03868839
    Other Study ID Numbers:
    • H00015574
    First Posted:
    Mar 11, 2019
    Last Update Posted:
    Mar 2, 2022
    Last Verified:
    Feb 1, 2022